Exenatide

节前，NMPA发布2024年09月14日药品批准证明文件送达信息，本批次共有69个受理号获批，多个重磅新药以及新适应症获批，其中： 成都康诺行生物的司普奇拜单抗注射液获批上市，用于治疗外用药控制不佳或不适合外用药治疗的成人中重度特应性皮炎。 司普奇拜单抗注射液是以IL-4Rα为靶点的单克隆抗体药物，通过阻断IL-4和IL-13与IL-4Rα受体的结合，抑制IL-4和IL-13引起的下游炎症因子的释放、蛋白表达及炎症细胞活性，治疗炎症反应过度诱发的特应性皮炎。 诺和诺德的注射用培妥罗凝血素α新适应症获批上市，具体适应症尚未披露。 注射用培图罗凝血素α（N8-GP）正是一款经聚乙二醇（PEG）修饰后半衰期得到显著延长的凝血因子。今年7月，诺和诺德的注射用培妥罗凝血素α首次在国内获批上市，适应症为：用于成人和儿童血友病A（先天性凝血因子VIII缺乏）患者按需治疗及控制出血事件、围手术期管理、常规预防治疗以防止或减少出血事件的发生。 优时比的比奇珠单抗注射液新适应症获批上市，用于非甾体类抗炎药给药后疗效不佳或不耐受的活动性放射学阴性中轴型脊柱关节炎伴客观炎症体征的成人患者。 比奇珠单抗是全球首个且目前唯一获批的IL-17A/F（白介素-17）双靶点一线生物制剂。此前，该药在国内获批用于常规治疗疗效不佳或不耐受的活动性强直性脊柱炎成人患者。随着新适应证获批，该药成为中国首个且目前唯一覆盖中轴型脊柱关节炎全疾病谱的双靶点一线生物制剂。 默沙东的帕博利珠单抗注射液新适应症获批上市，用于不可切除或转移性黑色素瘤的一线治疗。帕博利珠单抗2018年在华获批首个适应证即为晚期黑色素瘤二线治疗，现如今拓展适用于一线治疗。 除上述产品获批外，另有： 宜昌人福药业的烟酸缓释片；深圳翰宇药业的艾塞那肽注射液；上海宣泰医药的达格列净二甲双胍缓释片(Ⅰ) （Ⅱ）(Ⅲ)；石药集团中诺药业的注射用两性霉素B脂质体；齐鲁制药（海南）的盐酸特比萘芬喷雾剂；欧康维视的盐酸西替利嗪滴眼液；华益药业的阿司匹林肠溶片等多个产品获批。

– ZT002 was safe and well tolerated in both biweekly and monthly dosing arms in patients with overweight or obesity with a tolerability profile aligned with the GLP-1RA class – The open-label extension with ZT002 120 mg, once-monthly, showed 17.1% reduction in body weight at 30 weeks BEIJING, Sept. 12, 2024 /PRNewswire/ -- Beijing QL Biopharmaceutical Co., Ltd. ("QL Biopharm" or the "Company"), a clinical stage biopharmaceutical company developing innovative biologic drugs for the treatment of metabolic diseases, today announces Phase 1c clinical data for its lead drug candidate ZT002 was presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, Madrid, Spain. The presentation titled 'ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomized, placebo-controlled, multiple ascending dose phase 1c study' highlighted recent findings on QL Biopharm's lead drug candidate ZT002 - a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration. The study enrolled 28 overweight/obese patients in Part A in two cohorts. Eligible participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (dose escalated to 40 or 80 mg; n=10+10) or matched placebo (n=4+4) for a 12- or 14- week treatment period, in the 40 mg and 80 mg dose arms, respectively. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Following a 6-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). In this extension patients from the ZT002 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a once-monthly (Q4W) administration of ZT002 120 mg (n=8). The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Key conclusions from today's presentation are outlined below: ZT002 was considered safe and well tolerated across the investigated dose range, with a favorable tolerability profile aligned with the GLP-1RA class. The tolerability with both Q2W and Q4W dosing improved over time. The majority of adverse events (AEs) were mild or moderate in severity, no serious AEs were reported in the ZT002 treatment groups. Gastrointestinal (GI) treatment emergent adverse events were consistent with the GLP-1RA class; Most common treatment-related adverse events were nausea, vomiting, and diarrhea, occurring primarily during dose escalation and decreasing once target dose was reached. The GI AE profile of monthly dosing in Part B appeared similar to biweekly dosing in Part A In Part A, ZT002 demonstrated statistically significantly higher weight reduction compared to placebo with 13.0% body weight reduction from baseline to 14 weeks with ZT002 80 mg Q2W (p<0.001 vs placebo 1.7% body weight reduction). 9.6% body weight reduction from baseline to 12 weeks with ZT002 40 mg Q2W (p<0.001 vs placebo 0.8% body weight reduction). In Part B, a 17.1% body weight reduction from baseline was seen at 30 weeks, when further administering ZT002 120 mg once-monthly (after a 6-week off-drug period). All doses of ZT002 showed improved cardiometabolic parameters including blood pressure, waist circumference, insulin sensitivity, lipids, and liver enzyme levels. The results support further clinical investigation of ZT002 dosed monthly as a treatment for obesity. A Phase 2 program evaluating ZT002 for chronic weight management has been initiated in China and regulatory interaction is planned with U.S. FDA to advance the program outside China. Dr. Zhang Xujia, Ph.D., Founder, Chairman and Chief Executive Officer of QL Biopharm said: "We are pleased to present data highlighting the potential of ZT002 and its promising clinical profile in obesity care. The additional advantage of monthly dosing simplifies life for patients living with obesity. We look forward to advancing the Phase 2 program for ZT002 in overweight and obesity and providing further updates in due course." Abstracts are available on the EASD website here, and on the QL Biopharm website here. NOTES TO EDITORS About QL Biopharm QL Biopharm is a clinical-stage biopharmaceutical company focused on developing novel best-in-class peptide therapeutics for metabolic diseases. The Company leverages its proprietary E. coli manufacturing process enabling rapid and cost-effective scaling of manufacturing for high volume markets. The lead drug candidate, ZT002, is an ultra long-acting subcutaneously administered GLP-1 receptor agonist, currently in a Phase 2 study for obesity and in Phase 1 for type 2 diabetes. In Phase 1 studies, ZT002 demonstrated potential for once-monthly dosing with compelling weight loss and tolerability consistent with the GLP-1RA class. The Company is also advancing a broader portfolio of novel preclinical assets for the treatment of metabolic diseases, in addition to its biosimilar semaglutide program, currently in Phase 3. QL Biopharm is led by a team of pharma industry veterans with expertise in E. coli–based peptide manufacturing and the development of drugs for metabolic diseases. The Company is backed by leading professional life science investors. For additional information, please visit About EASD The European Association for the Study of Diabetes e.V. (EASD) is a membership-based academic non-profit organization. It was founded in 1965 and its headquarters is based in Duesseldorf, Germany. The aims of the Association are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge and to facilitate its application. SOURCE Beijing QL Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED