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CStone Pharmaceuticals Reports 2024 Results with License Fee Growth Offsetting Drug Sales Decline
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China-based CStone Pharmaceuticals (HKG: 2616) reported its 2024 financial results and recent business highlights. Revenues reached RMB 407.2 million (USD 56.1 million), a 12.2% year-on-year (YOY) decrease. This consisted of RMB 175 million (USD 24.1 million) in pharmaceutical product sales and RMB 232 million (USD 32 million) in license fee…
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CStone Pharmaceuticals Files for EMA Approval of Sugemalimab for Unresectable Stage III NSCLC
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China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) with the European Medicines Agency (EMA). The application seeks approval for sugemalimab’s use in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not…
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CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid…
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CStone Pharmaceuticals and SteinCares Ink Licensing Deal for PD-L1 Inhibitor in Latin America
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China-based CStone Pharmaceuticals (HKG: 2616) and Costa Rica-based drug maker and distributor SteinCares have entered into a licensing agreement. Under the terms of the agreement, SteinCares will obtain exclusive commercialization rights to CStone’s anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) in the Latin American market, including Brazil, Argentina,…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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CStone Pharmaceuticals Partners with SteinCares for Sugemalimab Commercialization in Latin America
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CStone Pharmaceuticals (HKG: 2616), a China – based biopharmaceutical company focused on oncology drug development, announced on January 27 a strategic commercialization partnership with SteinCares, a leading pharmaceutical company in the Latin American market. Under the licensing and commercialization agreement, SteinCares will obtain the rights to commercialize sugemalimab in 10…
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CStone Pharmaceuticals Initiates First-in-Human Trial for PD-1/VEGF/CTLA-4 Trispecific Antibody CS2009
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the clinical filing for its CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. This first-in-human study is registered and published on Clinicaltrials.gov with the NCT number: NCT06741644. Innovative Design and Mechanism of CS2009CS2009 boasts an innovative molecular design that simultaneously targets PD-1, VEGFA, and…
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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…
