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Junshi Biosciences Announces Positive Opinion from the European Medicines Agency’s CHMP For Toripalimab

Junshi Biosciences Announces Positive Opinion from the European Medicines Agency’s CHMP For Toripalimab

SHANGHAI, July 26, 2024 (Korea Bizwire) – 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 Committee for Medicinal Products for Human Use (CHMP) of the [...]

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

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 (Korea Bizwire) – 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: [...]

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Advanced TNBC

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Advanced TNBC

SHANGHAI, June 25, 2024 (Korea Bizwire) – 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 supplemental new drug application (sNDA) for toripalimab (product code: JS001) in [...]

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Small Cell Lung Cancer

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Small Cell Lung Cancer

SHANGHAI, June 18, 2024 (Korea Bizwire) – 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 supplemental new drug application (sNDA) for toripalimab (product code: JS001) in [...]

Junshi Biosciences Announces Phase 3 Study of Toripalimab Combined with Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint

Junshi Biosciences Announces Phase 3 Study of Toripalimab Combined with Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint

SHANGHAI, Jun. 11 (Korea Bizwire) — 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 primary endpoints of progression-free survival (“PFS,” based on independent radiographic review) and overall survival (“OS”) of a multi-center, randomized, open-label, [...]

Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab

Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab

SHANGHAI, China, Apr. 24 (Korea Bizwire) — 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 Drug Office, Department of Health, the Government of the Hong Kong Special Administrative Region (“DO”) has recently accepted the [...]

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

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

SHANGHAI, China, April 07, 2024 (Korea Bizwire) – 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 supplemental new drug application (“sNDA”) for toripalimab (product code: JS001) [...]

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

SHANGHAI, China, March 29, 2024 (Korea Bizwire) – 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 its financial results for the full year of 2023 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue was approximately RMB1,503 [...]

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

SHANGHAI, China, Feb. 01, 2024 (Korea Bizwire) – 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 Singapore Health Sciences Authority (“HSA”) had accepted the New Drug Application (“NDA”) for toripalimab, both in combination with [...]

Junshi Biosciences Announces JAMA Publication of Results from NEOTORCH, a Randomized Phase 3 Trial of Perioperative Toripalimab plus Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

Junshi Biosciences Announces JAMA Publication of Results from NEOTORCH, a Randomized Phase 3 Trial of Perioperative Toripalimab plus Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

SHANGHAI, China, Jan. 17, 2024 (Korea Bizwire) – 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 the publication of results from the prespecified interim analysis for event-free survival (EFS) in patients with stage III non-Small Cell [...]