SAN FRANCISCO and SUZHOU, China, July 25, 2024 /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, today announced a strategic partnership with WeComput to jointly advance the construction and improvement of Innovent Biologics' Artificial Intelligence for Drug Discovery pla ...

Core Insights - Innovent Biologics announced that the Phase 3 clinical trial (DREAMS-1) of mazdutide for type 2 diabetes (T2D) met its primary and key secondary endpoints, demonstrating significant efficacy in glycemic control and weight loss [1][3][6] - The company plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) soon, following the acceptance of its first NDA for chronic weight management in February 2024 [1][10] Clinical Trial Results - DREAMS-1 was a randomized, double-blind, placebo-controlled trial involving 320 participants, showing a reduction in HbA1c of 1.57% for the 4 mg group and 2.15% for the 6 mg group compared to 0.14% for placebo at week 24 [2][3] - Key secondary endpoints indicated that mazdutide led to a higher proportion of patients achieving HbA1c < 7.0% and weight reduction ≥ 5% compared to placebo [3][4] Safety and Tolerability - The safety profile of mazdutide was favorable, with gastrointestinal adverse events being the most common, mostly mild to moderate, and no new safety signals identified [5][6] - The incidence of hypoglycemia was low, with no severe cases reported [5] Broader Implications - The results of the DREAMS-1 study provide significant medical evidence supporting the use of next-generation multi-target GLP-1R/GCGR drugs for T2D treatment, addressing the urgent need for innovative medications in China, where over 140 million people live with diabetes [7][8] - Mazdutide is positioned as a dual agonist that not only lowers blood glucose but also offers multiple cardiometabolic benefits, including weight loss and improved metabolic indicators [4][9] Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, with 10 products currently on the market and several new drug applications under review [11]

香港股市 | 医药 信达生物(1801 HK) 玛仕度肽临床数据优异,上调 2025-26E 业绩预测 玛仕度肽减重及降低肝脏脂肪方面效果优异,公司预计 2025 年上半年有望获批 公司在美国糖尿病协会科学年会(ADA)公布 GLP—1/GCG 双受体激动剂玛仕度肽的 3 期临床研究结果,临床试验主要及次要终点均已达成。患者连续使用 6 毫克剂量的玛仕 度肽 32 周和 48 周后体重分别较基线下降 13.38%与 14.84%。除此以外,玛仕度肽能显 著改善肝脏代谢功能,6 毫克剂型使用 48 周后肝脏脂肪含量降幅高达 80.2%,以上数据 与目前全球最畅销的 GLP-1 药物司美格鲁肽及替尔伯肽相比并不逊色。除此以外,临床 数据显示使用玛仕度肽 48 周后腰围、血压及血脂指标均有改善,因此能有效降低心血 管疾病风险。玛仕度肽 6 毫克与 4 毫克剂量的减重适应症上市申请已于 2024 年 2 月提 交,公司预计 2025 年上半年有望获批,进度略快于我们原先预期。 上调 2025-26E 收入及盈利预测 公司早前曾公布一季度产品销售收入同比大幅增加 60%至约 17 亿元(人民币,下 同),主要产品达伯舒 ...

CVM/肿瘤数据优异,玛仕度肽放量可期 信达生物(1801) 评级: 增持 [当前价格 Table_CurPrice] :(港元) 39.05 2024.06.30 ——信达生物跟踪点评 | [table_Authors] | 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | 付子阳 ( 研究助理 ) | |-------------------|-----------------------|----------------------------|--------------------------| | | 0755-23976735 | 021-38675855 | 0755-23976666 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | fuziyang028496@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S0880123100022 | 本报告导读: 综合管线和肿瘤管线临床数据密集读出,PD-1/IL2、CLND18.2 ADC、CLDN18.2/CD3 临床数 ...

浦银国际研究 公司研究 | 医药行业 (1801.HK) 信达生物(1801.HK):玛仕度肽首个 三期减重数据符合预期 近期公司在 2024 ADA 大会汇报了玛仕度肽首个 3 期临床研究 GLORY1(4mg/6mg)整体疗效安全性数据以及 GLORY-1 试验和此前 9mg 二 期试验肝脏脂肪减少数据。总体而言,GLORY-1 整体疗效安全性数据 符合预期,肝脏脂肪降低数据亮眼,MASH 将成为未来适应症拓展的 一个重大方向。我们持续看好信达生物在国内减重领域的领先地位和 先发优势,重申我们的"买入"评级和目标价 60 港元。 阳景 首席医药分析师 Jing_yang@spdbi.com (852) 2808 6434 在 GLORY-1 试验中,6mg 剂量于 48 周实现减重 14.37%,符合预 期;安全性数据亦符合预期:在 GLORY-1 研究中,共 610 例中国 超重伴有至少一种体重相关合并症(BMI≥24kg/m2)或肥胖受试 者(BMI≥28kg/m2)按照 1:1:1 随机接受玛仕度肽 4mg(N=203), 6mg(N=202),或安慰剂(N=205)治疗。主要终点为两个,即 32 ...

交银国际研究 公司更新 信达生物 (1801 HK) 1 年股价表现 6/23 10/23 2/24 -30% -20% -10% 0% 10% 20% 30% 40% 50% 60%1801 HK 恒生指数 资料来源: FactSet 玛仕度肽 48 周减重/肝脂肪降低效果优异,重申买入 个股评级 买入 | | 目标价 | 潜在涨幅 | 2024 年 6 月 25 日 | |-------|--------------|------------|--------------------------------| | 37.95 | 港元 48.00 | +26.5% | | 医药 港元 | 股份资料 | | |------------------------|-----------| | 52 周高位 (港元 ) | 48.45 | | 52 周低位 (港元) | 28.70 | | 市值 ( 百万港元 ) | 61,783.36 | | 日均成交量 (百万) | 4.44 | | 年初至今变化 (%) | (11.23) | | 200 天平均价 (港元 ) | 38.15 | | | | 财务数据一览 ...

Core Insights - Innovent Biologics has presented the results of the Phase 3 clinical trial of mazdutide, demonstrating its efficacy in weight loss and reduction of cardiometabolic risk factors in adults with obesity or overweight [1][2][3] Group 1: Clinical Trial Results - The GLORY-1 trial met all primary and key secondary endpoints, confirming the advantages of mazdutide as a GLP-1R/GCGR dual agonist [1][3] - At week 48, participants receiving mazdutide 6 mg experienced a mean percentage weight change of -14.31% compared to placebo [3][4] - Significant weight loss was observed, with 82.0% of participants on mazdutide 6 mg achieving a weight reduction of 5% or more at week 32 [4][5] Group 2: Cardiometabolic Benefits - Mazdutide treatment resulted in significant reductions in waist circumference and multiple cardiometabolic risk factors, including systolic blood pressure and triglycerides [6][7] - At week 48, the pooled mazdutide group showed a reduction in liver fat content by an average of 80.2% in participants with high baseline liver fat [7] Group 3: Safety and Tolerability - The safety profile of mazdutide was favorable, with a low incidence of serious adverse events comparable to placebo [7] - Common adverse events were mostly mild or moderate gastrointestinal issues, with no new safety signals identified [7] Group 4: Regulatory and Market Potential - The first new drug application (NDA) for mazdutide is currently under review by the CDE of the National Medical Products Administration (NMPA) in China [2][12] - If approved, mazdutide is expected to provide a safe and effective treatment option for obesity, addressing a significant unmet clinical need in the Chinese market [10][11]

Core Insights - Innovent Biologics reported positive results from the Phase 3 study of mazdutide, a dual agonist targeting GLP-1R and GCGR, showing significant reductions in liver fat content in overweight or obese Chinese adults [1][2][3] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, autoimmune, cardiovascular, and metabolic disorders [1][9] - The company has launched 10 products and has multiple assets in clinical trials, including five Phase 3 studies for mazdutide [9] Study Details - The GLORY-1 trial involved 610 Chinese adults with a BMI of ≥28 kg/m² or ≥24 kg/m² with at least one weight-related comorbidity, randomized to receive mazdutide or placebo for 48 weeks [2][3] - The study demonstrated that mazdutide treatment led to a mean relative reduction in liver fat content of −63.3% for the 4 mg dose and −73.2% for the 6 mg dose, compared to an 8.2% increase in the placebo group [3][4] Clinical Implications - The results indicate that mazdutide may be more effective than GLP-1 receptor mono-agonists and other dual-target agonists in reducing liver fat, addressing significant unmet clinical needs in metabolic dysfunction-associated fatty liver disease (MAFLD) [2][4] - A high percentage of participants treated with mazdutide achieved significant reductions in liver fat, with 95.5% achieving a ≥30% relative reduction and 77.3% normalizing liver fat levels [4] Market Context - Obesity is a leading risk factor for various chronic diseases, and the prevalence of obesity in China has reached alarming levels, necessitating effective pharmacological interventions [6] - Traditional obesity treatments in China have shown limited efficacy, highlighting the need for innovative solutions like mazdutide [6] Future Prospects - The promising results from the GLORY-1 study support further exploration of mazdutide's clinical value in treating MAFLD and metabolic disorders [5][7] - The first New Drug Application (NDA) for mazdutide was accepted by the CDE of China's NMPA for chronic weight management, indicating potential market entry [8]

浦银国际研究 公司研究 | 医药行业 信达生物（1801.HK）：三项肿瘤管 阳景 浦 线资产公布积极的一期数据 首席医药分析师 银 Jing_yang@spdbi.com 国 (852) 2808 6434 近期公司在 2024 ASCO 和 ESMO Virtual Plenary 会议上公布了 3项肿 际 瘤管线资产积极的一期数据，包括 IBI363 (PD-1/IL-2)积极的一期 PD-1 胡泽宇 CFA 耐药及冷肿瘤数据、IBI343 (CLDN18.2 ADC)潜在同类最佳的一期胰腺癌 医药分析师 疗效安全性数据以及 IBI389 (CLDN18.2/CD3)初步胃癌胰腺癌数据。肿 ryan_hu@spdbi.com 瘤研发管线的持续推进反映了信达强大的研发能力和执行能力。重申 (852) 2808 6446 我们的“买入”评级和目标价 60港元。 2024年6月19日  IBI363 (PD-1/IL-2)一期疗效和安全性数据积极，有望成为实体瘤 公 PD-1 耐药及不响应的潜在疗法：近期公司在 2024 ASCO 和 ESMO 司 Virtual Plenary 会议上公布了潜在 Firs ...

Core Insights - Innovent Biologics, Inc. provided updates on its oncology pipeline, showcasing clinical data on multiple cancer drug candidates at an investor meeting, emphasizing its R&D strategy focused on global innovation [1][2][3] Oncology Pipeline Development Strategy - The company aims to address unmet clinical needs in cancer treatment through an extensive deployment of "IO + ADC" strategies, targeting limitations in current immunotherapies and anti-angiogenic drugs [2][3] - Innovent has developed a product pipeline consisting of 36 new drug candidates, with 22 focused on oncology, leveraging advanced antibody technology and scientific expertise [3] Key Product Milestones - Innovent is advancing its oncology pipeline through clinical proof-of-concept studies and global multi-regional clinical trials, with several promising molecules entering clinical development [4] - IBI363, a first-in-class PD-1/IL-2 α-bias bispecific antibody, has shown promising anti-tumor efficacy across multiple cancer types, including immunotherapy-treated and 'cold' tumors, with over 300 subjects involved in Phase 1 trials [4][5] - IBI343, an innovative TOPO1-inhibitor CLDN18.2 ADC, demonstrated a 40% objective response rate in pancreatic cancer patients, marking it as the first ADC to show breakthrough efficacy in this area [5] - IBI389, a bispecific antibody targeting CLDN18.2/CD3, has shown significant anti-tumor effects in pancreatic cancer, with an objective response rate of 29.6% in clinical trials [6] Future Directions - Innovent plans to continue advancing its oncology product line, focusing on high-quality clinical development and addressing unmet medical needs in cancer treatment [7] - The company emphasizes its unique competitive advantage in next-generation oncology treatment innovations, aiming to empower patients with affordable, high-quality biopharmaceuticals [7][8]