SAN FRANCISCO and SUZHOU, China, Aug. 21, 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, announces that China's National Medical Products Administration (NMPA) has approved Dupert®（fulzerasib）for the treatment of adult patients with advanced non-small cell lung ...

证券研究报告 港股公司|公司深度|信达生物（01801） 稀缺的平台型创新药企业，管线进入密 集兑现期 请务必阅读报告末页的重要声明 glzqdatemark1 2024年08月15日 证券研究报告 |报告要点 信达生物是国内稀缺的创新药平台型公司，拥有业内一流的创新药早期发现、临床开发、生产 制造及商业化能力。公司的创新药管线储备丰富，梯队层次合理，已上市的 10 款创新药产品 为公司提供了稳定增长的现金流，玛仕度肽、匹康奇拜单抗等重磅产品已递交上市申请，提供 第二增长曲线。PD-1/IL-2 双抗等早期管线具有同类最佳潜力，有望实现大额出海授权交易。 |分析师及联系人 郑薇 SAC：S0590521070002 请务必阅读报告末页的重要声明 1 / 35 港股公司|公司深度 glzqdatemark2 2024年08月15日 信达生物(01801) 稀缺的平台型创新药企业，管线进入密集兑 现期 | --- | --- | --- | |-------|------------|-------------------| | 行 | 业： | 医药生物/生物制品 | | | 投资评级： | 买入（维持） | ...

Investment Rating - Buy rating, first coverage [5] Core Views - The company is a leading domestic Biopharma player with validated commercialization capabilities, transitioning from Biotech to Biopharma [2] - The company is expanding its innovative drug business from oncology to non-oncology fields, including autoimmune, metabolic, and ophthalmic diseases [2] - In oncology, the company is enriching its late-stage pipeline through self-development and BD collaborations, building an "I/O+ADC" product cluster [2] - Multiple oncology pipeline products are expected to release early PoC data in 2024, further validating the company's R&D capabilities [2] - The company has several non-oncology products in late-stage clinical trials or NDA review, which are expected to provide new growth drivers in the long term [2] Company Overview - Founded in 2011, the company focuses on the R&D, production, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmic diseases [3] - The company has over 30 innovative drug candidates, with 10 products already commercialized, 4 under NDA review, and 4 in Phase III or key clinical trials [3] - In 2023, the company achieved total revenue of RMB 6.206 billion (+36.2% YoY), with product revenue of RMB 5.728 billion (+38.4% YoY) [3] - The core product, Sintilimab (PD-1 monoclonal antibody), generated sales of USD 393 million in 2023 [3] Oncology Pipeline - The company's oncology strategy revolves around "I/O+ADC," with Sintilimab as the anchor product, approved for seven indications across five major cancer types [3] - The company is enriching its late-stage oncology pipeline through BD collaborations, such as the KRAS G12C inhibitor fulzerasib and the ROS1 inhibitor taletrectinib, both of which have submitted NDAs [3] - The company is actively building ADC and bispecific antibody/fusion protein technology platforms, with several PoC products entering clinical trials [3] - Early clinical data for self-developed products such as IBI343 (Claudin18.2 ADC), IBI389 (Claudin18.2/CD3 bispecific antibody), and IBI363 (PD-1/IL-2) were presented at ASCO and ESMO 2024, showing promising potential [3] Non-Oncology Pipeline - The company is strategically expanding into non-oncology fields, including metabolic, autoimmune, and ophthalmic diseases, which are expected to become new growth drivers [4] - IBI362, a next-generation GLP-1/GCGR dual-target drug, is the fastest progressing domestic weight-loss drug, with an NDA submitted in February 2024 for the treatment of adult overweight or obesity [4] - Tafolecimab, the first domestically developed PCSK9 monoclonal antibody, has shown stronger affinity and longer dosing intervals compared to competitors [4] - IBI112, targeting psoriasis, is expected to become the first domestic IL-23p19 monoclonal antibody, with global sales of its counterparts exceeding USD 10 billion in 2023 [4] - IBI311, targeting thyroid eye disease, has submitted the first domestic NDA for the IGF-1R target, with Tepezza generating USD 1.966 billion in global sales in 2022 [4] Financial Projections - The company is expected to achieve revenues of RMB 7.929 billion, RMB 10.567 billion, and RMB 13.167 billion in 2024, 2025, and 2026, respectively [6] - Net profit is projected to be -RMB 573 million, RMB 364 million, and RMB 1.368 billion in 2024, 2025, and 2026, respectively [6] - EPS is expected to be -RMB 0.35, RMB 0.22, and RMB 0.84 in 2024, 2025, and 2026, respectively [6] Leadership and Shareholding - The company's leadership team has deep industry and academic backgrounds, with founder Dr. Yu Dechao holding 5.42% of the shares [12] - Temasek is the largest shareholder with a 5.52% stake, followed by The Capital Group with 6.06% [12] Commercialization and R&D - The company has 10 commercialized products, with Sintilimab sales rebounding to USD 393 million in 2023 after a decline in 2022 due to price reductions after inclusion in the national reimbursement list [15] - The company's R&D expenses have increased from RMB 1.295 billion in 2019 to RMB 2.871 billion in 2022, with over 1,500 R&D personnel [21] - The company's R&D focus includes FIC and BIC drugs in oncology, autoimmune diseases, and ophthalmology [21]

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]