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Sihuan Pharma’s Anaprazole Enters Phase II Study for Reflux Esophagitis
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its subsidiary Xuanzhu Biopharmaceutical Co., Ltd has received approval to proceed with a Phase II clinical study of anaprazole for the treatment of reflux esophagitis (RE) and associated symptoms, including acid reflux, heartburn, and retrosternal pain. Drug ProfileAnaprazole, the only…
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HutchMed Initiates Phase I Study of CD47 Monoclonal Antibody HMPL-A83 in China
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study for HMPL-A83, its monoclonal antibody (mAb) targeting CD47, in patients with advanced malignant tumors. The first patient was dosed on July 15, 2022. Study DetailsThe multi-center, open-label Phase I trial (NCT05429008) will evaluate the safety,…
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Kexing Pharmaceutical’s SHEN26 COVID-19 Drug Receives NMPA Approval for Clinical Trials
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China-based Kexing Pharmaceutical (SHA: 688136) announced that its oral small-molecule COVID-19 drug SHEN26, co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials. Drug ProfileSHEN26 is a novel coronavirus polymerase (RdRp) inhibitor that blocks viral nucleic acid synthesis.…
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Kelun Pharma’s SKB264 ADC Receives NMPA Green Light for Phase II Solid Tumor Study
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study in advanced solid tumors. The trial will assess SKB264 in…
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Beijing Science Sun’s LZ901 Shingles Vaccine Receives FDA IND Approval
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China-based Beijing Science Sun Pharmaceutical Co., Ltd (SHE: 300485) announced that its subsidiary Beijing Luzhu Biological Technology Co., Ltd has received IND approval from the US FDA for its recombinant shingles vaccine candidate, LZ901. The approval marks a milestone for China’s first homegrown shingles vaccine to enter global development. Vaccine…
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Hangzhou DAC Biotech Doses First Patient in DXC007 AML Study
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing in a Phase I clinical study of its antibody drug conjugate (ADC) DXC007 for relapsed/refractory (r/r) acute myeloid leukemia (AML). The open, multi-center, dosage escalation and expansion trial will assess the drug’s safety, tolerability, and pharmacokinetics. Drug…
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Zhejiang Medicine’s ARX305 ADC Receives Clinical Trial Approval for CD70-Positive Cancers
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) announced that its subsidiary NovoCodex Biopharmaceuticals Ltd has received approval to conduct a clinical study of ARX305, a Category 1 biologic drug targeting CD70 and AS269, for advanced tumors. The drug is designed to treat CD70-positive cancers, including renal cell carcinoma and multiple…
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Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA) has approved its injectable bispecific antibody (BsAb) JS203 for a clinical study in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The drug targets CD20 and CD3, leveraging these antigens to enhance tumor-inhibiting effects. Drug Profile…
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Hengrui Medicine’s SHR-1701 + Ameile Combo Greenlit for EGFR-Mutated NSCLC Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved an open, multi-center Phase Ib/II clinical study of its fusion protein SHR-1701 combined with Ameile (aumolertinib) for EGFR-mutated recurrent or advanced non-small cell lung cancer (NSCLC). Drug ProfileSHR-1701 targets PD-L1 and TGF-βRII,…
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Eucure Biopharma Doses First Patient in YH003 + Keytruda Trial for Mucosal Melanoma
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Eucure Biopharma, a subsidiary of Sino-US contract research organization Biocytogen, announced that the first patient has been dosed in a Phase II clinical study in China for a combination regimen of its CD40 monoclonal antibody (mAb) YH003 with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) and albumin paclitaxel. The trial targets first-line…
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Gan & Lee Pharmaceuticals’ GZR4 Ultra-Long-Acting Insulin Receives Clinical Trial Approval
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that its Category 1 therapeutic biologic product GZR4 has received clinical trial approval for treating diabetes. GZR4 is an ultra-long-acting insulin designed for once-weekly subcutaneous injection, addressing the need for more stable and convenient diabetes management. Product ProfileCurrent long-acting basal insulin analogs…
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Dizal Pharma’s DZD1516 Receives NMPA Green Light for HER2+ Breast Cancer Trial
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192), spun out from AstraZeneca’s China drug discovery unit in 2017, announced that the National Medical Products Administration (NMPA) has approved a Phase II clinical study for its pipeline candidate DZD1516. The trial will evaluate DZD1516, a small-molecule HER2-targeted tyrosine kinase inhibitor, in combination…
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Zhaoke Ophthalmology Enrolls First Patient in TAB014 Phase III Study for wAMD
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Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the first patient enrollment in a Phase III clinical study for its core product TAB014, a recombinant anti-VEGF antibody, in neovascular wet age-related macular degeneration (wAMD). The randomized, double-blind, non-inferiority Phase III study is designed to…
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Fosun Pharma’s FS-1502 Gets NMPA Approval for Gastric Cancer Study
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HER2 monoclonal antibody (mAb) injection FS-1502 in HER2-expressing advanced gastric cancer patients. The study will evaluate the…
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Inmagene and HutchMed Dose First Patient in IMG-007 Global Phase I Study
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China-based Inmagene Biopharmaceuticals and HutchMed (NASDAQ: HCM, HKG: 0013) announced the completion of first patient dosing in a global Phase I clinical study for their IMG-007 in Australia. The drug, an antagonistic monoclonal antibody (mAb) targeting OX40, was discovered by HutchMed. Inmagene owns exclusive global option rights to the drug…
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MabPharm’s CMAB017 Receives NMPA Approval for Clinical Study in Solid Tumors
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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 Category 1 innovative drug candidate CMAB017 in advanced solid tumors. The trial will include patients with colorectal cancer, head and…
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InnoCare Pharma’s ICP-490 Receives NMPA Approval for Hematological Malignancies
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Beijing InnoCare Pharma (HKG: 9969) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its targeted protein degrader ICP-490. The drug is approved for use in multiple myeloma (MM), non-Hodgkin lymphoma (NHL), and other hematological malignancies. Drug ProfileICP-490, developed through InnoCare’s molecular glue…
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PersonGen BioTherapeutics’ TAA06 Receives Clinical Trial Approval for B7-H3 CAR-T Therapy
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The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06, an in-house developed chimeric antigen receptor (CAR)-T cell targeting B7-H3, has obtained tacit clinical trial approval for relapsed/refractory neuroblastoma. This approval signifies that the world’s first B7-H3 CAR-T therapy will enter the regulatory study phase.…
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Arctic Vision Enrolls First Patient in ARVN003 Phase III Trial for Presbyopia
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China-based ophthalmic therapies developer Arctic Vision announced the first patient enrollment in a Phase III clinical study for its ARVN003, a proprietary pilocarpine formulation leveraging its micro-dosing platform Optejet. The study aims to evaluate the efficacy and safety of ARVN003 in temporarily improving vision in adults with presbyopia (long-sightedness) in…
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JW Therapeutics Initiates Phase I Study of JWATM204 for Hepatocellular Carcinoma
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China-based JW Therapeutics (HKG: 2126) announced the initiation of a Phase I clinical study for its JWATM204 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study aims to evaluate the safety, tolerability, dose-limiting toxicity, and pharmacokinetic profile of JWATM204 in adult subjects with advanced HCC. It will also explore…
