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Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?

 
• By Alaric DeArment

Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.

Sorrento's intention to go to the FDA raise the question of how the agency will view its China-only data • Source: Shutterstock

Sorrento Therapeutics, Inc.’s pivotal Phase I/II trial data for abivertinib in non-small cell lung cancer (NSCLC) looks compelling and, at least on the surface, would seem to have a decent shot at supporting US Food and Drug Administration approval. But since the trial was conducted solely in China, the company is in conflict with the agency’s latest thinking on single-country studies.

In recent months, the FDA has taken a negative view toward granting approvals based on China-only studies, prompting EQRx, Inc. to conduct new studies of the two cancer drugs...

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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

Pharma Women’s Workforce In India: Weak Start, Promotions, C-Suite Drop Off

 
• By Anju Ghangurde

McKinsey senior partner Vivek Pandit talks to Scrip about some of the intricacies underlying the key findings of a study on pharma’s workforce gender gap in India. Women’s representation starts low at entry level, peaks at senior manager positions and falls off again for C-suite roles, this found.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
• By Vibha Ravi

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

Japan Pharma Sees US Revenues Grow But Policy Impact Still Unclear

 
• By Lisa Takagi

Japanese majors put in generally solid performances in the fiscal year ended 31 March, but overseas revenues and forex effects, rather than the domestic market, provided most of the growth.