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CStone Pharmaceuticals Partners with Pharmalink for Suemalimab Commercialization in MENA and South Africa
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a strategic commercial collaboration with Pharmalink Store – L.L.C – O.P.C (Pharmalink), a prominent pharmaceutical company based in the United Arab Emirates (UAE), concerning its anti-PD-L1 monoclonal antibody (mAb) sugemalimab. Commercial Rights and Deal TermsUnder the agreement, Pharmalink will acquire the commercial rights…
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CStone Pharmaceuticals Presents CS5001 Clinical Data at the ASH Annual Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the presentation of the latest clinical data on CS5001, an anti-ROR1 antibody drug conjugate (ADC) for lymphoma, at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 is a leading asset in CStone’s Pipeline 2.0 and has shown significant promise in treating…
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CStone Pharmaceuticals’ Sugemalimab Wins UK Approval for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
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CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
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CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
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CStone Pharmaceuticals’ Sugemalimab Shows Promising Long-Term Survival Data at ESMO 202
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has presented long-term treatment and survival data for sugemalimab at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The data comes from the GEMSTONE-302 study, which combines sugemalimab with platinum-based chemotherapy. The Phase III trial, a multicenter, randomized,…
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CStone Pharmaceuticals Reports 2024 Interim Results with Strategic Collaborations and Regulatory Milestones
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CStone Pharmaceuticals, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2616), has reported its interim financial results for 2024, along with key business highlights. For the six months ending June 30, 2024, the company’s revenue reached RMB 254.2 million, which includes RMB 118.3…
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CStone to Manufacture Gavreto Locally Following NMPA Approval, Expanding Market Presence
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg), transitioning from overseas supply. Domestic production is anticipated to begin by late this year or early next year, following the approval of the 300mg…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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CStone Pharmaceuticals Gets NMPA Green Light for Local Production of Gavreto
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to begin local manufacturing of Gavreto (pralsetinib tablets, 300mg), moving away from overseas supply. The company anticipates that domestic production will start by the end…
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CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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Chinese Biopharma Companies Set to Showcase Oncology Pipelines at ASCO 2024
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A cohort of Chinese biopharmaceutical companies, including Wuhan YZY Biopharma Co., Ltd (HKG: 2496), Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), JW Therapeutics (HKG: 2126), and CStone Pharmaceuticals (HKG: 2616), are preparing to present updates on their pipeline products at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting,…
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CStone Pharmaceuticals Expands European Reach with Ewopharma Partnership for Sugemalimab
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced a strategic partnership with Ewopharma, granting the European firm commercialization rights to its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab across Switzerland and 18 Central and Eastern European Countries (CEECs). The CEECs include EU member states such as Bulgaria,…
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CStone Pharmaceuticals Submits New Drug Application for Gavreto in China, Eyes Local Manufacturing
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto…
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Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
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Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
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CStone Pharmaceuticals Regains Exclusive Rights to Tibsovo in Greater China and Singapore
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced an agreement with French pharmaceutical company Servier that returns exclusive development, manufacturing, and commercialization rights to Tibsovo (ivosidenib) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, as well as Singapore. Originally developed by US-based Agios Pharmaceuticals,…
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CStone Pharmaceuticals Disbands Sales Team for Gavreto After NRDL Setback
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CStone Pharmaceuticals (HKG: 2616) has confirmed media reports regarding the dismissal of its sales team for Gavreto (pralsetinib), marking a significant shift in the Chinese company’s commercial strategy for its first product to reach the market. Gavreto, which was licensed to Allist Pharmaceuticals Co., Ltd in November 2023, did not…
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Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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CStone Pharmaceuticals Enters Licensing Agreement with Allist Pharmaceuticals for Gavreto in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a licensing agreement with Allist Pharmaceuticals Co., Ltd, granting the Shanghai-based biotech exclusive commercial promotion rights to Gavreto (pralsetinib) in mainland China. CStone retains development, regulatory filing, and other rights excluding promotion in mainland China. Under the agreement, CStone will receive an undisclosed…
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3SBio Inc. and CStone Pharmaceuticals Enter Strategic Partnership for Nofazinlimab
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China-based 3SBio Inc., (HKG: 1530) has announced a strategic partnership and exclusive licensing agreement with compatriot firm CStone Pharmaceuticals (HKG: 2616), focusing on CStone’s anti-programmed death-1 (PD-1) antibody, nofazinlimab. This partnership signifies a significant expansion in the immuno-oncology space for both companies. Financial Terms and Agreement DetailsUnder the terms of…
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CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
