信达生物 20250306 2025-03-07 摘要 • 信达生物 2024 年产品收入超 82 亿元，同比增长 40%，四季度收入超 20 亿元，同比增长超 25%。PD-1 新迪利单抗全生命周期管理有望保持低双 位数增长，肿瘤领域多款产品峰值预计达 10-15 亿元。 • 公司已商业化 13 款产品，另有 4 款在审评，4 款进入三期临床，预计 2025 年上市眼科 IGF-1 YR-2 单抗等新产品，目标 2027 年国内产品营收 达 200 亿元。 • 生物类似药集采对营收有压力，三款主要产品占总营收约 37%，但新产品 上市预计能弥补损失，即使最悲观情况下，仍能保持 24%的 CAGR 增长 率。 • 信迪利单抗是唯一纳入五大高发肿瘤一线治疗的 PD-L1 抑制剂，预计未来 2-3 年达 50 亿元峰值，通过适应症拓展和外部合作有望延长生命周期。 • VEGFR2 单抗预计峰值超 20 亿元，已获批用于晚期胃癌和肝癌二线治疗， 在胃癌领域无直接竞争对手，肝癌领域与 PD-1/PDL-1 有联合潜力。 • 赛尔帕替尼作为 RET 抑制剂，在 NSCLC 和 MTC 适应症中表现优于竞品 普拉替尼和卡 ...

信达生物 摘要 • 信达生物 2025 年维持 44%高增长，营收达 82 亿元，现金储备近 100 亿 元，为管线开发提供充足资金。目标 2027 年实现 20 款商业化产品，营 收达 200 亿元。信迪利单抗 2025 年收入 38 亿元，同比增长 38%，预计 销售峰值超 50 亿元。 • 肿瘤管线围绕 PD-1、RIO 2.0 及 ADC 平台展开，覆盖肺癌等多种癌种。 已上市十款肿瘤相关产品，多款产品处于注册临床阶段。集采政策短期影 响有限，新药及综合管线将抵消部分负面影响。 • 慢病领域布局独特，拓展眼科及痛风治疗产品。马斯肽有望 2025 年上半 年获批，成为增长点。PCCKI 单抗进入医保目录后表现强劲，预计未来 3- 4 年收入达 20 亿元。 • PD-1 抑制剂在肺癌治疗中应用前景广阔，GCIC 抑制剂市场规模接近 50 亿元。ROS1 抑制剂一线治疗患者 CR 率达 90%，中国患者 PFS 达 46 个 月，有望 2026 年上半年获批。 • 新型 PD-1/PD-L2 融合蛋白针对 IO 失败后肿瘤，ORR 达 40%- 50%，DCR 接近 90%。计划 2025 年启动黑色素瘤 ...

Investment Rating - The report maintains a rating of "Outperform" for Innovent Biologics, with a target price of 60.2 HKD per share [6]. Core Viewpoints - Innovent Biologics is entering a rapid commercialization phase, with a strong pipeline of products expected to drive growth in the coming years. The company achieved revenue of 6.21 billion CNY in 2023, with product revenue of 5.73 billion CNY, reflecting a year-on-year growth of 38.4% [3][31]. - The company has a robust pipeline with 13 commercialized products and several in late-stage clinical trials, including IBI311 (IGF-1R) and others, which are anticipated to contribute to revenue growth by 2025 [3][4]. - Innovent's focus on oncology and chronic diseases, along with its strong research and development capabilities, positions it well for sustainable growth in the biopharmaceutical sector [3][5]. Summary by Sections Part 1: Market Concerns - The impact of biosimilar drug procurement on revenue is manageable, with projections indicating stable sales for key products like Bevacizumab and Rituximab [9][13]. - The commercial potential of Ma Shidu peptide (GLP-1/GCGR) is significant, given the large patient base for diabetes and obesity in China, with a low current penetration rate of GLP-1RA therapies [16][17]. Part 2: Company Development - Innovent Biologics aims to become a leading comprehensive biopharma in China, leveraging its strong product portfolio and international innovation strategies [20][24]. Part 3: Growth Areas - The oncology segment shows steady growth with a strong commercialization performance, while non-oncology areas like cardiovascular metabolism (CVM) and ophthalmology are expected to contribute to a second growth curve [5][31]. - The company has established a solid commercial team for CVM, with IBI306 (PCSK9) approved in 2023, and is preparing for the launch of Ma Shidu peptide [5][31]. Part 4: Financial Forecast and Valuation - Revenue forecasts for FY25-27 are projected at 10.59 billion CNY, 12.52 billion CNY, and 16.73 billion CNY, respectively, with expected EBITDA turning positive by 2025 [6][31].

Core Viewpoint - Innovent Biologics has received acceptance for the New Drug Application (NDA) of ipilimumab injection, a CTLA-4 inhibitor, for use in combination with sintilimab as a neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer, which has been granted Priority Review designation by China's National Medical Products Administration (NMPA) [1][2][7]. Group 1: NDA Acceptance and Clinical Trials - The NDA acceptance and Priority Review designation are based on the results from the NeoShot Phase 3 clinical trial, which demonstrated the safety and efficacy of ipilimumab combined with sintilimab compared to direct radical surgery for MSI-H/dMMR colon cancer [3][4]. - Interim analysis from the NeoShot trial indicated that the primary endpoint of pathologic complete response (pCR) rate was met, with detailed results to be shared in future academic forums [3][5]. Group 2: Treatment Efficacy - The combination of ipilimumab and sintilimab showed a significantly higher pCR rate of 80.0% compared to 47.7% for sintilimab alone, with no disease recurrence observed during a median follow-up of 5.65 months [6]. - The treatment is expected to increase the R0 resection rate, achieve pathological complete response, and alleviate the need for adjuvant chemotherapy in most patients [2][5]. Group 3: Market Position and Future Prospects - This NDA marks the first for a domestic CTLA-4 inhibitor in China, reinforcing sintilimab's leadership in cancer immunotherapy [2]. - The company aims to address the significant unmet clinical need for neoadjuvant therapy in resectable MSI-H/dMMR colon cancer, with plans to expedite regulatory approval [5][6]. Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including oncology, and has launched 14 products to date [10]. - The company collaborates with over 30 global healthcare firms, enhancing its capabilities in drug development and commercialization [10].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price raised to HKD 43.85 [4][6]. Core Insights - The company is expected to see a rapid increase in product sales revenue, with a projected year-on-year growth of over 40% in 2024, reaching over RMB 8.2 billion [1]. - Revenue forecasts for 2025 and 2026 are also optimistic, with expected increases of 27.5% and 20.0%, respectively [2]. - The core product, Dabu Shu, continues to see strong demand, particularly with the recent approval for a new indication in endometrial cancer [2]. - Additional products are also expected to contribute to revenue growth, including the anticipated approval of the diabetes drug Xinbile in late 2024 [2]. - The company has entered into a licensing agreement with Roche for the development of an antibody-drug conjugate, which is expected to generate significant milestone payments [2]. Financial Summary - Total revenue is projected to grow from RMB 8.459 billion in 2024 to RMB 11.321 billion in 2025, reflecting a growth rate of 33.8% [5]. - The company is expected to turn a profit in 2025, with a net profit forecast of RMB 185 million, compared to a loss of RMB 708 million in 2024 [5]. - The earnings per share (EPS) is expected to improve from a loss of RMB 0.43 in 2024 to a profit of RMB 0.11 in 2025 [5]. - The company's gross margin is projected to remain strong, with an expected gross margin of 84.9% in 2025 [11]. Revenue Breakdown - The pharmaceutical product sales revenue is expected to increase significantly, from RMB 8.202 billion in 2024 to RMB 10.455 billion in 2025 [11]. - Licensing revenue is also projected to rise, with expected income of RMB 838 million in 2025 [11]. Market Position - The company has a market capitalization of approximately HKD 59.71 billion, with a closing price of HKD 36.35 [6]. - The stock has a 52-week price range of HKD 28.65 to HKD 52.15, indicating volatility and potential for growth [6].

Core Viewpoint - Innovent Biologics and Jiangsu Aosaikang Pharmaceutical have received approval from China's National Medical Products Administration for limertinib, a new treatment for adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) [1][4][5] Group 1: Product Approval and Clinical Efficacy - Limertinib is the 14th product in Innovent's commercial portfolio, enhancing its TKI franchise and providing a precision therapy option for lung cancer patients [1][5] - A Phase 2b pivotal study involving 301 patients showed limertinib's overall response rate (ORR) at 68.8% and a disease control rate (DCR) of 92.4%, with a median progression-free survival (PFS) of 11.0 months [2][4] - The drug also met its primary endpoint in a Phase 3 trial comparing it to gefitinib for first-line treatment of NSCLC with EGFR mutations [3][8] Group 2: Future Prospects and Strategic Collaborations - A second NDA for limertinib is under review for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations [3][7] - The collaboration between Innovent and ASK Pharm aims to bring limertinib to market, with expectations of benefiting more patients in the near future [5][9] - ASK Pharm is also developing ASKC202, a new c-Met inhibitor, in combination with limertinib to address third-generation EGFR-TKI resistance [5][12] Group 3: Industry Context and Market Potential - Lung cancer is one of the deadliest cancers globally, with NSCLC accounting for approximately 85% of cases, and EGFR mutations are prevalent in 30% to 50% of Asian NSCLC patients [6][10] - EGFR-TKIs are the recommended first-line treatment for this patient group, indicating a significant market opportunity for limertinib [6][10]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company has made significant progress in its internationalization efforts, particularly with the global licensing of its DLL3ADC drug IBI3009 to Roche, which includes an upfront payment of $80 million and potential milestone payments up to $1 billion, along with a sales revenue share [7] - The company is expected to achieve EBITDA breakeven by 2025 and aims for domestic sales of 20 billion yuan by 2027, driven by multiple product launches and overseas collaborations [7] - The revenue forecast for 2024-2026 has been adjusted upwards, with expected revenues of 81 billion yuan in 2024, 114.91 billion yuan in 2025, and 151.78 billion yuan in 2026, indicating strong growth potential [7] Financial Summary - Total revenue for 2022 was 4,557 million yuan, with a projected increase to 6,206 million yuan in 2023, and further growth to 8,100 million yuan in 2024, 11,491 million yuan in 2025, and 15,178 million yuan in 2026, reflecting a compound annual growth rate of 36.19% from 2022 to 2023 [1] - The net profit attributable to the parent company is expected to improve from a loss of 2,179.27 million yuan in 2022 to a profit of 2,211.27 million yuan by 2026, showcasing a significant turnaround [1] - The latest diluted EPS is projected to turn positive, reaching 1.35 yuan per share by 2026, compared to a loss of 1.33 yuan per share in 2022 [1]

Investment Rating - Maintain BUY rating for Innovent Biologics with a target price raised from HK$55.21 to HK$57.67, reflecting a potential upside of 62.4% from the current price of HK$35.50 [1][9]. Core Insights - Innovent Biologics has out-licensed global rights of DLL3 ADC (IBI3009) to Roche, receiving an upfront payment of US$80 million and potential milestone payments up to US$1.0 billion, along with tiered royalties on net sales [1]. - The DLL3 ADC is a promising therapy for pre-treated extensive-stage small cell lung cancer (ES-SCLC), with DLL3 being a neuroendocrine-specific antigen expressed in 85% of SCLC cases [1]. - Innovent has a rich pipeline of innovative drug candidates, including IBI115 (DLL3/CD3 bispecific antibody) and IBI363 (PD-1/IL-2), which have shown encouraging clinical results [1]. Financial Summary - Revenue is projected to grow from RMB 6,206 million in FY23A to RMB 10,840 million in FY25E, representing a year-on-year growth of 32.4% and 31.9% respectively [8][19]. - Net profit is expected to improve from a loss of RMB 1,028 million in FY23A to a profit of RMB 281 million in FY25E [19]. - R&D expenses are forecasted to increase from RMB 2,228 million in FY23A to RMB 3,035 million in FY25E, indicating continued investment in innovative drug development [19]. Drug Development and Pipeline - DLL3 ADC represents a significant advancement in the treatment of SCLC, with various strategies targeting DLL3 being explored, including ADCs and bispecific antibodies [1]. - Innovent's next-gen immuno-oncology asset, IBI363, has shown promising results in multiple cancer types, indicating strong potential for future out-licensing opportunities [1]. - The company has multiple ADC assets in clinical stages targeting various antigens, enhancing its global market potential [1].

Core Insights - Lung cancer, particularly non-small cell lung cancer (NSCLC), has high global incidence and mortality rates, with NSCLC accounting for about 85% of all cases. In China, approximately 2.6% of NSCLC patients are ROS1-positive [1][3] - DOVBLERON® (taletrectinib) has been approved by China's National Medical Products Administration (NMPA) for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs, marking it as the 13th addition to Innovent's commercial portfolio [10][14] - The approval is based on positive results from the TRUST-I trial, which demonstrated DOVBLERON®'s efficacy, particularly in patients with brain metastases and those who have developed resistance to prior therapies [11][12] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for oncology and other major diseases, with a strong pipeline of targeted therapies [10][16] - The company has established partnerships with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [16] Product Details - DOVBLERON® is a next-generation ROS1 inhibitor designed for advanced ROS1-positive NSCLC, with a favorable safety profile and low rates of dose reduction due to adverse events [4][11] - Taletrectinib has received Orphan Drug Designation and Breakthrough Therapy Designations from the U.S. FDA and China's NMPA, indicating its potential to address unmet medical needs in this patient population [5][14]

Core Viewpoint - Innovent Biologics has announced the inclusion of SINTBILO® and a new indication for olverembatinib in the updated 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025, enhancing treatment options for patients in China [1][4]. Group 1: SINTBILO® (Tafolecimab Injection) - SINTBILO® is newly listed in the NRDL for treating adult patients with primary hypercholesterolemia and mixed dyslipidemia, marking Innovent's first entry into the cardiovascular field [2][6]. - The drug offers multiple dosing options: 150mg every two weeks, 450mg every four weeks, and 600mg every six weeks, significantly reducing low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lipoprotein a (Lp(a)) by nearly 50% [2][5]. - As the first domestic PCSK9 inhibitor included in the NRDL, SINTBILO® provides a crucial new treatment option for cholesterol management in China [2][4]. Group 2: Olverembatinib - The updated NRDL includes a renewed indication for olverembatinib, which treats adult patients with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation, and those resistant or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs) [3][8]. - Olverembatinib is recognized as the first third-generation BCR-ABL inhibitor approved by China's National Medical Products Administration (NMPA) [3][7]. - Innovent and Ascentage Pharma are committed to the commercialization of olverembatinib in the Chinese market [9]. Group 3: Company Mission and Future Outlook - The company aims to empower patients with affordable, high-quality biopharmaceuticals, focusing on oncology, cardiovascular and metabolic diseases, autoimmune conditions, and ophthalmology [4][10]. - Innovent has launched 11 products and has 5 new drug applications under regulatory review, with ongoing clinical trials for additional therapies [10]. - The company emphasizes a patient-centered approach to improve drug affordability and accessibility, contributing to better patient care [4][10].