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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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• By Dexter Jie Yan

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China Sentences Astellas Employee To 3.5 Years In Prison On Spy Charges

 
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Novartis Upbeat Even With Entresto Expiry Looming

 
• By Kevin Grogan

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J&J Delivers In Q2 Despite Stelara Drop, Raising Guidance

 
• By Jessica Merrill

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• By Anju Ghangurde

Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?