Junshi Biosciences Announces Toripalimab Obtained Approval for Marketing in India and China’s Hong Kong SAR

>TopAlliance Biosciences Inc. (TopAlliance Biosciences), announce that toripalimab (Indian trade name: ZYTORVI®, Hong Kong trade name: LOQTORZI®) has been approved for marketing in India and China’s Hong Kong Special Administrative Region (“SAR”), for treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). The approved indications are: 1) toripalimab in combination with cisplatin and gemcitabine, for first line treatment of adults with metastatic or with recurrent, locally advanced NPC; 2) toripalimab as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Zytorvi® shall be imported and commercialized in India by Dr. Reddy’s Laboratories Ltd.

Junshi Biosciences Announces Ongericimab’s NDA Approval in China

>SHANGHAI, China, October 11, 2024 -- 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 approved the new drug application (“NDA”) for ongericimab injection, a recombinant human anti-PCSK9 monoclonal antibody injection (trade name: Junshida (君适达)®) for the treatment of primary hypercholesterolemia and mixed dyslipidemia (in combination with statins) , making it the company’s fifth commercial product.

Junshi Biosciences Announces European Commission Approval for Marketing of Toripalimab

>SHANGHAI, China, September 24, 2024 -- 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, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announce that the European Commission (EC) has approved toripalimab (European trade name: LOQTORZI®) for the treatment of two indications

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

>The NMPA has approved the supplemental new drug application for toripalimab in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma