Financial Performance - For the six months ended June 30, 2024, total revenue was RMB 3,952.3 million, an increase of 46.3% compared to RMB 2,701.5 million for the same period in 2023[3]. - Product revenue for the same period was RMB 3,811.4 million, representing a growth of 55.1% from RMB 2,457.5 million in the prior year[3]. - Gross profit for the six months ended June 30, 2024, was RMB 3,274.7 million, compared to RMB 2,196.9 million in the same period of 2023, representing a growth of 49%[40]. - The company reported a pre-tax loss of RMB 392.6 million for the six months ended June 30, 2024, compared to a loss of RMB 256.1 million in the same period of 2023[40]. - The net loss for the period was RMB 392.6 million, an increase of RMB 253.5 million from RMB 139.1 million in the prior year[3]. - The company’s basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.24, compared to RMB 0.09 in the same period of 2023[72]. - Other income increased to RMB 300.6 million for the six months ended June 30, 2024, from RMB 232.4 million in the same period of 2023, marking a rise of 29.3%[44]. Research and Development - Research and development expenses increased to RMB 1,399.4 million, compared to RMB 922.8 million in the same period last year[3]. - The company delivered six molecules into clinical research for new drug applications (IND) during the reporting period, enhancing global innovation and sustainable growth[9]. - IBI362 has five ongoing Phase 3 clinical trials, with GLORY-1 and DREAMS-1 achieving study endpoints to support its NDAs[7]. - The company is focused on developing innovative therapies for chronic diseases, with IBI3016 (AGT siRNA) entering Phase 1 clinical trials for hypertension[19]. - The company is actively expanding its pipeline with next-generation innovations, including bispecific antibodies and ADCs, targeting unmet needs in oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology[36]. Product Development and Approvals - The company expanded its commercial product portfolio to 11 products, including the approval of the KRAS G12C inhibitor Daberet® for treating advanced NSCLC patients with KRAS G12C mutations[6]. - The NDA for IBI311 (anti-IGF-1R monoclonal antibody) was submitted and accepted by NMPA in May 2024, addressing a significant unmet need in the TED field in China[17]. - The NDA for IBI344 (Tazemetostat) was accepted by NMPA for patients with locally advanced or metastatic ROS1-positive NSCLC, with approval expected in 2024[29]. - IBI343, a novel CLDN18.2 antibody-drug conjugate, showed positive Phase 1 clinical results for gastric cancer treatment and received breakthrough therapy designation from NMPA[8]. - The company aims to expand its product portfolio to 12 by the end of 2024, including two targeted therapies for NSCLC expected to be approved in the second half of the year[12]. Marketing and Sales - Sales and marketing expenses were RMB 1,879.4 million, accounting for 47.6% of total revenue, down from 49.9% in the previous year[3]. - The company is enhancing its marketing output and operational efficiency through resource allocation and effective management methods[13]. - The company is committed to creating sustainable shareholder value through its strong commercialization and R&D capabilities, as well as a promising late-stage pipeline[20]. Corporate Governance and Compliance - The company has complied with all applicable provisions of the Corporate Governance Code, except for the separation of the roles of Chairman and CEO, which are currently held by the same individual[63]. - The company established a strategic clinical trial collaboration with ImmVirX Pty Limited to evaluate the combination therapy of its drug with ImmVirX's experimental oncolytic virus[39]. - The company will continue to review and monitor its corporate governance practices to ensure compliance and maintain high standards[63]. Financial Position and Assets - As of June 30, 2024, the company had cash and cash equivalents, structured products, and other financial assets totaling approximately RMB 10.112 billion[14]. - Total current assets as of June 30, 2024, were RMB 13,427.9 million, an increase from RMB 11,048.7 million as of December 31, 2023[54]. - Total liabilities as of June 30, 2024, were RMB 8,099.8 million, compared to RMB 7,869.3 million as of December 31, 2023[54]. - The company had unused long-term bank loan facilities of approximately RMB 2,080.5 million as of June 30, 2024[55]. Employee and Operational Metrics - As of June 30, 2024, the company had a total of 5,263 employees, an increase from 4,872 employees as of December 31, 2023, with over 1,000 in R&D and over 3,000 in sales and marketing[61]. - The total salary cost for the six months ended June 30, 2024, was RMB 1,391.6 million, compared to RMB 1,358.8 million for the same period in 2023, reflecting an increase of approximately 2.4%[61]. - There were no significant labor disputes or recruitment difficulties encountered by the company during the reporting period[61].

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 ...