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Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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Junshi Biosciences Reports Q3 2024 Financials with Revenue Growth and Narrowed Losses
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Junshi Biosciences (HKG: 1877; SHA: 688180) has released its financial results for the third quarter of 2024, reporting revenues of RMB 1.271 billion (USD 178.36 million) for the first three quarters, marking a 28.87% year-on-year (YOY) increase, and a net loss of RMB 927 million (USD 130 million). The third…
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Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under…
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Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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Shanghai Junshi Biosciences Inks Licensing Deal for IAMA-001 Nasal Spray with Nanjing JSIAMA
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Nanjing JSIAMA Biopharmaceutical Co., Ltd. This deal grants Junshi the rights to research and develop, manufacture, file for regulatory approval, commercialize, and hold other interests…
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Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Junshi Biosciences Logs 17.37% Revenue Growth in 2024H1, Fueled by Loqtorzi Sales Surge
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SHANGHAI—Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced its financial results for the first half of 2024, reporting a 17.37% year-on-year increase in revenue to RMB 786 million. The net loss attributable to shareholders narrowed by RMB 352 million compared to the same period last year, reaching…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This…
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Junshi Biosciences’ Subsidiary Secures EU GMP Certification, Strengthening Loqtorzi’s Market Prospects
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that its wholly-owned subsidiary, Suzhou Zhonghe Biomedical Technology Co., Ltd., has obtained the Certificate of GMP Compliance from the European Medicines Agency following a successful inspection by the Ireland Health Products Regulatory…
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Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
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Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
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Shanghai Junshi Biosciences’ Toripalimab Aims for Singapore Approval in Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has submitted market approval applications in Singapore for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug is proposed for use as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)…
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Shanghai Junshi Biosciences Forecasts 6.02% Revenue Growth in 2023 Driven by Commercialized Products
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a biopharmaceutical company based in China, has released its financial forecast for 2023. The company anticipates generating RMB 1.541 billion in revenues, marking a 6.02% year-on-year (YOY) increase. Junshi Biosciences’ research and development expenses for the period are estimated at RMB…
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China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
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The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
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Junshi Biosciences Regains Global Rights to JS006 as Coherus Terminates Licensing Agreement
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Junshi Biosciences (HKG: 1877; SHA: 688180), based in Suzhou, has announced the termination of its licensing agreement with US-based Coherus BioSciences Inc. (NASDAQ: CHRS) concerning the T cell immunoglobulin and ITIM domains (TIGIT) monoclonal antibody CHS-006/JS006. The original licensing deal, established in February 2021, granted Coherus exclusive rights to Junshi’s…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
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Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
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Coherus Biosciences Sets Price for PD-1 Inhibitor Loqtorzi at $8,892.03, Offering 20% Discount Compared to Keytruda
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Coherus Biosciences Inc. (NASDAQ: CHRS) announced yesterday in an SEC filing the wholesale price for its newly launched PD-1 inhibitor, Loqtorzi (toripalimab), in the U.S. market. The drug, co-developed under license from Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877; SHA: 688180), will retail at $8,892.03 per single-use vial. Loqtorzi received…
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Coherus’s Loqtorzi Gains FDA Approval for Nasopharyngeal Carcinoma Treatment
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Coherus Biosciences (NASDAQ: CHRS) executives held an investor conference call on October 30, 2023, to discuss the recent US FDA approval for Loqtorzi (toripalimab) as both a first- and second-line treatment for nasopharyngeal carcinoma (NPC). This approval, co-developed with Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), marks a…
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Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
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CNIPA Upholds Alnylam’s PCSK9-Targeted siRNA Patent Against Junshi Biosciences Challenge
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The China National Intellectual Property Administration (CNIPA) has rejected another challenge from Junshi Biosciences (SHA: 688180) against an Alnylam Pharmaceutical (NASDAQ: ALNY) patent (ZL201810143112.0) related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. This decision ensures the patent’s validity remains intact until December 5, 2033. Details of the Patent…
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Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
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Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study…
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Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
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CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
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The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences (SHA: 688180) against a patent held by Alynlam Pharmaceutical (NASDAQ: ALNY), which is related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. CNIPA’s decision to fully maintain Patent No. 561449, associated with application number…
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Shanghai Junshi Biosciences to Acquire Stake in Anlingke Biopharmaceutical for Cancer Therapy Programs
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced its intention to acquire a 9.45% stake in start-up biopharma company Shanghai Anlingke Biopharmaceutical Co., Ltd for a consideration of RMB 30.6 million. This strategic acquisition is set to be completed through the transfer of two cancer therapy…
