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Everest Medicines’ Velsipity Approved for Use in Select Hospitals in China’s Greater Bay Area
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval in the Greater Bay Area (GBA) for its drug Velsipity (etrasimod) to be used in Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University. These medical institutions are part of the…
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Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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Sanofi’s Dupixent Demonstrates Positive Results in Phase III Study for Chronic Urticaria
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
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Eli Lilly’s Alzheimer’s Drug Kisunla Secures Marketing Approval in Great Britain
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted…
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Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
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Lundbeck’s Vyepti Migraine Treatment Available at Sun Yat-sen Memorial Hospital Through Greater Bay Area Policy
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Vyepti (eptinezumab), a migraine treatment developed by Denmark-based biopharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF), has been introduced at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, facilitated by the “Hong Kong-Macau Drug and Device Access” policy. This policy, part of the broader Greater Bay Area initiative, enables patients to access…
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Lee’s Pharmaceutical’s Subsidiary Reports Positive Results from Phase III Myopia Treatment Study
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
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LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
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LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
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Grifols Partners with BARDA to Develop Treatment for Sulfur Mustard Ocular Injury
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Grifols (BME: GRF; NASDAQ: GRFS), a Spanish biopharmaceutical company, has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their potential to treat ocular damage resulting from sulfur mustard exposure. BARDA, which is part of the Administration…
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Walvax Biotechnology’s Weuphoria Vaccine Approved in Oman for Pediatric Pneumococcal Infections
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Walvax Biotechnology Co., Ltd (SHE: 300142), a Chinese biopharmaceutical company, has announced that it has received market approval in the Sultanate of Oman for its vaccine Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval marks a significant step for the company as it expands the reach of its…
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LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
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LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application. LNZ100…
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AstraZeneca’s Wainzua Earns CHMP Nod for hATTR-PN Treatment in the EU
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UK pharmaceutical juggernaut AstraZeneca (AZ, NASDAQ: AZN) has announced that Wainzua (eplontersen), an RNA-targeted therapy co-developed with US-based Ionis Pharmaceuticals (NASDAQ: IONS), has received a positive recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) within the European Union (EU). The treatment is intended for adults…
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Novo Nordisk’s Semaglutide Shows 14% Reduction in Cardiovascular Events in Landmark SOUL Trial
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Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%. The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals…
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AstraZeneca’s Saphnelo Approved for Use in Guangdong Under ‘Hong Kong-Macau Drug Access’ Policy
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay…
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BeiGene’s Tevimbra Receives CHMP Recommendation for Expanded Use in G/GEJ and ESCC Cancers in EU
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers…
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Olymvax Bio Receives NMPA Approval for Clinical Study of Trivalent Influenza Vaccine
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Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its trivalent influenza virus split vaccine (MDCK cells). This vaccine is designed for the prevention of influenza caused…
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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
