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Venus Medtech’s Transcatheter Prosthetic Pulmonary Valve Approved by NMPA
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The National Medical Products Administration (NMPA) has approved Venus Medtech (Hangzhou) Inc’s (HKG: 2500) transcatheter prosthetic pulmonary valve system for marketing, marking a milestone for the company’s innovative cardiac device. Product OverviewThe system comprises a self-expanding nickel-titanium alloy stent, porcine pericardium leaflets, and a delivery mechanism. The valve’s design enhances…
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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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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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Neurophth and Abogen Partner on mRNA Therapy for Retinal Diseases
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China-based Neurophth Biotechnology Ltd, a gene therapy specialist, has partnered with compatriot mRNA drug developer Abogen Biosciences Co., Ltd to develop lipid nanoparticles (LNPs) for mRNA delivery targeting retinal diseases. The collaboration combines Neurophth’s expertise in ophthalmology gene therapy with Abogen’s mRNA and LNP technology. Partnership DetailsThe partnership aims to…
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CASI Pharmaceuticals Invests in Precision Immune Therapeutics for CID-103 Development
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US-based CASI Pharmaceuticals Inc. (NASDAQ: CASI) announced the completion of a financing round for China’s Precision Immune Therapeutics (PAT), securing RMB 140 million ($21 million) for the firm. CASI invested RMB 20 million ($3 million) to take a 15% stake, alongside two other venture capital firms. Financing DetailsThe funding round…
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Sinopharm in Talks to Acquire BBI Life Sciences in USD 1B+ Deal
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China National Pharmaceutical Group Co., Ltd (Sinopharm) is reportedly considering a bid to acquire Shanghai-based BBI Life Sciences Corp., with a potential deal valued at over USD 1 billion, according to Bloomberg. The news cites insider sources stating Sinopharm has held preliminary talks with BBI’s founding Wang family, while other…
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Acer Therapeutics and Relief Therapeutics Awarded China Patent for ACER-001
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US-based Acer Therapeutics Inc. (Nasdaq: ACER) and Swiss partner Relief Therapeutics Holding SA (SWX: RLF) announced that China’s National Intellectual Property Administration (CNIPA) has awarded a utility model patent for their drug candidate ACER-001 (sodium phenylbutyrate). The patent, No. ZL202122004991.9, covers the polymer-coated formulation of ACER-001 for oral administration in…
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Bangbang Robot Raises USD 14.9M in Series B to Expand Mobility Tech
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Shanghai-based Bangbang Robot Co., Ltd, a developer of assisted mobility technology, has raised nearly RMB 100 million ($14.9 million) in a Series B financing round co-led by Lake Bleu Capital and BioTrack Capital, with participation from 01VC and Long Hill Capital. The funds will support manufacturing, installation of its products,…
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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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Aden Secures USD 29.8M Series B+ Funding to Expand DRG/DIP Solutions
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Beijing-based AI medical big data firm Aden, also known as Yading Data, has raised RMB 200 million ($29.8 million) in a Series B+ financing round led by Haier Capital. The round included participation from Xingtuo Capital and existing investors Innovation Works and Eastern Bell Capital. Proceeds will fuel market expansion,…
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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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Science Sun Pharma and Mabworks Biotech Sign Strategic Cooperation Pact
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Beijing Science Sun Pharmaceutical Co., Ltd (SHE: 300485) announced a strategic cooperation framework agreement with Beijing Mabworks Biotech Co., Ltd to collaborate in biomedical technology services and new drug development. The partnership will cover drug discovery, process R&D, production, quality control, and clinical research through joint development, commissioned R&D, technical…
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Hangzhou DAC Bio Partners with Janssen on ADC Development Deal
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China-based Hangzhou DAC Biotech Co., Ltd announced a licensing agreement with Janssen Pharmaceuticals Inc., a unit of US major Johnson & Johnson, to collaborate on the development of antibody drug conjugates (ADCs). The partnership will leverage DAC Bio’s proprietary ADC platform and Janssen’s antibody expertise for up to five targets.…
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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…
