Petrelintide

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes and overweight, non-obese individuals Preclinical data for BGM1812 supports further development as next-generation amylin analog for obesity treatment SUZHOU, China, June 23, 2025 /PRNewswire/ -- BrightGene Pharmaceutical Co., Ltd., an international, innovation-driven pharmaceutical company, presented data from two Phase 2 studies for BGM0504, its investigational dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), along with preclinical data for its novel amylin analog, BGM1812, at the 85th Scientific Conference of the American Diabetes Association (ADA). Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with type 2 diabetes (including superiority to semaglutide), and in overweight and obese non-diabetic individuals, respectively. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment. "These Phase 2 data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity, including potential superiority to semaglutide and a strong safety profile, while our preclinical data for BGM1812 support its continued development as a next-generation amylin analog for obesity treatment, underscoring the additional promise in our pipeline," said Dr. Jiandong Yuan, CEO, BrightGene. "Building on our extensive peptide expertise and strong heritage in high-quality, efficient drug development, BrightGene is committed to accelerating innovative therapeutics to help address unmet patient needs in metabolic disease and other important therapeutic areas." BGM0504 Phase 2 Study in Type 2 Diabetes This multicenter, randomized, double-blind (placebo-controlled) and open-label (semaglutide positive-controlled) evaluated the pharmacokinetics, safety and efficacy of once-weekly subcutaneous injection of BGM0504 across the primary endpoint, change from baseline in HbA1c at Week 12 of target dose administration, and multiple secondary endpoints including PPG-2h, FPG, body weight, HbA1c and combined HbA1c/body weight targets proportions, HOMA2-B, blood lipids, systolic blood pressure (SBP) and diastolic blood pressure (DBP). The study enrolled 67 participants with type 2 diabetes between the ages of 18 and 65, 64 received dose after randomization, randomized into five groups: 5mg (n=13), 10mg (n=12), 15mg (n=13), positive-control group (semaglutide; n=16) or placebo (n=13). Enrolled participants included adults with a baseline HbA1c between 7.0% and 10.0%, and a body mass index (BMI) between 19.5 and 35 kg/m2. At Week 12 of target dose administration, treatment with BGM0504 resulted in reductions in HbA1c across the three dose groups that were statistically significant compared with the placebo group and greater than treatment with semaglutide, including -1.72% in the 5mg dose group, -1.94% in the 10mg dose group, and -2.48% in 15mg dose group, compared to -1.43% in semaglutide and -0.28% in placebo. Similar results were observed in multiple secondary endpoints, including PPG-2h, FPG, body weight, and HbA1c and combined HbA1c/body weight target proportions, while varying improvement trends were observed in HOMA2-B, blood lipids, SBP and DBP. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose. The most common treatment-related gastrointestinal AEs were diarrhea, nausea and abdominal distension; no hypoglycemic or other unexpected adverse reactions occurred. BGM0504 Phase 2 Study in Obesity This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection). Enrolled participants included adults with a BMI ≥ 24kg/m2 (mean BMI at enrollment ≥ 27kg/m2) with prediabetes and/or at least one obesity-related comorbidity, or adults with obesity (BMI≥ 28kg/m2, mean BMI at enrollment ≥ 30kg/m2). Participants were randomized into four groups: 5 mg (n=30), 10 mg (n=30), 15 mg(n=30), or placebo (n=30). The study consisted of a titration phase (2-6 weeks), 24-week treatment with once-weekly dosing, and a 2-week follow-up. Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05). Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events. BGM1812 Preclinical Study In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model. At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model. About BGM0504 The peptide hypoglycemic drug BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by BrightGene. BGM0504 can stimulate the downstream pathways of GIP and GLP-1, produce biological effects such as controlling blood sugar, reducing weight and treating non-alcoholic steatohepatitis (NASH), and show potential for the treatment of various metabolic diseases. BGM0504 is currently in Phase 3 trials in China for weight management and type 2 diabetes and has completed a Phase 1 bridging study for weight management in the U.S. To date, BGM0504 has been investigated in more than 1,000 patients and demonstrated superior efficacy and a strong safety profile. About BGM1812 BGM1812 is a novel amylin analog designed using AI/ML-driven optimization to enhance agonist activities and formulation properties. A potent and ultra long-acting amylin, BGM1812 has the potential to be a once weekly oral tablet. About BrightGene BrightGene is an international, innovation-driven pharmaceutical company, listed on the Shanghai Stock Exchange, dedicated to developing and manufacturing high-quality therapeutics to address unmet patient needs. Founded in 2001, BrightGene has evolved from an established global leader in high-hurdle generics and biosimilars to developing innovative metabolic and respiratory therapeutics. An established leader in challenging chemistry and conjugation, BrightGene has proprietary, cutting-edge platforms in peptides, siRNA, nanobodies, as well as advanced formulations, and 272 patents. The company remains a global supplier of 15 APIs and 2 drug products to the US and EU. BrightGene is headquartered in China. Additional information is available at . SOURCE Bright Gene WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

II期数据显示，双靶点GLP-1/GIP受体激动剂BGM0504在2型糖尿病患者中，显示出在降糖和其他相关复合获益方面的综合潜质，并初步显示出优于司美格鲁肽的临床疗效；II期数据显示，双靶点GLP-1/GIP受体激动剂BGM0504在超重/肥胖非2型糖尿病成人群体中，展现出显著的体重管理潜力和代谢风险指标综合获益的潜质；胰淀素类似物BGM1812临床前数据支持其作为新一代肥胖治疗药物的开发潜力。中国苏州，2025年6月24日（北京时间）—— 创新驱动型国际化制药企业博瑞医药（BrightGene Pharmaceutical Co., Ltd.）在美国糖尿病协会（ADA）第85届科学会议上，公布了其自主研发的胰高血糖素样肽-1受体（GLP-1R）/葡萄糖依赖性促胰岛素多肽受体（GIPR）双靶点激动剂BGM0504的两项II期临床研究数据，以及新型Amylin BGM1812的临床前研究结果。两项独立的BGM0504 II期研究分别显示，该药物在2型糖尿病患者中表现出良好的降糖疗效，并初步显示出优于司美格鲁肽的临床疗效。同时在超重/肥胖非2型糖尿病成人群体中，展现出显著的体重管理潜力和代谢风险指标综合获益的潜质。BGM1812临床前数据显示，其受体激活能力显著增强，可实现强效减重，并与GLP-1/GIP双靶点激动剂产生协同作用，支持其作为新一代肥胖治疗药物开发。北京大学人民医院纪立农教授表示“BGM0504在中国成人2型糖尿病患者2期临床研究中初步显示出显著的降低患者糖化血红蛋白、空腹血糖、餐后2小时血糖、体重、收缩压/舒张压等指标；大多数不良事件严重程度为轻至中度，且无需干预即可自行缓解，未观察到低血糖或非预期的不良事件。总体风险获益评估良好。本研究结果表明BGM0504注射液不仅初步疗效显著且耐受性良好，使其有望成为2型糖尿病治疗进一步开发的强有力候选药物。在后续3期临床研究中通过优化剂量滴定周期有望进一步提升其安全性和耐受性。”博瑞医药首席执行官袁建栋博士表示“这些II期数据凸显了BGM0504作为2型糖尿病和肥胖症治疗药物的国际第一梯队潜力，包括其可能优于司美格鲁肽的疗效及良好的安全性表现。同时，BGM1812的临床前数据进一步验证了其作为新型Amylin的开发价值，彰显了我们产品管线中的更多潜力。依托我们在多肽领域的深厚积累和高效药物研发传统，博瑞医药致力于加速创新疗法开发，以满足代谢疾病等领域未被满足的临床需求。”BGM0504治疗2型糖尿病II期研究BGM0504注射液已完成的II期临床试验（CTR202232464）是一项在中国2型糖尿病患者中进行的一项多中心、随机、安慰剂双盲及阳性药开放平行对照的临床研究，阳性对照药为司美格鲁肽注射液 1.0 mg。本项研究共纳入67例，随机后实际给药64例18-65岁2型糖尿病参与者。目标剂量稳定给药12周，主要终点指标结果显示，BGM0504三个剂量组HbA1c降幅均显著优于安慰剂组，且初步优于司美格鲁肽组：5mg组-1.72%、10mg组-1.94%、15mg组-2.48%，司美格鲁肽组为-1.43%，安慰剂组为-0.28%。次要终点指标如PPG-2h、FPG、体重、HbA1c达标比例等均呈现类似趋势，HOMA2-B/IR、血脂、血压等指标亦呈现出不同改善趋势，尤其在血压改善方面表现出良好地降压效果。整体显示出，BGM0504注射液在降糖和其他相关复合获益方面的综合潜质。治疗期间不良事件多为1-2级，最常见胃肠道反应为本类产品常见的一过性腹泻、恶心和腹胀等，未发生任何低血糖或其他非预期的不良反应。BGM0504治疗肥胖症II期研究BGM0504注射液已完成的II期临床试验（CTR20233198）是一项在非2型糖尿病的超重或肥胖受试者中进行的一项多中心、随机、双盲、安慰剂平行对照的临床研究。结果显示，主要终点指标目标剂量给药24周各剂量组体重相对安慰剂组显著降低，经安慰剂调整后的LSM分别为5 mg 组: −10.77% (95% CI: −12.93 to −8.61)、−10.2 kg (−12.3 to −8.2)，10 mg 组: −16.21% (95% CI: −19.20 to −13.23)、−15.5 kg (−18.3 to −12.6)，15 mg 组: −19.78% (95% CI: −23.02 to −16.54)、−20.1 kg (−23.4 to −16.8)。并且，各剂量组患者腰围经安慰剂调整后的LSM分别减少8.0-12.98 cm（p<0.001）。此外，相关脂代谢/心血管等指标也有不同程度的综合获益，其中收缩压降低11.60-13.03 mmHg，舒张压降低5.98-7.50 mmHg（p<0.05）。次要终点进一步支持BGM0504的疗效，各剂量组整体耐受性良好，所发生的不良事件绝大多数为 1~2 级，且大多未经干预即可恢复的一过性不良事件，所发生的不良反应多见于胃肠道系统方面（GI），严重程度主要为 1 级，发生时间集中在剂量滴定阶段及目标剂量给药前4周，继续给药后可逐渐耐受。整个试验过程中未发生任何低血糖事件和其他非预期不良反应。BGM1812临床前研究临床前研究表明，BGM1812在胰淀素受体和降钙素受体上的激动剂活性（EC50）分别较petrelintide（Zealand Pharma在研药物）提高1.8倍和2.2倍。在饮食诱导的肥胖（DIO）大鼠模型中，该药物在0.012-0.12 mg/kg剂量范围内呈现剂量依赖性体重减轻效应；在0.04 mg/kg剂量下，不仅减重效果超越petrelintide，还更有利于脂肪与瘦体重比例的进一步改善。值得关注的是，在DIO模型中，BGM1812与BGM0504的联合用药方案初步展现出优于司美格鲁肽+Cagrilintide或Amycretin组合的减重持续性和疗效强度。关于BGM0504BGM0504 注射液是公司自主研发的GLP-1/GIP受体双重激动剂，可激动GIP和GLP-1下游通路，产生控制血糖、减重和治疗非酒精性脂肪性肝炎（NASH）等生物学效应，展现多种代谢疾病治疗潜力。该药物目前在中国开展针对体重管理和2型糖尿病的III期临床试验，并在美国完成US bridging 临床研究。迄今已有超1000例患者接受治疗，显示出卓越疗效和良好安全性。关于BGM1812BGM1812是一款基于AI/ML优化设计的新型Amylin，具有强效和超长效作用特点，未来有望开发为每周一次口服制剂。关于博瑞医药  博瑞医药是一家参与国际竞争的创新型制药企业，是具备全产业链产品和核心药物研发技术平台的上市公司。自设立以来，博瑞医药致力于高技术壁垒的医药中间体、原料药及制剂产品的研发、生产和销售。截至目前，博瑞医药的中间体及原料药产品主要覆盖抗肿瘤、抗病毒、抗真菌、免疫抑制等治疗领域。随着公司原料药与制剂一体化战略的推进，先后已取得恩替卡韦片、注射用艾司奥美拉唑钠、注射用醋酸卡泊芬净、磺达肝癸钠注射液、奥拉西坦注射液、注射用米卡芬净钠、磷酸奥司他韦胶囊、阿加曲班注射液、磷酸奥司他韦干混悬剂、注射用伏立康唑、甲磺酸艾立布林注射液、卡前列素氨丁三醇注射液、地诺孕素片等药品批件 ，逐步建立起了具有全球竞争优势的产品线。前瞻性声明*本新闻稿仅为展示公司业务最新进展，不代表对于治疗方法和药品的推荐，相关药品的使用请咨询专业医师。不应赖以作为预测、研究、宣传材料或投资建议。本新闻非产品功效宣传，仅是对既定事实的陈述及科普说明。新闻信息中可能会包含某些前瞻性表述，这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务；及(b) 因任何数据、信息、资料等内容的原创性、真实性、准确性、时效性和完整性而导致的任何责任。