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Shanghai Junshi Biosciences' Supplementary NDA Accepted by Chinese Regulator
Shanghai Junshi Biosciences' (HKG:1877) supplemental new drug application (NDA) for toripalimab in combination with bevacizumab has been accepted by China's National Medical Products Administration.
Junshi Biosciences Announces the Acceptance of the Supplemental New Drug Application for Toripalimab Combined With Bevacizumab for the First-Line Treatment of Advanced Hepatocellular Carcinoma
SHANGHAI, July 17, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (NMPA) has accepted for review the supplemental new drug application (sNDA) for toripalimab (trade name: TUOYI, product code: JS001) combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
HKEX News | Junshi Biosciences (01877) rose more than 4% as the new application for Trelagliptin monoclonal antibody was accepted.
Junshi Bio (01877) rose more than 4%. As of press time, it rose 4.11% to HKD 13.16 with a turnover of HKD 4.2279 million.
Express News | Shanghai Junshi Biosciences - Received Acceptance Notice From National Medical Products Administration
Express News | Shanghai Junshi Biosciences - Acceptance of Supplemental New Drug Application for Toripalimab in Combination With Bevacizumab
Junshi Bio (688180.SH): The new indication for the combination of Toripalimab and Bevacizumab as first-line treatment for advanced hepatic cell carcinoma has been accepted for market application.
On July 17th, Gelunhui reported that Junshi Bio (688180.SH) received a "Notice of Acceptance" approved and issued by the National Medical Products Administration, and the application for new indications for Teriprizumab (trade name: Tuoyi) combined with Bevacizumab for first-line treatment of unresectable or metastatic liver cancer patients has been accepted for review.
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