India’s first indigenous CAR T therapy is expected to cost around $50,000, nearly one-tenth of the price of top-selling CAR Ts in the U.S. India President Droupadi Murmu officially launched Immunoadoptive Cell Therapy’s (Immunoact) NexCAR19 (actalycabtagene autoleucel), a CD19-targeted CAR T, and dedicated it to the nation in April 2024.
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
China and U.S. biotech Jacobio Pharmaceuticals Group Co. Ltd.’s shares (HKEX:1167) rose nearly 20% after it filed an NDA in China on May 6 for its independently developed KRAS G12C inhibitor, glecirasib (JAB-21822), to treat lung cancer.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
As of Jan. 31, 2024, there were more than 300 CAR T trials registered in China, surpassing the U.S. and becoming the country with the most CAR T therapy clinical trials. Among them, CD19 is the most frequently studied target, according to BioWorld and Cortellis. The rapid evolution of CAR T-cell therapies in China has escalated over the past decade from the start of the first clinical trials in 2013 to the country becoming an established host for CAR T-cell-related trials by 2017, according to Yongxian Hu and researchers from Zhejiang University in Hangzhou, China. Chinese cell therapy companies – backed by $2.37 billion in funding in 2021 – have since significantly increased basic research and trial output for CAR Ts, which was welcomed by large patient demand.
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations.
The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
RSS
