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InnoCare Pharma Doses First Patient in ICP-488 Study for Autoimmune Diseases
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China-based InnoCare Pharma (HKG: 9969) announced that the first subject has been dosed in a clinical study for ICP-488, its TYK2 JH2 allosteric inhibitor. The drug is being developed for autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD). Mechanism of ActionICP-488 is a potent and selective inhibitor of…
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Eccogene Receives FDA Approval for ECC4703 Phase I Study in NASH and Dyslipidemia
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Shanghai-based biopharmaceutical company Eccogene announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for ECC4703, a thyroid hormone receptor (THR) agonist. The study will assess the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and subjects with elevated…
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Lion TCR Enrolls First Patient in LioCyx-M004 Study for HBV-Related Liver Cancer
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Singapore-based clinical-stage biotech Lion TCR announced the enrollment of the first subject in a clinical study for LioCyx-M004, its autologous T-cell therapy targeting HBV-related hepatocellular carcinoma (HCC). The therapy uses mRNA-engineered T-cells to recognize and destroy hepatitis B virus (HBV)-related liver cancer cells. Therapy DetailsLioCyx-M004 leverages Lion TCR’s RNA technology…
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Innovent and Laekna Dose First Patient in Afuresertib and Tyvyt Study for PD-1 Resistant Tumors
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China’s Innovent Biologics Inc. (HKG: 1801) and partner Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in a Phase I/II clinical study (NCT05383482) evaluating afuresertib combined with Tyvyt (sintilimab) plus chemotherapy in solid tumors resistant to PD-1/PD-L1 inhibitors. Study DetailsThe multi-center, single-arm, open-label, dose-escalation study…
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Mabwell Bioscience Gets FDA Approval for Nectin-4 ADC 9MW2821 in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials…
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LaNova Medicines Gets FDA Green Light for LM-305 Myeloma Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I/II study of LM-305, an antibody drug conjugate (ADC) targeting GPRC5D, in patients with multiple myeloma (MM). Drug ProfileLM-305 is the first GPRC5D-targeting ADC…
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MabPharm’s CMAB015 Biosimilar Receives NMPA Approval for Clinical Study
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Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its CMAB015, a biosimilar of Novartis’ Cosentyx (secukinumab). The study will target psoriasis and ankylosing spondylitis. Drug ProfileCosentyx was first approved…
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Nuance Pharma Initiates Phase I Study for Ketorolac IV Infusion (NTM-001)
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China-based Nuance Pharma announced the initiation of subject enrollment and the first drug infusion in a Phase I clinical study for its ketorolac for IV infusion (NTM-001), a non-opioid analgesic co-developed with US-based Neumentum Inc. Study DetailsThe Phase I study enrolled 16 healthy subjects, who have completed the 96-hour sample…
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SinoPharm CNBG’s F61 Monoclonal Antibody Receives NMPA Clinical Trial Approval
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SinoPharm CNBG Wuhan Institute of Biological Products Co., Ltd’s F61, a recombinant broad-spectrum novel coronavirus monoclonal antibody (mAb), has received clinical trial approval from the National Medical Products Administration (NMPA). Development and ResearchF61 was co-developed by Yang Xiaoming’s team with CNBG and Liang Mifang’s team from the Chinese Center for…
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Betta Pharmaceuticals Enrolls First Patient in BPI-442096 Phase I Study for Solid Tumors
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China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
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Sirnaomics’ STP705 Receives Approval for Liver Cancer Trial in Taiwan
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced that it has received approval from the Ministry of Health and Welfare of Taiwan to conduct a Phase I clinical study of its therapeutic candidate STP705 for advanced liver cancer. Drug ProfileSTP705 is a siRNA (small interfering RNA) therapeutic that leverages…
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Ascentage Pharma’s Olverembatinib Receives Health Canada Approval for Phase Ib Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from Health Canada to conduct a Phase Ib clinical study of its third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), olverembatinib (HQP1351), for drug-resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Study DetailsThe open-label, multi-center, randomized, global…
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Ji Xing Pharmaceuticals Enrolls First Patient in OC-01 Phase III Study for Dry Eye
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that the first patient has been enrolled in a Phase III clinical study for its OC-01 (varenicline) nasal spray in China. The study aims to evaluate the efficacy and safety of OC-01 in treating dry eye and neurotrophic keratopathy. Drug ProfileOC-01…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR18 Phase II Study for Diabetes and Obesity
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase II clinical study for its Category 1 biologic product GZR18, a novel glucagon-like peptide-1 (GLP-1) receptor agonist designed for once-weekly administration. Study DetailsThe Phase Ib/IIb study will evaluate the safety, tolerability, pharmacokinetics,…
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CANbridge Pharmaceuticals Doses First Patient in CAN103 Gaucher Disease Trial
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China-based rare disease firm CANbridge Pharmaceuticals announced the dosing of the first patient in a Phase I/II clinical trial for CAN103, its enzyme replacement therapy (ERT) candidate, in treatment-naïve patients with type I and III Gaucher disease. The trial marks progress in CANbridge’s partnership with WuXi Biologics (HKG: 2269) to…
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DAC Biotech’s DXC005 ADC Doses First Patient in Beijing Cancer Hospital Trial
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing of its antibody drug conjugate (ADC) DXC005 in a clinical study at Beijing Cancer Hospital’s gastrointestinal oncology department. The trial marks progress in DAC Bio’s pipeline of oncology-focused ADC candidates. Drug ProfileDXC005 combines a MUC-1 targeting antibody…
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MicroPort CardioFlow Completes First Clinical Use of Dry Valve Transcatheter Mitral Valve System
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), announced the successful completion of the first clinical application of its transcatheter mitral valve replacement (TMVR) system. The procedure demonstrated the system’s safety and efficacy, with postoperative mitral regurgitation resolved and no complications such…
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Kexing Pharmaceutical Launches Phase III Influenza Vaccine Study in Chile
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China-based Kexing Pharmaceutical (SHA: 688136) announced the start of a Phase III clinical trial in Chile to evaluate the safety and immunogenicity of its quadrivalent influenza virus split vaccine in individuals aged three and older. The vaccine received market approval in China in June 2020. Study DetailsThe trial will enroll…
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Henlius Biotech’s HLX14 Biosimilar Wins TGA Approval for Global Phase III Osteoporosis Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA) to conduct a global multi-center Phase III study of HLX14, its biosimilar of Amgen’s Prolia/Xgeva (denosumab), targeting postmenopausal osteoporosis in high-fracture-risk women. Study DetailsThe trial will evaluate the efficacy, safety, tolerability, and immunogenicity of HLX14…
