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 ...

Group 1 - The National Healthcare Security Administration released the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, along with the Commercial Health Insurance Innovative Drug Catalog [1] - Innovent Biologics has seven innovative products successfully included in the new medical insurance catalog, including the PD-1 inhibitor, Tyvyt (sintilimab injection), which has a new indication for advanced endometrial cancer [1][2] - Tyvyt is the only PD-1 inhibitor in its treatment area to be included in the medical insurance catalog, and it has been approved for eight indications since its launch in 2018, covering various cancers [1] Group 2 - Another innovative drug included in the new medical insurance catalog is IBI302 (teprotumumab), which is the first IGF-1R antibody drug approved in China and the second globally, marking a significant advancement in the treatment of thyroid eye disease [2] - Other innovative drugs added to the catalog target prevalent diseases such as lung cancer and hematological malignancies, including drugs like IBI308 (lazertinib), IBI310 (entrectinib), and IBI311 (ibrutinib) [2] - The inclusion of innovative drugs in the medical insurance catalog is a crucial step towards making these treatments accessible and affordable for more patients in China [2]

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]