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NMPA Issues New Vaccine Manufacturing and Distribution Rules
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China’s National Medical Products Administration (NMPA) has released the “Vaccine Manufacturing and Distribution Management Measures,” effective immediately. The finalized document includes amendments to a draft proposal from March, addressing pharmacovigilance, personnel requirements, and post-marketing management. Key Changes Overseas MAHs Supervision and Management Export and Import Rules
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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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NHSA Sets 2022 Goals for Basic Medical Insurance Funding and Reforms
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The National Healthcare Security Administration (NHSA), Ministry of Finance (MOF), and State Taxation Administration (STA) jointly released a notification outlining 2022 work goals for urban employee and rural/residential Basic Medical Insurance (BMI) schemes, focusing on improving funding standards and expanding accessibility. Funding Standards Household Registration RelaxationThe government will loosen restrictions…
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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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Rainmed Medical Makes IPO Debut on Hong Kong Exchange with Valuation Over USD 764M
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Suzhou Rainmed Medical Technology Co., Ltd, a China-based vascular intervention robot manufacturer, has completed its initial public offering (IPO) on the Hong Kong Stock Exchange. The company’s shares (02297) were priced at HKD 6.24 each, giving it an initial market valuation of over HKD 6 billion (USD 764 million). Company…
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MicuRx Pharmaceuticals Approved for STAR Market IPO by CSRC
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The China Securities Regulatory Commission (CSRC) has approved the initial public offering (IPO) of Sino-US firm MicuRx Pharmaceuticals Inc. on Shanghai’s Sci-Tech Innovation Board (STAR). The company, established in 2007, focuses on developing novel drugs for infectious diseases and kidney disorders. Company BackgroundMicuRx has a pipeline of in-house developed drugs…
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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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WuXi XDC Partners with AbTis to Advance ADC Development and Manufacturing
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WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA (SHA: 603259), announced a partnership with Korean biotech AbTis to accelerate the development and manufacturing of antibody drug conjugates (ADCs). The collaboration will leverage WuXi XDC’s integrated services and AbTis’s proprietary ADC platform technology. Partnership DetailsAbTis will…
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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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ClouDr Group’s Hong Kong IPO Nets HKD 482 Million with Sanofi as Investor
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Hangzhou-based ClouDr Group Ltd (HKG: 9955), a one-stop chronic disease management and smart medical platform, has completed an initial public offering (IPO) on the Hong Kong Stock Exchange, raising HKD 482 million (USD 61.4 million). France-based pharmaceutical giant Sanofi acted as one of its cornerstone investors. Proceeds will be used…
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Baifu Laser Raises RMB 100 Million in Series A Funding for Optoelectronic Equipment
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China-based Nanjing Baifu Laser Technology Co., Ltd reportedly raised close to RMB 100 million (USD 14.9 million) in a Series A financing round led by Yuanbio Venture Capital, with existing investor Northern Light Venture Capital also participating. The proceeds will be used for clinical filings and global market promotion of…
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Oriomics Launches XiaoWeiAn Multi-Tumor Early Screening Product
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Hangzhou Ao’rui Biological Technology Co., Ltd (Oriomics) announced the market launch of XiaoWeiAn, a multi-tumor early screening product targeting liver, gastric, intestinal, esophageal, and pancreatic cancers. The product, a first-in-class multi-omics cancer joint inspection product based on the real-time PCR and chemiluminescence dual platform, boasts 88.4% overall sensitivity, 98.5% specificity,…
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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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GeneRulor Medical Technology Raises Funds for Gene Editing Diagnostics
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China-based gene editing specialist ZhuHai GeneRulor Medical Technology Co., Ltd. reportedly raised “tens of millions” of renminbi in a recent financing round. The round was led by YF Capital and Gree Group, with contributions from Z & H Investment and Shanzhi Investment. Proceeds will be used to advance the commercialization…
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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…
