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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…
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Accropeutics Doses First Patient in AC-101 Phase Ib UC Study
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Accro Bioscience (Suzhou) limited, better known as Accropeutics, a clinical-stage biotech operating out of New York, US, and Suzhou, China, announced the first patient dosing in a Phase Ib study. The study is designed to assess the safety and efficacy of its RIPK2 inhibitor AC-101 in moderate to severe ulcerative…
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China Launches Major Public Health Initiatives to Enhance Healthcare Accessibility
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In a bid to bolster public health infrastructure and improve healthcare services, China’s National Health Commission (NHC), alongside the National Administration of Traditional Chinese Medicine and the National Disease Control and Prevention Administration, has unveiled its first batch of practical projects for 2024. These initiatives are part of a broader…
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Sanofi and J&J’s E. coli Vaccine Fails Phase III Study
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France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared…
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Antengene’s Xpovio Included in Taiwan’s NHI Drug List for Myeloma Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that its Xpovio (selinexor), the world’s first FDA-approved oral XPO1 inhibitor, has been included in Taiwan’s National Health Insurance (NHI) drug list. The approved indication is for use in combination with bortezomib and dexamethasone in adults previously treated with one therapy for…
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Boehringer Ingelheim Partners with ExpressionEdits on Gene Therapy Tech
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German pharmaceutical giant Boehringer Ingelheim has entered into a collaboration and licensing agreement with UK-based ExpressionEdits. The deal leverages ExpressionEdits’ Genetic Syntax Engine technology to advance gene therapy development. Technology DetailsThe Genetic Syntax Engine is a proprietary AI-powered platform. It uses optimized introns to enhance gene expression without altering the…
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Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric…
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Hainan Unveils Biomedical New Technology Policy to Boost Medical Innovation
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In-Depth Analysis and Orientation Guide for Hainan’s Biomedical New Technology PolicyThe Hainan Provincial Health Commission, Medical Products Administration, and Boao Lecheng International Medical Tourism Pilot Zone Management Bureau have jointly released the “Implementation Measures for Biomedical New Technology Translation and Application in the Boao Lecheng International Medical Tourism Pilot Zone…
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Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
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Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds). Drug DetailsEvrysdi is a survival…
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Shanghai’s Ambitious Plan to Revolutionize Brain-Computer Interfaces
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In-Depth Analysis and Orientation Guide for Shanghai’s Brain-Computer Interface (BCI) PolicyShanghai has unveiled a groundbreaking initiative to advance brain-computer interface (BCI) technology, marking a significant step toward fostering disruptive innovation and establishing the city as a global hub for future industries. The “Shanghai BCI Future Industry Cultivation Action Plan (2025-2030)”…
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Pfizer’s Adcetris Gets New FDA Approval for Lymphoma Treatment
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US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from the US FDA for its Adcetris (brentuximab vedotin). The antibody-drug conjugate (ADC) can now be used in combination with lenalidomide and a rituximab product. It is approved for the treatment of adult patients with relapsed…
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StairMed Raises Record RMB350m for Implantable BCI Development
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Shanghai StairMed Technology Co., Ltd., a specialist in implantable brain-computer interface (BCI) technology, has reportedly raised RMB350 million (USD48 million) through a Series B financing round. This is the largest financing round in the implantable BCI industry in China so far. Funding DetailsThe funding round was led by Qiming Venture…
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Lundbeck’s Amlenetug Receives FDA Fast Track for Multiple System Atrophy
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Denmark-based pharma company Lundbeck A/S (VIE: LUNB) has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its investigational drug amlenetug. The drug is expected to provide a new treatment option for patients with multiple system atrophy (MSA). Drug DetailsAmlenetug is…
