Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.

Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli Lilly and Co.’s GLP-1, dulaglutide, for glycemic control.

Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli Lilly and Co.’s GLP-1, dulaglutide, for glycemic control.

Suzhou Sanegene Bio Inc.’s clinical trial application for SGB-3908 injection, an siRNA drug for the treatment of hypertension, has been accepted in China by the National Medical Products Administration (NMPA)’s Center for Drug Evaluation (CDE).

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.

China’s CAR T market is expected to grow from $72 million in 2022 to $342 million over the next decade. There are currently more than 400 CAR T therapies in the pipeline in China, and most of these are being developed by specialized Chinese biotechs. Research by Clarivate plc, BioWorld’s parent company, indicates that a notable proportion of CAR T-cell therapies in late-phase development in China are being developed through strategic partnerships and joint ventures between multinational corporations and domestic companies, including Johnson & Johnson and Nanjing Legend Biotech Corp., Juno Therapeutics Inc. and Wuxi Apptec Co. Ltd., and CASI Pharmaceuticals Inc. and Juventas Cell Therapy Ltd.

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.

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.