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LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
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Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission (EC) for its Korjuny (catumaxomab), making the trifunctional anti-CD3 x anti-EpCAM antibody (trAb) the only approved therapy for patients with malignant ascites (MA) across Europe. Drug BackgroundCatumaxomab was originally discovered by German firm Trion Pharma…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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Innovent Biologics’ IBI363 Receives FDA Fast-Track Designation for sqNSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced,…
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Tianyi Medical Acquires Bellco’s CRRT Filter Business for EUR11.99m
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Tianyi Medical (SHE: 301097), a Ningbo-based developer of Class III medical consumables, has announced plans to acquire the CRRT-filter business assets of Italy-based Bellco S.R.L., a leader in blood purification treatments, for EUR11.99 million (USD12.59 million). Acquisition DetailsThe acquisition is set to position Tianyi Medical as the third company globally…
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Konruns Pharmaceutical’s KC1036 Enters Phase II Trial for Ewing’s Sarcoma in Adolescents
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced the first patient dosing in a Phase II clinical study of its KC1036 for adolescents aged 12 and above with advanced Ewing’s sarcoma (ES). Drug DetailsKC1036 is a Category 1.1 chemical drug and a tyrosine kinase inhibitor (TKI) targeting AXL, VEGFR2, and…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Deep Analysis and Strategic Insights: The Impact of Vice President Yu Bing’s Departure on BCHT Biotechnology
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In a move that has sent ripples through China’s vaccine industry, Changchun BCHT Biotechnology Co., Ltd (BCHT, SHA: 688276) announced on February 15 that Vice President Yu Bing has stepped down from his roles as director and deputy general manager due to personal reasons. This departure has sparked speculation about…
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Beijing Wanjie Medical Device Completes Near-Hundred Million Yuan B-Round Financing
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Beijing Wanjie Medical Device Co., Ltd. recently announced the successful completion of a B-round financing of nearly 100 million yuan. The round was invested by the fund under CAS Investment Management Co., Ltd., with Mailin Capital serving as the exclusive financial advisor. The funds raised will be mainly used for…
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Pharmaceutical Giants Race to Integrate DeepSeek AI for Efficiency Gains
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On February 14, China’s stock market saw a significant upsurge in the AI pharmaceuticals sector, with healthcare stocks across the board performing strongly. The rally was particularly driven by AI Pharmaceuticals, medical services, and DRG/DIP segments, with companies like Shanghai Runda Medical Technology Co., Ltd. leading the charge, resulting in…
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LinkZill Completes Multi-Million-Dollar A-Round Financing Led by ProximaVentures
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Hangzhou LinkZill Technology Co., Ltd. has recently completed a multi-million-dollar A-round financing, exclusively led by Proxima Ventures. The funds will be used to accelerate product delivery and global market expansion. Company BackgroundFounded in 2019 with its headquarters in Hangzhou, China, and a research and business center in Cambridge, UK, LinkZill…
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New Guidelines for Advanced Gastric Cancer Drug Development Released in China
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The National Medical Products Administration (NMPA) of China has published the “Guidance Principles for Clinical Trial Design of New Drugs for Advanced Gastric Cancer,” offering a comprehensive framework to optimize drug development and accelerate patient access to innovative treatments. Key Components of the Guidance 1. Molecular Profiling and BiomarkersThe document…
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Bristol Myers Squibb’s Opdualag Fails to Meet Primary Endpoint in Melanoma Study
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US pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) provided an update on the RELATIVITY-098 study for its Opdualag (nivolumab and relatlimab-rmbw). The Phase III study, which evaluated the drug as an adjuvant treatment for patients with completely resected stage III-IV melanoma, failed to meet its primary endpoint of recurrence-free survival…
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Hengrui’s Vunakizumab Receives NMPA Approval for nr-axSpA Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its IL-17A monoclonal antibody (mAb), vunakizumab. The Chinese company plans to study the drug as a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). Drug BackgroundVunakizumab is intended…
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GE Healthcare Posts 1% Annual Revenue Growth in 2024 Financials
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) released its Q4 and full-year 2024 financial results. The company reported annual revenues of USD19.7 billion, representing a 1% year-on-year (YOY) growth in constant currency terms. Group revenues for Q4 grew by 2% YOY to USD5.3 billion.…
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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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Lee Kai and Yangshun Partner on Polyvinyl Alcohol Embolization Microspheres
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Chinese companies Shanghai Lee Kai Technology Co., Ltd (Kai Medtech) and Hangzhou Yangshun Medical Technology Co., Ltd have entered into a collaboration for the market promotion and application of Yangshun’s polyvinyl alcohol embolization microspheres. The financial terms of the agreement were not disclosed. Collaboration DetailsThe partnership aims to accelerate the…
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Nanos Medical Raises Over RMB300m to Boost Otolaryngology Device Lead
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China-based Nanos Medical (Shanghai) Limited, an otolaryngology device maker, has reportedly raised over RMB300 million (USD42 million) in another financing round. The funding was led by Qiming Venture Partners and included contributions from River Head Capital. Funding DetailsThe proceeds will facilitate Nanos Medical’s leading position in the otolaryngology and cranial…
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SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
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China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical Products Administration (NMPA). The approval allows its Vibativ (telavancin) to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by sensitive isolates of Staphylococcus aureus. Drug DetailsVibativ is a rapidly bactericidal glycopeptide antibiotic with bactericidal activity…
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Trinomab’s Antitetanus mAb Injection TNM002 Approved by NMPA
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China-based Trinomab Biotech Co., Ltd has received market approval for its antitetanus toxin monoclonal antibody (mAb) injection TNM002 from the National Medical Products Administration (NMPA). Product DetailsTNM002 is a Category 1 product, an iterated novel tetanus shot used for emergency prevention of tetanus in adults. It delivers emergency protection through…
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NMPA Releases 90th Batch of Reference Drugs for GQCE
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The National Medical Products Administration (NMPA) has released the 90th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch involves a total of 51 specifications. Details of the ReleaseThe 90th batch includes 42 new specifications and 9 specifications with modifications. This release is part of the…
