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Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
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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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Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
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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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Hanx Biopharmaceuticals Receives NMPA Approval for HX009 Combination Therapy Phase II Trial
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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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European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
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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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Manufacturing Challenges for Novo Nordisk’s Ozempic Impact Diabetes and Obesity Treatments in Europe
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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’ Gene Therapy Receives FDA Orphan Drug Designation for Retinitis Pigmentosa Treatment
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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’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
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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’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
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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 and Chongqing Genrix Launch Anti-IL-17 Therapies for Psoriasis in China
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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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Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
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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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Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
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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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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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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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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
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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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GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
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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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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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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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China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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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…
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Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
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BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a long-acting erythropoietin (EPO) product, rhEPO-Fc, developed by Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), for review. The product is intended for the treatment of anemia associated with chronic kidney disease (CKD). Anemia is a common…
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Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
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Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200,…
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Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
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Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US pharmaceutical giant Regeneron Pharmaceuticals Inc. to oversee the market launch and commercialization of Libtayo (cemiplimab), Regeneron’s proprietary programmed death-1 (PD-1) inhibitor, in South Korea and Taiwan. Financial details of the agreement were not disclosed. Libtayo…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
