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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…
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Weimai Qingtong Medical Technology Completes Tens of Millions Yuan B+ Round
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Weimai Qingtong Medical Technology (WEMT), a medical device company based in Wuxi, has completed a B+ financing round worth tens of millions of yuan. The round was led by Wuxi Capital Group Co., Ltd. and Jinsheng Capital, with WinX Capital serving as the exclusive financial advisor. The funds will be…
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InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
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Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will…
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Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye drops, designed to delay myopia progression in children aged 6-12, has been accepted by the National Medical Products Administration (NMPA). The product targets children with spherical diopters ranging from -0.50D to -4.00D and astigmatism/anisometropia ≤…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR4 Phase III Study for Diabetes
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase III clinical study for GZR4, its Category 1 therapeutic biologic product. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Drug ProfileGZR4 aims to provide a convenient…
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Stedical Scientific Raises RMB100M in Series B Financing for Global Expansion
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Stedical Scientific, a Hangzhou-based tissue engineering and regenerative medicine company, has raised over RMB100 million (USD13.7 million) in a Series B financing round co-led by Lapam Capital and Shanghai Healthcare Capital. The funds will support the commercial expansion of its core products, particularly in the US and China, as well…
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Zelgen Biopharmaceuticals’ ZG005 Bispecific Antibody Receives NMPA Approval for Biliary Tract Cancer Trials
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate ZG005. The Category 1 biologic product will be tested in combination with a platinum-containing chemotherapy regimen for advanced biliary tract cancer. Drug ProfileZG005…
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Bristol-Myers Squibb Releases Five-Year Data on Sotyktu’s Long-Term Efficacy and Safety
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In a recent announcement, US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) unveiled the latest five-year results from its POETYK PSO long-term extension study. The study evaluates the sustained efficacy and safety of Sotyktu (deucravacitinib), a groundbreaking treatment for adults with moderate-to-severe plaque psoriasis. Sotyktu, recognized as the world’s first…
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Wanbangde New Building Materials’ Mecobalamin Earns FDA Orphan Drug Designation for ALS
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) announced that its mecobalamin product has received an orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The designation highlights the drug’s potential to address unmet medical needs in ALS,…
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Biokin Pharmaceutical Registers Phase III Study for BL-B01D1 in EGFR Mutant NSCLC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has registered a Phase III study on chinadrugtrials.org.cn to evaluate the efficacy of BL-B01D1 combined with osimertinib versus osimertinib alone as a first-line therapy for EGFR mutant locally advanced or metastatic non-small cell lung cancer (NSCLC). The study, led by Professor Zhou Caicun…
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AccurEdit’s ART002 Becomes First In Vivo Gene Editing Product to Reduce LDL-C in Humans
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Suzhou-based gene editing specialist AccurEdit Therapeutics announced that its in vivo gene editing product, ART002, has achieved drug saturation and safely reduced low-density lipoprotein cholesterol (LDL-C) with a single dose in a multi-center, open, single-arm, exploratory investigator-initiated trial (ITT) for heterozygous familial hypercholesterolemia. This marks the first time an in…
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Beihai Biotech Licenses Beizary to Zydus Lifesciences for US Market
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China-based Zhuhai Beihai Biotech Co., Ltd announced a licensing agreement with Zydus Lifesciences, granting the India-headquartered firm exclusive commercialization rights to Beizary, a modified version of docetaxel, in the United States. Deal TermsUnder the agreement, Beihai will handle manufacturing and supply of Beizary. The company will receive an upfront payment…
