Clinical & Regulatory
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.
估值超8.29亿美元！宜明昂科港股过聆讯
“8月14日，宜明昂科港股上市正式通过聆讯，预计不久后将成为今年少有的biotech上市股。中金公司和摩根士丹利担任联席保荐人。（关注公众号后台回复“宜明昂科”获取招股书PDF） 宜明昂科核心产品IMM0306（CD47×CD20）、IMM2902（CD47×HER2）及IMM2520（CD47×PD-L1）均为三个基于CD47的双特异性分子。其他10款处于不同开发阶段可靶向关键先天及适应性免疫靶点的候选药物，包括CD24抗体、CD47×CD24双抗、PD-L1×CD24双抗及3款处于临床及IND阶段的适应性免疫药物（VEGF×PD-L1双抗、CTLA-4 ADCC增强型单抗、CD70单抗），其他先天免疫检查点早期靶点包括IL-8抗体、NKG2A抗体、PSGL-1抗体。 近年来除CD47外，宜明昂科还选择并验证了另一个先天免疫检查点CD24。正在围绕CD24开发一款处于IND准备阶段及多款发现阶段及临床前阶段的候选药物，每一款都有可能成为同类中最早进入临床阶段的全球少数首创药物。2022年Pheast Therapeutics完成7600万美元A轮融资。融资由ARCH和Catalio Capital Management领投。这家临床前公司从斯坦福大学Irv Weissman教授的实验室中分离出来，专注于免疫肿瘤学。Weissman和Ravi Majeti博士是Forty Seven的联合创始人，该公司于2020年被Gilead Sciences收购。该公司的主要项目针对表面蛋白CD24，这是一种被许多癌症（包括卵巢癌和乳腺癌）征用的“不要吃我”信号，以避免被肿瘤内巨噬细胞检测和清除” Continue reading at the original source, linked here.
Kelun-Biotech announces that a Phase III clinical trial of core product SKB264 (MK-2870, TROP2-ADC) in patients with unresectable locally advanced, recurrent or metastatic TNBC who have failed second-line or above prior standard of care has met its primary endpoint
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-ADC (SKB264, also known as MK-2870) met the primary endpoint in the randomized, controlled, open-label, multi-center Phase III clinical trial of SKB264 for injection versus investigator selected regimens in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed second-line or above prior standard of care.
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).
Minghui Pharmaceutical Inc. Announces First Patient Enrollment in the Phase 3 Clinical Study of MH004 Cream for Treatment of Mild to Moderate Atopic Dermatitis
Minghui Pharmaceutical, Inc., a leading clinical-stage biopharmaceutical company, today announced the successful enrollment of the first patient in the phase 3 clinical study for MH004 Cream targeting mild to moderate atopic dermatitis. This achievement marks a significant milestone in the pursuit of providing effective and innovative treatment options for patients suffering from this prevalent skin condition.
Innovent Announces the NMPA Approval of SINTBILO® (Tafolecimab Injection) for the Treatment of Adult Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia
Innovent announced that China's National Medical Products Administration (NMPA) has approved SINTBILO® (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia.
