SAN FRANCISCO and SUZHOU, China, May 6, 2025 /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 the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor r ...

研究报告 Research Report 6 May 2025 信达生物 Innovent Biologics (1801 HK) 评级 优于大市 OUTPERFORM 现价 HK$54.30 目标价 HK$62.50 HTI ESG 3.6-1.4-3.5 E-S-G: 0-5, (Please refer to the Appendix for ESG comments) 市值 HK$88.95bn / US$11.48bn 日交易额 (3 个月均值) US$108.38mn 发行股票数目 1,638mn 自由流通股 (%) 93% 1 年股价最高最低值 HK$54.95-HK$30.00 注：现价 HK$54.30 为 2025 年 05 月 06 日收盘价 资料来源： Factset 1mth 3mth 12mth 绝对值 8.9% 64.3% 29.7% 绝对值（美元） 9.4% 65.2% 30.9% 相对 MSCI China 9.9% 56.9% 11.0% [Table_Profit] Rmb mn Dec-24A Dec-25E Dec-26E Dec-27E Revenue 9,422 ...

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） 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 证券分析师 张翀翯 二代 IO 潜力可期，慢病管线开始商业兑现 2025 年 05 月 06 日 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 6,206 | 9,422 | 11,491 | 15,178 | 20,089 | | 同比(%) | 36.19 | 51.82 | 21.96 | 32.09 | 32.36 | | 归母净利润（百万元） | (1,027.91) | (94.63) | 574.47 | 2,187.99 | 3,026.89 | | 同比(%) | 52.83 | 90.79 | 707.06 | 280.87 | 38.34 | | EPS-最新摊薄（元/股） | (0.62) | (0.06) | ...

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） 二代 IO 潜力可期，慢病管线开始商业兑现 2025 年 05 月 06 日 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 6,206 | 9,422 | 11,491 | 15,178 | 20,089 | | 同比(%) | 36.19 | 51.82 | 21.96 | 32.09 | 32.36 | | 归母净利润（百万元） | (1,027.91) | (94.63) | 574.47 | 2,187.99 | 3,026.89 | | 同比(%) | 52.83 | 90.79 | 707.06 | 280.87 | 38.34 | | EPS-最新摊薄（元/股） | (0.62) | (0.06) | 0.35 | 1.33 | 1.84 | | P/E（现价&最新摊薄） | (88.03) | (956.18) | ...

金融界4月29日消息，上证指数低开震荡，中证港股通医疗主题指数 (港股通医疗主题，932069)上涨 1.33%，报781.03点，成交额126.19亿元。 数据统计显示，中证港股通医疗主题指数近一个月下跌6.08%，近三个月上涨13.86%，年至今上涨 15.30%。 据了解，中证港股通医疗主题指数从港股通证券范围内选取50只业务涉及医疗器械、医疗商业与服务、 制药与生物科技服务等领域的上市公司证券作为指数样本，以反映港股通内医疗领域上市公司证券的整 体表现。该指数以2018年12月31日为基日，以1000.0点为基点。 从指数持仓来看，中证港股通医疗主题指数十大权重分别为：药明生物（16.49%）、京东健康 （10.88%）、阿里健康（7.36%）、国药控股（5.73%）、药明康德（5.43%）、金斯瑞生物科技 （3.8%）、威高股份（3.55%）、信达生物（2.48%）、康方生物（2.38%）、微创医疗（2.28%）。 从中证港股通医疗主题指数持仓的市场板块来看，香港证券交易所占比100.00%。 从中证港股通医疗主题指数持仓样本的行业来看，医疗商业与服务占比33.04%、制药与生物科技服务 占比30. ...

Financial Performance - In 2024, the company achieved total revenue of RMB 9.422 billion, representing a year-on-year growth of 51.8%[9] - Revenue for 2024 reached RMB 9,421,888 thousand, representing a 51.8% increase compared to RMB 6,206,070 thousand in 2023[16] - Total revenue for the year ending December 31, 2024, reached RMB 9,421.9 million, a 51.8% increase from RMB 6,206.1 million for the year ending December 31, 2023[19] - Product revenue reached RMB 8.228 billion, with a year-on-year increase of 43.6%, establishing a leading position in the oncology sector[9] - Product revenue for the year ending December 31, 2024, was RMB 8,227.9 million, up 43.6% from RMB 5,728.3 million for the year ending December 31, 2023[19] - Gross profit for 2024 was RMB 7,911,678 thousand, a 56.1% increase from RMB 5,069,804 thousand in 2023[16] - Gross profit for the year ending December 31, 2024, was RMB 7,911.7 million, an increase of RMB 2,841.9 million from RMB 5,069.8 million for the year ending December 31, 2023, with a gross margin of 84.0%[19] - The company achieved a significant reduction in IFRS loss by 90.8%, narrowing it to RMB 94,631 thousand from RMB 1,027,913 thousand in 2023[17] - For the first time since its listing, the company reported a Non-IFRS profit of RMB 331,611 thousand, compared to a loss of RMB 514,540 thousand in 2023[17] - Non-IFRS EBITDA improved to RMB 411,582 thousand, a turnaround from a loss of RMB 600,148 thousand in 2023, marking a 168.6% improvement[17] Product Development and Pipeline - The product portfolio expanded to 15 commercialized products, with five new drugs approved, including innovative treatments for lung cancer and hematological malignancies[10] - Three new drug molecules have entered Phase III or pivotal clinical studies, with 15 additional new drug candidates in clinical research[5] - The commercial product portfolio expanded to 15 products, with five new drugs approved, including three targeted therapies for lung cancer[22] - A new oncology pipeline submitted NDA, with multiple innovative ADCs and a next-generation IO pipeline entering Phase III or critical clinical studies[24] - The company plans to launch several new targeted drugs, including the first PCSK9 inhibitor in China, and a dual agonist for GCG/GLP-1 expected to be approved this year[12] - The company is advancing multiple innovative dual antibodies and ADC projects, including IBI3001 and IBI3020, into clinical development[13] - The company has initiated several key clinical studies, including the Phase III trial of IBI343 for third-line gastric cancer and IBI354 for PROC, with positive results expected to be presented at major conferences in 2024[30] - The company has received FDA Fast Track Designation for IBI363 in treating IO-refractory melanoma and squamous NSCLC, indicating strong potential for these therapies[30] - The company is focusing on building a new generation of differentiated innovative pipelines, with the global first IBI363 (PD-1/IL-2α-bias) showing potential in IO therapy for resistant and low PD-L1 expressing populations[33] - The ADC technology platform has demonstrated clear advantages in safety and efficacy, with candidates like IBI343 (CLDN18.2 ADC) and IBI354 (HER2 ADC) progressing to Phase III clinical trials[39] Financial Position and Cash Flow - The company has approximately RMB 10.22 billion in cash and short-term financial assets, equivalent to over USD 1.4 billion, ensuring solid support for long-term development[9] - The company has a cash and cash equivalents balance of approximately RMB 10.22 billion (over USD 1.4 billion) as of December 31, 2024, providing solid financial support for its long-term strategic vision[32] - The company reported a pre-tax loss of RMB 78.6 million for the year ended December 31, 2024, a significant improvement compared to a loss of RMB 1,144.4 million in 2023[119] - The company reported a net loss of RMB 94.63 million for the year ended December 31, 2024, significantly improved from a loss of RMB 1,027.91 million in 2023[131] - Total current assets decreased to RMB 10.27 billion in 2024 from RMB 13.43 billion in 2023, while total non-current assets increased to RMB 11.33 billion[136] Research and Development - R&D expenses for the year ending December 31, 2024, were RMB 2,681.1 million, compared to RMB 2,227.6 million for the year ending December 31, 2023[19] - The company's total research and development expenses were RMB 2,681.1 million for the year ended December 31, 2024, compared to RMB 2,227.6 million in 2023, reflecting a rise of about 20.3%[125] - The company is committed to advancing its research in cardiovascular and metabolic diseases, as well as autoimmune disorders[44] - The company is enhancing its commercialization capabilities in the chronic disease sector, focusing on multi-channel strategies and brand influence[32] Strategic Goals and Future Outlook - The company aims to achieve sustainable growth and global innovation, positioning itself as a leading international biopharmaceutical enterprise[10] - The strategic focus for 2025 includes dual-driven growth and global innovation development, marking a critical year for the company[10] - 2025 is identified as a key year for achieving mid-to-long-term strategic goals, focusing on consolidating leadership in oncology and expanding into chronic disease commercialization[35] - The company aims to expand its global R&D system, with plans to advance more clinical studies from China to key markets like the U.S.[38] - The company is focusing on global market expansion, particularly in mainland China, Hong Kong, Macau, and Taiwan[44] Corporate Social Responsibility and ESG - The company achieved an MSCI ESG rating upgrade to AAA, being one of only three in the biotechnology sector globally and the only one in China[14] - The company has provided assistance to over 200,000 patients through various aid projects, with a total drug donation value of RMB 3.6 billion[14] - The company is committed to social responsibility, employee welfare, and sustainable growth, as outlined in its environmental, social, and governance report[153] - The group made charitable donations of approximately RMB 204.6 million for the year ending December 31, 2024, compared to RMB 154.7 million in 2023[168] Shareholder Information and Corporate Governance - The board does not recommend the distribution of a final dividend for the year ending December 31, 2024, consistent with 2023[171] - The company had no significant transactions or contracts involving directors or related entities during the year ending December 31, 2024[177] - The company had no controlling shareholders as of December 31, 2024[178] - The company has purchased liability insurance to provide appropriate protection for its directors[172] - The total number of employees increased to 5,659 as of December 31, 2024, up from 4,872 in the previous year, with approximately 1,100 in R&D and over 3,300 in sales and marketing[157]

Core Insights - Innovent Biologics is showcasing preclinical data on multiple novel bispecific antibodies, tri-specific antibodies, and bispecific antibody-drug conjugates (ADCs) at the AACR Annual Meeting 2025, highlighting its advancements in oncology research [1][2] Research Highlights - IAR037, a novel CD40/PD-L1 bispecific antibody, shows potent anti-tumor efficacy in PD-1-resistant models and has a favorable safety profile in cynomolgus monkeys [3][4] - IBI3010, a FRα targeting biparatopic ADC, demonstrates superior cytotoxicity compared to existing treatments and is being developed for FRα-expressing tumors [5][6] - IBI3014, a TROP2xPD-L1 bispecific ADC, integrates tumor killing with immune checkpoint blockade, showing promising efficacy and safety in preclinical models [8][9] - IBI3022 targets Trop2 and B7H4, exhibiting improved efficacy and safety profiles for gynecologic cancers [10][11] - IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, shows potential as a new immuno-oncology therapy with strong immune activation [12][13] - IBI3019, a tri-specific antibody for colorectal cancer, demonstrates potent efficacy and an excellent safety profile in preclinical studies [16][17] - A novel PD1-IFNα fusion protein shows superior anti-tumor efficacy compared to PD1 mAb alone, potentially benefiting patients with ICB-refractory cancers [18][19][20] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, having launched 15 products and with multiple assets in clinical trials [21]

Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for limertinib as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, marking a significant advancement in cancer treatment options in China [1][5]. Group 1: Drug Approval and Clinical Trial Results - The approval of limertinib is based on positive outcomes from a Phase 3 clinical trial involving 337 treatment-naïve patients, which demonstrated significant improvements in progression-free survival (PFS) compared to gefitinib [2][3]. - Limertinib achieved a median PFS of 20.7 months versus 9.7 months for gefitinib, indicating a 56% risk reduction in disease progression or death [3]. - In patients with central nervous system (CNS) lesions, limertinib also showed a median CNS PFS of 20.7 months compared to 7.1 months, representing a 72% risk reduction for CNS progression or death [3]. Group 2: Safety Profile and Efficacy - The safety profile of limertinib aligns with known EGFR-targeted therapies, with adverse events primarily mild to moderate and no new safety signals identified during the trial [4]. - The drug has shown exceptional efficacy as a first-line therapy, particularly in patients with brain metastases, addressing a critical clinical need in this population [5]. Group 3: Company Strategy and Collaborations - Innovent has established a commercial collaboration with ASK Pharm for limertinib in Mainland China, enhancing its market presence and treatment accessibility [1][9]. - The company is focused on expanding its portfolio of precision therapies for lung cancer, which includes limertinib and other targeted therapies [6]. - ASK Pharm is also advancing a clinical trial for limertinib in combination with a cMET inhibitor for NSCLC patients resistant to third-generation EGFR-TKIs, indicating ongoing innovation and collaboration in treatment development [6]. Group 4: Industry Context - Lung cancer is one of the most common and deadly cancers globally, with NSCLC accounting for approximately 85% of cases, and EGFR mutations are prevalent among Asian NSCLC patients [7]. - EGFR-TKIs are the standard of care in the first-line setting, with third-generation EGFR-TKIs like limertinib offering broad treatment applicability [7]. Group 5: About Innovent - Innovent Biologics, founded in 2011, aims to provide affordable, high-quality biopharmaceuticals and has launched 15 products, with several more under regulatory review or in clinical trials [10]. - The company collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [10].

信达生物 2025042220250416 摘要 • 信达生物 2024 年产品收入达 82 亿元，商业化团队人均产出 200 万元， 显示出强大的商业化能力。公司构建了完善的管线梯队，包括 PD-1、信迪 利单抗以及双抗和 ADC 产品，解决了管线断层问题，并在自免领域进行了 前瞻性布局。 • 信达生物在肿瘤领域重点投入 ADC 和双抗药物研发，PD-1 收入同比增长 34%至 38 亿元。PIONE 双抗在黑色素瘤、非小细胞肺癌和结直肠癌中显 示出突出疗效，尤其在 PD-1 耐药的非小细胞肺癌患者中，客观缓解率 （ORR）达到 50%。 • 信达生物 2024 年总收入 94 亿元，其中产品收入 82 亿元，授权费及投资 收入 11 亿元。虽然按港股标准 CIS 口径计算亏损 0.95 亿元，但预计 2025 年将实现扭亏。销售费用率已降至 50%以下，管理费率稳定下降， 研发费率保持在 30%左右。 • 信达生物股价表现相对滞后于其他创新药公司，但仍存在预期差和投资机 会。港股通占比 31%，显示南下资金对其定价权较高，分散的股权结构有 助于管理层受到制约，保障公司发展。 Q&A 为什么在当前时间点推荐 ...

就是这个性牙生物的一个深度报告解读那么从其实这两天的一个两会的一个工作政府工作报告内容来看其实我们可以看到国家对于创新药的政策鼓励还是有持续加强的这里面可能就包括一个是健全的一个药品的一个价格形成机制然后包括这个药品的一个集材政策的一个优化 所以我们认为其实自去年上半年以来就是相关部门对于这个创新药的定位已经发生了较大改进那么医保局也是逐渐从这个支持产业发展就是从这个支付端包括供给端都是有一些政策上的一些利好基于此我们最近也是陆续外发一方包括心理态百激性达生物的一系列深度报告 那么在H谷这边我们阅读组合也是在持续推荐像科文伯泰信达以及在鼎中生等标的那么我们之所以这个位置去推荐信达生物也是主要基于以下几个原因第一个就是公司的一个营收表现还是持续表现非常优异的这个高增速的一个增长一个确定性是比较高的 那么2024年我们也可以看到就是公司实现了一个全年的一个产品收入超82亿啊就是同比增长40%啊那么Q4一个单季度这个产品收入也是超20亿元啊同比增长25%以上啊所以我们认为公司最大的单品啊PD1啊星际第三抗呢啊由于进行了一个全产呃全生命周期管理的一个研发布局 后续5年内其实还是非常有希望继续去保持一个低双位数到高个位 ...