Henlius Biotech's Serplulimab NDA for Gastric Cancer Combo Granted Priority Review by NMPA

Reuters12-12

Henlius Biotech's Serplulimab NDA for Gastric Cancer Combo Granted Priority Review by NMPA

Shanghai Henlius Biotech Inc. announced that its New Drug Application (NDA) for HANSIZHUANG (serplulimab injection) in combination with chemotherapy for neo-/adjuvant treatment of gastric cancer has been accepted by the National Medical Products Administration (NMPA) of China and has been granted priority review. This regulatory milestone follows the achievement of the primary endpoint in a Phase 3 clinical trial in mainland China. No other organizations were mentioned as recipients of this regulatory review.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251212-11953671), on December 12, 2025, and is solely responsible for the information contained therein.

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