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Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from the European Medicines Agency (EMA) for its drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years who weigh at least 15 kg. The approval covers patients who are inadequately…
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China’s NHC Announces Initiative to Boost Gerontology Medical Services
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The National Health Commission (NHC) has issued a notification aimed at enhancing gerontology medical service capabilities, outlining specific work requirements. These include the construction of geriatric medicine departments, development of geriatric medical talent teams, standardization of geriatric medical diagnosis and treatment services, and enrichment of service models. Improving Geriatric Medicine…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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CARSgen Therapeutics Presents Latest CAR-T Data at ASH Annual Meeting
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CARSgen Therapeutics Holdings Ltd (HKG: 2171), a China-based specialist in chimeric antigen receptor (CAR)-T cell therapies, has announced the presentation of the latest data for its CAR-T therapies, CT053 (zevorcabtagene autoleucel; zevor-cel), CT071, and CT0590, at the 66th American Society of Hematology (ASH) annual meeting. CT053 Phase II Study Subgroup…
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Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
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Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading China-based company, has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin, a long-acting somatropin, for the treatment of idiopathic short stature (ISS). Understanding Idiopathic…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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Ascentage Pharma to Present Olverembatinib and Lisaftoclax Clinical Data at ASH Annual Meeting
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China-based Ascentage Pharma (HKG: 6855) has announced that it will present the results of multiple clinical studies for its olverembatinib (HQP1351) and three clinical studies for its lisaftoclax (APG-2575) at the 66th American Society of Hematology (ASH) annual meeting. These presentations highlight the company’s commitment to advancing treatments for various…
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CStone Pharmaceuticals Presents CS5001 Clinical Data at the ASH Annual Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the presentation of the latest clinical data on CS5001, an anti-ROR1 antibody drug conjugate (ADC) for lymphoma, at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 is a leading asset in CStone’s Pipeline 2.0 and has shown significant promise in treating…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
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Legend Biotech to Showcase CARTITUDE-4 Trial Data on Carvykti at ASH Annual Meeting
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China-based Legend Biotech Corporation (NASDAQ: LEGN) is set to present new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting in San Diego. The data will compare Carvykti (ciltacabtagene autoleucel; cilta-cel) treatment with the…
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Asieris Pharmaceuticals Receives NMPA Approval for Hexvix (APL-1706) in Bladder Cancer Diagnosis
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that the National Medical Products Administration (NMPA) has approved a marketing filing for its product Hexvix (APL-1706), which is used in the diagnosis and management of bladder cancer. Product Approval and ImpactThe approval of Hexvix by the NMPA marks a…
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Frontier Biotechnologies Inc. Gets NMPA Approval for Phase II Study of Albuvirtide as HIV Therapy
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Nanjing-based Frontier Biotechnologies Inc. (SHA: 688221) has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its version of albuvirtide, marking a significant step forward for China’s first domestically developed innovative HIV therapy. The study will evaluate albuvirtide as a maintenance…
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Windtree Therapeutics Secures Hong Kong Patent for Istaroxime Heart Failure Treatment
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US biotechnology company Windtree Therapeutics, Inc. (NASDAQ: WINT) has announced the receipt of a patent approval in Hong Kong for its drug istaroxime. The patent, titled “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF),” covers formulations comprising istaroxime and methods of use, either alone or in combination with…
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BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
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HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD). BRIGHT Study to Assess Safety and Tolerability of HG202The upcoming BRIGHT study, an open-label, multicenter dosage escalation…
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Isap Biotech Secures FDA IND Approval for iSAP-0909 for Bladder Cancer Imaging
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Beijing-based biotech firm Isap Biotech has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable agent, iSAP-0909. The agent will be assessed for its use in the auxiliary diagnosis and intraoperative localization of non-muscle invasive bladder cancer (NMIBC).…
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China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
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Innorna Co., Ltd Receives FDA Rare Pediatric Disease Designation for mRNA Drug IN015
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Shenzhen-based Innorna Co., Ltd has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for its proprietary mRNA drug, IN015, developed for the treatment of progressive familial intrahepatic cholestasis (PFIC). Understanding PFIC and the Impact of IN015Progressive familial intrahepatic cholestasis (PFIC)…
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Teva Pharmaceutical Reports Positive Phase III Results for TEV-‘749 in Schizophrenia Trial
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia. SOLARIS Study Design and TEV-‘749’s EfficacyThe SOLARIS…
