Teprotumumab N01

“点击蓝字 关注我们信达生物玛仕度肽第二项头对头司美格鲁肽临床研究：在中国超重或肥胖合并脂肪肝受试者中的III期临床研究GLORY-3完成首例受试者给药 PPS 2025年5月16日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售用于治疗肿瘤、自免、代谢、眼科等重大疾病领域创新药物的生物制药公司，宣布：胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂玛仕度肽在中国超重或肥胖合并代谢相关脂肪性肝病（MAFLD）的受试者中的一项III期临床研究（GLORY-3）完成首例受试者给药。该研究是一项在中国超重或肥胖合并MAFLD受试者中比较玛仕度肽与司美格鲁肽有效性和安全性的多中心、随机、开放标签的III期临床研究（NCT06884293）。该研究计划入组约470例超重或肥胖（BMI≥27 kg/m2）合并代谢功能障碍相关性脂肪性肝病（MAFLD）受试者，按1:1的比例随机分配至玛仕度肽9 mg组或司美格鲁肽2.4 mg组。研究的主要终点是第48周时磁共振质子密度脂肪分数（MRI-PDFF）评估肝脏脂肪含量较基线百分比变化及第48周时体重较基线的百分比变化。在一项中国肥胖受试者（BMI≥30 kg/m2）中开展的II期研究(NCT04904913)结果显示，在给药48周后，玛仕度肽9 mg组体重降幅相较安慰剂组的差值达−18.6%，平均变化值与安慰剂组的差值达−17.8 kg；玛仕度肽 9 mg组中51.2%的受试者体重较基线下降15%以上，34.9%的受试者体重较基线下降20%以上。在基线肝脏脂肪含量（由MRI-PDFF测量）超过5%的受试者中，玛仕度肽9 mg组治疗24周后肝脏脂肪含量较基线平均百分比下降73.3%，该降幅在48周延长治疗期得以维持。提示玛仕度肽可有效降低超重或肥胖受试者的体重及肝脏脂肪，为超重或肥胖合并MAFLD的患者带来获益。该项研究的主要研究者、北京医院郭立新教授表示：“代谢功能障碍相关性脂肪性肝病（MAFLD）是全球最常见的慢性肝病，且已经取代病毒性肝炎成为中国第一大慢性肝病。肥胖是MAFLD的危险因素之一，中国肥胖人群MAFLD患病率为81.8%[1]。GLP-1类药物如司美格鲁肽已被最新的《中国肥胖患者长期体重管理和药物临床应用指南》推荐可用于肥胖合并MAFLD的治疗。作为GCG/GLP-1双受体激动剂，玛仕度肽9mg在超重或肥胖人群中减重疗效强劲，且因其对GCG受体的额外激动作用，可使肝脏脂肪含量和肝酶水平大幅降低，可为受试者带来更显著的肝脏获益。GLORY-3将在超重或肥胖合并MAFLD的受试者中比较玛仕度肽9mg和司美格鲁肽2.4mg的疗效和安全性，这也是第一个在这类患者人群对比GCG/GLP-1双受体激动剂和GLP-1单靶点药物的临床研究。我将与GLORY-3的研究者们一起同心协力推进和高质量完成此项研究，在获得高质量的临床证据的同时，为中国超重或肥胖合并MAFLD的人群提供更优的治疗选择。”信达生物制药集团临床开发高级副总裁钱镭博士表示：“玛仕度肽作为GCG/ GLP-1双受体激动剂，相较于GLP-1单受体激动剂药物，激动GCG受体可促进脂肪分解和脂肪酸氧化，并带来一系列代谢综合获益。在中国肥胖受试者中开展的II期研究中，基线肝脏脂肪含量超过5%的受试者接受玛仕度肽9 mg组治疗24周后其肝脏脂肪含量即可较基线平均百分比下降73.3%，初步证明了玛仕度肽降低肝脏脂肪含量的疗效。我非常有信心玛仕度肽在GLORY-3研究中会继续在前期研究中的强大减重及改善肝脏代谢等临床指标，为超重或肥胖且合并MAFLD的患者带来全面的代谢获益和更优的治疗选择。”关于肥胖中国是全球超重和肥胖人口最多的国家，且呈现逐渐上升趋势[2]。肥胖可以导致一系列并发症或者相关疾病，进而影响预期寿命或者导致生活质量下降。在较为严重的肥胖患者中，心血管疾病、糖尿病和某些肿瘤的发生率及死亡率明显上升。2019年超重和肥胖导致的死亡在慢性非传染性疾病相关死亡中占比11.1%，相比1990年的5.7%显著增加[3]。肥胖症是需要长期治疗的慢性疾病，目前缺乏长期有效且安全的治疗手段。生活方式干预是超重或肥胖者的首选和基础治疗手段，但是仍有相当一部分患者由于种种原因不能达到期望的减重目标，需用药物辅助减重。传统减肥药减重效果有限，且存在安全性问题，对疗效更好且安全的减肥疗法的需求尚未得到满足。关于代谢相关脂肪肝病（MAFLD）MAFLD是全球最常见的慢性肝病，全球MAFLD总体患病率估计为32.4%，且患病率逐年升高。肥胖作为MAFLD的危险因素之一，全球肥胖人群中的MAFLD患病率达到75.3%。在中国，MAFLD且已经取代病毒性肝炎成为中国第一大慢性肝病。中国肥胖人群MAFLD患病率为81.8%[1]。同时，中国MAFLD年发病率在正常人群或肥胖人群中均为全球最高。MAFLD治疗目标包括减少体质量和腰围、改善胰岛素抵抗、防治代谢相关综合征、逆转纤维化等等，与肥胖患者的治疗原则存在相似之处。对于超重或肥胖合并MAFLD的患者，在生活方式干预的基础上辅以药物治疗是实现有效减重、改善合并症以及提高生活质量的优选方案。关于玛仕度肽（IBI362）玛仕度肽（IBI362）是信达生物与礼来制药共同推进的一款胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂。作为一种哺乳动物胃泌酸调节素（OXM）类似物，玛仕度肽除了通过激动GLP-1R促进胰岛素分泌、降低血糖和减轻体重外，还可通过激动GCGR增加能量消耗增强减重疗效，同时改善肝脏脂肪代谢。玛仕度肽已在多项临床研究中展现出优秀的减重和降糖疗效，以及降低腰围、血脂、血压、血尿酸、肝酶及肝脏脂肪含量，以及改善胰岛素敏感性，带来多重代谢获益。玛仕度肽当前共有两项NDA获NMPA受理审评，包括：用于成人肥胖或超重患者的长期体重控制；用于成人2型糖尿病患者的血糖控制。玛仕度肽当前共开展了六项III期临床研究，包括：在中国超重或肥胖受试者中开展的III期临床研究（GLORY-1）；在中国中重度肥胖受试者中开展的III期临床研究（GLORY-2）；在中国超重或肥胖合并MAFLD受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（GLORY-3）;在初治的中国2型糖尿病受试者中开展的III期临床研究（DREAMS-1）；在口服药物治疗血糖控制不佳的中国2型糖尿病受试者中开展的对比玛仕度肽和度拉糖肽的III期临床研究（DREAMS-2）；在中国2型糖尿病合并肥胖的受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（DREAMS-3）。其中，GLORY-1、DREAMS-1和DREAMS-2研究均已达成终点。此外，玛仕度肽的多项新临床研究计划启动，其中包括治疗青少年肥胖和阻塞性睡眠呼吸暂停（OSA）的两项III期临床研究，以及治疗代谢相关脂肪性肝炎（MASH）、射血分数保留心力衰竭（HFpEF）等新临床研究。关于信达生物“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让信达生物的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。参考文献：[1] Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399.[2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.3Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool.http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).文章来源：信达生物美编排版：陈鑫茹文章审核：隋艾蓉 陈鑫茹 罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

SAN FRANCISCO and SUZHOU, China, May 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the release of its "2024 Environmental, Social and Governance (ESG) Report", highlighting the Company's strategies, actions, and achievements in sustainable development across five pillars, which include "Excellent Governance", "Enjoying Good Health", "High Quality as Key", "People First" and "Embracing Ecology". Continue Reading MSCI ESG RATING Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "As China's leading biopharmaceutical company, Innovent consistently navigates the pulse of the times with strategic foresight, forging a closed-loop system for value creation through synergistic integration of global innovation-driven strategies and sustainable development practices. We achieved an MSCI ESG rating of AAA, as the only biotech in China and one of just three globally to receive this rating. Throughout the year of 2024, we remained committed to our mission, 'to empower patients worldwide with affordable, high-quality biopharmaceuticals,' and stayed true to our original aspiration, 'Start with Integrity, Succeed through Action.' We deeply integrated social responsibility into our business practices, actively responded to the United Nations Sustainable Development Goals (SDGs), strengthened our governance structure, improved operational efficiency, advanced high-quality innovation, promoted diversity and empowerment among employees, and strived for low-carbon development. These initiatives firmly honored our commitment to sustainable growth. We have embedded ESG principles into the fabric of our organization, which enables us to continuously create multidimensional value for shareholders, employees, patients, and society." Building Enduring Excellence through Lean Governance Robust governance is the cornerstone of sustainable business development. In 2024, Innovent further refined its ESG governance framework to ensure agility in responding to global changes while maintaining steady, compliant operations. We strengthened compliance management through continuous improvement of risk management systems and the upholding of rigorous business ethics standards. Looking ahead, we are committed to building a stable and sustainable business ecosystem in collaboration with our partners. Board Diversity: added one female Executive Director, with every Board Committee now including at least one female chair or member. Compliance, anti-corruption, and business ethics training: 100% participation among Directors and employees. Supplier business ethics: 100% of suppliers signed the "Commitment to Compliance". Official ESG website: launched in 2024, underscoring the company's firm commitment to sustainable development. ESG recognition: achieved an MSCI ESG rating of AAA, the only biotech in China and one of just three globally to receive this rating. Driving Inclusive Healthcare through Innovation Bridging geographic and economic gaps through innovative therapies remains Innovent's unwavering goal. Guided by our company strategy, "To discover new medicines through innovation and deliver them through our global platforms", Innovent has solidified its oncology leadership in China, achieved multiple groundbreaking advancements in chronic disease therapies, and expanded our global impact. Out dedication to scientific progress is grounded in a strong sense of social responsibility, which extends to improving drug accessibility and affordability for patients worldwide, rural education, volunteer activities, and broader community support initiatives. Improving drug accessibility through an innovative pipeline: 15 commercialized products have benefited 5 million patients cumulatively. 3 New Drug Applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 molecules in early clinical development. Oncology and general biomedicine have become the Company's two growth engines. 6 drugs or assets granted 13 orphan drug designations, with 2 drug candidates for rare diseases in preclinical and clinical stages. SYCUME® (teprotumumab N01 injection) was launched as China's first IGF-1R antibody for the treatment of thyroid eye disease, ending a 70-year absence of treatment options and transforming care for this rare condition. Enhancing drug affordability by supporting medical insurance coverage with 6 medicines (TYVYT®, BYVASDA®, HALPRYZA®, SULINNO®, Olverembatinib, and SINTBILO®) included in China's National Reimbursement Drug List (NRDL) and 8 medicines (Pemazyre®, Cyramza®, Retsevmo®, FUCASO®, TYVYT®, DOVBLERON®, Jaypirca® and DUPERT®) included in the Catalog of Specific Drug Reimbursements under Huimin Insurance Programs. SINTBILO® became China's first domestically developed PCSK9 inhibitor included in the NRDL. Patient assistance programs have benefited over 200,000 patients, with donated medicines valued at more than RMB 3.6 Billion. Health education and public welfare programs benefited over 240,000 patients. Ongoing efforts in supporting rural education have cumulatively benefited nearly 4,000 teachers and students. Innovent volunteer teams contributed a total of 2,754 hours of community service, reflecting our long-term commitment to social responsibility. Delivering Life-Changing Quality High-quality is a foundational principle at Innovent that underpins our mission to deliver safer, more effective therapies to patients. Patient-centricity drives our adherence to internationally recognized quality standards across the entire product lifecycle, from development and manufacturing to distribution. Even in the face of complex external environments, we actively collaborate with industry partners to elevate sector-wide benchmarks and maintain a resilient, sustainable dual-sourcing supply chain. Our responsible marketing practices further prioritize transparency and the protection of patient rights. Innovent Biologics currently operates 140,000 L of total production capacity, comprising 60,000L of antibody production capacity at Suzhou manufacturing site and 80,000L of antibody and ADC production capacity at Hangzhou manufacturing site. With an additional 90,000L of capacity in plan at the Hangzhou site, the total production capacity will reach 230,000L upon full completion. All commercially operational production facilities are 100% GMP-certified. Reached 100% batch success rate in drug substance manufacturing. Maintained 100% pass rate in audits conducted by regulatory authorities and strategic partners. Established dual-source supply chains for raw materials used in self-manufactured commercial products. Conducted 122 quality audits of suppliers; delivered capacity-building training to approximately 170 suppliers; deployed over 400 personnel to provide on-site quality supervision, guidance, and training at 10 key supplier sites. Empowering Talent and Igniting Potential A thriving talent ecosystem fuels our innovation. At Innovent, we view our employees as the foundation of long-term success and are deeply committed to cultivating a fair, inclusive, and empowering workplace. We offer diverse career development pathways and a multi-tiered professional development training system tailored to different career stages. Our comprehensive compensation and benefits framework is designed to strengthen employees' sense of belonging, while enhancing our ability to attract, retain, and develop top talent. Committed to making Innovent a learning institution, we support employees in achieving both personal and professional growth. Women represent 51% of total employees and hold 44.2% of management positions. Key talent retention rate reached 96.8%. Employee satisfaction rate exceeded 98%. The "Innovent Beginning" Campus Recruitment Program offered over 2,100 job opportunities to new graduates from nearly 20 provinces. All operational production facilities are 100% ISO 45001 occupational health and safety (OH&S) certified. Safeguarding the Green Future with a Commitment to Sustainability Green development underpins Innovent's high-quality growth strategy. We are committed to eco-friendly practices that protect natural resources and ecosystems while actively contributing to global climate action. Through comprehensive climate risk assessments, we evaluate the potential operational impacts of climate change and implement measures to reduce our business activities' climate impacts. By integrating green, low-carbon principles across all aspects of our production and operations, we continue to set clear targets that drive continuous improvement in our environmental performance and contribute to a more sustainable future. 100% of operational production facilities are certified under the ISO 14001 Environmental Management System. Successfully completed one internal and one external environmental management audit to ensure ongoing compliance and system integrity. 29% reduction in energy consumption (per unit of production) compared to the previous year. Reduced fresh water use by 22% (per unit of production) compared to the previous year. Recycled a total of 51,100 tons of water, reflecting out commitment to resource conservation. Innovent Shanghai Global R&D Center was awarded LEED Gold certification by the U.S. Green Building Council (USGBC). Innovent remains firmly committed to sustainable development and global innovation. We will continue strategically consolidating our business momentum while pursuing breakthrough innovations in science. By harmonizing business success with long-term social value, Innovent is steadily progressing toward its vision of becoming a premier global biopharmaceutical company. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. 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