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Waters and Kehua’s LC-MS Systems Gain NMPA Approval for IVD Use
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Two home-grown liquid chromatography with tandem mass spectrometry (LC-MS) systems, the ACQUITY UPLC I-Class PLUS / Xevo TQ-Loong System and the ACQUITY UPLC I-Class PLUS / Xevo TQ-S cronos System, have obtained marketing approvals from the National Medical Products Administration (NMPA). These products, developed jointly by US firm Waters Corporation…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Shanghai BioScience Completes RMB 100M Financing Round Led by HUAGAI Capital
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China-based Shanghai BioScience Co., Ltd., a life sciences service platform, announced the completion of a new financing round, raising RMB 100 million (USD 13.73 million). The funding round was solely led by HUAGAI Capital. The proceeds will be used to accelerate the construction of independent brand product lines through mergers…
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Bayer HealthCare and JD Healthcare Partner on Women’s Health Ecosystem
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German pharmaceutical giant Bayer HealthCare (ETR: BAYN) has entered into a new partnership with JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), focusing on women’s health. The collaboration aims to establish a comprehensive health management ecosystem covering the entire life cycle of women, integrating Bayer’s medical expertise…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HDM1005, a long-acting agonist targeting the GLP-1 receptor and GIP receptor. The drug is set for development to treat adult patients with heart failure with preserved…
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Bio-heart’s Iberis RDN System Completes First Commercial Surgery in Germany
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the successful completion of its first commercial surgery using the Iberis multi-electrode renal radiofrequency denervation (RDN) system in Germany. The procedure was performed by Dr. Saarraaken Kulenthiran at the University Hospital of Saarland, with no complications or adverse events reported.…
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Geneseeq and MGI Tech Form Global Partnership for Oncology Solutions
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Geneseeq Technology Inc., a genetic cancer testing service provider operating in Canada and China, has entered into a global partnership with China-based gene sequencing specialist MGI Tech Co., Ltd (SHA: 688114). The collaboration leverages MGI’s DNBSEQ gene sequencing platform to conduct in-depth cooperation in clinical basic research, product regulatory filing…
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Tonghua Dongbao’s Tongboli Under GMP Inspection in Egypt
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced that the on-site Good Manufacturing Practice (GMP) inspection by the Ministry of Health of Egypt for its Tongboli, a biosimilar version of Novo Nordisk’s GLP-1 receptor agonist Victoza (liraglutide), is well underway in the country. Product BackgroundTongboli, the Victoza knockoff, received marketing approval…
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United Laboratories’ UBT251 Receives FDA Green Light for Phase II CKD Study
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that it has received approval from the US Food and Drug Administration (FDA) to assess its Category 1 drug UBT251 in a Phase II study for the treatment of chronic kidney disease (CKD). Drug ProfileUBT251 is a triple agonist targeting…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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AbbVie Enters Obesity Field with Gubra’s GUB014295 Licensing Deal
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US pharmaceutical giant AbbVie (NYSE: ABBV) announced that it is making significant progress in the obesity treatment field through a licensing agreement with Denmark-based Gubra A/S (CPH: GUBRA). AbbVie has secured exclusive global development and commercialization rights to GUB014295, a potential best-in-class, long-acting amylin analog for the treatment of obesity.…
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Zeiss Group’s VISUMAX 800 with SMILE pro Software Approved by China’s NMPA
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Germany-based Zeiss Group, a specialist in optical systems and optoelectronic product manufacturing, announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new-generation femtosecond laser system VISUMAX 800 with the innovative minimally invasive surgery SMILE pro software. Product HighlightsThe addition of SMILE pro software…
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Laekna’s LAE120 Receives FDA Approval for Solid Tumor Clinical Trials
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Sino-US biotech company Laekna, Inc. (HKG: 2105) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug LAE120 in advanced solid tumors. The drug, a selective USP1 allosteric inhibitor, has a unique chemical structure that differentiates it from other USP1…
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SynerK’s SNK-2726 Gets FDA Green Light for Phase I Hypertension Study
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SynerK, an RNA-targeted therapy developer with operations in Boston, US, and Beijing and Suzhou, China, announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its SNK-2726. The angiotensinogen (AGT)-targeted small nucleic acid (siRNA) drug is expected to…
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Omron Healthcare and China Jo-Jo Drugstores Launch Atrial Fibrillation Screening Zone
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A joint effort between Japan-based Omron Healthcare and China Jo-Jo Drugstores, Inc. (NASDAQ: CJJD), a large open-shelf affordable pharmacy headquartered in Hangzhou, the atrial fibrillation (AF) risk screening zone became operational late last week. The initiative aims to help the public better identify the risk of atrial fibrillation and raise…
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WORK Medical and Chartwell Med Partner on Investment Tools for Healthcare Projects
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WORK Medical Technology Group Ltd (NASDAQ: WOK), a medical consumables company based in Hangzhou, has entered into a strategic partnership with Shanghai Chartwell Medical Science & Technology Co., Ltd. The collaboration aims to establish investment tools that integrate industrial and financial resources, facilitate capital collaboration, and drive major project investments.…
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Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory study for its IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein. The trial compares IBI363 monotherapy with Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not…
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Eyebright Medtech Plans Private Placement to Expand Contact Lens Production
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050), an ophthalmic medical device manufacturer, announced plans for a private placement of 3,593,615 shares at RMB 79.2 (USD 10.9) per share. The proceeds, expected to reach RMB 285 million (USD 39 million), will be used to expand its contact lens production…
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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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Danatlas Raises RMB 150M to Advance Synthetic Lethality Drug Pipeline
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Beijing-headquartered Danatlas, a first-in-class drug developer in the synthetic lethality field, has reportedly raised RMB 150 million (USD 21 million) in a new financing round. The round was led by Bayland Capital and included contributions from AstraZeneca-CICC Health Industry Investment Fund, Growth Investment, Panlin Capital, and returning investor Sequoia Capital.…
