더바이오 - ENGLISH NEWS

LAMEDITECH’s professional-grade multifunctional laser skin device ‘PURAXEL MX’ secures CE LVD certification in Europe

jyj@thebionews.net (Ji, Yong Jun) — Fri, 04 Jul 2025 17:12:25 +0900

Source: LAMEDITECH [by Ji, Yong Jun] LAMEDITECH, a company specializing in laser-based healthcare solutions, announced on July 3 that its professional-grade multifunctional laser skincare device, ‘PURAXEL MX (FX-7000)’, has received official certification under the European CE LVD (Low Voltage Directive). The CE LVD certification is a mandatory safety certification for electrical and electronic products in the European Union (EU). With this certification, PURAXEL MX has cleared a key technological hurdle for entry into the European market, and distribution partners in Europe, with whom contracts have already been signed, are preparing for a full-scale market launch, focusing on the UK, Poland, and the Benelux region. PURAXEL MX obtained medical device certification in Vietnam in April and is currently undergoing the Nationally Recognized Testing Laboratory (NRTL) certification process to facilitate its entry into the North American market. In addition, certification procedures for other global markets are being carried out sequentially as part of the company’s international expansion. LAMEDITECH’s personal home-use beauty device, ‘PURAXEL MEin (FX-2000)’, is also actively undergoing multiple international certification processes, including the CE LVD and U.S. NRTL. PURAXEL MEin is a home-use beauty platform utilizing high-power laser technology. LAMEDITECH is targeting the Korean and international B2B markets, such as aesthetic clinics, oriental medicine clinics, and hair loss treatment centers, through its professional ‘PURAXEL’ series (PURAXEL, PURAXEL MX). Concurrently, the company is expanding into the B2C home care sector with its personal-use ‘PURAXEL ME’ and ‘PURAXEL MEin’ product lines. The company anticipates that exports to overseas regions, including North America, will accelerate in earnest beginning in the second half of this year, as global certifications, including the CE mark, are obtained sequentially. “Leveraging the global competitiveness of the PURAXEL series, we aim to establish a strong foothold in the medical and beauty device industry,” a LAMEDITECH official said.

ENCell secures KRW 5.7 billion custom 'AAV gene therapy' CDMO deal, marking 80% sales growth year-on-year

jyj@thebionews.net (Ji, Yong Jun) — Fri, 04 Jul 2025 16:53:13 +0900

Source: ENCell [by Ji, Yong Jun] ENCell, a contract development and manufacturing organization (CDMO) specializing in advanced biopharmaceuticals and novel drug development, announced on July 3 the signing of a CDMO agreement valued at around KRW 5.7 billion (approximately USD 4.1 million) with the Gene Cell Therapy Strategy Research Group of the Korea Research Institute of Bioscience & Biotechnology (KRIBB). This agreement represents the largest single order contract in the company’s history, accounting for nearly 80% of ENCell’s total sales of KRW 7.2 billion in 2024. The contract will remain in effect until May 31, 2029. Under the agreement, ENCell will collaborate with KRIBB to establish a clinical production platform for the development and production of customized adeno-associated virus (AAV) gene therapies. AAV is widely used in in vivo gene therapy development owing to its low immunogenicity and favorable safety profile, as it does not integrate into the patient’s genome. According to the 'Global Gene Therapy Market Status and Outlook' report released by the Korea Biotechnology Industry Organization (KoreaBio) in May, the global gene therapy market is projected to expand from approximately USD 7.2 billion (around KRW 10 trillion) in 2023 to approximately USD 36.6 billion by 2032, reflecting an average annual growth rate of 19.4% over the next nine years. ENCell is the only company in Korea equipped with a global-level GMP facility capable of simultaneously producing cells and viruses. The company states that it offers optimal CDMO solutions to customers through one-stop services and differentiated production and quality management systems. Leveraging this contract as an opportunity, ENCell plans to strengthen its marketing efforts to secure additional CDMO orders in the AAV sector and is committed to making every effort to build a customer-oriented platform and delivering satisfactory outcomes. Through its collaboration with ENCell, the KRIBB aims to establish a clinical production platform for the development of customized AAV gene therapies, positioning this technology as a potential next-generation growth driver for the country. This initiative also seeks to lay the groundwork for the domestic introduction of AAV therapies developed using original Korean technology. “ENCell holds the number one position in sales and market share in the Korean cell and gene therapy (CGT) CDMO sector, and based on our unmatched performance record, we have successfully secured the contract to establish a platform for the development of customized AAV gene therapies,” said Chang Jong-wook, CEO of ENCell. “In collaboration with the KRIBB, we aim to advance the introduction of AAV-based therapies gaining global attention and to deliver results of international caliber through our outstanding technological capabilities.” Conversely, ENCell is broadening its partnerships with Korean and international advanced pharmaceutical developers, having signed a CMO agreement with a major global pharmaceutical company in December of last year, following previous collaborations with Novartis and Janssen.

Celltrion's 'Darzalex biosimilar' receives Phase 3 IND approval in Korea after U.S. clearance

suin@thebionews.net (Yu, Suin) — Fri, 04 Jul 2025 16:50:15 +0900

Panoramic view of Celltrion's Plant 2 (Source: Celltrion) [by Yu, Suin] Celltrion announced on July 3 that its multiple myeloma treatment 'Darzalex' biosimilar 'CT-P44' received approval for a Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety. The approval comes three and a half months after the IND application was submitted on March 20. In this clinical trial, Celltrion plans to evaluate and compare the efficacy and safety of Darzalex and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma. The original drug, Darzalex, is a targeted anticancer drug that binds to a specific protein expressed on the surface of multiple myeloma cells, thereby inhibiting cancer cell growth. As of 2023, global sales of Darzalex reached approximately USD 9.744 billion. CT-P44 also received approval for a Phase 3 clinical trial IND from the U.S. Food and Drug Administration (FDA) in 2024. Celltrion aims to accelerate clinical procedures in other major global countries as well. Conversely, through the clinical development of CT-P44, Celltrion has expanded its anticancer drug portfolio by introducing a new targeted anticancer drug pipeline. The company plans to actively strengthen its portfolio of anticancer antibody therapies, including immuno-oncology agents and novel antibody-drug conjugates (ADCs), in the future.

Jeong Bo-young appointed head of business development at Preclina to drive expansion as an anticancer CRO

zenith@thebionews.net (Kang, In Hyo) — Thu, 03 Jul 2025 16:36:08 +0900

Jeong Bo-young, CEO of Design by J, newly appointed Head of Business Development at Preclina, a clinical trial contract research organization (CRO) specializing in preclinical trials for immune diseases, poses after an interview with THE BIO. (Photo: Reporter Kang In Hyo) [by Kang, In Hyo] Jeong Bo-young, CEO of Design by J, has been appointed Head of Business Development at Preclina, a clinical trial contract research organization (CRO) specializing in preclinical trials for immune diseases. This move follows the memorandum of understanding (MOU) signed in late 2024 between Preclina and Design by J, a consulting firm focused on non-clinical business strategy and development, which marked the beginning of Preclina’s full-scale domestic and international business expansion. With Jeong’s appointment as a key executive, Preclina aims to strengthen its in-house business development capacity and accelerate its entry into the global market. In a recent interview with , Jeong Bo-young, newly appointed Head of Business Development at Preclina, stated, “I officially joined Preclina on July 1,” adding, “As the CEO of Design by J, I have been collaborating with the company in an advisory role over the past six months and developed strong rapport with the internal team.” “Preclina CEO Kang Young-mo and I have formed a complementary partnership in terms of roles and expertise, and we believe this will generate meaningful synergy,” she further remarked. “To drive market growth, we recognized that organic collaboration with a trustworthy partner is essential, as there are inherent limitations to what we can achieve individually.” The newly appointed executive, Jeong Bo-yeong, holds a Ph.D. in bioengineering from the National University Corporation Shizuoka University in Japan and an additional doctorate degree from Braunschweig University of Technology in Germany. Her career began as a researcher at the Korea Research Institute of Bioscience & Biotechnology (KRIBB), followed by a position as a senior researcher at the Korea Research Institute of Chemical Technology (KRICT). She has since held various leadership roles, including Head of the Technology Sales Team at Clinomics, Head of the Technology Sales Group at Cytogen, Head of the Business Division at Humic, and Head of Business Development at WOOJUNGBIO. “My career began in the R&D field before transitioning to technology sales, during which I have held a wide range of roles, from frontline operations to executive management,” Jeong stated. “Drawing on both domestic and international business experience, I have developed and implemented short-, mid-, and long-term strategies aimed at converting CRO operations into tangible sales and profits.” Commenting on the recent appointment, Jeong expressed, “Preclina’s overall CRO business structure, technological foundation, and internal team align well with my vision, and I believe there is potential to pursue a strategy that not only drives revenue growth but also positions the company for a future KOSDAQ listing.” She added, “While I will concurrently oversee business development, my primary focus will be on advancing Preclina’s CRO operations.” “The non-clinical market has grown increasingly competitive in recent times, with a rise in the number of available assets driven by the economic downturn. With heightened competition among major players anticipated in the second half of the year, this presents an opportune moment for Preclina, already having secured investment, to advance to the next stage,” Jeong emphasized. “As the external environment surrounding the CRO industry continues to evolve, Preclina is poised to play a central and substantial role in driving business expansion.” Preclina is a CRO specializing in preclinical studies targeting immune and inflammatory diseases, including rheumatoid arthritis and lupus. The company possesses extensive experience and a high level of expertise in efficacy evaluation through cell-based bioassays and disease-specific animal models. Recently, Preclina has advanced its capabilities by developing a ‘humanized mouse’ model that replicates the human immune system, thereby expanding its services to function as a platform for biopharmaceutical validation. Leveraging this foundation, Preclina continues to solidify its role as a key partner in the development of innovative biotherapeutic agents. “Preclina is the only CRO in Korea dedicated exclusively to preclinical trials for autoimmune diseases, and its competitive edge lies in the fact that the company was founded by a practicing rheumatologist,” Jeong explained. “By leveraging data accumulated from real-world clinical trials, we have built a lineup of disease models applicable to the non-clinical stage. This specialized expertise has enabled us to secure consistent demand both in Korea and in global markets.” Preclina has steadily built a diverse portfolio of disease models, most notably including interstitial pulmonary fibrosis (IPF), with a primary focus on autoimmune diseases. In response to evolving market demands, the company has recently broadened its capabilities to include a humanized mouse platform to support the development of ‘immunotherapies.’ “We have already completed the first client order and are currently conducting experimental studies. We are also actively working to expand our oncology pipeline to meet the growing demand for combination therapies of immunotherapy and antibody-drug conjugates (ADCs),” Jeong highlighted. According to Jeong, Preclina is not merely a conventional CRO but a specialized partner supporting the entire drug development cycle, from early-stage anticancer drug testing to the pre-IND submission phase, leveraging its expertise in autoimmune disease models and immunotherapies. “We have established a strong network with research managers from various development companies and possess extensive experience in collaborating with global clients,” she emphasized. “This foundation enables us to accurately identify and address the technical requirements and expectations of our partners, an area where I bring distinct strength.” Jeong believes that ‘who leads the work’ is an important factor in Preclina’s ability to establish a differentiated position in the preclinical CRO market. At the core of the company’s experimental operations is its founder and CEO, Dr. Kang Young-mo, a practicing rheumatologist who continues to provide outpatient care twice a week at Kyungpook National University Hospital. Jeong noted that it is highly uncommon among Korean non-clinical CROs for a currently practicing physician to directly oversee experimental research. “CEO Kang is personally involved in the entire experimental process, including the drafting and revision of result reports, which greatly increases the medical reliability and overall quality of the research,” Jeong said. “Thanks to this, Preclina has earned strong market trust, securing repeat orders from major Korean and international pharmaceutical companies specializing in autoimmune diseases,” she added. Preclina is strengthening its capabilities to manage complex projects, extending beyond high-difficulty immune disease studies to include anticancer drug development. In particular, with the growing demand anticipated for ‘turnkey (batch execution)’ projects, where a single developer entrusts a range of experimental tasks to be executed in an integrated manner, Jeong is leading the planning of new service offerings tailored to each development stage and preemptively formulating strategic responses. “The CRO industry is poised to grow even bigger in the future. As internal development teams become more specialized and labor costs continue to rise, the number of active pipelines in Korea is also increasing,” Jeong asserted. “From the perspective of developers, it is becoming increasingly impractical to conduct animal testing in-house. Instead, they are compelled to concentrate on material development and rely on specialized CROs. Accordingly, the demand for outsourcing is expected to grow steadily.” Jeong cited Preclina’s advanced expertise in the autoimmune disease field as a key factor differentiating the company’s competitive advantage in the CRO market. “Autoimmune disease models are inherently challenging to design and execute, and the ability to conduct such experiments with stability alone gives Preclina a competitive edge in the market,” she noted. “Leveraging this specialized know-how, Preclina is now expanding its business into a more scalable oncology sector.” In fact, Preclina is reinforcing its portfolio as a non-clinical CRO by initiating the development of oncology models grounded in its accumulated expertise with autoimmune disease experiments. As part of these efforts, the company is advancing the development of its core platform for innovative immuno-oncology drug research, the ‘immune cell fractionation-enhanced humanized CDX/PDX platform.’ “Our objective is to position Preclina as a high-end (highest quality) CRO brand that prioritizes high added value, rather than functioning merely as a basic experimental service provider,” Jeong emphasized. “Based on our technological prowess and specialized expertise, we aim to establish ourselves as a ‘premium CRO’ distinctly set apart from conventional CROs.” Jeong Bo-young (center right), newly appointed Head of Business Development at Preclina, poses for a commemorative photo with CEO Kang Myeong-mo (center left) and company staff. (Source: Preclina)

Vaxcellbio secures domestic patent for high-purity, high-cytotoxicity NK cell proliferation core technology

suin@thebionews.net (Yu, Suin) — Thu, 03 Jul 2025 10:02:52 +0900

source : Vaxcellbio [by Yu, Suin] Vaxcellbio announced on July 1 that it has completed patent registration in Korea for its core proprietary technology, ‘Composition for Proliferation of Natural Killer Cells Including Feeder Cells.’ This patent represents an advanced technology that enables the mass production of high-purity, high-cytotoxicity natural killer (NK) cells using ‘Feeder Cells’ independently developed by Vaxcellbio. Vaxcellbio completed patent registration for this technology in Japan in April and is currently pursuing registration in the United States, Europe, China, Canada, Australia, and Hong Kong. Given that Japan is known for applying particularly stringent evaluation standards to foreign biotechnology patents, the company stated that securing registration in both Korea and Japan serves as strong validation of the technology’s originality and technical completeness. This technology is distinguished by its superior amplification rate and cell purity compared to conventional feeder cell-based methods, significantly increasing the production efficiency of NK cell therapies. Leveraging this technology, Vaxcellbio successfully completed a Phase 2a clinical trial for ‘VCB-1102 (development code),’ an NK cell therapy candidate targeting hepatocellular carcinoma. “As evidenced by the successful patent registrations in both Korea and Japan, the originality and competitiveness of our NK cell therapy production technology have been recognized on the global stage,” said Lee Je-jung, CEO of Vaxcellbio. “Building on this foundation, we aim not only to reinforce the commercialization potential of NK cell therapies but also to broaden the scope of our cell therapy platform to include next-generation pipelines such as bone marrow infiltrating lymphocytes and dual-target chimeric antigen receptors (CARs), thereby further strengthening our competitiveness in the global market.” Conversely, Vaxcellbio has recently expanded its intellectual property (IP) portfolio by securing a series of patents related to its CAR pipeline. These include patents for a ‘monobody-based chimeric antigen receptor’ and a ‘novel method for manufacturing natural killer cells, as well as a liver cancer treatment method using the same.’ Moreover, the recent selection of CAR-MIL (chimeric antigen receptor myeloinfiltrating lymphocyte) therapy for multiple myeloma and dual-targeting chimeric antigen receptor T cell (CAR-T) therapy for solid tumors as national projects has drawn significant attention to the company’s capabilities in developing and commercializing next-generation therapeutic pipelines.

정보영 프리클리나 신임 사업개발 총괄 “항암 CRO로 사업 확장 박차”

zenith@thebionews.net (강인효 기자) — Thu, 03 Jul 2025 07:30:00 +0900

정보영 디자인바이제이 대표가 면역질환 전임상시험 전문 임상시험수탁기관(CRO)인 프리클리나에 사업개발 총괄로 합류했다. 정 프리클리나 신임 사업개발 총괄이 더바이오와 인터뷰를 마친 뒤 포즈를 취하고 있다. (사진 : 강인효 기자) [더바이오 강인효 기자] 정보영 디자인바이제이 대표가 면역질환 전임상시험 전문 임상시험수탁기관(CRO)인 프리클리나에 사업개발 총괄로 합류했다. 앞서 프리클리나는 지난해 말 비임상 사업전략 및 사업개발 컨설팅 회사인 디자인바이제이와 상호 협력을 위한 업무협약(MOU)을 체결하고, 국내외 사업 확장을 본격화한 바 있다. 프리클리나는 이번에 정 대표를 주요 경영진으로 영입하면서 사업개발 역량을 내부에 본격적으로 구축하고 글로벌 시장 공략에 박차를 가할 방침이다. 정보영 프리클리나 신임 사업개발 총괄은 최근 <더바이오>와 가진 인터뷰에서 “7월 1일부로 프리클리나에 공식 합류하게 됐다”며 “디자인바이제이 대표로서 지난 반년간 자문 형태로 협력해왔고, 내부 인력들과의 호흡이 특히 잘 맞았다”고 밝혔다. 이어 “강영모 프리클리나 대표와는 역할과 역량 면에서 상호 보완적인 파트너십을 형성해왔고, 이를 통해 시너지를 기대할 수 있다고 판단했다”며 “시장 성장을 위해서는 혼자만의 힘으로는 한계가 있는 만큼, 신뢰할 수 있는 팀과의 유기적인 협업이 무엇보다 중요하다고 느꼈다”고 덧붙였다. 정보영 신임 총괄은 일본 국립시즈오카대에서 생물공학 박사를, 독일 브라운슈바익 공과대학에서 박사 학위를 각각 취득했다. 한국생명공학연구원에서 연구원을 지낸 뒤 한국화학연구원에서 선임연구원으로 활동했다. 이후 클리노믹스 기술영업팀장, 싸이토젠 기술영업그룹장, 휴믹 사업총괄대표, 우정바이오 사업개발본부장 등을 지냈다. 정 신임 총괄은 “원래 연구개발(R&D) 분야에서 출발해 기술영업으로 전환했고, 실무부터 총괄 임원까지 다양한 직책을 맡아왔다”며 “국내외 사업 경험을 바탕으로 단기·중기·장기 플랜을 수립해 CRO 사업을 매출화하고 흑자로 전환한 경험이 있다”고 말했다. 정 신임 총괄은 이번 합류에 대해 “프리클리나는 CRO 전체 사업 구조와 기술력, 내부 팀과의 결이 잘 맞았고, 매출 신장과 향후 코스닥 시장 상장까지도 함께 바라볼 수 있는 플랜이 가능하다고 판단했다”며 “겸직 형태로 사업개발 총괄을 맡게 됐지만, CRO 비즈니스는 프리클리나에 집중할 계획”이라고 밝혔다. 그는 “최근 비임상 시장은 경쟁이 치열해지고 있고, 경기 위축으로 인해 매물도 늘고 있다”며 “하반기로 갈수록 대형 업체 중심의 치열한 경쟁이 본격화될 것으로 예상되는 만큼, 이미 투자를 유치한 프리클리나에는 오히려 도약할 수 있는 적기”라고 강조했다. 이어 “CRO 사업을 둘러싼 외부 환경이 변화하는 시점에서 프리클리나가 중심이 돼 비즈니스를 확장해 나가는데 실질적인 역할을 하겠다”고 덧붙였다. 프리클리나는 류머티즘 관절염, 루푸스 등 면역질환 및 염증질환에 특화된 전임상시험 전문 CRO로 자리매김하고 있다. 세포 기반 바이오에세이와 질환 동물모델을 활용한 효능 평가 연구에서 풍부한 경험과 높은 전문성을 보유하고 있다. 최근에는 인간 면역체계를 모사한 ‘인간화 마우스’를 개발해 바이오의약품의 유효성 검증 플랫폼으로 영역을 확장했다. 이를 바탕으로 프리클리나는 혁신적인 바이오 치료제 개발을 지원하는 핵심 파트너로서의 입지를 더욱 강화하고 있다. 정 총괄은 “프리클리나는 국내 유일의 자가면역질환 특화 전임상시험 전문 CRO로, 창업자가 류마티스내과 전문의 출신이라는 점에서 차별화된 경쟁력을 갖추고 있다”며 “실제 임상에서 축적한 데이터를 기반으로 비임상 단계에서 활용이 가능한 질환 모델 라인업을 구축했으며, 이러한 특화된 전문성 덕분에 국내외에서 꾸준한 수요를 확보하고 있다”고 설명했다. 프리클리나는 자가면역질환 분야를 중심으로 폐섬유화(IPF)를 포함한 다양한 모델을 안정적으로 확보하고 있으며, 최근 시장 확대에 발맞춰 ‘면역항암제’ 개발을 위한 인간화 마우스 플랫폼까지 영역을 확장했다, 정 총괄은 “이미 첫 고객 수주를 완료해 실험을 진행 중이며, 면역항암제와 항체약물접합체(ADC) 병용요법의 수요 증가에 대응하기 위한 항암 라인 확장도 추진하고 있다”고 강조했다. 프리클리나는 단순한 CRO를 넘어, 자가면역질환에서 면역항암제로 이어지는 전문 시험 역량을 기반으로 고객사의 초기 항암물질 실험부터 임상시험계획(IND) 제출 전 단계까지 전 주기를 지원할 수 있는 역량을 갖추고 있다는 게 정 총괄의 설명이다. 그는 “다양한 개발사의 연구 총괄 책임자들과 긴밀한 네트워크를 형성해왔고, 글로벌 고객사들과도 폭넓은 협업 경험이 있다”며 “이를 바탕으로 고객사들의 기술적 수요와 니즈를 보다 정확하게 파악하고 대응할 수 있다는 점이 나만의 차별화된 강점”이라고 강조했다. 프리클리나가 전임상 CRO 시장에서 차별화된 입지를 다지는 데에는 ‘누가 총괄 지휘하느냐’가 중요한 요인으로 작용하고 있다는 게 정 총괄의 생각이다. 프리클리나의 핵심 실험을 이끄는 총괄 연구 책임자는 창업자인 강영모 대표로, 현재도 경북대병원에서 주 2회 외래 진료를 병행 중인 현직 류마티스내과 전문의다. 국내 비임상 CRO 가운데 현직 의사가 실험을 총괄하는 사례는 이례적이라는 게 정 총괄의 설명이다. 정 총괄은 “강 대표는 전체 실험 과정을 직접 진행하고, 결과 보고서 작성 및 수정까지 전 과정을 책임지고 있어 의학적 신뢰도와 완성도를 크게 높이고 있다”며 “덕분에 프리클리나는 자가면역질환 분야에서 국내외 대형 제약사로부터 반복 수주가 이어지는 등 시장 신뢰를 확보하고 있다”고 말했다. 프리클리나는 고난도 면역질환 실험을 넘어 더욱 항암제 등 복합적인 프로젝트에 대응할 수 있는 역량을 강화하고 있다. 특히 하나의 개발사로부터 다양한 실험 과제를 일괄 수주해 수행하는 ‘턴키(일괄 수행)’ 형태의 수요가 늘어날 것으로 예상되면서 정 총괄은 단계별 실험에 접목할 수 있는 신규 아이템을 기획하고 선제적으로 대응 전략을 마련하는 역할을 맡는다. 정 총괄은 “CRO 사업은 앞으로 더욱 커질 수밖에 없다”고 단언했다. 그는 “내부 개발 인력이 고급화되고 인건비도 상승하는 가운데, 국내에서 진행 중인 파이프라인 자체도 많아지고 있다”며 “개발사 입장에서는 동물실험까지 직접 수행하기보다는 물질 개발에 집중하고, 전문화된 CRO를 활용할 수밖에 없다”고 말했다. 이어 “아웃소싱 수요는 앞으로도 더욱 커질 것”이라고 덧붙였다. 정 총괄은 프리클리나의 차별화된 경쟁력으로 자가면역질환 분야에 대한 높은 전문성을 꼽았다. 그는 “자가면역질환 모델은 실험 설계와 구축이 까다롭기 때문에 이를 안정적으로 수행할 수 있다는 것만으로도 시장에서 강점을 갖는다”며 “이러한 노하우를 바탕으로 프리클리나는 보다 확장성이 큰 항암 분야로도 사업 영역을 넓혀가고 있다”고 설명했다. 실제로 프리클리나는 자가면역질환 모델에서 축적한 실험 경험을 기반으로 항암 모델 구축에 착수하며, 비임상 CRO로서의 포트폴리오를 강화하고 있다. 회사는 혁신 면역항암제 개발 코어 플랫폼인 ‘면역세포 분획-강화 인간화 CDX/PDX 플랫폼’을 개발하고 있다. 정 총괄은 “프리클리나를 단순한 실험 대행을 넘어, 고부가가치 중심의 기술적 하이엔드(High-end, 최고 품질) CRO로 브랜딩하는 것이 목표”라며 “기술력과 전문성을 바탕으로 일반적인 CRO와는 다른 ‘프리미엄 CRO’로 자리매김할 수 있도록 하겠다”고 강조했다. 정보영(사진 가운데 오른쪽) 프리클리나 신임 사업개발 총괄이 강명모(사진 가운데 왼쪽) 대표와 임직원들과 함께 기념 촬영을 하고 있다. (출처 : 프리클리나)

LigaChem Biosciences CEO Kim Yong-zu: “20 ADC candidates to advance into clinical trials by 2027”

jyj@thebionews.net (Ji, Yong Jun) — Wed, 02 Jul 2025 13:31:42 +0900

Kim Yong-zu, CEO of LigaChem Biosciences, delivers a speech at the LigaChemBio Global R&D DAY 2025 held on July 1. (Photo: Reporter Ji Yong Jun) [by Ji, Yong Jun] “We aim to advance a total of 20 antibody-drug conjugate (ADC) assets into clinical trials by 2027.” Kim Yong-zu, CEO of LigaChem Biosciences (hereinafter referred to as LCB), made this announcement during the ‘LigaChemBio Global R&D DAY 2025’ held on July 1 in Yeouido, Seoul. “We currently have five ADC assets in clinical trials,” he further commented. “We are aggressively expanding our pipeline to ensure that an additional 15 ADC candidates enter clinical trials by 2027.” Building upon its existing portfolio of ADCs utilizing small molecule compounds, LCB plans to advance the development of next-generation modalities, including ‘dual antibody ADCs,’ ‘immunomodulatory antibody conjugates (AICs),’ and ‘dual payload ADCs.’ The company also intends to explore the therapeutic potential of ‘peptide drug conjugates (PDCs).’ “Several of the ADC candidates currently under development incorporate a significant portion of novel targets,” Kim noted. LCB is also actively pursuing the development of novel payloads, with the objective of addressing resistance issues associated with currently used payloads in ADCs. At present, ADC payloads are broadly categorized into two groups: those with high cytotoxicity, such as the ‘MMAE,’ ‘DM1,’ and ‘PBD’ series, and those with relatively low toxicity, such as the ‘Topo1’ series. LCB introduced a series of new payload candidates, including TOPOi (non-camptothecins), immuno-oncology STING agonists (I-O STING), TLR7/8 agonists, novel payloads, and targeted protein degraders (TPD). “Identifying new payloads is a difficult task, but it is absolutely necessary,” Kim stated. “We intend to develop new payloads through open innovation in collaboration with external partners, rather than relying solely on internal development,” he added.

AbClon reports interim results of ‘Nespe-cel’ CAR-T Phase 2 clinical trial with 94% ORR and 68% CRR

sjj@thebionews.net (Sung, Jae Jun) — Wed, 02 Jul 2025 12:04:41 +0900

Source: AbClon [by Sung, Jae Jun] AbClon announced on July 1 that it had received interim top-line results from the Phase 2 clinical trial of ‘Nespe-cel (development code: AT101),’ a next-generation anti-CD19 chimeric antigen receptor T cell (CAR-T) treatment candidate, as evaluated by an Independent Data Monitoring Committee (IDMC). This marks the first official assessment that proves Nespe-cel’s independent anticancer efficacy and is viewed as a potential turning point for the company’s entry into the global CAR-T treatment market. According to AbClon, the interim analysis of the Phase 2 clinical trial of Nespe-cel demonstrated an objective response rate (ORR) of 94% and a complete remission rate (CRR) of 68%. These results exceed the efficacy levels reported for existing global CAR-T therapies such as ‘Kymriah’ and ‘Yescarta.’ The credibility of the data was further reinforced by independent imaging assessments, which were consistent with the researchers’ evaluations. The IDMC concluded that Nespe-cel achieved statistical significance and demonstrated “very excellent efficacy” based on a comprehensive assessment of tumor response and safety. Furthermore, major adverse events, including cytokine release syndrome (CRS) and neurotoxicity, were observed within the expected parameters and were deemed manageable. Based on the favorable evaluation, AbClon plans to submit an application to the Ministry of Food and Drug Safety for designation of Nespe-cel as a fast-track treatment candidate, aiming to obtain early approval through the advanced biopharmaceutical fast-track review process. Concurrently, the company intends to continue its Phase 2 clinical trial to collect long-term survival data. Nespe-cel was developed using AbClon’s proprietary antibody platform, ‘NEST’ technology. Characterized by a differentiated mechanism of action and excellent pharmacokinetic properties, Nespe-cel demonstrated a clear therapeutic correlation with blood cancers. These findings were published in the international peer-reviewed academic journal ‘Molecular Cancer,’ garnering significant attention. “With the interim results, Nespe-cel has reached a turning point, positioning itself as a globally competitive candidate among CAR-T treatments developed in Korea,” an AbClon official said.

ABL Bio reports 18% ORR for dual antibody ‘ABL111’ targeting Claudin18.2 and 4-1BB in esophageal cancer

zenith@thebionews.net (Kang, In Hyo) — Wed, 02 Jul 2025 11:46:19 +0900

Source: ABL Bio [by Kang, In Hyo] ABL Bio, a company specializing in dual antibody therapeutics, announced on July 2 that its partner company I-Mab has published clinical data on the monotherapy of ‘ABL111 (givastomic),’ a bispecific antibody targeting Claudin18.2 and 4-1BB, in the international academic journal Clinical Cancer Research (CCR). CCR is a leading peer-reviewed journal in the field of clinical oncology, published by the American Association for Cancer Research (AACR). The recently published article presents encouraging efficacy and safety data from a Phase 1 clinical trial of ABL111 monotherapy in patients with Claudin18.2-positive gastric cancer. The Phase 1 clinical data for ABL111 monotherapy had previously been presented in poster format at the European Society for Medical Oncology (ESMO) annual meetings in 2023 and 2024. The clinical trial enrolled a total of 75 patients with solid tumors, including gastric cancer, among whom 43 had advanced or metastatic gastroesophageal cancer expressing Claudin18.2. Data analysis revealed that 7 out of the 43 patients with Claudin18.2-positive achieved a partial response (PR), with an objective response rate (ORR) of 16% (7/43) for ABL111 monotherapy. Following the data cutoff presented at ESMO 2024, 2 additional patients were enrolled, with 1 achieving PR, thereby increasing the ORR to 18% (8/45). The disease control rate (DCR) was 49% (21 out of 43 patients), including 14 patients who achieved stable disease (SD). Most adverse reactions were reported as mild, classified as grade 1 to 2. Notably, the Claudin18.2 expression levels in patients who responded to ABL111 monotherapy ranged from 11% to 100%, indicating that the treatment may demonstrate therapeutic efficacy even in patients with relatively low Claudin18.2 expression, according to the company. “We are pleased to publish the clinical data of ABL111 monotherapy as the first paper in the prestigious international academic journal CCR,” said Lee Sang-hoon, CEO of ABL Bio. “Moving forward, we will make every effort to successfully advance global clinical trials of ABL111 through close collaboration with I-Mab, and to produce meaningful results in combination therapy clinical trials that may offer new treatment options for patients with gastric cancer,” he added. ABL111 is a bispecific antibody targeting Claudin18.2-positive tumors, with a mechanism of action that enables selective activation of T cells via the 4-1BB pathway specifically in the tumor microenvironment where Claudin18.2 is expressed. The treatment is currently in Phase 1b clinical trial as part of a triple combination therapy with the immune checkpoint inhibitor nivolumab and chemotherapy, with the goal of developing it as a ‘first-line treatment’ for patients with gastric cancer. In the previous Phase 1 clinical trial, ABL111 monotherapy demonstrated strong antitumor activity driven by the close interaction between Claudin18.2 and 4-1BB, while mitigating the toxicity commonly seen in conventional 4-1BB-targeting antibodies.

Lunit and Microsoft Collaborate to Advance AI-Driven Cancer Diagnosis

zenith@thebionews.net (Kang, In Hyo) — Wed, 02 Jul 2025 10:05:19 +0900

source : Lunit [by Kang, In Hyo] Lunit, a medical AI company, announced on July 2 that it was collaborating with Microsoft to accelerate the delivery of AI-powered healthcare solutions. In conjunction with their recent acquisition of Volpara, a Microsoft Industry Health Certified Partner, this collaboration will give health professionals globally access to tools that will assist in the detection of cancer. This underscores Lunit’s long-term vision to move beyond standalone AI tools—toward building integrated solutions that align with real-world clinical practice. By joining forces with Microsoft, Lunit is poised to deliver scalable technologies that not only streamline radiology workflows but also drive measurable improvements in diagnostic consistency and patient care across diverse healthcare settings. This marks a significant milestone in Lunit’s mission to expand access to AI tools, particularly in the U.S. market, by leveraging Microsoft Azure’s global cloud infrastructure and deep expertise in healthcare-focused AI technologies. Key highlights of the collaboration include: • Co-Development of AI Model Customization Service on Azure: Lunit and Microsoft collaborate to develop a service that allows fine-tuning of AI models using site-specific clinical data from each customer. This approach helps mitigate cross-site model performance variability—one of the key challenges in deploying AI in real-world clinical environments—and ensures more reliable, tailored outcomes in diverse clinical settings. • Leveraging Microsoft’s AI Platform for Innovative Workflow Solutions: Moving beyond point solutions, Lunit will leverage Microsoft's agentic AI frameworks—designed to support intelligent task automation—to develop end-to-end workflow automation tools. These solutions aim to simplify clinical decision-making and enhance operational efficiency across the care continuum. “For AI to truly make an impact in healthcare, it must be accessible, scalable, and seamlessly integrated into clinical practice,” said Brandon Suh, CEO of Lunit. “Our collaboration with Microsoft enables us to bring our AI to more providers through trusted platforms like Microsoft Azure, helping us expand access in the U.S. and beyond. This collaboration brings us one step closer to delivering high-quality, consistent care through AI—at scale.” “With Microsoft Azure, we are shaping an ecosystem that supports partners like Lunit in delivering scalable AI innovations,” said Naveen Valluri, General Manager, Health and Life Sciences Data and AI at Microsoft. “By combining our infrastructure with clinical-grade AI developed in close collaboration with leaders like Lunit, we’re accelerating the development of intelligent, integrated solutions for radiology and beyond.”

GI Innovation unveils first Phase 2 data on ‘GI-102 + Keytruda’ combination… initial ORR reaches 75%

jyj@thebionews.net (Ji, Yong Jun) — Tue, 01 Jul 2025 17:23:45 +0900

Jang Myoung-ho, CEO of GI Innovation, speaks during an online corporate briefing (IR) for shareholders, institutional investors, and the press. (Source: GI Innovation IR screenshot) [by Ji, Yong Jun] GI Innovation has reported promising early clinical outcomes from the combination therapy of its immunotherapy candidate ‘GI-102 (development code)’ and MSD (Merck, USA)’s immune checkpoint inhibitor ‘Keytruda’ in patients who were refractory or resistant to prior immunotherapy. As of July 6, the objective response rate (ORR) for the ‘GI-102 + Keytruda’ combination therapy reached 75% (3 out of 4 patients), with one patient achieving complete remission (CR). On the afternoon of June 30, GI Innovation conducted an online corporate briefing (IR) session for shareholders, institutional investors, and media press, during which it presented early data from the Phase 2 clinical trial of the ‘GI-102 + Keytruda’ combination therapy. Participating in the briefing were GI Innovation CEO Jang Myoung-ho, CEO Hong Jun-ho, and Clinical Dev & Strategy SVP Yun Nari. The session included updates on the development status of GI-102, the company’s strategy for pursuing accelerated approval, an overview of its next-generation pipeline currently under development, and information related to ongoing technology licensing efforts. ◇GI-102 + Keytruda combination shows promising preliminary data in its early Phase 2 clinical trial The early Phase 2 clinical data for the ‘GI-102 + Keytruda’ combination therapy was publicly disclosed for the first time during the briefing. GI Innovation expressed optimism regarding the results, noting that 3 out of 4 patients with melanoma or renal cancer, who are refractory or resistant to prior immunotherapy, achieved an ORR. In particular, in the melanoma subgroup, the ORR reached 100% (2 out of 2 patients), including one case of CR. Additionally, GI Innovation reported that in renal cancer patients not formally counted in the ORR metric, target lesions were nonetheless reduced by more than 30%, indicating that tumor responses were observed in the entire cohort of immunotherapy-resistant patients. “Although these are preliminary results, we have observed early anticancer activity that is significantly stronger and more promising than what is typically seen with monotherapy,” SVP Yun emphasized. “This is a particularly encouraging development, given the current lack of effective treatment for patients who are resistant or unresponsive to existing immunotherapies,” she added. GI-102 is a bispecific Fc fusion protein composed of ‘CD80’ and ‘modified interleukin-2 (IL-2v3),’ designed to enhance immune cell activity within the tumor microenvironment. It exhibits potent ‘anticancer immune cell proliferation capacity,’ increasing immune cell counts by an average of 5 times. In monotherapy dose-escalation clinical trials, GI-102 has demonstrated promising efficacy, with seven cases of confirmed partial remissions (PR) observed. Initial patient response data from the Phase 2 clinical trial of the GI-102 + Keytruda combination therapy. (Source: GI Innovation IR screenshot) ◇“Targeting FDA ‘Accelerated Approval’ of GI-102 in 2028” GI Innovation also presented its strategy for pursuing ‘Accelerated Approval’ of GI-102 by the U.S. Food and Drug Administration (FDA), targeting the third quarter of 2028 as the anticipated approval timeline. The company noted that it is formulating its accelerated regulatory strategy by referencing the approval procedure of the U.S.-based company Replimune. Replimune observed a meaningful therapeutic response in its clinical trial (IGNYTE), involving 156 melanoma patients who were refractory or resistant to existing PD-1 inhibitors. The study evaluated a combination therapy of Replimune’s tumor-derived oncolytic virus treatment ‘RP1 (vusolimogene oderparepvec)’ and MSD’s immune checkpoint inhibitor ‘nivolumab.’ Based on these results, Replimune is currently pursuing the FDA’s Accelerated Approval procedure for the corresponding indication. According to GI Innovation, the global market for immune-oncology resistance is projected to grow from KRW 52 trillion (approximately USD 38.4 billion) in 2023 to about KRW 153 trillion by 2033. “We have already conducted an analysis, in collaboration with consulting firms and Dr. Yoo Tae-ho, to assess the feasibility of obtaining accelerated FDA approval,” Yun stated. “GI-102 is poised to become the first immuno-oncology drug developed in Korea to secure accelerated FDA approval.” ◇Accelerated development of PD-1·VEGF+‘α’ ‘triple antibody’ GI Innovation has also initiated the development of triple antibody therapeutics. This follows recent advancements such as ‘ivonescimab,’ a PD-1·VEGF dual antibody candidate co-developed by China’s Akeso Biopharma and the U.S.-based Summit Therapeutics, which has introduced a novel treatment approach in the immuno-oncology market. Building on this momentum, GI Innovation plans to retain the two PD-1 and VEGF targets of dual antibodies while enhancing the tumor-targeting capability of a third antibody. “Our VEGF-targeting antibodies have been developed to a level that matches, if not exceeds, the performance of existing therapies currently on the market or in development,” CEO Jang Myoung-ho explained. ◇40 executives from global pharmaceutical companies visit company… “Targeting technology transfer deal within the year” Global technology transfer negotiations for GI-102 are reportedly proceeding smoothly. Recently, around 40 executives from major global pharmaceutical companies visited GI Innovation to conduct an on-site due diligence inspection of GI-102’s clinical development status, toxicity data, chemistry, manufacturing, and controls (CMC), intellectual property, and other related fields. “Is it highly unusual for global pharmaceutical companies to carry out technology evaluations involving more than 40 vice presidents and team leaders,” Jang remarked. “Internally, we interpret this level of engagement as a strong ‘green light’ for potential technology export.” Jang has set a goal of securing a technology licensing deal for GI-102 within the year. He emphasized that the broad patent protection for GI-102, which extends until 2045, provides a significant strategic advantage in negotiations with global pharmaceutical companies targeting the immunotherapy resistance market. “For GI-102, we are open to both indication-specific technology licensing and full asset transfer,” Jang said. “As we place a high priority on shareholder interests, any proposal exceeding KRW 10 trillion will be subject to serious internal consideration,” he added.

[Inaugural Interview] Park Yeong-min, CEO of KDDF: “China’s lessons show the need for more funding and better regulation”

lys@thebionews.net (Lee, Young Sung) — Tue, 01 Jul 2025 15:16:51 +0900

Park Yeong-min, CEO of the Korea Drug Development Fund (KDDF), being interviewed by THE BIO (THE BIO DB). On the occasion of its second anniversary, the Korea Drug Development Fund (KDDF), which functions as the central coordinating body for national new drug development R&D, has underscored the urgent need for increased governmental support for research and development (R&D) funding. Despite achieving a 30% increase in clinical trial activity this year through its initiatives, the KDDF maintains that the current level of support remains inadequate to establish a sustainable ‘virtuous cycle’ encompassing global clinical trials and subsequent commercialization. The organization particularly highlighted the rapid development of China’s biopharmaceutical sector on the international stage as a pressing impetus for accelerating Korea’s national-level competitiveness of the bioindustry. conducted an interview with Park Yeong-min, CEO of KDDF, on July 1 to commemorate the second anniversary. [Editor’s Note] [by Lee, Young Sung] In a recent interview with at the KDDF headquarters in Mapo District, Seoul, CEO Park Yeong-min stated, “The government is actively pursuing top-level investments in basic research and is focusing R&D support for talent acquisition.” However, he noted, “When it comes to supporting new drug development, the current scale and structure of government assistance fall short, particularly for small and medium-sized enterprises, which struggle to secure the capabilities required for clinical trials, the most cost-intensive phase of the development process.” “Merely expanding government subsidies may inadvertently increase the burden on companies, as larger subsidies can also entail greater obligations, thereby failing to alleviate the fundamental challenges associated with conducting global clinical trials,” Park emphasized. “To generate tangible clinical outcomes, it is essential not only to increase the clinical development support budget but also to review and reform related regulations from multiple perspectives.” He particularly highlighted the importance of recognizing the value of accumulated experience, even in cases where new drug development efforts do not result in successful outcomes. “If we consider the increasing technological capabilities as a national asset, even in the face of development failures, it becomes clear that a long-term and stable support framework is essential. Such a policy should focus on seed-stage development and foundational research with the potential to advance into clinical phases,” Park commented. ◇China equipped with clinical big data…Underscoring Korea’s urgent need for national new drug R&D support The urgency of strengthening government support is further underscored by the recent advancements of neighboring China, which has been generating substantial volumes of high-quality clinical data, standing tall at the global level. Korea has long designated the 'pharmaceutical and biotechnology' sectors as key future growth engines for national development. However, China has already outpaced its regional competitors in this domain, giving rise to numerous globally competitive enterprises. "China’s advancement in pharmaceutical and biotechnology capabilities is the outcome of robust governmental policy support for the biotech and biopharmaceutical sectors, which was launched in earnest in 2015," Park assessed. "I believe that the improvement in China's new drug development competencies has directly contributed to the significant increase in its clinical trial output." In addition, several factors have contributed to the growing global recognition of Chinese clinical data: the return of Chinese professionals with experience in new drug development in the United States, the establishment of centers equipped to conduct large-scale clinical trials, and enhanced data reliability driven by improvements in Good Clinical Practice (GCP) standards in China’s clinical trial system. "In this environment, the focus is not merely on increasing the volume of clinical data, but rather, a virtuous cycle has emerged in which ongoing global deals and FDA approvals serve to accelerate investment and development," Park further noted. Park, who attended the American Society of Clinical Oncology (ASCO 2025) Annual Meeting held in Chicago, USA, at the end of May, remarked that he personally witnessed the growing influence and credibility of China's clinical data on the global stage. At the 'ADC 2.0' special session (2.0: Discovering the Targets That Will Change the Game) held during ASCO 2025, early clinical results of the latest antibody-drug conjugate (ADC) candidates were presented. Among the various ADC assets highlighted, two candidates from China's Jiangsu Hengrui Pharmaceuticals, 'SHR-1826' and 'SHR-A2102', were featured. ADCs are currently regarded as one of the most promising therapeutic classes in the global market, with the potential to surpass existing anticancer drugs. Furthermore, during the special session on anticancer drugs using dual antibody technology (Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies), all three clinical presentations featured anticancer compounds based on dual antibodies developed by Chinese pharmaceutical companies. Notably, one of these candidates is currently being co-developed with the global biotechnology firm BioNTech following a technology transfer agreement. ◇"China is merely a reference point…Korea must compete in new drug development with smart strategies" Park emphasized that China should not be regarded merely as a competitor. "While there is a growing volume of clinical data emerging from China, the focus should not be on reacting to China specifically, but rather on acknowledging that China's share in the global market has expanded," Park emphasized. "We must examine how China’s clinical outcomes are being utilized in new drug development and global licensing deals and consider how to establish and promote effective clinical development strategies accordingly." In essence, the underlying recommendation is that Korea should focus on accumulating its own technological capabilities while concurrently drawing lessons from these reference books. “Korean companies should also pursue FDA and EMA new drug approvals, rather than focusing solely on short-term objectives, and should work to enhance data quality and reliability from the early stages of development,” Park further commented. “It is essential to continuously validate development strategies and strengthen global competitiveness by responding to shifts and anticipating trends in the market environment.” Park particularly emphasized, “In an environment where competing with sheer volume is difficult, a smart development strategy becomes all the more necessary. It is necessary to actively adopt a ‘gate’ evaluation approach, namely, a ‘Go/No-Go’ judgment framework, prior to entering the next development stages, to ensure the efficient allocation of limited resources.” He further advised, “Companies should also prioritize data generation and quality improvement from the outset by engaging with overseas regulatory authorities through formal meetings and work to improve regulatory compliance.” The KDDF is scheduled to conclude the first phase of its five-year project by the end of this year, with the second phase set to start in 2026 and continue through 2030. "We have reached a critical juncture at which it is essential to support domestic new drug development projects in a way that ensures the investments made thus far translate into tangible results," Park stated. "In response to the rapidly evolving new drug paradigm and external environment, we have initiated a comprehensive review of our R&D portfolio strategy and are formulating an efficient support framework aimed at delivering concrete results and fulfilling the overarching objectives of the Fund," he added. "We will respond sensitively and proactively to feedback from the field and shifts in the global landscape," Park further said. "Our aim is to serve as a strong partner in Korean new drug development by offering diverse recommendations to ensure the continuous advancement of national drug development initiatives while acting as a bridge and guide connecting core institutions, government ministries, potential overseas partners, investment firms, consulting entities, CMOs, and other development support organizations." The KDDF is the sole organization dedicated to implementing an ‘intensive’ support program exclusively on domestic new drug development. Its ongoing initiatives encompass a wide range of R&D stages, including base expansion research (from validation to lead compound identification), novel drug R&D ecosystem establishment research (from candidate selection to non-clinical development), clinical development support (from Phase 1 to Phase 2 trials), and commercialization support for new drug R&D outcomes.

Huons Meditech offers a new paradigm for ESWT in urology

jyj@thebionews.net (Ji, Yong Jun) — Mon, 30 Jun 2025 15:50:46 +0900

Huons Meditech held a ‘CP&CPPS Treatment Symposium’ at Seoul Dragon City Hotel to showcase IMPO88 Plus competitiveness.(source : Huons Meditech) [by Ji, Yong Jun] Huons Meditech of Huons Group offers a new paradigm for extracorporeal shock wave therapy (ESWT) in urology. Huons Meditech announced on June 30 that it successfully held the Chronic Prostatitis&Chronic Pelvic Pain Syndrome Treatment Symposium (CP&CPPS Treatment Symposium) on June 28 at Seoul Dragon City Hotel. Huons Meditech, which holds the largest domestic ESWL (Extracorporeal Shock Wave Lithotriptor) market share, gathered local urologists to showcase and share clinical cases of its newest ESWT device ‘IMPO88 Plus’. IMPO88 Plus is the next generation of IMPO88, the ESWT device designed for Erectile Dysfunction (ED) treatment and chronic pain management. Meanwhile, ESWT devices were generally used to treat musculoskeletal disorders; however, IMPO88 Plus is known as Korea’s first low intensity ESWT, clinically proven to have effect on relieving symptoms of ED and CP&CPPS. Professor Hong Sung Kyu (Department of Urology at Seoul National University Bundang Hospital) chaired the symposium, while Professor Park Heung Jae (Department of Urology at Kangbuk Samsung Hospital) presented clinical cases of IMPO88 Plus for ED. Certified Director Han Byoung Kyu (Urological Endoscopy Certification Committee at The Korean Urological Association) shared his knowledge on disinfection of urological endoscopes. Professor Shin Dongho (Department of Urology at Seoul St. Mary's Hospital) who led the clinical study attracted much attention when he presented the efficacy and safety of ESWT on CP&CPPS. Professor Shin Dongho said, “IMPO88 Plus is the only ESWT device in Korea that has proven effect on inflammatory and non-inflammatory CPPS. This device provides a new treatment option which can reduce or even replace antibiotic prescriptions for CP&CPPS patients.” CEO of Huons Meditech, Lee Jin-suk said “Following the CP&CPPS Treatment Symposium, I expect that IMPO88 Plus will lead a paradigm shift of ESWT treatment in urology. Huons Meditech will continue to develop innovative medical devices that can be used in various fields such as in gynecology and dermatology. Huons Meditech continues to put efforts in process standardization and training programs to foster skilled manufacturing workers in order to manufacture high-quality medical devices. The company has a dedicated aftersales quality control organization and operates an advanced system for same-day response and immediate action in response to customer complaints.

MediRama partners with U.S. anticancer drug specialist CRO ‘TD2 Oncology’

suin@thebionews.net (Yu, Suin) — Fri, 27 Jun 2025 13:57:06 +0900

Screenshot of the MediRama official website. [by Yu, Suin] MediRama, a clinical contract research organization (CRO) specializing in oncology, announced on June 26 that it has entered into a global clinical collaboration partnership with TD2 Oncology (The Translational Drug Development Institute), a U.S.-based CRO specializing in anticancer drug development. This strategic alliance is anticipated to serve as a foundation for providing a comprehensive clinical pathway for Korean biotech firms and startups aiming to penetrate the U.S. market, encompassing the full spectrum from early-phase clinical trials to U.S. Food and Drug Administration (FDA) registration. Leveraging its clinical operational expertise in Korea and the Asian region, MediRama has supported domestic biotechnology companies in formulating clinical development strategies, initiating early-phase (Phase 1) clinical trials for anticancer drugs, and facilitating connections with the U.S. market. Through this agreement, both parties intend to offer tailored joint services to Korean firms pursuing anticancer drug development in the United States. These services will include access to a network of U.S. hospitals, collaboration with expert researchers, and strategic support for regulatory submissions and compliance. “A successful clinical trial in the United States serves as a critical turning point for attracting investment and facilitating technology export,” said Moon Hanlim, CEO of MediRama. “We aim to deliver practical solutions that enable Korean biotech startups to enter the U.S. clinical market swiftly and efficiently,” she added. “This agreement represents the launch of a powerful strategic partnership between two leading CROs with complementary strengths in oncology drug development and clinical trial execution,” expressed Dr. Stephen Gately, President and CEO of TD2 Oncology. “Together, we will advance our shared mission of transforming cancer treatment and improving patient outcomes.”

“‘AI colonoscopy’ proven to improve polyp detection and diagnostic accuracy… Validated in Vietnam as well”

suin@thebionews.net (Yu, Suin) — Fri, 27 Jun 2025 13:56:45 +0900

“In this study, WAYMED endo played a key role in enhancing the overall quality of gastrointestinal endoscopy,” said Pham Nhu Hien (from the right), Deputy Director of Endoscopy Center at Hue Central Hospital. On the left is Dr. Tan, a fellow researcher on the study. (Source: Waycen) [by Yu, Suin] “Numerous patients expressed a notably positive response and a sense of relief upon learning that advanced artificial intelligence (AI) systems like ‘WAYMED endo’ were utilized in analyzing their endoscopic images. This contributed significantly to increasing the overall perceived reliability of the examination process.” Ms. Md. Pham Nhu Hien, Deputy Director of the Endoscopy Center at Hue Central Hospital (HCH), recently shared these insights in a written interview with . ‘WAYMED endo’ is an AI-powered gastrointestinal endoscopy system developed by Waycen, a Korean medical AI development company. Since the beginning of the year, Pham has been working in collaboration with Waycen to implement the system in clinical practice and evaluate its clinical efficacy. Pham, an expert in endoscopy and a practicing surgeon, participated in the ‘International Digestive Endoscopy Network 2025 (IDEN 2025),’ held at Walkerhill Seoul from June 12 to 14, where he presented preliminary research findings. Founded in 1894, Hue Central Hospital is Vietnam’s first established hospital and operates under the jurisdiction of the Ministry of Health. With a capacity of 5,500 beds, it is the largest public medical institution in central Vietnam. The hospital offers a full spectrum of medical services, ranging from primary care to highly complex treatments, in all major specialties, including surgery, oncology, cardiology, obstetrics and gynecology, pediatrics, and organ transplantation. Additionally, it functions as a key academic institution, actively running graduate programs and specialist training courses both domestically and internationally. Pham noted that, although ‘AI-based gastrointestinal endoscopy’ remains a relatively nascent field in Vietnam, it is garnering increasing interest among medical professionals. He noted that those healthcare professionals who have experienced the AI system have expressed high regard for its supportive role in identifying lesions in anatomically challenging areas with limited visibility. Pham further emphasized that the technology is being recognized as a valuable tool for training novice endoscopists and for promoting the standardization of endoscopic examination protocols. Source: Waycen The clinical efficacy of WAYMED endo was further validated through real-world application by Vice Director Pham. An assessment of 656 patients who underwent colonoscopy between January and April confirmed the system’s contribution to improving the adenoma detection rate (ADR). In a comparative analysis, the group that used the AI-based computer-assisted detection (CADe) system (WAYMED endo group) achieved a significantly higher detection rate of adenomas and colorectal cancer at 35.1%, compared to 23.2% in the control group, which used conventional endoscopy systems from Fujifilm and Olympus (Japan). In cases involving adenomas alone, the cure rate was notably higher in the WAYMED endo group, reaching 33.5%, compared to 22% in the control group. Furthermore, the AI-based system demonstrated superior performance in identifying ‘non-neoplastic polyps’ and exhibited a significant detection rate even for lesions that are typically challenging to identify. The WAYMED endo group demonstrated particular effectiveness in the detection of small-sized polyps. For polyps measuring less than 5 mm, the detection rate reached 15.5%, markedly higher than the 7.9% observed in the control group. Similarly, for polyps measuring between 6 and 9 mm, the AI-assisted (CADe) group achieved a detection rate of 11%, surpassing the 6.1% reported in the control group. Colorectal cancer remains a leading cause of cancer-related mortality. The combined use of colonoscopy and polypectomy has been shown to effectively reduce cancer incidence and mortality. However, certain neoplastic lesions, particularly small, flat polyps or those located in anatomically challenging regions, continue to be overlooked during examination. According to Pham, the ADR serves as an important quality indicator for colonoscopy, nonetheless, it exhibits considerable variability among physicians, influenced by a varied range of factors. “An approximate 10% difference in ADR represents a meaningful improvement in identifying precancerous or abnormal colonic lesions. This facilitates early detection and timely treatment intervention, thereby improving clinical prognosis,” Pham stated. “Ultimately, such improvements can contribute positively to extending patients’ life expectancy.” “While numerous international studies have demonstrated that AI systems can increase ADR and reduce the rate of missed lesions, supporting evidence in the Vietnamese clinical context remains limited. Nevertheless, in this study, WAYMED endo proved instrumental in enhancing the overall quality of gastrointestinal endoscopy procedures,” he further noted. “In particular, the system demonstrated outstanding performance in accurately detecting early-stage lesions, with a notably low false positive rate. As a result, unnecessary alerts rarely disrupted the flow of the examination,” he explained. Pham emphasized that this level of precision increased diagnostic reliability and allowed for more focused examinations, even in anatomically complex or visually restricted cases. “Above all, WAYMED endo holds significant value in achieving ‘high-quality screening,’ which is the essential purpose of endoscopy,” he further explained. “By supporting real-time consistency and accuracy in lesion detection, the system contributes to a more effective and standardized treatment experience for both patients and healthcare providers. It also exhibits excellent compatibility with next-generation endoscopy devices and demonstrates strong potential as a scalable AI solution well-suited to the evolving demands of modern medical practice,” he added. In addition, WAYMED endo contributed significantly to enhancing patient trust and satisfaction. “During the study period, patients were generally cooperative and showed a very positive attitude overall,” Pham remarked. “The system helped foster a sense of comfort and confidence among patients during the ‘screening phase,’ which is a critical component of endoscopy examinations.” Through ongoing collaboration with Waycen, Pham aims to further refine and adapt the WAYMED endo system to better align with the clinical conditions of developing countries such as Vietnam. However, Pham emphasized that before AI-based endoscopic examinations can be widely implemented, several factors must be addressed, including system compatibility, the establishment of clear guidelines, and the provision of adequate training of medical personnel. “At present, most AI solutions demonstrate optimal performance when integrated with the latest endoscopic equipment. However, many healthcare institutions in developing countries, including Vietnam, continue to rely on older-generation devices. This technological gap poses a real barrier to the adoption and spread of AI systems, and addressing it should be a top priority,” Pham expressed. “For medical professionals to effectively recognize and utilize AI as an effective diagnostic support tool, it is essential to establish standardized usage guidelines and provide practical clinical training.” “Additional validation in diverse clinical settings is also essential to ensure that the AI system maintains its accuracy and stability under real-world conditions. During the research process, there were instances where excessive notifications disrupted the examination flow or where the system’s assessment of suspicious lesions lacked sufficient accuracy,” he further noted. “Given that most medical professionals hold a positive view of the technology’s potential, it is crucial to demonstrate that the performance of AI is not confined to specific conditions but can consistently deliver high-quality outcomes in actual clinical practice.” “Many Vietnamese research teams have expressed a strong willingness to actively participate in research aimed at increasing the practical applicability of the system in real clinical settings. In the next step, the research team will proceed with the planned collection and analysis of endoscopic data while maintaining ongoing collaboration to assess the AI system’s performance under actual clinical conditions,” Pham further remarked. “We will compare the AI-generated analyses with the interpretations of medical professionals to determine how effectively the system supports clinical decision-making.” “The feedback obtained from medical staff during actual system use will serve as an important critical reference point for future system improvements. Ultimately, we plan to consolidate the findings of this study and publish them through publication in international academic journals and presentations at professional conferences,” he further added. “Through these efforts, we aim to raise broader awareness of the clinical value of AI-based endoscopic technology and increase its potential for practical implementation in the medical field in the future.”

LigaChem Biosciences to host R&D DAY, unveils 2030 business development roadmap

jyj@thebionews.net (Ji, Yong Jun) — Fri, 27 Jun 2025 13:56:23 +0900

Panoramic view of LigaChem Biosciences headquarters offices (Source: LigaChem Biosciences) [by Ji, Yong Jun] LigaChem Biosciences (hereinafter referred to as LCB) announced on June 26 that it will host 'LigaChemBio Global R&D DAY 2025' in Yeouido, Seoul, on July 1. The event will serve as a platform for LCB to present its current R&D status and mid- to long-term strategic plans to key stakeholders, including investors, analysts, and media representatives. It will also highlight the company's globally competitive antibody-drug conjugate (ADC) technology and its broader business vision. To engage both Korean and international investors and ADC experts, the event will be live-streamed on YouTube in both Korean and English. The first part of the event will feature an analysis of the scalability of ADC technology, along with a presentation detailing how LCB's platform technology is differentiated in terms of clinical strategy. In addition, the session will include updates on the global clinical development status of core pipelines such as HER2-ADC and ROR1-ADC, real-world application cases, interim results of Phase 1 clinical trials, and future development plans. The second part of the event will center on next-generation ADC technologies and innovation in the field of immuno-oncology. This session will introduce a range of innovative candidates currently under development while also highlighting the distinctiveness of recently acquired targets and outlining the company’s strategic plans for expanding its technological platform into the immuno-oncology sector. In the final session, LCB will outline its global business strategy and long-term growth vision. This will include detailed plans for technology transfer aimed at expanding international partnerships, as well as a mid- to long-term business roadmap and key growth drivers through 2030. Each presentation will be followed by an in-depth Q&A session, fostering direct discussion with attendees. LCB is actively advancing the development of next-generation ADCs through its proprietary ConjuALL platform technology, with multiple pipeline candidates having already progressed into clinical stages. "Through Global R&D DAY, we aim to comprehensively showcase the distinct competitiveness of our ADC technology, our strategic expansion into the immuno-oncology field, and our approach to forming global partnerships. This event will serve to further concretize our vision of becoming a leading company in the development of next-generation anticancer treatments," an LCB official emphasized.

[BIO USA] Oscotec advances ‘chemotherapy resistance novel drug’…“Expanding pipeline with at least two additional assets”

jyj@thebionews.net (Ji, Yong Jun) — Thu, 26 Jun 2025 23:49:29 +0900

Yoon Tae-young, CEO of Oscotec, poses for a commemorative photo following an interview with THE BIO at the ‘2025 Bio International Convention (BIO USA)’ in Boston, USA, on June 19 (local time). (Photo: Reporter Ji Yong Jun) [by Ji, Yong Jun] Oscotec plans to initiate development efforts aimed at identifying at least two lead compounds and advancing them to the clinical stage, supported by a stable cash inflow structure derived from milestone payments (stage-by-stage technology fee) of ‘lazertinib (marketed in Korea as Leclaza and globally as Lazcluze),’ beginning the second half of 2026. The company’s primary focus will be on addressing ‘chemotherapy resistance.’ Treatments targeting chemotherapy resistance remain largely unexplored in all stages, from basic hypothesis to clinical design and demonstration of patient efficacy. Oscotec aims to accelerate the discovery of novel candidates for chemotherapy resistance by pursuing innovative therapeutic concepts in parallel with its existing clinical-stage pipeline, ‘OCT-598 (development code). On June 19 (local time), during an interview with at the ‘2025 Bio International Convention (BIO USA)’ held in Boston, USA, Oscotec CEO Yoon Tae-young stated, “We plan to establish a treatment platform for chemotherapy resistance and operate two to three more pipelines.” ◇Focusing on ‘chemotherapy resistance’…“Exploring development of novel targets” Chemotherapy resistance represents a therapeutic area with significant unmet medical needs, as most anticancer treatments ultimately face the challenge of resistance, often resulting in the progression to more aggressive malignancies. Despite ongoing efforts, even major global pharmaceutical companies have yet to establish definitive standards for addressing resistance mechanisms. In this context, Oscotec is effectively venturing into ‘uncharted territory.’ In parallel, Oscotec is developing pipelines such as ‘OCT-598’ and ‘P4899,’ the latter being a lead compound for a NUAK 1/2 dual inhibitor. These candidates are based on the premise that ‘blocking the underlying causes of cancer treatment failure’ will emerge as a core mechanism for next-generation anticancer therapies. Notably, OCT-598, an EP2/4 dual inhibitor, recently received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial targeting patients with solid tumors. “In addition to advancing our existing development pipeline, we will initiate a new project specifically targeting chemotherapy resistance,” Yoon said. “We also plan to identify novel, conceptually innovative targets with new mechanisms of action that will garner strong interest from global pharmaceutical companies.” “To develop a first-in-class target in the field of chemotherapy resistance, we cannot limit ourselves to a single specific target,” he further explained. “Our strategy is to simultaneously explore multiple targets, identify the most promising candidates during the cell or animal testing phases, and bring them up to the clinical stage.” ◇‘Lazertinib’ milestone revenue fuels asset expansion Oscotec’s expansion of its chemotherapy resistance asset portfolio is set to begin in earnest in the second half of 2026, aligning with the anticipated full-scale inflow of milestone payments from lazertinib. This drug was originally co-developed by Oscotec and its subsidiary Genosco. In 2015, the technology was licensed out to Yuhan Corporation, which subsequently entered into a global licensing agreement with Johnson & Johnson (J&J) in 2018. Currently, lazertinib is being developed as part of a combination therapy with J&J's 'amivantamab (marketed as Rybrevant),' and the regimen received first-line treatment approval for non-small cell lung cancer (NSCLC) in the United States in August 2024, followed by subsequent approvals in Europe and Japan. J&J projects annual global sales for the 'lazertinib + amivantamab' combination to reach about KRW 7 trillion (approximately USD 5.1 billion). A portion of these revenues will be distributed as royalties, with Yuhan Corporation receiving 60%, and Oscotec and Genosco each receiving 20%. ◇‘Cevidoplenib’ and ‘ADEL-Y01’ show growing potential for expanded partnerships Yoon reported that he achieved the desired outcomes at this year’s BIO USA. With the rapid advancement of artificial intelligence (AI) in the novel drug development sector, a new strategic development direction has been proposed for Cevidoplenib, a ‘SYK inhibitor’ for which Oscotec has completed a global Phase 2 clinical trial targeting autoimmune diseases. “At BIO USA, we received a proposal to develop cevidoplenib for rheumatoid arthritis (RA) using AI,” Yoon explained. “We view this as a positive signal for advancing follow-up clinical development, particularly through biomarker-based patient segmentation, in partnership with organizations that can support AI-driven patient analysis and group selection.” Oscotec is also engaged in ongoing discussions regarding the sub-licensing of ‘ADEL-Y01’, a second-generation tau-targeting treatment candidate for Alzheimer’s disease currently under co-development with the Korean biotech firm ADEL. The prospective licensing partner is a global pharmaceutical company. “We are actively pursuing discussions with global pharmaceutical companies, with the aim of securing a technology transfer (licensing out) agreement during the Phase 1 clinical trial period,” Yoon remarked. Oscotec is also formally initiating a business development (BD) strategy centered on technology collaboration. “We have engaged in business development discussions with several incubator organizations to foster partnerships with academia and industry overseas,” Yoon emphasized. “Through these collaborations, we plan to continuously identify and pursue promising licensing-in (technology introduction) opportunities for novel drug candidates.”

Vaxcellbio’s multiple myeloma treatment candidate ‘CAR-MIL’ chosen for the National New Drug Development Project

suin@thebionews.net (Yu, Suin) — Thu, 26 Jun 2025 23:47:11 +0900

Source: Vaxcellbio [by Yu, Suin] Vaxcellbio announced on June 24 that it had signed an agreement with the Korea Drug Development Fund (KDDF) for the development of CAR-MIL (chimeric antigen receptor-expressing bone marrow infiltrating lymphocytes) targeting BCMA (B-cell maturation antigen) for the treatment of multiple myeloma. Under the agreement, Vaxcellbio will receive research and development funding over the next two years to support the development of its ‘BCMA-targeting CAR-MIL therapy for the treatment of multiple myeloma.’ According to Vaxcellbio, CAR-MIL is a therapeutic approach that involves the genetic modification of lymphocytes extracted from a patient’s bone marrow. It is being developed as a cell therapy candidate characterized by enhanced survival and persistence in the tumor microenvironment, along with maximized anticancer efficacy. In prior mouse models, the BCMA-targeting CAR-MIL experimental group demonstrated superior tumor-killing capacity and improved survival rates compared to the conventional CAR-T control group, while also exhibiting a favorable safety profile. As part of this national new drug development project, Vaxcellbio aims to carry out non-clinical trials and obtain approval for its clinical trial plan (IND). The company also intends to address key challenges associated with current CAR-T therapies, including a complex manufacturing process, high production costs, and reduced efficacy due to treatment resistance. The company notes that no bone marrow infiltrating lymphocyte therapy expressing BCMA CAR has yet been commercialized globally, positioning Vaxcellbio at the forefront of research and development (R&D) in this field. “CAR-MIL is one of our company’s core technologies that has secured a distinct position in the multiple myeloma blood cancer treatment market,” said Lee Je-jung, CEO of Vaxcellbio. “Through our selection for the National New Drug Development Project, we will lay the clinical trial foundation for the first CAR-MIL therapy in Korea and further solidify our leadership in the global market.” The National New Drug Development Project is a government-led R&D initiative established to strengthen the global competitiveness of the Korean pharmaceutical and biotechnology industries. The project provides comprehensive support throughout the entire new drug development cycle, aiming to reinforce the domestic R&D ecosystem for new drug development and to facilitate successful global commercialization outcomes. “We hope that this research, based on an innovative immune cell therapy platform, will offer new hope to patients with intractable blood cancers who face limited treatment options. The fund will continue to actively support this outstanding technology to ensure it delivers meaningful outcomes on the global stage,” expressed Park Yeong-min, CEO of the Korea Drug Development Fund (KDDF).

Tiumbio presents European Phase 2a study results of 'Merigolix' for endometriosis at ESHRE

jyj@thebionews.net (Ji, Yong Jun) — Thu, 26 Jun 2025 23:46:25 +0900

Source: Tiumbio [by Ji, Yong Jun] Tiumbio, a company specializing in research and development of rare and intractable disease treatments, announced on June 25 its upcoming participation in the 2025 European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting. During the event, the company will present clinical data and explore the potential development of Merigolix (development code: TU2670), a treatment candidate for endometriosis and uterine fibroids. The 2025 ESHRE Annual Meeting will be held in Paris, France, from June 29 to July 2. ESHRE is recognized as one of the most prestigious international academic societies in the field of reproductive medicine alongside the American Society for Reproductive Medicine (ASRM). Tiumbio is set to present the results of its European Phase 2a clinical trial of Merigolix for endometriosis during a session titled ‘Breaking Boundaries in Endometriosis: From the Microbiome to Maternal Outcomes,’ highlighting new approaches and treatments in endometriosis research. The presentation will be delivered by Dr. Krzysztof Szymanowski, the study’s principal investigator (PI) based in Poland. Merigolix, the investigational treatment for endometriosis and uterine fibroids to be presented by Dr. Szymanowski to leading academic and industry figures, has demonstrated efficacy and safety by meeting the primary endpoint in Phase 2 clinical trials conducted for both indications. Notably, the high-dose cohort exhibited dose-dependent therapeutic effects, further supporting Merigolix’s mechanism of action and reinforcing its potential as a viable treatment option. In addition, Merigolix has secured positive outcomes in key secondary endpoints. In the endometriosis clinical trial, it demonstrated improvement in nonmenstrual pelvic pain (NMPP), while in the uterine fibroid trial, it led to increased hemoglobin levels and a reduction in fibroid size. It has also proven overall safety and tolerability. “It is meaningful to have the opportunity to directly share the clinical performance and therapeutic potential of Merigolix with globally renowned scholars at this conference,” said Kim Hun-taek, CEO of Tiumbio. “With positive clinical outcomes secured in both indications, endometriosis and uterine fibroids, the value of Merigolix as a novel drug has been further increased,” he added.

AimedBio receives ‘A, A grade’ in technology evaluation…“Accelerates full-scale KOSDAQ listing plans”

zenith@thebionews.net (Kang, In Hyo) — Thu, 26 Jun 2025 23:45:39 +0900

Source: AimedBio [by Kang, In Hyo] AimedBio, a company specializing in the development of antibody-drug conjugates (ADCs), announced on June 25 that it has successfully passed the technology evaluation required for listing on the technology-specialized market. AimedBio demonstrated its technological excellence and strong business potential by receiving A and A grades from two Korea Exchange-designated technology evaluation agencies. With this achievement, the company has fulfilled the main requirements for a technology-specialized listing and plans to initiate full-scale preparations for listing on the KOSDAQ market in H2 2025. Mirae Asset Securities is serving as the lead manager, and AimedBio intends to submit a securities registration statement within the year. AimedBio has established a differentiated ADC pipeline by integrating new target discovery, antibody development, intermediary research technologies, and its proprietary linker-payload platform, all centered on addressing unmet medical needs. Leveraging these integrated R&D capabilities, the company successfully signed a technology transfer agreement last year with U.S.-based Biohaven for ‘AMB302 (development code).’ More recently, AimedBio further demonstrated its technological competitiveness by entering into co-development and licensing agreements with SK Plasma for AMB303. In addition, AimedBio successfully completed its pre-IPO (pre-listing investment) round ahead of schedule, securing a total investment of KRW 51.1 billion (approximately USD 37.7 million) from major Korean institutional investors, reflecting the market’s strong expectations in the company’s potential. “This technology evaluation is the result of officially recognizing our technological perfection and global commercialization capabilities,” stated Her Nam-gu, CEO of AimedBio. “We will leverage the momentum gained through the listing process to accelerate our growth and leap forward as a global biotechnology company at the forefront of innovative anticancer drug development.”