Group 1 - The core viewpoint of the article highlights a significant rally in Hong Kong's innovative drug concept stocks, with notable increases in companies such as WuXi AppTec (2268.HK), which rose by 5.5% to HKD 68.75, marking its fourth consecutive day of gains [1] - Other companies in the sector also experienced substantial increases, including 3SBio, which rose over 7%, WuXi Biologics, which increased over 6%, Innovent Biologics, which gained nearly 6%, and WuXi AppTec, which saw a nearly 5% rise, all achieving their fourth consecutive day of growth [1] - According to a report by CMB International published in December, the trend of innovative drugs going overseas is expected to continue in the long term, with a focus on the clinical progress and data validation of pipelines that have already gone abroad as a key catalyst [1] Group 2 - On the policy front, the U.S. Biodefense Act has been signed into law; however, its impact on Chinese CXO companies is expected to be limited due to its non-coverage of Medicaid and Medicare procurement and clear definitions of related parties, as well as the relatively small proportion of revenue from U.S. administrative agencies for Chinese CXOs [1] - The industry outlook from CMB International indicates a more conservative investment approach, focusing on undervalued stock opportunities, with recommendations to buy 3SBio, Genscript Biotech, WuXi AppTec, and China National Pharmaceutical Group [1]

Core Viewpoint - The implementation of the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) marks a significant milestone in improving access to innovative treatments for patients, particularly for thyroid eye disease (TED) patients in China [1] Group 1: Drug Introduction and Impact - The first prescription of the targeted drug Tislelizumab (信必敏) was issued on the same day the new drug catalog was implemented, highlighting its immediate availability to patients [1] - Tislelizumab is the first and only targeted therapy in China that can reverse proptosis, with a response rate of 85.8% and an overall eye efficacy rate of 94.2% [1] - The drug's price has decreased by approximately 60% after being included in the insurance coverage, significantly reducing the financial burden on patients [1] Group 2: Patient Demographics and Disease Prevalence - There are over 4 million patients suffering from thyroid eye disease in China, indicating a substantial market for effective treatments [1] - The condition often leads to serious symptoms such as proptosis and vision impairment, underscoring the need for effective therapeutic options [1]

Core Insights - China's State Council has announced a significant acceleration in the review and approval process for breakthrough therapeutic drugs, indicating strong government support for pharmaceutical innovation and potentially faster market access for novel treatments [2][7] - The Cabinet is committed to promoting green trade and facilitating cross-border e-commerce, aiming to enhance China's global trade footprint with a focus on sustainability and digital platforms [3][7] - Comprehensive measures for facilitating overall cross-border trade were discussed, reflecting a governmental push to reduce friction and improve efficiency in international commerce [4][7] Pharmaceutical Sector - The acceleration in the review and approval process for therapeutic drugs is expected to benefit domestic biotech and pharmaceutical companies, streamlining their path from development to commercialization [2][7] - Companies such as BeiGene (BGNE) and Innovent Biologics (1801.HK) may see substantial boosts due to reduced time-to-market for innovative medicines [2] Trade and E-commerce - The promotion of green trade aligns with global environmental initiatives and is likely to stimulate demand for eco-friendly products and technologies [3] - Major platforms like Alibaba (BABA) and JD.com (JD) are expected to be empowered in their international operations due to the emphasis on cross-border e-commerce [3] - The initiative aims to drive growth in environmentally friendly exports and imports while expanding the reach and efficiency of online international commerce [7]

Core Insights - The announcement of Innovent Biologics being included in the Hang Seng Index marks a significant milestone, as it becomes the first Chinese innovative pharmaceutical company to transition from Biotech to Biopharma under the Hong Kong Stock Exchange's 18A system [1] - This achievement aligns with the company's recognition as "Annual High-Quality Development Listed Company" in the 2025 New Consumption and New Economy Awards [3] Group 1: Market Position and Financial Performance - Innovent Biologics has transitioned from a story-driven early biotech firm to a stable investment asset, supported by 18 commercialized innovative drugs and a complete industry chain from R&D to production [4] - The company's revenue has surged from 1 billion yuan in 2019 to 9.4 billion yuan in 2024, representing an 840% increase over five years, with expectations to exceed 10 billion yuan in 2025 [4] - The inclusion in the Hang Seng Index is expected to attract billions of dollars in passive capital inflow, optimizing the investor structure and reducing stock price volatility [4] Group 2: Product Development and Innovation - Innovent's mature products, such as Sintilimab, continue to provide stable cash flow, while new products like MaShidu Peptide strengthen its market position in the weight management sector [5] - The company has achieved significant milestones in R&D, with its MaShidu Peptide being the first globally approved dual-target receptor agonist for GCG/GLP-1, addressing specific health issues in Chinese patients [6] - Innovent's innovative capabilities are further demonstrated by its IL-23p19 monoclonal antibody showing strong efficacy in clinical trials for psoriasis, and the introduction of China's first IGF-1R antibody for thyroid eye disease [6] Group 3: Globalization and Strategic Partnerships - Innovent's globalization strategy has evolved from licensing to co-development, exemplified by a landmark $11.4 billion global strategic partnership with Takeda Pharmaceuticals [7] - The partnership adopts a "Co-Co" model, allowing Innovent to participate deeply in global clinical design and commercialization processes, marking a shift from traditional licensing agreements [7] - This collaboration signifies a critical step for Chinese pharmaceutical companies to engage in high-standard international platforms, enhancing their global competitiveness [8] Group 4: Overall Impact and Future Outlook - Innovent Biologics' journey from a local lab to a prominent player in the Hang Seng Index illustrates a successful model for the sustainable development of China's biopharmaceutical industry [9] - The company's integrated approach of capital, product strength, and globalization serves as a promising template for future growth and stability in the sector [9]

Core Viewpoint - Innovent Biologics (01801.HK) announced that its drug, Dabrusin® (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer when combined with Sintilimab [1] Group 1 - Dabrusin® is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has received approval from the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer, in combination with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant treatment of colorectal cancer [1] - The combination therapy with Sintilimab significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients, in combination with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - Innovent Biologics (01801.HK) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients when combined with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

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 Viewpoint - The National Medical Products Administration (NMPA) has approved the launch of the anti-CTLA-4 monoclonal antibody, Ipilimumab N01 injection (brand name: Daberxin), developed by Innovent Biologics, for neoadjuvant treatment in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, marking it as China's first domestically approved anti-CTLA-4 monoclonal antibody and the first globally for this indication [1][5]. Group 1 - The approval is based on the results of a randomized, controlled, multi-center Phase III registration study (NeoShot-III, NCT05890742) conducted in China, which aimed to evaluate the efficacy and safety of Ipilimumab N01 in combination with Sintilimab compared to direct radical surgery [3][7]. - The primary endpoints of the study included pathological complete response (pCR) and event-free survival (EFS) [3][7]. - The interim analysis of the NeoShot-III study showed that the predefined primary endpoints were met, as assessed by the Independent Data Monitoring Committee (iDMC) [3][7]. Group 2 - As of November 28, 2024, among the first 50 patients in the trial group, 41 achieved pathological complete response after neoadjuvant treatment, resulting in a pCR rate of 82% [4][8]. - In terms of safety, the combination of Ipilimumab N01 and Sintilimab did not significantly increase additional safety risks compared to the direct surgery group [4][8]. - The Chief R&D Officer of Innovent Biologics, Dr. Zhou Hui, emphasized the significant unmet clinical need for neoadjuvant treatment in resectable MSI-H/dMMR colorectal cancer, highlighting the importance of the NeoShot-III study's interim analysis for this treatment area [4][8].