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CANbridge Pharmaceuticals Doses First Patient in CAN108 Biliary Atresia Study
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that the first patient has been dosed in the Phase II EMBARK study of CAN108 (maralixibat) for biliary atresia (BA). The global, multi-center, randomized, controlled trial aims to enroll 72 patients, including 20 in China, to evaluate the drug’s efficacy…
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Xellsmart’s iPSC Therapy XS-228 Receives FDA Approval for ALS Study
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Suzhou-based stem-cell startup Xellsmart announced that the U.S. FDA has approved its regulatory study of XS-228, an iPSC-derived neural precursor cell therapy, for amyotrophic lateral sclerosis (ALS). The therapy, designed to provide a universal cell treatment for ALS patients, received orphan drug designation (ODD) from the FDA in December 2023.…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for OSA Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its HDM1005, a long-acting GLP-1/GIP receptor agonist, has received clinical trial approval from the National Medical Products Administration (NMPA) for obstructive sleep apnea (OSA) combined with obesity or overweight. The drug previously received nods for type 2 diabetes, weight loss, and…
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CanSino Biologics Receives NMPA Approval for DTcP Hib MCV4 Combined Vaccine
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China-based vaccine specialist CanSino Biologics Inc. (HKG: 6185) announced that its absorbed diphtheria, tetanus, acellular pertussis (DTcP), Haemophilus influenzae type b (Hib), and Group ACYW135 meningococcal (MCV4) combined vaccine has received clinical trial approval from the National Medical Products Administration (NMPA). The single-dose vaccine aims to provide comprehensive immune protection…
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CSPC Pharmaceutical Initiates Phase III Trial for Ammuxetine in Depression Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced the start of a Phase III clinical trial for its Category 1 chemical drug ammuxetine at the Shanghai Mental Health Center, a top-tier Class 3A mental hospital. Drug ProfileAmmuxetine, a small molecule SNR inhibitor discovered by the Chinese Academy of Military Medical…
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Joyo Pharma’s JYP0015 Receives CDE Approval for RAS Mutation Cancer Trials
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China’s Center for Drug Evaluation (CDE) has tacitly approved Joyo Pharma’s Category 1 drug JYP0015, a molecular glue product, for clinical studies in hematological and solid tumors with RAS mutations. The approval follows positive preclinical data and a strategic licensing deal with U.S.-based Erasca, Inc. Drug ProfileJYP0015, a novel pan-RAS…
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Zhejiang Huahai Pharma’s HB0056 Receives NMPA Approval for Asthma Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development. Clinical…
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Corxel Pharmaceuticals to Test JX10 in Acute Ischemic Stroke Patients with NMPA Approval
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China-based Corxel Pharmaceuticals (CORXEL) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the functional recovery of acute ischemic stroke (AIS) patients treated with JX10 within a time window of 4.5 to 24 hours from the “last known well.” Drug ProfileJX10 is an…
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Boehringer Ingelheim Launches LENTICLAIR Study for CF Gene Therapy BI 3720931
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German pharmaceutical company Boehringer Ingelheim announced the initiation of the Phase I/II LENTICLAIR study for its gene therapy candidate BI 3720931 in cystic fibrosis (CF). The study is being conducted in collaboration with IP Group, the UK Respiratory Gene Therapy Consortium (GTC), and OXB. Study DetailsBI 3720931 is an inhaled…
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Phanes Therapeutics Doses First Patient in Peluntamig Study for SCLC and NEC
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Sino-US biotech Phanes Therapeutics Inc. announced that the first patient has been dosed in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy. The trial focuses on patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). Drug ProfilePeluntamig is a bispecific antibody (BsAb) targeting DLL3 and CD47.…
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Hepalink Pharmaceutical’s H1710 Heparanase Inhibitor Approved for Phase I Study
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of its proprietary drug candidate H1710, a heparanase (HPA) inhibitor, for the treatment of advanced solid tumors. Drug ProfileH1710 is designed…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical study of its antibody drug conjugate (ADC), BL-M07D1, for the treatment of HER2 positive breast cancer. The trial will evaluate BL-M07D1 in combination…
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InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
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Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR4 Phase III Study for Diabetes
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase III clinical study for GZR4, its Category 1 therapeutic biologic product. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Drug ProfileGZR4 aims to provide a convenient…
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Zelgen Biopharmaceuticals’ ZG005 Bispecific Antibody Receives NMPA Approval for Biliary Tract Cancer Trials
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate ZG005. The Category 1 biologic product will be tested in combination with a platinum-containing chemotherapy regimen for advanced biliary tract cancer. Drug ProfileZG005…
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Biokin Pharmaceutical Registers Phase III Study for BL-B01D1 in EGFR Mutant NSCLC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has registered a Phase III study on chinadrugtrials.org.cn to evaluate the efficacy of BL-B01D1 combined with osimertinib versus osimertinib alone as a first-line therapy for EGFR mutant locally advanced or metastatic non-small cell lung cancer (NSCLC). The study, led by Professor Zhou Caicun…
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Kexing Biopharm’s GB05 Receives FDA Approval for Pediatric RSV Infections
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its human interferon α1b inhalation solution, GB05. The drug is designed to treat pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as…
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Konruns Pharmaceutical’s KC1036 Enters Phase II Trial for Ewing’s Sarcoma in Adolescents
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced the first patient dosing in a Phase II clinical study of its KC1036 for adolescents aged 12 and above with advanced Ewing’s sarcoma (ES). Drug DetailsKC1036 is a Category 1.1 chemical drug and a tyrosine kinase inhibitor (TKI) targeting AXL, VEGFR2, and…
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Hengrui’s Vunakizumab Receives NMPA Approval for nr-axSpA Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its IL-17A monoclonal antibody (mAb), vunakizumab. The Chinese company plans to study the drug as a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). Drug BackgroundVunakizumab is intended…
