The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise.
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
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.
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.
With a frozen IPO market, investors are tightening their belts and figuring out where to hedge their bets. In Asia, that means having different strategies for different countries while keeping a global mindset, venture capital (VC) investors said during the Asia Bio Partnering Forum in Singapore on April 25.
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 industry in the U.K. is starting to get concerned about the U.S. Biosecure Act and the possible impact on its ability to use Chinese service providers, and the implications for future dealmaking with U.S.-based companies.