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Fast And Furious: Lessons From China FDA's Innovation Push

 
• By Brian Yang

One year after the China FDA dashed out a flurry of policies to encourage innovative new drugs, a regulatory affairs veteran sheds light on how the policies are being implemented in practice and what lessons have been learned.

BEIJING – Should it be a celebration or a cause for soul-searching?

Last July 11 , when China FDA commissioner Bi Jingquan gave a speech to a gathering crowd during a ceremony of Peking University's Pharmaceutical Engineering Management class, no one realized...

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More from China

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By Xu Hu

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

Strong Data For CARsgen’s CAR-T In Late-Line Gastric Cancer

 
• By Dexter Jie Yan

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.

Hengrui Set For Biggest Biopharma IPO So Far This Year

 
• By Dexter Jie Yan

Jiangsu Hengrui Pharmaceuticals is gearing up for what will be 2025's biggest biopharma IPO so far, hoping to raise up to $1.27bn on the Hong Kong Stock Exchange. China's top drug maker by pipeline size plans to use part of the proceeds to reboot its overseas clinical trials ambitions.

China Biopharma Podcast

 
• By Dexter Jie Yan and Xu Hu

Join our China-based editors Dexter Yan and Xu Hu in this Chinese-language podcast looking at some of their recent interviews and other key coverage.

More from Focus On Asia

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.