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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for the MediBeacon Transdermal GFR System (TGFR), a Category III medical device licensed from US firm MediBeacon Inc. The device is designed to assess the glomerular filtration rate (GFR)…
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Sunshine Guojian and Shenyang 3SBio License 612 and 708 Programs for Anti-Tumor Development
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd and Shenyang 3SBio Co., Ltd, both subsidiaries of 3SBio Inc. (HKG:1530), have entered into a licensing agreement for Sunshine Guojian’s 612 and 708 programs. Under the agreement, Shenyang 3SBio will obtain exclusive rights to develop, file regulatory applications, modify, use, manufacture, and market…
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Antengene to Boost T Cell Engager Platform with AI Investment and DeepSeek Deployment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced plans to increase investment in establishing a specialized artificial intelligence (AI) department. The move includes deploying DeepSeek, a Chinese advanced AI model for complex reasoning and natural language processing, to accelerate the development of its T cell engager (TCE) platform with spatial…
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Jiangxi Rimag Group and Xunfei Healthcare Form Strategic Alliance for Smart Healthcare
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China-based Jiangxi Rimag Group Co., Ltd (HKG: 2522) announced a strategic alliance with Xunfei Healthcare Technology Co., Ltd, a subsidiary of iFlytek Co., Ltd (SHE: 002230), to collaborate on smart healthcare initiatives. Collaboration FocusThe partnership will focus on:
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Rendu Biotechnology Partners with Green Apple Medical System for RNA Diagnostics Expansion
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Rendu Biotechnology Co., Ltd., (SHA: 688193) a Shanghai-based specialist in RNA molecular diagnostics, has entered into a strategic partnership with India’s Green Apple Medical System. The collaboration aims to leverage the strengths of both companies to promote the widespread application of RNA diagnostic technology in India and other markets. Partnership…
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Genuine Biotech Files for Hong Kong IPO with Azvudine and ZS-1003 in Pipeline
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China-based Genuine Biotech Limited has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, according to the bourse’s website. Key details such as the unit price and offering size have not yet been disclosed. Company ProfileGenuine Biotech is focused on the development, manufacturing, and commercialization of…
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AstraZeneca Faces Class Action Lawsuits Over China Legal Issues
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AstraZeneca plc (AZ, NASDAQ: AZN) is facing multiple class action lawsuits in the United States related to recent legal issues in China, including the arrest of its former China market president, Leon Wang. The lawsuits allege that the UK-based pharmaceutical giant made misleading statements about its operations in China, failing…
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Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
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US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc. (NASDAQ: STOK), securing exclusive commercialization rights to zorevunersen, a drug for Dravet syndrome, in all territories outside the United States, Canada, and Mexico. Drug ProfileZorevunersen is an antisense oligonucleotide (ASO) targeting the SCN1A gene, the…
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TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
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Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
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Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June…
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CSPC Pharma Licenses SYS 6005 to Radiance Biopharma for Global Markets
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced a licensing agreement with Radiance Biopharma, Inc., granting the US firm exclusive development and commercialization rights to its SYS 6005 in multiple countries, including the United States, European Union, United Kingdom, Switzerland, Australia, and Canada. Deal TermsUnder the agreement, CSPC Pharma will…
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Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical study of its antibody drug conjugate (ADC), BL-M07D1, for the treatment of HER2 positive breast cancer. The trial will evaluate BL-M07D1 in combination…
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Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), has been accepted by the US Food and Drug Administration (FDA) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date…
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Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
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US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received conditional approval from the European Commission (EC) for its oral drug Welireg (belzutifan) for the treatment of von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC). Drug ProfileWelireg is a hypoxia-inducible factor-2…
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GSK and Abbott Announce Leadership Changes in Key Roles
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Recent days have seen significant leadership changes at two pharmaceutical giants: UK-based GSK plc (LON: GSK) and US-based Abbott Laboratories (NYSE: ABT). GSK Appoints Jocelyn Luo as Mix Team LeaderJocelyn Luo has been appointed as the leader of GSK’s Mix team, reporting to Westly Yu, head of GSK’s respiratory business…
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Medtronic Q3 Earnings Show 4.1% Organic Growth, Driven by Cardiac Ablation
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US-Irish medical device company Medtronic (NYSE: MDT) reported financial results for the third quarter (Q3) of fiscal year 2025 (FY25), which ended on January 24, 2025. The company posted revenues of USD 8.3 billion, marking a 4.1% increase on an organic basis. Segment Performance OutlookMedtronic reiterated its organic revenue growth…
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QuantumPharm and Hengjian Launch GBA AI+ Innovation Consortium
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Shenzhen-based QuantumPharm Inc. (HKG: 2228), also known as Xtalpi Inc., and Guangdong Hengjian Investment Holding Co., Ltd. are jointly selecting a location to launch the Greater Bay Area (GBA) “AI+” technology and industry integration innovation consortium project. The initiative aligns with the national “Innovation Consortium” strategy and aims to integrate…
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Deepwise Information Integrates DeepSeek into Medical Data Platform
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Deepwise Information, a leading artificial intelligence company in the medical field, has fully integrated its big data products with DeepSeek, completing the delivery of the DeepSeek R1 model to a hospital in the southwestern region on February 16. Leveraging the outstanding performance of the DeepSeek R1 model in complex tasks…
