2025年12月获纳入恒生指数成分股的信达生物（01801.HK）发布公告指，其2025年第4季和2025年全年产品收入实现强劲 增长，但其股价却并未因此而有起色，于2月5日收跌0.93%，报79.90港元，市值1,386亿港元。 全年营收破百亿 该公司预计，其2025年全年实现总产品收入约119亿元（单位人民币，下同），同比保持约45%的增长态势，我们留意到， 其2024年的产品销售收入增幅为43.64%，2025年上半年增幅为37.32%，这意味着其下半年的产品销售收入增长加快。 2025年第4季，信达生物有六款新药首次纳入2026年国家医保目录，因而计提了相应金额的一次性库存不差，即便如此，其 第4季总产品收入或仍达33亿元，同比增长60%以上，显著高于前三个季度。 值得留意的是，信达生物当前的商业化产品组合或已扩展至18款，第4季或新增达伯欣（伊匹木单抗N01注射液）和信美悦 （匹康奇拜单抗注射液）获准上市。 2025年12月29日，信达生物公告称，达伯欣（伊匹木单抗N01注射液）获国家药监局（NMPA）批准上市，根据公司提供的 资料，达伯欣或是中国第一款获批的国产抗CTLA-4单抗，也是全球第一个获 ...

Core Insights - The company achieved total product revenue of approximately RMB 11.9 billion in 2025, marking a strong year-on-year growth of about 45% [1] - In Q4 2025, the company recorded total product revenue of approximately RMB 3.3 billion, with a year-on-year increase of over 60%, driven by the inclusion of six new drugs in the 2026 National Medical Insurance Directory [1] Group 1 - 2025 marked a milestone year for the company as product revenue surpassed RMB 10 billion, reflecting the successful implementation of its "dual-driven and global innovation" strategy [2] - The company has expanded its oncology product portfolio to 13 products, with core products like Dabrushe (sintilimab injection) showing steady growth and new products contributing significantly to revenue [2] - The company has successfully entered the chronic disease commercialization sector, leveraging unmet needs and strong product competitiveness to drive growth [2] Group 2 - The company’s innovative pipeline focuses on next-generation immunotherapy (IO) and antibody-drug conjugates (ADC), along with developments in metabolic and cardiovascular (CVM), autoimmune, and ophthalmology fields, which are making significant progress [3] - The company aims to become an internationally leading biopharmaceutical company, supported by its global clinical development efforts [3]

Core Insights - The company achieved total product revenue of approximately RMB 11.9 billion in 2025, marking a strong year-on-year growth of about 45% [1] - In Q4 2025, the company recorded total product revenue of approximately RMB 3.3 billion, with a year-on-year increase of over 60%, driven by the inclusion of six new drugs in the 2026 National Medical Insurance Directory [1] Group 1 - 2025 marked a milestone year for the company as product revenue surpassed RMB 10 billion, reflecting the successful implementation of its "dual-driven and global innovation" strategy [2] - The company has strengthened its leading position in the oncology treatment sector, expanding its oncology product portfolio to 13 products, with core products like Darbeshou (Sintilimab injection) showing steady growth [2] - The company has successfully ventured into the chronic disease commercialization field, leveraging unmet needs and strong product competitiveness to drive growth, with key products like Xin'ermei (Masitide injection) and Xinbile (Torecilizumab injection) becoming significant revenue contributors [2] Group 2 - The company's global innovation strategy continues to make breakthroughs, focusing on next-generation immunotherapy (IO) and antibody-drug conjugates (ADC) in oncology, as well as innovations in metabolism, cardiovascular, autoimmune, and ophthalmology fields [3] - The company aims to become an internationally leading biopharmaceutical company, supported by its ongoing clinical development and strategic advantages in flexible layout and efficient execution [3]

Core Insights - The National Healthcare Security Administration released the 2025 medical insurance negotiation results, with 7 innovative products from Innovent Biologics successfully included in the new national medical insurance drug list, enhancing patient accessibility and affordability for critical diseases like cancer and cardiovascular conditions [1][2][3] Group 1: Medical Insurance Negotiation Results - A total of 127 products participated in the negotiation, with 114 successfully included, marking an 88% success rate for innovative drugs, the highest in seven years, surpassing the 76% success rate of 2024 [2][3] - The updated national medical insurance drug list will officially take effect on January 1, 2026, increasing the total number of drugs in the list to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2][3] Group 2: Innovent Biologics' Product Inclusion - The newly included products cover significant disease areas, including lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, hematological tumors, and metabolic diseases [3][4][5][6][7] - Specific products included are: 1. **Daboshu (Sintilimab)**: New indication for advanced mismatch repair-deficient endometrial cancer [3] 2. **Xinbimin (Tislelizumab)**: Inclusion for moderate to severe thyroid eye disease, a breakthrough therapy after 70 years without effective treatment [3] 3. **Aoyixin (Leratinib)**: First-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations [4] 4. **Dabote (Fuzuloparib)**: Targeting KRAS G12C mutation in advanced NSCLC [5] 5. **Dabole (Entrectinib)**: For ROS1-positive advanced NSCLC [6] 6. **Ruituo (Selpercatinib)**: For RET fusion-positive NSCLC and thyroid cancer [6] 7. **Jiepalai (Pirtobrutinib)**: For relapsed or refractory mantle cell lymphoma [7] Group 3: Clinical Trial Updates - At the 2025 American Society of Hematology (ASH) meeting, Innovent Biologics presented preliminary data on IBI3003, a tri-specific antibody for relapsed or refractory multiple myeloma, showing promising efficacy and manageable safety profiles [9][10] - The trial included 39 patients, with a median follow-up of 3.25 months, demonstrating an overall response rate (ORR) of 83.3% at doses ≥120 μg/kg [11][12] Group 4: Future Prospects and Collaborations - Innovent Biologics has a robust pipeline with 17 commercialized drugs and several in advanced clinical stages, indicating strong growth potential [12][13] - A strategic collaboration with Takeda aims to accelerate the global market entry of next-generation immuno-oncology and antibody-drug conjugate therapies, with a total deal value of $11.4 billion [12][13]

Core Viewpoint - The company, Innovent Biologics (01801), has successfully included seven innovative products in the new National Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List (2025), enhancing patient accessibility and affordability for critical diseases in China [1] Group 1: Product Inclusion - Seven innovative drugs have been added to the updated National Medical Insurance Drug List, effective January 1, 2026 [1] - The included products are: - Daboshu (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tremelimumab N01 injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabotai (Fuzuloparib tablets, KRAS G12C inhibitor) - Dabolet (Entrectinib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepalin (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Impact on Patients - The inclusion of these drugs covers significant diseases such as lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, hematological tumors, as well as cardiovascular and metabolic diseases [1] - The company aims to enhance the accessibility and affordability of medications for patients, aligning with its mission to develop high-quality biologics that are affordable for the public [1] Group 3: Commitment to Patients - The company is committed to a patient-centered approach and will actively cooperate with medical insurance policies to ensure the effective implementation of these drugs across various regions [1] - The goal is to expedite the availability of high-quality medications to more patients and families [1]

Core Viewpoint - The company, Innovent Biologics (01801.HK), has successfully included seven innovative products in the new National Medical Insurance Drug List (2025), enhancing patient accessibility and affordability for critical diseases [1] Group 1: Product Inclusion - Seven innovative drugs have been added to the National Medical Insurance Drug List, including: - Daberhu (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tislelizumab injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabet (Fuzuloparib tablets, KRASG12C inhibitor) - Dabele (Dabrafenib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepal (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Disease Coverage - The newly included drugs address significant social burdens in oncology (lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, and hematological malignancies) as well as cardiovascular and metabolic diseases [1] Group 3: Company Mission and Commitment - The company is committed to developing high-quality biopharmaceuticals that are affordable for the public, emphasizing continuous innovation and patient-centered approaches [1] - The company aims to cooperate with medical insurance policies to ensure that high-quality drugs reach more patients and families promptly [1]

Core Viewpoint - The company has successfully included seven innovative products in the 2025 version of the National Medical Insurance Drug List, enhancing patient accessibility and affordability for critical diseases [1][2]. Group 1: Product Inclusion - Seven innovative products from the company have been added to the new National Medical Insurance Drug List, including: - Dabrus (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tislelizumab injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabrut (Fuzuloparib tablets, KRAS G12C inhibitor) - Dabele (Entrectinib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepal (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Impact on Patients - The inclusion of these products covers significant diseases such as lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, and hematological tumors, which are major social burdens [2] - The company aims to enhance the accessibility and affordability of medications for patients, aligning with its mission to develop high-quality biopharmaceuticals that are affordable for the public [2] - The company is committed to patient-centered approaches and will actively cooperate with medical insurance policies to ensure that high-quality drugs reach more patients and families promptly [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 達伯舒®、信必敏®等七款創新產品（含新適應症） 成功納入2025年版國家醫保藥品目錄 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，本公司七款創新產品成功納入新版《國家基 本醫療保險、生育保險和工傷保險藥品目錄（2025年）》（「國家醫保藥品目錄」）， 包括：達伯舒® （信迪利單抗注射液，抗PD-1單克隆抗體）新增適應症、信必敏® （替妥尤單抗N01注射液，抗IGF-1R單克隆抗體）、奧壹新® （利厄替尼片，EGFR TKI）、達伯特® （氟澤雷塞片，KRAS G12C抑制劑）、達伯樂® （己二酸他雷替尼膠 囊，ROS1TKI）、睿妥® （塞普替尼膠囊，RET ...

Core Viewpoint - Innovent Biologics has successfully included seven innovative products in the new National Medical Insurance Drug List (2025), which will be implemented on January 1, 2026 [1] Group 1: Product Inclusion - The seven innovative products included are: - Daboshu® (sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin® (tremelimumab N01 injection, anti-IGF-1R monoclonal antibody) - Aoyixin® (leratinib tablets, EGFR TKI) - Dabote® (furazolidone tablets, KRAS G12C inhibitor) - Dabolet® (dihydroartemisinin capsules, ROS1 TKI) - Ruituo® (sepafitinib capsules, RET inhibitor) - Jiepalin® (pembrolizumab tablets, BTK inhibitor) [1] Group 2: Implementation Timeline - The new National Medical Insurance Drug List will officially take effect on January 1, 2026 [1]

Core Insights - The company achieved total product revenue exceeding RMB 3.3 billion in Q3 2025, reflecting a robust year-on-year growth of approximately 40% driven by both oncology and comprehensive product lines [1] Oncology Sector - The company maintains a leading position in the oncology treatment field, with significant advantages in its product portfolio, including steady growth of key products like Dabu Shu (sintilimab injection) [1] - The contribution of innovative product revenue has further increased, enhancing the overall revenue mix [1] Comprehensive Product Line - The potential of the comprehensive product line is rapidly being realized, providing new growth drivers with significant revenue contributions from products like Xin Er Mei (masitinib injection), Xin Bi Le (toripalimab injection), and Xin Bi Min (tremelimumab N01 injection) [1] - Successful market access and channel marketing efforts have accelerated product uptake, leading to substantial revenue growth [1] - The second indication for masitinib for diabetes has also received approval from the National Medical Products Administration of China, expanding access to high-quality innovative treatment options for a broader patient base [1] Strategic Focus - The company is committed to sustainable growth and global innovation as its two core strategies, with a rich pipeline in oncology and comprehensive product lines (cardiovascular, metabolism, autoimmune, ophthalmology) [1] - As of now, the company has obtained approvals for 16 products, with 2 under review by the National Medical Products Administration of China, and 4 new drug molecules in Phase 3 or pivotal clinical studies, alongside approximately 15 new drug candidates in clinical research [1] - The year 2025 marks a significant milestone for the company as it enters a new phase of dual-driven growth and global innovation, progressing towards its vision of becoming a world-class biopharmaceutical company [1]