股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[信I Tnaf 达bol]e 生_Ti物tle]（ 1801） [评Tab级le_：Inv est] 增持 当前价格（港元）： 38.10 业绩符合预期，高潜力管线提供增长动力 2024.03.23 海 ——信达生物2023 年年报点评 [ 交Ta易bl数e_M据a rket] 外 丁丹(分析师) 甘坛焕(分析师) 52周内股价区间（港元） 28.70-48.45 当前股本（百万股） 1,623 公 0755-23976735 021-38675855 当前市值（百万港元） 61,820 司 dingdan@gtjas.com gantanhuan028803@gtjas.com 证书编号 S0880514030001 S0880523080007 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 公司商业化产品组合不断丰富，创新产品布局肿瘤、CVM、自免、眼科多领域，打造 信达生物 恒生指数 肿瘤和综合产品线两大增长动力，运营效率不断提升，维持“增持”评级。 香 28% 摘要： 港 17 ...

证券研究报告·海外公司点评·药品及生物科技(HS) 信达生物（01801.HK） 2023 年年报点评：信达生物业绩略超预期， 2024 年 03月 24日 慢病产品进入收获期 证券分析师 朱国广 买入（维持） 执业证书：S0600520070004 zhugg@dwzq.com.cn [Table_EPS] 盈利预测与估值 2022A 2023A 2024E 2025E 2026E 股价走势 营业总收入（百万元） 4,557 6,758 7,256 10,515 15,178 同比 6.73% 48.31% 7.36% 44.91% 44.35% 信达生物 恒生指数 24% 归母净利润（百万元） -2,179.27 -1,027.91 -393.38 165.99 2,211.42 19% 14% 同比 30.55% 52.83% 61.73% 142.19% 1,232.29% 9% 4% -1% EPS-最新摊薄（元/股） -1.34 -0.63 -0.24 0.10 1.36 -6% -11% P/E（现价&最新摊薄） - - - 351.91 26.41 --- 221 616 %%% [ [TT ...

本报告仅供 Choice 东方财富 使用，请勿传阅。 公司快报 2024 年 03 月 21 日 信 达生物(01801.HK) 证券研究报告 商业化产品不断丰富，多个催化剂值得 药品(HS) 投资评级 买入-A 期待 维持评级 6个月目标价 54.47港元 事件：公司发布 2023年业绩报告，报告期内公司实现营业收入 股价 (2024-03-21) 38.10港元 62.06亿元，同比增长 36.2%；净利润亏损 10.28亿元，较上年同 期亏损减少 11.51亿元。2023年全年产品销售额达 57.28亿元， 交易数据 同比增长 38.4%。 总市值(百万港元) 61,820.41 流通市值(百万港元) 61,820.41 2024 年里程碑事件丰富，多个催化剂值得期待。 总股本(百万股) 1,622.58 数据披露方面；玛仕度肽（GLP-1R/GCGR）减重3期试验数据、匹 流通股本(百万股) 1,622.58 康奇拜单抗(IL-23p19)银屑病3期CLEAR 试验数据、IBI311（IGF- 12个月价格区间 28.7/48.45港元 1R）治疗甲状腺眼病 3 期 RESOTRE-1 试验数据有望于 ...

M N 22 Mar 2024 CMB International Global Markets | Equity Research | Company Update Innovent Biologics (1801 HK) More than obesity  Strong product sales in FY23. In FY23, Innovent recorded total revenue of Target Price HK$55.00 RMB6.21bn, including RMB5.73bn product sales revenue (+38.4% YoY), in line with (Previous TP HK$57.35) our expectation. Innovent had a strong 2H23, with product sales +33.1% HoH vs the Up/Downside 44.4% first half. As per Eli Lilly, total sales of sintilimab in FY23 reached US$393.3 ...

Investment Rating - The investment rating for the company is upgraded to "Buy" [2][3][15] Core Views - The company reported a larger-than-expected loss in 2023, but its main product sales revenue grew rapidly, with total revenue increasing by 36.2% year-on-year to 6.21 billion RMB [2][5] - The company is expected to maintain strong revenue growth, with a projected CAGR of 22.1% from 2023 to 2026 [2][5] - The target price has been adjusted to 46.00 HKD based on a revised DCF model [2][11] Summary by Sections Financial Performance - In 2023, the company's revenue reached 6.21 billion RMB, with a gross profit of 5.07 billion RMB, reflecting a gross margin increase of 39.8% year-on-year [2][5] - The net loss attributable to shareholders decreased by 52.8% to 1.03 billion RMB [2][5] - The company’s revenue forecast for 2024-25 has been slightly raised by 0.05% and 0.3% respectively, with expected revenues of 8.31 billion RMB and 9.90 billion RMB [2][5] Product Pipeline and Growth Drivers - The main product, 达伯舒 (Daboshu), is expected to see steady growth, with sales projected to increase from approximately 2.83 billion RMB in 2023 to 4.20 billion RMB in 2025 [2][5] - Other products have also shown rapid sales growth, with their contribution to total revenue rising from 26.6% in 2021 to 50.65% in 2023 [2][5] - Several products are expected to achieve significant milestones in 2024, including new drug applications and clinical trial advancements [2][7] Adjustments and Projections - The sales and marketing expenses forecast for 2024-25 has been increased due to management's commitment to promoting new products [2][5] - The net loss forecast for 2024 has been adjusted from 230 million RMB to 620 million RMB, while the net profit forecast for 2025 has been revised down from 550 million RMB to 180 million RMB [2][5] - The company’s financial metrics indicate a recovery path, with expectations of turning profitable by 2025 [2][5]

浦银国际研究 公司研究 | 医药行业 信达生物（1801.HK）：运营效率提升 阳景 浦 推动净亏损好于预期 首席医药分析师 银 Jing_yang@spdbi.com 国 (852) 2808 6434 信达生物 2H23 收入符合我们预期，由于经营效率的提高，净亏损好 际 于我们预期。我们预计 2024年收入同比增速约为 25%。公司将心血管 胡泽宇 CFA 代谢、自身免疫、眼科三大业务合并为综合产品线，且新任的心血管 医药分析师 代谢商业化负责人之前有着丰富的中国市场 GLP-1 推广经验，显示出 ryan_hu@spdbi.com 公司正在稳步推进其非肿瘤业务商业化进程。受益于收入和运营效率 (852) 2808 6446 的进一步提升，我们认为公司目前正有条不紊地走在其之前设立的盈 利目标轨迹上（2025年实现 non-IFRS EBITDA 盈亏平衡）。重申我们的 2024年3月21日 “买入”评级和首选股票推荐，上调目标价至 60港元。 公 司  2H23 收入符合预期，净亏损好于我们预期：2H23 公司实现总收入 评级 研 人民币 35 亿元 （51.3% YoY/29.7% HoH），其中 ...

[Table_Page]公 告点评|制药、生物科技与生命科学 证券研究报告 [【Table_T广itle] 发 医 药 & 海 外 】 信 达 生 物 [公Tab司le_I评nves级t] 买入 当前价格 38.10港元 （01801.HK） 合理价值 58.45港元 前次评级 买入 商业化表现强劲，创新兑现驱动新增长 报告日期 2024-03-21 [ 核Tabl 心e_Su 观mm 点ary] ： 相[Ta对ble市_Pi场cQu表ote现] ⚫ 公司发布2023年年度业绩公告：公司23年实现收入62.06亿元，同 19% 比增长 36.2%；净亏损 10.28 亿元，同比大幅减亏 11.51 亿元。公司 9% 加强费用管理，持续提升研发和营销效率，23年研发开支22.28亿元 -1% 03/23 05/23 07/23 09/23 11/23 01/24 03/24 (yoy -22.4%)、行政费用7.50亿元(yoy -10.2%)、销售费用31.01亿元 -10% (yoy +19.7%)，销售费用占产品收入比例为54.1%(yoy -8.5pct)。 -20% ⚫ 商业化品种不断丰富，创新驱动业 ...

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 6,206.1 million, an increase of 36.2% compared to RMB 4,556.4 million for the year ended December 31, 2022[3]. - Product revenue reached RMB 5,728.3 million, up 38.4% from RMB 4,139.1 million in the previous year[3]. - Gross profit for 2023 was RMB 5,069,804 thousand, up from RMB 3,625,390 thousand in 2022, reflecting a gross margin improvement[52]. - The company reported a net loss of RMB 1,027,913 thousand for 2023, significantly improved from a loss of RMB 2,179,270 thousand in 2022[52]. - Loss before tax was RMB 1,144.4 million, a significant improvement from RMB 2,170.5 million in 2022[2]. - Adjusted net loss for the year was RMB 514.5 million, a decrease of 79.1% from RMB 2,461.8 million in the previous year[5]. - The company reported a pre-tax loss of RMB 1,144.4 million for 2023, an improvement from a loss of RMB 2,170.5 million in 2022[92]. - The company’s net asset value increased to RMB 12,527.6 million in 2023 from RMB 10,729.9 million in 2022[94]. Research and Development - Research and development expenses for the year were RMB 2,227.6 million, down from RMB 2,871.2 million in 2022[3]. - The company has successfully advanced eight new molecules into IND preparation in 2023, focusing on antibody and ADC development[21]. - The company is advancing multiple early-stage products into IND preparation and Phase 1 clinical trials, including IBI3016 and IBI3002, to explore global market potential[49]. - The company has established strategic collaborations to enhance innovation and expand its product pipeline, including partnerships with SanegeneBio USA Inc. and Synaffix B.V.[10]. Product Development and Pipeline - The commercial product portfolio expanded to ten products, with two new innovative products, Fucosu® and Xinbile® approved for market in China[6]. - IBI362 (Masitide) is undergoing five Phase 3 clinical trials in China for obesity and Type 2 diabetes, with results expected in 2024 to support a second NDA submission[8]. - The company has achieved positive proof of concept results for IBI310 and IBI343, with plans to initiate Phase 3 clinical trials in 2024 for MSI-H/dMMR colorectal cancer and third-line gastric cancer, respectively[9]. - The company has a robust pipeline in multiple therapeutic areas, including CVM, autoimmune diseases, and ophthalmology, which is expected to enhance long-term growth potential[13]. - The company plans to submit a new NDA for the combination of its IO product with a second-line treatment for endometrial cancer in the first half of 2024[17]. Market Position and Strategy - The company aims to maintain sustainable growth by leveraging its existing product portfolio and expanding its late-stage pipeline, particularly in the oncology sector[13]. - The company has established a strong market position in oncology with eight products launched in the past five years, supported by a commercial team of nearly 3,000 employees[13]. - The company is strategically building its commercialization capabilities in the cardiovascular (CVM) sector to establish a competitive advantage and long-term barriers[14]. - The company anticipates the approval of two innovative products, Fluorazeles® and Taziratinib, in 2024, providing targeted treatment options for NSCLC patients[13]. Environmental, Social, and Governance (ESG) - The company has made significant progress in its environmental, social, and governance (ESG) governance, achieving an "A" rating in the latest MSCI ESG ratings for 2023, placing it at a leading level in the Chinese pharmaceutical industry[10]. - The company continues to focus on multiple factors to strengthen ESG management, emphasizing integrity in operations and effective compliance management[10]. - The company’s ESG rating improved to "A" in the 2023 MSCI evaluation, reflecting market recognition of its governance and sustainability commitments[21]. Financial Position and Assets - The company had approximately RMB 10,969.6 million in cash and short-term financial assets, equivalent to about $1.5 billion, supporting long-term strategic goals[15]. - The total current assets as of December 31, 2023, were RMB 13,427,985,000, up from RMB 11,506,708,000 in 2022[66]. - Total liabilities rose to RMB 8,099,779,000 in 2023 from RMB 6,858,896,000 in 2022, with current liabilities at RMB 4,476,816,000 compared to RMB 3,499,198,000 in the previous year[66]. - The company's cash and cash equivalents increased to RMB 10,052,100,000 as of December 31, 2023, from RMB 9,166,000,000 in 2022, primarily due to a capital raise of approximately RMB 2,163,000,000 in September 2023[67]. Corporate Governance - The audit committee, consisting of four independent non-executive directors, reviewed the audited financial statements for the year ending December 31, 2023[81]. - The company has adopted the standard code for securities trading by directors and confirmed compliance for the year ending December 31, 2023[79]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with the corporate governance code[78]. - The company believes that having the same individual serve as both the chairman and CEO enhances leadership consistency and decision-making efficiency[78].

智通财经APP讯，信达生物(01801)发布公告，公司研发的重组抗胰岛素样生长因子1受体(IGF-1R)抗体注射液(研发代号：IBI311)在中国甲状腺眼病(Thyroid Eye Disease,TED)受试者中开展的III期注册临床研究(RESTORE-1)达成主要终点。公司计划将向国家药品监督管理局(NMPA)药品审评中心(CDE)递交IBI311治疗TED的新药上市申请(NDA)。 RESTORE-1(CTR20223393)是一项在TED受试者中评估IBI311有效性和安全性的多中心、随机、双盲安慰剂对照的II/III期临床研究。研究结果显示，RESTORE-1的III期阶段主要研究终点顺利达成：第24周时，接受IBI311治疗的受试者研究眼的眼球突出应答率(研究眼相对于基线突眼度回退≥2mm，且不伴有对侧眼突眼度增加≥2mm的受试者比例)显著优于安慰剂组：IBI311组和安慰剂组研究眼的眼球突出应答率分别为85.8%和3.8%，两组差异为81.9%(95%CI：69.8%-93.9%，P<0.0001)。 此外，研究的关键次要研究终点如研究眼的眼球总体应答率(研究眼相对于基线突眼度回退≥2mm及研 ...

Investment Rating - The report maintains a "Buy" rating for the company [1][2]. Core Views - The company has achieved the primary endpoint in the Phase III clinical trial of IBI311 for Thyroid Eye Disease (TED) and plans to submit a new drug application to the NMPA [2][3]. - IBI311, an IGF-1R monoclonal antibody, shows significant potential as no targeted therapies for TED have been approved in China, with the drug demonstrating superior efficacy and safety in clinical trials [3]. - The company is positioned for growth with a robust pipeline, having 10 drugs approved, 3 under NDA review, and 4 in Phase III or critical clinical studies [3]. Financial Summary - Revenue projections for 2023-2025 are estimated at 5.346 billion, 6.866 billion, and 11.929 billion CNY, representing year-on-year growth rates of 17.3%, 28.4%, and 73.7% respectively [3][5]. - The company is expected to report a net profit of -0.952 billion, -0.534 billion, and 0.379 billion CNY for the same years, indicating a path towards profitability by 2025 [5][6]. - The earnings per share (EPS) is projected to improve from -0.59 CNY in 2023 to 0.23 CNY in 2025 [5][6]. Clinical and Product Development - IBI311 has shown an eye protrusion response rate of 85.8% compared to 3.8% in the placebo group, with a significant difference of 81.9% (P<0.0001) [3]. - The company is expanding its therapeutic areas, with ongoing research in metabolic, cardiovascular, endocrine, and ophthalmic diseases [3].