SAN FRANCISCO and SUZHOU, China, Sept. 1, 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 multiple clinical study results of mazdutide (GLP1R/GCGR dual agonist) will be presented at the European Association for the Study of Diabetes® (EASD) 60th An ...

收入增长强劲，创新管线加速推进 信达生物(1801) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——信达生物 2024H1 点评 [当前价格 Table_CurPrice] (港元)： 42.45 本报告导读： 24H1 收入增长强劲，多临床管线进展顺利，运营效率持续提升，多款非肿瘤管线有 望于 2025 年获批上市，推动公司实现 EBIDAT 盈亏平衡，维持"增持"评级。 投资要点： 股 票 研 究 [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 [Table_Market] 交易数据 海 外 公 司 （ 中 国 香 港 ） 登记编号 S0880514030001 S0880523080007 S0880123100022 52 周内股价区间（港元） 30.10-48.45 当前股本（百万股） 1,629 当前 ...

Investment Rating - The investment rating for the company is "Buy" with a target price raised to HKD 60.00, indicating a potential upside of 36.0% from the current price of HKD 44.10 [3][5]. Core Insights - The company reported a better-than-expected adjusted net loss in 1H24, with strong product sales growth and improved operational efficiency. Total revenue increased by 46% year-on-year to RMB 39.5 billion, driven by a 50% increase in PD-1 sales to over RMB 1.7 billion and a growing portfolio of biosimilar products [1][2]. - The company expects to achieve EBITDA breakeven by 2025, with a cash reserve of RMB 10.1 billion as of the end of 1H24. The guidance for product revenue is set to reach RMB 20 billion by 2027, supported by at least seven products expected to launch between 2H24 and 2027 [1][2]. Summary by Sections Financial Performance - In 1H24, the adjusted gross margin improved by 1.8 percentage points, while adjusted selling and administrative expenses decreased by 5.9 and 4.9 percentage points, respectively. The adjusted net loss narrowed to RMB 160 million from RMB 190 million in 1H23, outperforming market expectations [1]. - The company anticipates a 57% increase in R&D expenses for the year, with total R&D spending expected to be nearly USD 400 million [1]. Pipeline Strategy - The company maintains a clear pipeline strategy with a focus on oncology, utilizing an "IO+ADC" approach. The lifecycle management of PD-1 will explore major indications such as colorectal cancer and perioperative lung cancer. The next-generation IO candidate IBI363 has shown promising preliminary data [2]. - The company plans to launch the weight loss and diabetes indication for its product Masitide in 2025, with several other products also expected to be approved in the coming years [2]. Financial Projections - Revenue projections for 2024-2026 have been raised by 2-8%, with expected revenues of RMB 8.06 billion in 2024, RMB 10.94 billion in 2025, and RMB 13.20 billion in 2026 [7]. - The DCF valuation model estimates a share value of HKD 60.00, based on projected free cash flows and a perpetual growth rate of 2% [4].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% within the next 6-12 months [3][7]. Core Insights - The company reported a strong revenue growth of 55% year-on-year in 1H24, driven by the success of its commercial products, particularly the drug Dabrushe (Sintilimab) [2][3]. - The gross margin improved by 1.6 percentage points to 82.9%, attributed to increased production and ongoing cost optimization [3]. - The company is expanding its commercial product offerings, with expectations to increase the number of commercialized products to 12 by the end of the year [3]. Financial Summary - **Revenue Growth**: The company’s revenue is projected to grow from 6,206 million RMB in 2023 to 7,823 million RMB in 2024, reflecting a growth rate of 26.05% [1]. - **Net Profit**: The net profit is expected to improve significantly, moving from a loss of 1,028 million RMB in 2023 to a loss of 524 million RMB in 2024, with a forecasted profit of 1,098 million RMB by 2026 [1]. - **Earnings Per Share (EPS)**: The diluted EPS is projected to improve from -0.63 RMB in 2023 to 0.09 RMB in 2025, and further to 0.67 RMB in 2026 [1]. - **Return on Equity (ROE)**: The ROE is expected to turn positive by 2025, reaching 1.23% and further increasing to 8.29% by 2026 [1]. Research and Development - The company has six New Drug Applications (NDAs) currently under review by the National Medical Products Administration, with significant advancements in the cardiovascular and metabolic (CVM) fields [3]. - The company has multiple late-stage clinical projects making milestone progress, with several innovative pipelines showing promising preliminary data [3].

SAN FRANCISCO and SUZHOU, China, Aug. 28, 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 nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) ...

Strong commercial performance and significant pipeline milestones support sustained growth and innovationSAN FRANSISCO and SUZHOU, China, Aug. 28, 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 cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates.Dr. Michae ...

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]