ZT002

– 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

* ZT002每两周一次和每月一次给药在超重或肥胖患者中的安全性和耐受性均良好，整体耐受性特征与GLP-1RA类药物一致 * 在开放标签拓展研究期间，ZT002 120 mg每月一次给药在第30周降低体重17.1% 中国北京，2024年9月12日 – 北京质肽生物医药科技有限公司（以下简称“质肽生物”或“公司”）是一家致力于开发治疗代谢疾病领域、处于临床开发阶段的创新药公司。在 2024年欧洲糖尿病研究协会（EASD）年度会议上公布了其每月一次新型GLP-1RA ZT002的Ic期临床数据。 北京大学人民医院纪立农教授代表公司做了题目为“ZT002，一种新型超长效GLP-1 受体激动剂在超重或肥胖成人中：一项随机、安慰剂对照、多剂量递增Ic期研究”的大会报告，重点介绍了ZT002的最新进展。ZT002是一种在研的新型超长效GLP-1受体激动剂（GLP-1RA），每月一次皮下注射，用于肥胖治疗。 这项研究分A和B两个部分，其中A部分的两个队列共纳入了28例超重或肥胖患者。合格受试者随机接受每两周一次（Q2W）皮下注射ZT002（剂量递增至40 mg或80 mg，n=10+10）或对应的安慰剂（n=4+4），40 mg和80 mg组分别治疗12周和14周。主要终点为安全性和耐受性，次要终点为药代动力学、药效学和免疫原性。在A部分末次给药后停药6周以评估其药代动力学，随后开展了开放标签的拓展研究（B部分）。ZT002 80 mg Q2W组自愿参加拓展研究的患者（n=8）接受了额外12周ZT002 120 mg每月一次（Q4W）治疗。主要终点是安全性和耐受性，次要终点是药代动力学、药效学和免疫原性。本项研究达成了全部终点。 主要结论： ● ZT002在研究剂量范围内安全性和耐受性良好，整体耐受性特征与GLP-1RA类药物一致。Q2W和Q4W给药的耐受性均随时间的推移而改善。 ● 大多数不良事件（AE）的严重程度为轻度或中度，ZT002治疗组未报告严重不良事件。 ● 治疗中出现的胃肠道（GI）不良事件与GLP-1RA类药物一致。最常见的治疗相关不良事件是恶心、呕吐和腹泻，主要发生在剂量滴定过程，在达到目标剂量后减少。 ● 每月给药的GI AE特征（B部分）与每两周给药（A部分）相似。 ● 在A部分，与安慰剂相比，ZT002在统计学上显示出更显著的减重效果。 ○ 给药后第14周，ZT002 80 mg Q2W组的体重较基线减轻13.0%（p<0.001 vs.安慰剂组体重减轻1.7%）。 ○ 给药后第12周，ZT002 40 mg Q2W组的体重较基线减轻9.6%（p<0.001 vs.安慰剂组体重减轻0.8%）。 ● 在B部分，进一步给予ZT002 120 mg每月一次（在A部分停药6周后）治疗，第30周的体重较基线减轻17.1%。 ● 所有剂量的ZT002均显示改善了心血管代谢指标，包括血压、腰围、胰岛素敏感性、血脂和肝酶水平。 ● 本项研究结果支持ZT002在超重或肥胖患者中进一步开展临床研究。目前在中国已经启动一项评估ZT002慢性体重管理的II期临床研究，并计划近期与美国食品药品监督管理局进行沟通交流，以推进ZT002在海外的临床试验。 北京大学人民医院纪立农教授表示： “肥胖在全球和中国存在巨大的未被满足的临床需求，近年来以GLP-1RA类药物为代表的新型减重药物在为患者提供安全、有效且便利的治疗选择方面取得了突破性进展。经过分子结构优化的 ZT002拥有超长效的优势，有望通过每月给药方案实现持续高效的减重治疗，兼具良好的安全性和耐受性，进一步改善长期体重管理的便利性，提高患者生活质量，为肥胖治疗领域提供新的选择。” 质肽生物创始人、董事长兼首席执行官张旭家博士表示： “我们非常高兴有机会在EASD报告ZT002项目的最新研究成果。此次研究结果，充分体现了ZT002的潜力及其在肥胖治疗方面的临床前景。与每周给药相比，每月给药使肥胖患者的生活质量有了显著的提升，也极大地提高了患者的依从性，治疗效果更佳。我们将尽快推进ZT002在超重和肥胖方面的II期临床研究，期待进一步研究成果，并适时提供更新。” 关于质肽生物 质肽生物是一家专注于开发代谢疾病新型最佳疗法的临床阶段生物制药公司。公司利用特有的大肠杆菌生产工艺，能够快速、高效地扩大生产规模，以满足大规模市场的需求。质肽生物的创新药产品ZT002是一种超长效皮下注射GLP-1受体激动剂，目前正在进行肥胖症的II期临床试验，以及2型糖尿病的I期临床试验。在I期临床试验中，ZT002显示出每月一次给药的潜力，并显示出与GLP-1受体激动剂类药物一致的令人信服的安全性和耐受性。除此以外，公司在同步推进的丰富产品管线包括处于临床前研究阶段的一系列代谢类疾病创新药，以及进展到三期临床研究阶段的司美格鲁肽生物类似药。质肽生物的核心管理团队都是来自有长期开发代谢疾病类药物经验的制药行业资深人士，并得到了国内外专业生物医药投资机构的支持。 关于欧洲糖尿病研究协会 欧洲糖尿病研究学会（EASD）是一个基于会员制的学术非营利组织。它成立于1965年，总部设在德国杜塞尔多夫。学会的目标是鼓励和支持糖尿病领域的研究，促进专业知识的迅速传播和临床应用。 质肽生物 ZT002 GLP-1