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]

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 達伯欣® （伊匹木單抗N01注射液）獲中國國家藥品監督管理局批准 聯合信迪利單抗用於結腸癌新輔助治療 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」）欣然宣佈達伯欣® （伊匹木單抗N01注射液，細胞毒性T 淋巴細胞相關蛋白4（「CTLA-4」）單克隆抗體（「單抗」），研發代號：IBI310）獲得 中國國家藥品監督管理局（「NMPA」）批准上市，聯合信迪利單抗用於可手術切除 的IIB-III期微衛星高度不穩定型（「MSI-H」）或錯配修復缺陷型（「dMMR」）結腸 癌患者的新輔助治療。達伯欣® （伊匹木單抗N01注射液）是中國首個獲批的國產抗 CTLA-4單抗，也是全球首個 ...

Core Insights - The approval of the dual immunotherapy regimen for the treatment of resectable IIB-III stage MSI-H/dMMR colorectal cancer marks a significant breakthrough in the field of immunotherapy for colorectal cancer [1][3][4] - This therapy is the first and only dual immunotherapy regimen approved globally for neoadjuvant treatment in colorectal cancer, potentially changing treatment paradigms for patients with this specific cancer type [1][3] Group 1: Treatment Approval and Characteristics - The National Medical Products Administration approved the new drug application for Daberxin (Ipilimumab N01 injection), which can be used in combination with Daberush (Sintilimab injection) for neoadjuvant therapy in patients with resectable IIB-III stage MSI-H/dMMR colorectal cancer [1] - MSI-H/dMMR colorectal cancer accounts for approximately 15% of all resectable colorectal cancer cases, and these tumors are less responsive to traditional chemotherapy [1][3] Group 2: Clinical Implications and Efficacy - Existing treatments for locally advanced MSI-H/dMMR colorectal cancer primarily involve radical surgery and postoperative adjuvant chemotherapy, with a recurrence or metastasis rate of 10%-30% among patients [3] - The dual immunotherapy regimen has shown to significantly increase the pathological complete response rate in neoadjuvant therapy, potentially reducing the need for postoperative adjuvant chemotherapy [3][4] Group 3: Patient Considerations and Safety - For patients with MSI-H/dMMR colorectal cancer, surgery may not be the only option due to the challenges associated with radical surgery and poor prognosis [4] - While the dual immunotherapy regimen is generally considered safe and controllable, there are potential immune-related adverse reactions that may occur, necessitating timely medical intervention for severe cases [4]

Group 1 - The core point of the news is that Innovent Biologics has received approval from the National Medical Products Administration (NMPA) for its self-developed anti-CTLA-4 monoclonal antibody, Daberhe, in combination with the PD-1 inhibitor, Dabeoshu, for neoadjuvant treatment of resectable IIB-III stage microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients, marking a significant milestone in China's oncology treatment landscape [1][2] - Daberhe becomes the first domestically approved anti-CTLA-4 inhibitor in China and represents the world's first "dual immunotherapy" neoadjuvant treatment regimen for this indication [1] - The combination of Daberhe and Dabeoshu is now the ninth approved indication for Dabeoshu in China, which has already been approved for multiple indications including lung cancer, liver cancer, and esophageal cancer [1] Group 2 - With the approval of Daberhe, Innovent Biologics has successfully launched seven innovative drugs by 2025, focusing on key disease areas such as oncology (PD-1 and CTLA-4 combination), metabolism (GCG/GLP-1 dual-target drugs), autoimmune diseases (IL-23p19), and ophthalmology (Tebentafusp N01) [2] - The company is transitioning from a single focus on oncology to a dual-driven model of "oncology + chronic diseases," with plans to establish a comprehensive commercialization platform for chronic diseases [2] - As of now, Innovent Biologics has a total of 18 innovative drugs approved for market, and with the ongoing strengthening of its R&D and commercialization systems, the company is expected to further expand its leading position in the domestic biopharmaceutical industry [2]

Group 1 - The approval of the anti-CTLA-4 monoclonal antibody Daberxin (Ipilimumab N01 injection) by the National Medical Products Administration (NMPA) marks it as the first domestically developed anti-CTLA-4 inhibitor approved in China, providing a significant breakthrough in neoadjuvant treatment for resectable IIB-III stage microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients [1][2] - The approval is based on the interim analysis results of the Phase III registration study NeoShot-III, which showed that 82% of the first 50 patients receiving the "dual immune" neoadjuvant therapy achieved pathological complete response (pCR), with no additional safety risks compared to direct surgery [2] - The combination of Daberxin and the PD-1 inhibitor DabuShu (Sintilimab injection) is expected to change clinical practice and fill the gap in neoadjuvant treatment for colorectal cancer, benefiting more patients [2] Group 2 - As of 2025, the company has successfully launched 7 innovative drugs, with significant products or key data emerging in oncology, metabolism, autoimmune diseases, and ophthalmology [3] - The company is transitioning from a single focus on oncology to a dual-driven model of "oncology + chronic diseases," aiming to become a leader in the chronic disease innovation sector [3] - The company has set a target of exceeding 20 billion yuan in product revenue by 2027, supported by the continued growth of chronic disease products and stable contributions from core oncology products [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 stock of Innovent Biologics (01801) has experienced a significant decline of over 6%, currently trading at 87 HKD with a transaction volume of 1.86 billion HKD, despite the inclusion of seven innovative products in the new medical insurance directory [1] Group 1: Product Developments - Innovent Biologics has successfully included seven innovative products, including the PD-1 inhibitor Tyvyt (sintilimab injection), in the new medical insurance directory, expanding the indications for mature products [1] - With the recent addition of indications, Tyvyt now has all eight approved indications covered by medical insurance [1] - The new drugs included in the directory target areas such as oncology and chronic diseases [1] Group 2: Financial Transactions - Innovent Biologics has completed a share issuance to Takeda Pharmaceutical, issuing 6.9138 million shares, which accounts for approximately 0.4% of the total issued share capital, raising nearly 780 million HKD in net proceeds [1] - There have been significant large transactions in the market, involving approximately 13.0734 million shares at an average price of 92 HKD per share, totaling over 1.2 billion HKD [1]

Core Viewpoint - The stock of Innovent Biologics (01801) has experienced a significant decline of over 6%, currently trading at 87 HKD with a transaction volume of 1.86 billion HKD, despite the inclusion of seven innovative products in the new medical insurance directory [1] Group 1: Product Developments - Innovent Biologics has successfully included seven innovative products, including the PD-1 inhibitor Tyvyt (sintilimab injection), in the new medical insurance directory, expanding the indications for mature products [1] - With the recent additions, all eight approved indications for Tyvyt are now covered by medical insurance, which may enhance market access and patient affordability [1] Group 2: Financial Transactions - The company has completed a share issuance to Takeda Pharmaceutical, issuing 6.9138 million shares, which represents approximately 0.4% of the total issued share capital, raising nearly 780 million HKD in net proceeds [1] - There have been significant large transactions in the market, involving approximately 13.0734 million shares at an average price of 92 HKD per share, totaling over 1.2 billion HKD [1]

Core Insights - The Chinese medical insurance directory will undergo its largest expansion of innovative drugs in history starting January 1, 2026, adding 114 new drugs, including 50 class 1 innovative drugs, while removing 29 drugs that are either unavailable or can be replaced by better alternatives [1][2] - The total number of drugs in the directory will increase to 3,253, significantly enhancing coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [1][2] - The inclusion of innovative drugs in the medical insurance directory reflects a strong commitment to support genuine innovation and differentiated innovation in the healthcare sector [1][2] Medical Insurance Directory Expansion - The new directory will include 114 drugs, with nearly 44% being class 1 innovative drugs, indicating a growing emphasis on innovative treatments [1][2] - The directory will enhance the insurance coverage for critical areas, improving access to necessary medications for patients [1][2] Innovative Drug Market Dynamics - The entry of innovative drugs into the medical insurance directory is a key driver for market growth, with those included typically experiencing rapid sales growth within a year [4] - Companies like Heng Rui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend towards increased market access for innovative therapies [4][5] Clinical Needs and Treatment Options - The new directory addresses significant clinical needs, particularly in oncology, with new drugs targeting various types of cancers, thereby expanding treatment options for patients [9][10] - The inclusion of targeted therapies for conditions like severe asthma and breast cancer provides patients with more accessible and effective treatment options [6][10] Commercial Insurance Directory - The introduction of a commercial insurance directory for innovative drugs aims to balance clinical value, corporate profits, and the sustainability of insurance funds [2][12] - The commercial insurance directory includes 19 innovative drugs, highlighting a focus on high-value treatments that exceed basic insurance coverage [12][15] Policy and Regulatory Environment - Recent reforms in drug approval and medical insurance payment systems have created a conducive environment for the development of innovative drugs in China [17][18] - The acceleration of drug approvals and the establishment of a more rigorous evaluation system for innovative drugs are reshaping the landscape for pharmaceutical companies [17][18] Future Outlook - The ongoing expansion of the medical insurance directory signifies a shift towards making innovative drugs more accessible and affordable for the general population, enhancing overall healthcare outcomes [20][21] - The collaboration between policy, industry, and capital markets is essential for fostering high-quality development in the innovative drug sector [19][20]