SAN FRANCISCO and SUZHOU, China, Sept. 11, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical trial results for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with ...

SAN FRANCISCO and SUZHOU, China, Sept. 10, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the presentation of Phase 1 clinical data (ClinicalTrials.gov, NCT04085185) for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in adva ...

华福证券 司 मे 信达生物（01801.HK） 自主研发已入佳境，四大领域商业化势如破竹 投资要点： 研发引擎强劲，商业化能力持续兑现，公司 2027 年营收目标 200 亿元 公司目前已有 11 个产品获得批准上市，2024H1 产品收入达 38 亿，同 比增长 55%。公司拥有约 3000 人的成熟商业化团队，商业化能力已被初步 验证。公司在肿瘤、心血管及代谢、自身免疫和眼科四大关键疾病领域拥 有可持续和多元化的长期成长空间，拥有 1500 多名员工的产品研发团队， 其中，信达国清院 300 多名员工致力于发现全球同类首创（FIC）和同类最 佳(BIC）的创新药，是公司强大的研发引擎。公司预计 2027 年实现接近 20 款获批产品销售，并提出 2027 年发展目标：国内 200 亿元营业收入。 信迪利单抗仍保持快速增长，自研 IO+ADC 将开启第二增长曲线 公司已有 9 款肿瘤领域产品获批上市，1 款递交 NDA，2 款处于关键 临床阶段，超 10 款处于临床开发阶段。公司的信迪利单抗 2023 年销售约 27.5 亿元，同比增长 34%。2023 年医保目录新增治疗 EGFR-TKI 治疗失败 的 ...

SAN FRANCISCO and SUZHOU, China, Sept. 9, 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 an oral presentation of updated results from a pivotal Phase 2 clinical trial of Dupert®（fulzerasib）for the treatment of adult patients with advanced non-small cel ...

2024 年 9 月 2 日 医药: 超配 证券研究报告 / 业绩点评报告 信达生物 (1801 HK, 买入, 目标价: HK$61.98) 买入 搏有 萝出 | --- | --- | --- | --- | |--------------------------------------------------|----------|--------|-------------| | 目标价 : HK$61.98 | 当前股价 | | : HK$43.50 | | 股价上行/下行空间 | | | +42% | | 52 周最高/最低价 (HK$) | | | 49.80/28.30 | | 市值 (US$mn) | | | 8,121 | | 当前发行数量(百万股 | ) | | 1,456 | | 三个月平均日交易額 (US$mn) | | | 30 | | 流通盘占比 (%) 主要股东 (%) | | | 57 | | TLS BETA Dechao Yu | | | 6 | | Temasek | | | 6 3 | | 按 2024 年 8 月 29 日收市数据 资料来源: FactSet | | ...

证券研究报告 | 半年报点评 gszqdatemark 2024 09 03 年 月 日 信达生物（01801.HK） 产品销售强劲增长，经调整 LBITDA 显著收窄 信达生物发布 2024 年中期业绩。公司 2024 年上半年总收入为 39.52 亿元，同比 +46.3%；其中产品收入约 38.11 亿元，同比+55.1%。期内亏损 3.93 亿元，2023 年 同期为亏损 1.39 亿元。经调整 LBITDA 为 1.61 亿元，2023 年同期为 2.67 亿元，同比 减亏 39.9%。 信达生物宣布 KRAS G12C 抑制剂达伯特®获得 NMPA 批准上市。达伯特®用于至少 接受过一种系统性治疗的 KRAS G12C 突变型的晚期非小细胞肺癌（NSCLC）成人患者， 是中国首个获批的 KRAS G12C 抑制剂，也是信达生物的第 11 款产品。 观点：产品销售强劲增长，经调整 LBITDA 显著收窄 收入端，信迪利单抗保持快速增长，新产品表现也比较强势，产品销售收入共 38.11 亿 元，同比增长 55.1%；期内亏损同比增加，主要由于非现金项目汇兑收益减少（绝对 额减少 2.13 亿元）、一次性 ...

研究报告 Research Report 2 Sep 2024 信达生物 Innovent Biologics (1801 HK) 商业策略稳步执行，运营效率不断提升 The Business Strategy is Being Steadily Executed, and Operational Efficiency is Continuously [Table_yemei 观点聚焦 1] Investment Focus | --- | --- | |----------------------------------------------------------------|------------------------| | | | | | | | [Table_Info] 维持优于大市 Maintain OUTPERFORM | | | 评级 | 优于大市 OUTPERFORM | | 现价 | HK$42.45 | | 目标价 | HK$67.80 | | HTI ESG | 3.6-1.4-3.5 | | E-S-G: 0-5, (Please refer to the Appendix f ...

信达生物（1801 HK） | 2024 年 9 月 1 日 香港股市 | 医药 信达生物（1801 HK） 上半年销售表现优异，2024-26E 收入将快速增长 2024 年上半年主营业务收入略超预期 公司上半年收入同比增加 46.3%至 39.5 亿元（人民币，下同），其中主营业务医药销售 业务的收入同比增加 55.1%至 38.1 亿元并略超预期。公司上半年股东净亏损同比扩大 182.1%至 3.9 亿元，但亏损扩大主要是因为缺失了去年同期获得的 1.36 亿元的一次性退 税收入及研发费用率同比上升 1.3 个百分点。公司目前正在快速扩充产品管线，加大研 发投入为正常现象。 现有产品与新产品并进，2024-26E 收入将快速增长 根据 2024 年上半年情况，我们将 2024E 收入与股东净亏损预测分别上调 0.04%与 17.7%。除此以外，我们将 25-26E 收入分别上调 4.4%、5.9%，股东净利润预测分别上调 0.8%、8.8%。根据调整后的预测，我们预计 2023-26E 收入 CAGR 将达 26.4%，基于： 1）肿瘤领域核心产品达伯舒适应症仍在增加，收入有增长空间：达伯舒从 2018 ...

Investment Rating - Maintain "Recommend" rating [1][3] Core Views - Revenue growth driven by strong demand for innovative product portfolio and effective commercialization strategy, with product revenue increasing by 55.1% YoY to 3.811 billion CNY [2] - Operating efficiency improved with product sales expense ratio decreasing by 5.9 percentage points and administrative expense ratio decreasing by 4.9 percentage points [2] - EBITDA loss narrowed by 39.9% to 160 million CNY, with potential to achieve EBITDA breakeven next year [2] - Solid foundation in oncology with PD-1 approved for seven indications and included in the national reimbursement drug list [2] - CVM pipeline commercialization expected to materialize soon, with 11 commercialized products and expanding reimbursement coverage [2] - Early-stage pipeline is rich with multiple innovative molecules showing positive data, including IBI363, IBI343, and IBI389 [3] - Revenue forecasts for 2024-2026 are 8.133 billion, 10.867 billion, and 13.595 billion CNY, with net profit turning positive in 2025 [3][5] Financial Performance - 2024 H1 revenue reached 3.952 billion CNY, a 46.3% YoY increase [2] - R&D investment in 2024 H1 was 1.294 billion CNY, with cash on hand at 10.112 billion CNY [2] - Gross margin expected to remain stable at 80.76% in 2024, increasing to 85.22% by 2026 [5][6] - Net profit forecasted to turn positive in 2025 at 53 million CNY, with significant growth to 818 million CNY in 2026 [5][6] Pipeline and Commercialization - Oncology: PD-1 remains a cornerstone product with seven approved indications, and new drugs like Tareltinib (ROS1) expected to be approved soon [2] - CVM: Masdutide for weight loss and type 2 diabetes, and Teprotumumab for thyroid eye disease have submitted NDAs [2] - Autoimmune: Piconibart (IL-23p19) plans to submit NDA within the year [2] - Early-stage pipeline includes IBI363 (PD-1/IL-2a), IBI343 (CLDN18.2 ADC), and IBI389 (CLDN18.2/CD3) showing promising results in clinical trials [3]

Investment Rating - Buy (Maintained) [1] Core Views - The company's revenue is expected to grow rapidly, with projected revenues of 7.9 billion, 10.3 billion, and 13.2 billion RMB for 2024, 2025, and 2026 respectively [4] - The company's net profit is forecasted to turn positive in 2025, reaching 436.85 million RMB, and further increasing to 1.16 billion RMB in 2026 [1] - The company's EPS is expected to improve significantly, from -0.37 in 2024 to 0.27 in 2025 and 0.71 in 2026 [1] Financial Performance - In the first half of 2024, the company achieved revenue of 3.95 billion RMB, a 46.3% year-on-year increase [2] - The company reported a net loss of 390 million RMB in the first half of 2024, with product revenue reaching 3.81 billion RMB, a 55.1% increase [2] - The company's revenue growth is driven by the strong performance of Tyvyt® (sintilimab injection) and other products, as well as the accelerated growth of new products [2] Product Pipeline - The company has launched one new innovative drug, expanding its commercialized products to 11 [3] - Six NDAs are under review by the NMPA, including IBI344 (taletrectinib, ROS1) for first-line and second-line indications, and IBI362 (mazdutide) for weight management and type 2 diabetes [3] - IBI344 (taletrectinib) is expected to be approved in the second half of 2024, and IBI112 (IL-23p19) is expected to submit an NDA [4] Key Data Updates - The company will present updated Phase 1 data for its global first-in-class PD-1/IL-2α-bias in lung cancer treatment at WCLC [4] - Key clinical data for IBI354 (HER2 ADC) in HER2-positive solid tumors will be presented at ESMO [4] - Multiple clinical data updates for Tyvyt® (sintilimab injection) are expected at upcoming conferences [4] Financial Metrics - The company's revenue growth rate is projected to be 27.34% in 2024, 30.87% in 2025, and 28.06% in 2026 [1] - The company's net profit growth rate is expected to be 171.51% in 2025 and 166.12% in 2026 [1] - The company's ROE is forecasted to improve from -5.13% in 2024 to 3.54% in 2025 and 8.60% in 2026 [1]