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Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for Two Cancer Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
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AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
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Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
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Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its drug candidate, HPG7233. This small-molecule thyroid hormone receptor beta (THR-β) agonist is poised for development as a treatment for non-alcoholic steatohepatitis (NASH) and…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approval for Two Novel Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
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Eli Lilly Partners with Boundless Bio to Develop CHK1 Inhibitor for Solid Tumors
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Eli Lilly (NYSE: LLY) has announced a partnership with precision oncology specialist Boundless Bio to clinically develop Boundless’s CHK1-targeting small-molecule inhibitor (SMI) BBI-355 in combination with Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib). This collaboration aims to target locally advanced or metastatic solid tumors with oncogene amplifications, with Boundless highlighting its candidate…
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Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from the Food and Drug Supervisory Agency of Indonesia to initiate a Phase III clinical study for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine. Study Design and ObjectivesThe Phase III study is a randomized, blinded,…
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Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb), for the treatment of moderate to severe chronic obstructive pulmonary…
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Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
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Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational injectable drug, NCB003. This next-generation targeted coupling long-acting human interleukin-2 (IL-2) drug is being developed to treat patients…
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Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
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Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
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InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced that it has received the green light to conduct a clinical study in China for its drug candidate ICP-189, in combination with ArriVent Biopharma Inc.’s furmonertinib, for the treatment of advanced non-small cell lung cancer (NSCLC). The collaboration between InnoCare and…
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Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
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Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the Brightline-2 study in China. The study will assess the safety and efficacy of the company’s MDM2-p53 antagonist, brigimadlin (BI 907828), in patients with locally advanced/metastatic, MDM2 amplification, TP53 wild-type…
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Gan & Lee Pharmaceuticals Initiates Phase II Clinical Study for Weekly Insulin GZR4
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the dosing of the first patient in a Phase II clinical study for its Category 1 therapeutic biologic product, GZR4. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Design and Objectives of…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for HRS-7450 Acute Ischemic Stroke Study
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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 conduct a clinical study for its investigational drug HRS-7450 in patients with acute ischemic stroke. HRS-7450: A Next-Generation Thrombolytic DrugHRS-7450 is…
