机构：中信建投证券 研究员：贺菊颖/袁清慧/赵旭 核心观点 12 月7 日，国家医疗保障局发布了2025 年医保谈判结果，信达生物此次有6 款相关创新产品及1 款产品 新适应症成功纳入新版国家医保药品目录，涵盖肿瘤和心血管及代谢等社会负担较重的疾病领域，继续 提高患者的用药可及性和可负担性。 12 月8 日，信达生物在2025 年美国血液学会年会(ASH)上以口头报告形式首次公布其自主开发的抗 GPRC5D/BCMA/CD 3 三特异性抗体IBI3003 用于复发或难治性多发性骨髓瘤（R/R MM）患者的首次人 体试验的初步数据。IBI3003 展示出良好的耐受性和可控的安全性特征，尽管当前随访时间尚短， IBI3003 已经显现出令人鼓舞的初步疗效信号，特别在伴有髓外病变或既往接受抗BCMA 和GPRC5D 单 一或双重靶向治疗的高危患者中展现了积极的疗效。 未来可以关注：①IBI363（PD-1/IL2α）1L CRC POC、1L NSCLC POC数据读出，②IBI3002 （IL4/TSLP）哮喘适应症1 期数据读出，③IBI3001（EGFR/B7H3 ADC）实体瘤1 期数据读出， ④IBI30 ...

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]

Core Viewpoint - The company reported significant financial growth in the first half of 2025, with a 50.6% increase in revenue and a successful turnaround from losses to profits, driven by strong performance in oncology products and strategic partnerships [1][3]. Financial Summary - Revenue for the first half of 2025 reached RMB 59.53 billion, up from RMB 39.52 billion in the same period last year, marking a 50.6% increase [2]. - Gross profit increased to RMB 51.20 billion, a 56.3% rise compared to RMB 32.75 billion in the previous year [2]. - The company achieved a net profit of RMB 8.34 billion under IFRS, compared to a loss of RMB 3.93 billion in the same period last year [1][3]. - Non-IFRS net profit rose to RMB 12.13 billion, up from a loss of RMB 1.60 billion in the previous year [1][3]. - Non-IFRS EBITDA reached RMB 14.13 billion, a significant improvement from a loss of RMB 1.61 billion in the prior year [3]. Business Performance - The revenue growth was primarily driven by strong sales of oncology products, which generated RMB 52.34 billion, a 37.3% increase year-on-year [2]. - Licensing revenue surged to RMB 6.66 billion, up from RMB 1.16 billion, largely due to upfront payments from exclusive licensing agreements with Roche [2]. - The gross margin improved to 86.0%, up from 82.9% in the previous year, attributed to increased production and cost optimization [3]. Cost Management - Research and development expenses decreased by 28.0% to RMB 10.09 billion from RMB 13.99 billion in the previous year, indicating improved efficiency [3]. - Sales and marketing expenses accounted for 39.9% of total revenue, down from 47.6% in the previous year, reflecting enhanced commercialization efficiency [3]. Product Development - The company expanded its commercial product portfolio to 16 products, including 12 oncology products and 4 comprehensive pipeline products [4]. - Five new drugs were successfully commercialized during the reporting period, including key oncology treatments and products for other therapeutic areas [4]. - Several products are in the process of new drug application (NDA) approvals, including IBI112 for psoriasis and IBI310 for colorectal cancer [4][5].