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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its Category 1 chemical drug HSK44459. The drug will be assessed for use in treating psoriasis and atopic dermatitis (AD), chronic, recurrent, and immune-inflammatory skin diseases with…
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Johnson & Johnson MedTech Gains FDA Clearance for MONARCH QUEST with AI Algorithms
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US major Johnson & Johnson MedTech announced receiving U.S. 510(k) regulatory clearance for its MONARCH QUEST. This latest advancement in MONARCH navigation technology features AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System. MONARCH QUEST TechnologyThe MONARCH QUEST platform represents a…
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Arvinas and Pfizer Announce Positive Phase III Results for Vepdegestrant in ER+/HER2- Breast Cancer
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase III VERITAC-2 study. The trial assessed vepdegestrant alone versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer who experienced disease progression following prior…
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Harbour BioMed Launches Élancé Therapeutics to Tackle Obesity Treatment Challenges
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China-based Harbour BioMed (HKG: 2142) announced the establishment of Élancé Therapeutics, a new subsidiary focused on developing innovative therapies to address key challenges in current obesity treatment, including muscle preservation and long-term efficacy. This move underscores Harbour BioMed’s commitment to expanding its presence in the global obesity treatment market. Technological…
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Pierre Fabre Partners with RedRidge Bio on BPA Drug Development for Oncology and Dermatology
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France-based Pierre Fabre Laboratories announced an exclusive R&D collaboration and license agreement with Switzerland-headquartered RedRidge Bio AG. The partnership focuses on discovering and developing biparatopic antibody (BPA) drug candidates against multiple targets, with therapeutic applications in precision oncology, dermatology, and rare diseases. Collaboration DetailsUnder the agreement, RedRidge Bio will be…
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Visen Pharmaceuticals IPO Launches on Hong Kong Stock Exchange Amid Growth in Endocrine Therapies
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China-based Visen Pharmaceuticals, a joint venture between Denmark-headquartered Ascendis Pharma and Vivo Capital, has successfully launched its initial public offering (IPO) on the Hong Kong Stock Exchange. The offering price ranges from HKD68.44 to HKD75.28 per share, with net proceeds potentially reaching HKD603.3 million (USD77.6 million) if calculated at the…
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Roche and Zealand Pharma Collaborate to Develop Petrelintide for Weight Management
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced a strategic exclusive collaboration and licensing agreement with Denmark-based Zealand Pharma (CPH: ZEAL). The partnership aims to develop and commercialize petrelintide, Zealand Pharma’s amylin analog, both as a standalone therapy and in a fixed-dose combination with Roche’s lead incretin asset CT-388.…
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China Issues Guidelines for Informatization of Compact County-level Medical Communities
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The National Health Commission (NHC), National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration jointly released a notification to guide the informatization function of compact county-level medical communities. This initiative aims to enhance healthcare service integration and efficiency at the county level through advanced information technology.…
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CDE Releases 91st Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 91st batch of reference preparations for generic drug quality and consistency evaluation (GQCE). This update is part of the ongoing efforts to standardize and improve the quality of generic drugs in the country. New Additions and RejectionsThe latest batch includes 59…
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China’s NHSA Issues Guidelines for Neurological Medical Services Pricing
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China’s National Healthcare Security Administration (NHSA) has released the “Guidelines for the Pricing Project Initiation for Neurological Medical Services (Trial)”, aimed at guiding provincial healthcare security administration bureaus to formulate unified provincial price benchmarks. This initiative integrates the current pricing items for the nervous system into 82 items, including 24…
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Grand Pharmaceutical Group Reports Strong 2024 Financials with 12.8% Revenue Growth
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) revealed its 2024 financial performance, recording revenues of HKD 11.64 billion (USD 1.5 billion), marking a 12.8% year-on-year increase. Net profits reached HKD 2.47 billion (USD 318 million), up 34% from the previous year. Based on this strong performance, the company plans…
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Ping An Healthcare Reports 2024 Financial Turnaround with Growth in Healthcare Services
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China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as Ping An Good Doctor, released its 2024 financial report. The company recorded RMB 4.8 billion (USD 664 million) in revenues, marking a 2.9% year-on-year (YOY) increase. Notably, Ping An Healthcare achieved a significant turnaround by posting RMB88.32…
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Jiuzhitang’s Stem Cell Therapy for Autism Receives NMPA Clinical Trial Approval
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China-based Jiuzhitang Co. Ltd (SHE: 000989) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product, human bone marrow mesenchymal stem cells (hBMSCs), to treat autism spectrum disorder (ASD). This marks a significant step forward in exploring novel therapeutic options for ASD.…
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Newdel Biotech Secures A+ Round Funding to Accelerate DEL+AI-Driven Drug Discovery
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Newdel Biotech recently announced the completion of an A+ round strategic investment led by XtalPi Holdings Limited (HKG: 2228), a global leader in AI+ automation technology platforms. This investment will fuel the deep integration of Newdel Biotech’s DNA-encoded compound library (DEL) technology with XtalPi’s AI platform, aiming to accelerate the…
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Sun-Novo Partners with Youjia Biomedical to Develop Antibody-Oligonucleotide Conjugate for Metabolic Diseases
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has formed a partnership with compatriot firm Youjia (Hangzhou) Biomedical Technology Co., Ltd to jointly develop an antibody-oligonucleotide conjugate (AOC) for the treatment of metabolic diseases. This collaboration aims to leverage the combined expertise of both companies to advance innovative therapeutic…
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Merck Sharp & Dohme Expands Durham Facility with $1B Investment for Vaccine Production
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US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the opening of a 225,000 sq. ft. extension to its manufacturing facility in Durham, North Carolina. The expansion, which has received a USD1 billion investment, will focus on vaccine manufacturing and is a key part of MSD’s ongoing commitment…
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Novartis’ Cosentyx Approved by NMPA for Moderate to Severe Hidradenitis Suppurativa
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Swiss giant Novartis’ (NYSE: NVS) Cosentyx (secukinumab) has secured another indication approval from China’s National Medical Products Administration (NMPA), this time for the treatment of moderate to severe hidradenitis suppurativa (HS). This IL-17A-targeted therapy previously gained approval in China for moderate-to-severe plaque psoriasis, ankylosing spondylitis, and active psoriatic arthritis (PsA).…
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Legend Biotech Reports Strong Q4 and Full Year 2024 Financial Results
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China-based Legend Biotech Corporation (NASDAQ: LEGN) released its Q4 and full-year 2024 financial results, highlighting significant revenue growth. In Q4, the company reported revenues of USD187 million, marking a 134.7% year-on-year increase. For the entire year, revenues surged by 120.0% to USD627 million. Carvykti’s Impact on RevenueThe BCMA-directed chimeric antigen…
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Ono Pharmaceutical Licenses Ionis’ Sapablursen for Global Development in Polycythemia Vera
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Japan-based Ono Pharmaceutical Co., Ltd. (TYO: 4528) announced an agreement with Ionis Pharmaceuticals, Inc. to license sapablursen, an investigational RNA-targeted medicine for the treatment of polycythemia vera (PV). Under the terms of the agreement, Ono has secured global development and commercialization rights to the drug. Terms of the AgreementOno will…
