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Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
• By Dexter Jie Yan

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

Nasopharyngeal carcinoma is a rare form of head and neck cancer in western populations. (Shutterstock)

Akeso has garnered a regulatory nod for penpulimab from the US Food and Drug Administration, making the agent the second PD-1 checkpoint inhibitor originating from a Chinese drug maker in the US market for nasopharyngeal carcinoma (NPC), a rare form of head and neck cancer in mostly Western populations.

Akeso generated the first positive clinical evidence worldwide supporting the first-line use of an anti-PD-1/L1 agent in this form of...

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More from China

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 
• By Dexter Jie Yan

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.

China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

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• By Edwin Elmhirst

Many assets underperform their pre-launch sales predictions, which can be disastrous to their developers and marketers. In this article, Scrip highlights several historic examples and the factors that influenced their poorer-than-expected performance.

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

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