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Chinese Language Podcast: 创新药美国获批, AI新药研发, 三季度业绩和中美峰会

Regulatory Trends, AI Drug Discovery, US-China Dialog

Executive Summary

Topics in this latest Chinese-language podcast include the US approval of Chinese innovative drugs including Junshi’s anti-PD-1 antibody toripalimab, Sanofi’s deal with BioMap for AI-powered drug discovery, Chinese companies' third-quarter results and the Biden-Xi summit on the sidelines of APEC and its implications for bilateral regulatory dialog.

The US Food and Drug Administration recently granted approvals to several novel drugs originating from China, including toripalimab from Shanghai Junshi Biosciences Co., Ltd., which has become the first "Made in China" immuno-oncology drug to gain US approval.  (Also see "Riding US Approval, Junshi, Coherus Swing For PD-1 Combo Therapy Partnerships" - Scrip, 3 Nov, 2023.)

Scrip editors Brian Yang and Dexter Yan discuss the significance of these and other recent developments in this new Chinese-language podcast. 

Artificial intelligence-aided drug discovery has seen much discussion but scant concrete deals so far. But Sanofi has signed a collaboration with Baidu-backed BioMap to use large language models, machine learning and a database comprising billions of proteins to aid hit discovery and lead optimization.

Sanofi, in what it says is a bid to become an "AI-powered" big pharma, is planning to also plug in its own data to the models, although the process will require patience and tweaks along the way, BioMap told Scrip in a recent interview. (Also see "Sanofi AI Drug Discovery Deal Bolsters Baidu-Backed Startup BioMap" - Scrip, 9 Nov, 2023.)

Amid China’s massive year-long anti-corruption campaign, how are domestic innovative drug makers doing in terms of key product sales? BeiGene, Ltd., Junshi and Innovent Biologics, Inc. all reported third-quarter results, including sales of PD-1 drugs, which provided some indications.

The results were mixed - while BeiGene and Junshi reported a negative impact, Innovent saw its PD-1 franchise continue to deliver.

Finally, Chinese President Xi Jinping and US President Joe Biden met in person for the first time in a year on the sidelines of the recent Asia Pacific Economic Cooperation (APEC) forum in San Francisco. Brian and Dexter discuss the current status of regulatory dialog between the countries. (Also see "China-US Health Regulatory Dialogue In Crosshairs Amid Biden-Xi Summit" - Pink Sheet, 15 Nov, 2023.)

China has also applied for membership of the PIC/S pharmaceutical quality forum and what can the US FDA do to further stalled bilateral collaboration?









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