Fast-tracking entry into the CAR-T market growing rapidly at approximately 40% annually
[by Ji, Yong Jun] AbClon, an antibody-based novel drug development company, announced on September 18 that its next-generation chimeric antigen receptor T-cell (CAR-T) treatment candidate, ‘Nespe-cel (development code: AT101),’ has been designated as an ‘orphan drug in development’ by the Ministry of Food and Drug Safety (MFDS).
바카라 꽁 머니 is a personalized treatment candidate for patients with relapsed or refractory hematologic malignancies. The treatment entails extracting a patient's T cells, genetically engineering them with AbClon’s proprietary ‘H1218’ antibody to selectively target cancer cells, and subsequently reinjecting the modified cells into the patient.
According to the company, 바카라 꽁 머니 is garnering attention for its outstanding therapeutic efficacy. Interim results from a Phase 2 clinical trial demonstrated an objective response rate (ORR) of 94% among patients whose cancer cell burden was reduced to a measurable level, substantially higher than the 52% ORR achieved with existing therapies currently available in Korea. The company further highlighted that the complete remission (CR) rate reached 68%, markedly surpassing the 40% observed with standard treatments.
Unlike existing global CAR-T therapies that employ the mouse-derived ‘FMC63 antibody,’ AbClon incorporated its proprietary CD19-specific humanized antibody, ‘H1218,’ into 바카라 꽁 머니. The company explained that the application of the H1218 antibody enhances the durability of therapeutic efficacy and holds the potential to induce more potent anticancer effects.
The Ministry of Food and 바카라 꽁 머니 Safety's designation of an ‘orphan 바카라 꽁 머니 in development’ supports the development of treatments for rare and intractable diseases affecting fewer than 20,000 patients in Korea. Under this system, the product approval period is extended from five to ten years, and administrative benefits such as streamlined data submission are granted during the approval process. Furthermore, the exclusivity period for data protection is lengthened from four to six years to ten years. These incentives are expected to improve development efficiency and secure market exclusivity, providing companies with a competitive advantage in commercialization.
According to data from the Korea Biotechnology Industry Organization (KoreaBio), the global CAR-T cell therapy market was valued at USD 3.74 billion (approximately KRW 5 trillion) in 2023 and is projected to grow at an annual rate of roughly 40%, reaching USD 29 billion by 2029. CD19-targeted therapies currently dominate the sector, accounting for 74% of the market, reaching USD 2.76 billion in 2023, with the market size anticipated to grow to USD 22 billion by 2029.
AbClon is advancing the clinical development of 바카라 꽁 머니 with support from the Korea Drug Development Fund (KDDF). In Turkey, the biotechnology company TCT Health Technology has acquired technology transfer rights and is developing processes for local commercialization. Domestically, Chong Kun Dang Pharmaceutical has secured priority commercialization rights for 바카라 꽁 머니 in Korea and continues to collaborate with AbClon in a co-development partnership for novel drugs.
“바카라 꽁 머니 is a treatment that will offer new hope to patients with relapsed or refractory blood cancer by overcoming the limitations of existing third-line treatments, and it will serve as an innovative medicine that elevates the global standing of Korean biotechnology in the CAR-T market, which is valued at around KRW 39 trillion (approximately USD 28.1 billion) annually,” an AbClon official said. “We will make every effort to accelerate commercialization through mechanisms such as ‘fast track review’ and ‘conditional approval,’ in addition to its designation as an orphan drug in development.”