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Hanx Biopharmaceuticals Gains NMPA Approval for HX044 Clinical Trials
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China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global…
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Likang Life Sciences Gains FDA Approval for LK101 Clinical Trials
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Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical trials for its LK101, an mRNA neoantigen vaccine. This marks a significant milestone in the development of personalized cancer treatments. Innovative Vaccine TechnologyLK101 is an innovative…
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Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
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Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its BPI-452080 in von Hippel-Lindau (VHL) syndrome-related tumors and solid tumors. This marks a significant step forward in the development of new treatments for…
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Haisco’s HSK39004 Gains NMPA Approval for COPD Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HSK39004. The targeted small molecule inhibitor is now cleared to be assessed in clinical trials for chronic obstructive pulmonary disease (COPD), marking a significant step…
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Junshi Biosciences Receives NMPA Approval for JS213 Clinical Trials
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its JS213 sterile powder for injection. The drug is intended for use in combination with other anti-tumor drugs or as a standalone treatment for advanced…
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Harbour BioMed Receives NMPA Clearance for COPD Treatment HBM9378/SKB378
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China-based biopharmaceutical company Harbour BioMed (HKG: 2142) has announced receiving clinical clearance from China’s National Medical Products Administration (NMPA) for its investigational drug HBM9378/SKB378, also known as WIN378. This fully human antibody targets thymic stromal lymphopoietin (TSLP) and is intended for the treatment of chronic obstructive pulmonary disease (COPD). Drug…
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MediLink Therapeutics’ YL217 Receives FDA IND Clearance for Novel ADC Targeting Gastrointestinal Cancers
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MediLink Therapeutics, a clinical-stage biotech company, announced today that its internally developed antibody-drug conjugate (ADC), YL217, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). YL217 is the 11th ADC candidate to enter clinical development based on MediLink’s proprietary TMALIN® platform. YL217: A Novel…
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BioCity Biopharma Launches Phase III Study for Kidney Disease Drug SC0062
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BioCity Biopharma, a leading biopharmaceutical company, has announced the initiation of a Phase III clinical study for its kidney disease drug SC0062 at the Guangdong Provincial People’s Hospital, the leading institution for the study. The study, named SUCCESS-01, aims to evaluate the efficacy and safety of SC0062 capsules in patients…
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Shenzhen Beike Initiates First Chinese Stem Cell Study for Systemic Lupus Erythematosus
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China-based stem cell specialist Shenzhen Beike Biotechnology Co., Ltd has announced the initiation of a Phase I/II clinical study for human umbilical cord mesenchymal stem cells in patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first regulatory study for stem cell therapy targeting SLE in China,…
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YolTech Initiates Study for YOLT-204 in Transfusion-Dependent Beta-Thalassemia
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Shanghai-based YolTech Therapeutics, a biotech startup specializing in lipid nanoparticle delivery and gene editing, has announced the initiation of a dosage escalation study to preliminarily assess the safety and efficacy of a single-dose regimen with YOLT-204 in transfusion-dependent beta-thalassemia (TDT). This marks a significant step forward in the development of…
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Haichang Bio’s siRNA Drug HC016 Cleared for US Clinical Trials
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China-based Zhejiang Haichang Biotech Co., Ltd has announced that its siRNA drug, HC016 complex lipid, has been cleared by the US Food and Drug Administration (FDA) for clinical trials. This marks a significant milestone in the development of innovative treatments for solid tumors, leveraging Haichang Bio’s proprietary QTsome technology platform.…
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Haisco’s HSK44459 Approved for Clinical Trials in Behcet’s Disease
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its investigational product HSK44459 in Behcet’s disease. This rare disease is listed in China’s second catalogue of rare diseases, highlighting the significant unmet medical need it represents. Behcet’s…
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Belief BioMed’s BBM-D101 Receives FDA Approval for DMD Clinical Trial
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China-based gene therapy specialist Belief BioMed Inc. (BBM) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its BBM-D101. An open, single-dose clinical study is scheduled to commence, assessing the safety and efficacy of the gene therapy in boys aged 4 to 9 with…
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United Laboratories’ UBT251 Approved for Phase II Trials in Chronic Kidney Disease
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical trials for its Category 1 drug UBT251 in chronic kidney disease (CKD). This marks a significant step forward in the development of innovative therapies for…
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CD Biopharma Initiates Phase I Trial for CD-001 in Advanced Solid Tumors
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Suzhou-based tumor immunotherapy specialist CD Biopharma has announced the first subject dosing of a Phase I study for its novel anti-tumor drug CD-001 in patients with advanced solid tumors. The patient is reported to be stable with all indicators being normal. This milestone marks the beginning of clinical evaluation for…
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Humanwell’s HWH340 Receives Clinical Approval for Prostate Cancer Treatment
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that its Class 1 chemical drug HWH340 has received clinical approval from the National Medical Products Administration (NMPA). The drug is indicated for use in combination with abiraterone acetate for the treatment of advanced prostate cancer. This approval marks a significant…
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Jiangsu Lianhuan Completes Enrollment for Phase III Study of LH-1801 in Type 2 Diabetes
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China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) has announced the completion of subject enrollment for the Phase III clinical study of its Category 1 drug LH-1801, in combination with metformin. The study aims to evaluate the efficacy and safety of LH-1801 in treating type 2 diabetes, building on its…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study
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Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China’s first domestically developed innovative HIV therapy. The study will assess the drug’s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients…
