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Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
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The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing for Talzenna (talazoparib) has been approved, clearing the way for the poly ADP-ribose polymerase (PARP) inhibitor to treat metastatic castration-resistant prostate cancer (mCRPC) in China. Talazoparib’s Global Approvals and IndicationsTalazoparib received approval in the US…
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Shouyao Holdings Adjusts Development Strategy for SY-1530, Halts Monotherapy Clinical Trials
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced a strategic adjustment regarding its drug candidate SY-1530. The company has decided to proactively terminate the clinical development of the BTK inhibitor as a monotherapy for recurrent/refractory mantle cell lymphoma (MCL) and other B-cell derived non-Hodgkin lymphoma (B-NHL). Despite this,…
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Nanjing Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
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Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its Category 1 drug LBL-034, which is intended for the treatment of multiple myeloma (MM). LBL-034: A Novel Bispecific Antibody Targeting GPRC5D…
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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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Novartis Forges Partnerships at CIIE to Strengthen Radioligand Therapy Ecosystem in China
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At the 7th China International Import Expo (CIIE), Swiss pharmaceutical giant Novartis (NYSE: NVS) announced strategic partnerships with US medical device and life sciences company GE Healthcare Technologies Inc., (NASDAQ: GEHC), and Chinese firms Shanghai Pharmaceuticals Holding Co., Ltd (HKG: 2607, SHA: 601607; SPH) and C.Q. Pharmaceutical Holding Co., Ltd…
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Vantive Secures Collaborations with Kertone and Qiantang Longyue at CIIE for Dialysis Solutions
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Vantive, a planned spin-off from U.S.-based Baxter International (NYSE: BAX) specializing in kidney care, has entered into separate collaboration agreements with the Chinese unit of UK’s Kertone Ltd. and Hangzhou Qiantang Longyue Biotechnology Co., Ltd. at the 7th China International Import Expo (CIIE). These partnerships focus on hemodialysis and peritoneal…
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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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Boston Scientific Launches Vercisie Genius DBS System in China for Parkinson’s Disease Treatment
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US major Boston Scientific Corporation (NYSE: BSX) has officially launched its Vercisie Genius, an implantable deep brain stimulation (DBS) system, at the 7th CIIE. This move is set to enhance the treatment options available to China’s growing Parkinson’s disease (PD) population. Parkinson’s Disease and Deep Brain Stimulation TherapyParkinson’s disease (PD),…
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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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Northeast Pharmaceutical to Acquire Majority Stake in Dingcheng Peptide Source for RMB 186.8 Million
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China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has announced its intention to acquire a 70% stake in Beijing Dingcheng Peptide Source Biotechnology Co., Ltd, a fellow Chinese firm, for a consideration of RMB 186.8 million. This strategic move is aimed at bolstering Northeast Pharmaceutical’s presence in the cell therapy sector.…
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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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Shanghai Duoning Biotechnology Partners with Branca Bunús for Transfection Reagents Innovation
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Shanghai Duoning Biotechnology Co., Ltd, a prominent biopharmaceutical company in China, has entered into a strategic partnership with Ireland-based Branca Bunús Ltd, a leader in gene delivery technology. This collaboration aims to provide biopharmaceutical customers with innovative transfection reagents through resource sharing, focusing on the development, optimization, and application of…
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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…
