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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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Overland ADCT BioPharma Launches Global Phase III Trial for Zynlonta in DLBCL
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Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the initiation and first patient dosing of the global Phase III LOTIS-5 trial for Zynlonta (loncastuximab tesirine), an anti-CD19 antibody-drug conjugate (ADC). The study will evaluate Zynlonta in combination with rituximab as…
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Bio-Thera Solutions Doses First Patient in BAT8006 Phase I Study for Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that the first patient has been dosed in a Phase I clinical study of BAT8006, an in-house developed antibody drug conjugate (ADC) targeting folate receptor alpha (FRα), for advanced solid tumors. The multi-center, open-label trial will assess the drug’s safety, tolerability, and preliminary efficacy.…
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OBI Pharma Halts OBI 888 Trial Over Manufacturing Costs, Shifts Focus to Globo H ADC
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Taiwan-based OBI Pharma (TPEx: 4174) announced the discontinuation of a Phase I/II trial for its Globo H antibody OBI 888, citing manufacturing cost challenges. The decision comes despite preliminary data showing the antibody was safe, well-tolerated, and demonstrated efficacy. Reasons for HaltThe trial was stopped because OBI 888 required a…
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Hengrui Medicine’s SHR8554 Accepted for NMPA Review in Postoperative Pain
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its market filing for SHR8554, an injectable drug candidate for moderate to severe postoperative pain, has been accepted by the National Medical Products Administration (NMPA). The drug, a small-molecule μ-opioid receptor (MOR) agonist, met superiority standards in a Phase III…
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CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an anti-RANKL monoclonal antibody (mAb) developed by subsidiary Shanghai JMT Biotechnology Co., Ltd, has been prioritized for review by the Center for Drug Evaluation (CDE). The drug is designed to address deficiencies in existing RANKL antibodies,…
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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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VivaVision Biotech’s VVN539 Enters Phase II Trial for Open-Angle Glaucoma in US
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China’s VivaVision Biotech Inc. announced the first patient enrollment in a Phase II clinical study of its dual-targeting drug VVN539 for open-angle glaucoma in the US. The trial marks progress in the company’s pipeline targeting ophthalmic disorders. Study DetailsThe randomized, double-blind, vehicle-controlled Phase II study will assess VVN539’s safety and…
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Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
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China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth Biological Technology Co., Ltd’s NR082 for the treatment of Leber hereditary optic neuropathy (LHON) caused by the G11778A mutation. The drug, an innovative intraocular injection gene therapy, uses a recombinant adeno-associated virus serotype 2 vector…
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Biotheus Inc.’s PM1009 Bispecific Antibody Enters Clinical Trial Review for Solid Tumors
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China-based Biotheus Inc. announced that its clinical trial filing for PM1009, a bispecific antibody (BsAb) targeting T cell immunoglobulin and ITIM domains (TIGIT) and poliovirus receptor related immunoglobulin domain (PVRIG), has been accepted by the Center for Drug Evaluation (CDE). The drug, co-developed with US firm Adimab, is aimed at…
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Innovent Biologics’ Pemazyre Becomes First FGFR2 Inhibitor Approved in China
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China-based Innovent Biologics Inc. (HKG: 1801) announced that the first prescription has been filled in China for Pemazyre (pemigatinib), the world’s first targeted therapy for cholangiocarcinoma (bile duct cancer). The drug, an FGFR2-targeted protein kinase inhibitor, was originally discovered by US biotech Incyte Therapeutics and licensed to Innovent for Greater…
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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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GenScript Biotech’s Legend Biotech Terminates LB1901 CAR-T Phase I Trial
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Hong Kong-based GenScript Biotech Corporation (HKG: 1548) announced that its subsidiary Legend Biotech Corporation (NASDAQ: LEGN) has terminated a Phase I clinical study for LB1901, a chimeric antigen receptor (CAR) T cell therapy candidate targeting CD4. The decision follows the FDA’s clinical hold in February 2022 and the lifting of…
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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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Brii Biosciences Launches Anti-COVID-19 Antibody Cocktail in China
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China-based Brii Biosciences Ltd (HKG: 2137) announced the commercial launch in China of the anti-COVID-19 antibody cocktail amubarvimab + romlusevimab. The regimen represents a long-acting neutralizing antibody therapy against COVID-19. The first commercial batch of the antibodies was released today, marking an important milestone in the commercialization of the combination…
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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Under FDA Review for NPC Treatment
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the Biologics License Application (BLA) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has been re-filed with and is under review by the US FDA. The filing covers two indications: Tuoyi’s use in combination with gemcitabine/cisplatin as a first-line treatment of…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR101 Phase I Study
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a China-based Phase I clinical study for its drug candidate GZR101. The first-in-human study aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of the GZR101 injection and its component GZR33. Drug Details and…
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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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GeneScience’s Somatropin Wins NMPA Approval for Prader-Willi Syndrome
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China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its somatropin to treat Prader-Willi Syndrome (PWS). This latest approval marks the tenth indication for the company’s somatropin and represents the first approval for a home-grown growth hormone…
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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…
