Greater China News
Transcenta to Present Three Study Results at ESMO 2023
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it is going to present three posters highlighting study results from ongoing trials related to Osemitamab (TST001) at the 2023 European Society of Medical Oncology (ESMO) Congress including updated efficacy and PK/PD analysis data from the phase 2 study of Osemitamab (TST001)/CAPOX in CLDN18.2 positive first line G/GEJC as well as preclinical data on the combination study of Osemitamab (TST001) with PD1 inhibitor.
Akeso Announced First Patient Dosed in Phase 3 Trial of Ivonescimab versus Tislelizumab for First-line Treatment of Squamous NSCLC
Akeso Inc. ("Akeso", 9926. HK) announced today that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso.
European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Hong Kong Department of Health has Approved the Registration Applications for the Uro-G and Uro-V Disposable Cystoscopic System
Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the Government of Hong Kong Special Administrative Region Department of Health has approved the registration applications for the Uro-G and Uro-V disposable cystoscopic system.
Everest Medicines’ Partner Venatorx Receives FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI)
Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.
Successful FDA inspection at Aurisco’s manufacturing site in Yangzhou, China
Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).
Inmagene’s OX40 mAb, with an extended half-life and silenced ADCC, enters POC study in Atopic Dermatitis
Inmagene Biopharmaceuticals ("Inmagene"), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, announced that the first patient has been dosed in a global multicenter proof-of-concept (POC) study of IMG-007 in adult patients with moderate-to-severe atopic dermatitis (AD).
Neurophth Announces First Patient Dosed in Phase I/II Clinical Trial of Second Gene Therapy
Neurophth Therapeutics, Inc. ("Neurophth") announced today that the first patient has been dosed in the international multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation (ND1-LHON).
国内首家申请上市！荃信生物/华东医药乌司奴单抗生物类似药获受理
“8月11日，江苏荃信生物医药股份有限公司（以下简称“荃信生物”）同华东医药(000963.SZ)全资子公司杭州中美华东制药有限公司（以下简称“中美华东”）联合开发的乌司奴单抗生物类似药（研发代码：QX001S/HDM3001）获得国家药品监督管理局（NMPA）签发的《受理通知书》（受理号：CXSS2300065），用于治疗成年中重度斑块状银屑病。 QX001S/HDM3001注射液是强生公司Stelara®（喜达诺®，乌司奴单抗注射液）的生物类似药，其作用机理为阻断IL-12和IL-23共有的p40亚基与靶细胞表面的IL-12Rβ1受体蛋白的结合，从而抑制IL-12和IL-23介导的信号传导和细胞因子级联反应。IL-12和IL-23是两种天然存在的细胞因子，在免疫介导的炎症性疾病中发挥着关键作用。 银屑病是一种慢性、复发性、炎症性疾病，主要累及皮肤和关节系统，目前尚无法治愈，需长期甚至终身治疗。根据弗若斯特沙利文的资料，2021年中国银屑病的患病人数为670万人，预计于2030年将达到690万。斑块银屑病约占所有银屑病病例的80%～90%，是银屑病中最常见的类型。目前，生物治疗已经成为银屑病的主要治疗方法之一，在治疗重症、难治以及特殊类型银屑病方面发挥了积极而有效的作用。” Continue reading at the original source, linked here.
Schroders Capital to expand private equity operations in China
Schroders Capital is close to launching its first onshore private equity offering in China, as it looks to capitalise on the growing renminbi market.
