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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical studies for its investigational drug KYS202004A for the treatment of psoriasis. This Category 1 biologic is a novel, dual-targeted…
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Viatris Inc. (NASDAQ: VTRS), a leading global pharmaceutical company based in the U.S., has announced the official launch of its nasal spray combination therapy, Dymista (azelastine, fluticasone), in China. This medication is now available to treat moderate to severe seasonal and perennial allergic rhinitis in adults and children aged 12…
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Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Sogroya (somapacitan), a long-acting somatotropin. This once-weekly treatment is designed to address adult growth hormone deficiency (AGHD) and has already received approval in the US in…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma…
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The Center for Drug Evaluation (CDE) has given the green light for the review of a new indication submission for Jiangsu Hengrui Pharmaceuticals Co., Ltd’s (SHA: 600276) ivarmacitinib, as per the latest update on the CDE’s website. The potential new indication is speculated to be adult alopecia areata, aligning with…
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On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) for the Phase II clinical trial of its investigational drug HX009 in combination therapy for biliary tract cancer (BTC). The application met the relevant requirements for drug registration,…
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Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
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Novo Nordisk (NYSE: NVO), a leading Danish pharmaceutical company, has released a joint statement with the European Medicines Agency (EMA) addressing the ongoing supply challenges for its GLP-1 receptor agonist, Ozempic (semaglutide). The statement cites increased demand and manufacturing site capacity constraints as the primary factors contributing to the shortages,…
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Skyline Therapeutics, a biopharmaceutical company based in China, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its proprietary adeno-associated virus (AAV) gene therapy, SKG1108, for the treatment of retinitis pigmentosa (RP). This innovative therapy utilizes a novel AAV vector, including a groundbreaking capsid…
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, IBI363. This PD-1/IL-2α bispecific antibody fusion protein is under development for the treatment of unresectable locally advanced or metastatic melanoma, excluding…
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received a significant boost with the clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HW071021. This novel drug, designed to combat advanced solid tumors, stands as a unique…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) and Chongqing Genrix Biopharmaceutical Co., Ltd, two leading Chinese pharmaceutical companies, have embarked on the commercialization journey of their innovative anti-IL-17 antibodies, vunakizumab and xeligekimab, respectively. These domestically developed treatments received marketing approval late last month, marking a significant milestone in addressing moderate…
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PARIS—French pharmaceutical giant Sanofi (NASDAQ: SNY) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to…
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FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for its mineralocorticoid receptor (MR) antagonist, finerenone. Originally approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, finerenone is now being developed for heart failure, a condition with significant market potential.…
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
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SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
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SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Evopoint Biosciences’ XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated…