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Hengrui Pharmaceuticals Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
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Laekna’s Anti-ActRIIA Antibody LAE102 Clears FDA Hurdle for Obesity Treatment Trial
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Sino-American biotech firm Laekna has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary monoclonal antibody, LAE102. The molecule is set to be evaluated as a potential treatment for obesity, a condition that affects a significant portion of the global…
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Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study for its Category 1 product, jacktinib cream, in adolescent and adult patients suffering from non-segmental vitiligo. Jacktinib, a Janus kinase (JAK) inhibitor, exhibits…
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Haisco Pharmaceutical Gets NMPA Green Light for HSK31858 COPD Trial
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK31858. The drug, a reversible dipeptidyl peptidase 1 (DPP1) inhibitor, is now approved for assessment in chronic obstructive…
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Yantai Dongcheng Secures Approval for Phase I Study of 68Ga-LNC1007 in Singapor
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Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has received approval from the Health Sciences Authority of Singapore to initiate a Phase I clinical study for its radiopharmaceutical candidate, 68Ga-LNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3, and is being developed to aid in the treatment…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
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Jiangsu Hengrui Pharmaceuticals Advances Pipeline with NMPA Approvals for Three Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
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Jiangsu Hengrui Pharmaceuticals Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
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Gan & Lee Pharmaceuticals Commences Clinical Trial for Innovative GLP-1 Agonist GZR18
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading Chinese pharmaceutical company, has announced the commencement of dosing in a Phase I clinical study for its investigational GLP-1 receptor agonist, GZR18 tablets. This oral formulation is designed to target GPRC5D, BCMA, and CD3, and is intended to treat patients with recurrent…
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Jiangsu Hengrui Pharmaceuticals Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Abbisko Therapeutics Achieves Milestone in Global Phase III Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the completion of subject enrollment and dosing in its ABSK021-301 study, a pivotal Phase III trial evaluating the efficacy and safety of its investigational drug ABSK021 (pimicotinib) in treating tendon sheath giant cell tumor (TGCT). This marks the first…
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Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
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Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
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Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HP501 in combination with febuxostat for the treatment of primary gout with hyperuricemia. This marks a significant step forward in addressing…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
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Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
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Shanghai Fosun Pharma and Meiji Seika Pharma Launch Phase III Studies for Anti-Infective Nacubactam
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced the commencement of two Phase III clinical studies in collaboration with Japan’s Meiji Seika Pharma. These studies are focused on their co-developed anti-infective, Nacubactam (OP0595), which is being tested in combination…
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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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Novatim Immune Therapeutics’ KQ-2003 Gains Tacit Approval for POEMS Syndrome Clinical Trial in China
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Novatim Immune Therapeutics (Zhejiang) Co., Ltd, a China-based specialist in cancer immunotherapy, has received tacit clinical trial approval from Chinese regulatory authorities for its investigational therapy, KQ-2003. This autologous chimeric antigen receptor (CAR)-T cell therapy targets BCMA and CD19 and is poised to be evaluated for the treatment of recurrent/refractory…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
