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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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CanSino Biologics Launches Phase III Study for Menhycia Vaccine in Indonesia
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China-based CanSino Biologics (HKG: 6185) has announced the launch of a Phase III clinical study for its ACYW135 Meningococcal Conjugate Vaccine (CRM197), branded as Menhycia, in Indonesia, with the first subject already enrolled. This pivotal study aims to evaluate both the safety and immunogenicity of the vaccine in individuals aged…
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Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
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Jenscare Scientific Completes Enrollment in Clinical Study for Mitral Valve Repair System
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, has announced the successful completion of patient enrollment in a confirmatory study for its flagship product, the JensClip transcatheter mitral valve repair and clamping system. The system is designed to address severe mitral regurgitation,…
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Lynk Pharmaceuticals Doses First Patient in Phase III Trial for Atopic Dermatitis Treatment
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Lynk Pharmaceuticals Co., Ltd, based in China, has announced the dosing of the first patient in a Phase III clinical study for its highly selective JAK1 inhibitor, LNK01001, aimed at treating atopic dermatitis (AD). This randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of LNK01001 in…
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HutchMed Launches Phase II/III Study for Sovleplenib in Autoimmune Hemolytic Anemia
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of the Phase II/III ESLIM-02 study for its investigational drug, sovleplenib, in patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The ESLIM-02 trial is a randomized, double-blind, placebo-controlled study aimed at confirming the safety and efficacy of…
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Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
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Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
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CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, SYH2039, which targets advanced malignant tumors. SYH2039 is a potent inhibitor of methionine adenosine…
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China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding…
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Sino Biopharmaceutical Advances Lanifibranor and TQA2225 into Late-Stage Clinical Trials for MASH
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the commencement of Phase III and Phase II clinical studies for two of its drug candidates. Lanifibranor, a PPAR agonist, and TQA2225, an FGF21-Fc fusion protein, are both being evaluated as potential treatments for metabolic dysfunction-associated…
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Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
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Merck Plans Broader HPV Vaccine Development, Targeting African and Asian Populations
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled plans to develop a multi-valent human papillomavirus (HPV) vaccine aimed at providing broader protection than the currently approved 9-valent Gardasil 9. This new candidate will include additional virus-like particles (VLPs) targeting HPV types that disproportionately affect populations in Africa and Asia,…
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Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) has received clearance from the National Medical Products Administration (NMPA) in China to commence a Phase I clinical study of its AST2169 liposome. This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST2169 in patients with advanced solid tumors…
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Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
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Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
