对恒瑞医药而言，瑞拉芙普-α（SHR-1701）的成功上市，是一场从Fast Follow到FIC的"幸运逆袭"。 当PD-L1/TGF-β双抗赛道的领头羊默克四次折戟，让这一领域的未来充满变数时，恒瑞却凭借这款药物顺利突围，不 仅成为全球首个该靶点获批上市的企业，更充分展现了传统大药企在临床设计与注册沟通上的深厚功底。 1月7日，瑞拉芙普-α如期而至。据NMPA官网，恒瑞医药的抗PD-L1/TGF-βRII双功能融合蛋白瑞拉芙普-α正式获批上 市，其适应症为联合氟尿嘧啶类和铂类药物，用于局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治 疗。 但争议也随之而来。瑞拉芙普-α的注册临床治疗组为瑞拉芙普-α联合化疗，对照组为安慰剂联合化疗——这一设计让 它的成功显得"似是而非"。 在当前胃癌一线治疗领域，免疫联合化疗已成为HER2阴性患者的标准方案，纳武利尤单抗、信迪利单抗等多款PD- （L）1抑制剂联合化疗的方案均已被全球指南推荐，且市场价格已降至"白菜价"水平。 尽管跨试验对比并不严谨，但从现有数据来看，瑞拉芙普-α并未展现出疗效和安全性优势。叠加PD-（L）1抑制剂成 熟的市场格局，让瑞拉芙普-α ...

Market Overview - The Hang Seng Index has short-term support at the 25,000 point level, with expectations of two interest rate cuts in 2026 following the Federal Reserve's recent 0.25% rate cut, which brings the federal funds rate to a range of 3.5% to 3.75% [1][4] - The market anticipates a dovish monetary policy stance post-2026 leadership change, but further observation of economic data is necessary [1] - The Chinese economy is facing a supply-demand imbalance, with a focus on stabilizing investment and the real estate market, while the US-China tariff war has paused, limiting the incentive for aggressive policy adjustments in the short term [1] Company News - Xiaomi's co-founder Lin Bin plans to sell up to $2 billion worth of shares, with proceeds intended for establishing an investment fund [10] - Leapmotor has received a premium subscription from FAW for nearly 75 million shares, amounting to over 4.1 billion RMB [10] - ByteDance is expected to purchase Huawei's Ascend chips next year, with total orders potentially exceeding 40 billion RMB, marking a significant increase from nearly zero in 2025 [10] - UBTECH Robotics has acquired a 43% stake in Fenglong for approximately 1.665 billion RMB, focusing on garden machinery and automotive components [10] - Vanke's domestic bond extension proposal was not approved, but a grace period extension was passed, allowing for a 30-day extension [10] Industry Insights - The National Development and Reform Commission (NDRC) is addressing "involution" competition in new energy vehicles and related industries, emphasizing price monitoring and quality checks to prevent disorderly competition [9] - The Chinese government is set to implement a more proactive fiscal policy in 2026, focusing on boosting consumption and effective investment in key areas [9] - The industrial profits in China fell by 13.1% year-on-year in November, indicating challenges in the industrial sector [9] - The Ministry of Industry and Information Technology forecasts a 5.9% growth in industrial value added for the year, with significant growth in high-tech manufacturing [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]

信达生物(01801)发布公告，达伯欣(伊匹木单抗N01注射液，细胞毒性T淋巴细胞相关蛋白4(CTLA-4)单 克隆抗体(单抗)，研发代号：IBI310)获得中国国家药品监督管理局(NMPA)批准上市，联合信迪利单抗 用于可手术切除的IIB-III期微卫星高度不稳定型(MSI-H)或错配修復缺陷型(dMMR)结肠癌患者的新辅助 治疗。达伯欣(伊匹木单抗N01注射液)是中国首个获批的国产抗CTLA-4单抗，也是全球首个获批的用于 结肠癌新辅助治疗的抗CTLA-4单抗，通过联合信迪利单抗的短期新辅助治疗，可显著提升病理完全缓 解率，惠及MSI-H/dMMR结肠癌患者。 ...

智通财经APP讯，信达生物(01801)发布公告，达伯欣 (伊匹木单抗N01注射液，细胞毒性T 淋巴细胞相 关蛋白4(CTLA-4)单克隆抗体(单抗)，研发代号：IBI310)获得中国国家药品监督管理局(NMPA)批准上 市，联合信迪利单抗用于可手术切除的IIB-III期微卫星高度不稳定型(MSI-H)或错配修復缺陷型(dMMR) 结肠癌患者的新辅助治疗。达伯欣 (伊匹木单抗N01注射液)是中国首个获批的国产抗 CTLA-4单抗，也 是全球首个获批的用于结肠癌新辅助治疗的抗CTLA-4单抗，通过联合信迪利单抗的短期新辅助治疗， 可显著提升病理完全缓解率，惠及MSI-H/ dMMR结肠癌患者。 ...

格隆汇12月29日丨信达生物(01801.HK)宣布，伯欣®(伊匹木单抗N01注射液，细胞毒性T淋巴细胞相关 蛋白4("CTLA-4")单克隆抗体("单抗")，研发代号：IBI310)获得中国国家药品监督管理局("NMPA")批准 上市，联合信迪利单抗用于可手术切除的IIB-III期微卫星高度不稳定型("MSI-H")或错配修复缺陷型 ("dMMR")结肠癌患者的新辅助治疗。达伯欣®(伊匹木单抗N01注射液)是中国首个获批的国产抗CTLA- 4单抗，也是全球首个获批的用于结肠癌新辅助治疗的抗CTLA-4单抗，通过联合信迪利单抗的短期新辅 助治疗，可显著提升病理完全缓解率，惠及MSI-H/dMMR结肠癌患者。 ...

瑞银发布研报称，信达生物旗下六款新产品及信迪利单抗新适应症已被纳入最新版《国家基本医疗保 险、生育保险和工伤保险药品目录(2025年)》。此外，信达生物已正式纳入恒生指数。瑞银维持其"买 入"评级，目标价137.4港元。 智通财经APP获悉，香港联交所最新资料显示，12月24日，信达生物(01801)股东将股票存入香港上海汇 丰银行，存仓市值45.98亿港元，占比3.31%。 ...

Core Viewpoint - The latest data from the Hong Kong Stock Exchange indicates that on December 24, shareholders of Innovent Biologics (01801) deposited shares worth HKD 45.98 billion, representing 3.31% of the total [1] Group 1: Company Developments - UBS reported that six new products from Innovent Biologics and a new indication for Tyvyt (sintilimab) have been included in the latest version of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List (2025) [1] - Innovent Biologics has officially been included in the Hang Seng Index [1] Group 2: Analyst Ratings - UBS maintains a "Buy" rating for Innovent Biologics with a target price of HKD 137.4 [1]

瑞银发布研报称，信达生物(01801)旗下六款新产品及信迪利单抗新适应症已被纳入最新版《国家基本 医疗保险、生育保险和工伤保险药品目录(2025年)》。此外，信达生物已于今日(8日)起正式纳入恒生指 数。瑞银维持其"买入"评级，目标价137.4港元。 瑞银认为，上述消息带来的积极影响主要包括:预计新产品(IGF-1R、EGFR、BTK、ROS1、KRAS G12C、RET等靶点)销售额将在2026年实现快速增长;同时，替尔泊肽糖尿病适应症进入医保目录，对预 计于2026年上市的玛仕度肽具有正面影响，但需关注其价格下调。此外，公司股票纳入恒指有望进一步 提升流动性。 ...

Core Insights - The conference "2025 Financial Empowerment of the Medical and Health Industry (Guangxi) Innovation Conference" was successfully held in Nanning, focusing on building a closed-loop ecosystem of "technology innovation + capital empowerment + industry landing" to support Guangxi in becoming a healthcare industry hub facing ASEAN [2] - The "2025 China Innovative Drug Industry Investment Blue Book" was jointly released, providing authoritative and practical development trend analysis and investment layout guidance for industry participants, investors, and policymakers [2] Industry Development Background - The demand for innovative drugs is shifting from "curative" to "long-term management" and "precision" due to population aging and chronic diseases [6] - The number of rare diseases is increasing, necessitating the development of effective treatments [6] - AI-driven drug development is shortening research cycles, and innovative biopharmaceutical technologies are flourishing [6] Global Innovative Drug Development Trends - The number of innovative drugs in the oncology field is steadily increasing, with its share rising from 35% in 2020 to 45% in 2024, driven by breakthroughs in targeted therapies and CAR-T cell therapies [8] - From 2015 to 2024, a total of 12,263 innovative drugs are expected to be developed globally, with 9,427 still active by the end of 2024 [10] - China has become the country with the most innovative drugs since 2020, reaching 704 by 2024, surpassing the U.S. [11] China’s Innovative Drug Industry Development - The Chinese innovative drug industry has evolved through four stages: initial stage, combination of imitation and innovation, rise of innovation, and globalization [19] - The policy environment has increasingly focused on supporting innovative drugs, with a systematic policy matrix established to accelerate their transition from laboratory to clinical application [17] Market Size and Financing Trends - The innovative drug market in China is projected to reach CNY 1,620 billion by 2024, with commercial health insurance accounting for only 7.7% of the payment market [25] - The financing landscape has shifted from a focus on quantity to quality, with a notable increase in the proportion of domestic companies' innovative drugs approved in China, rising from under 10% in 2015 to 50% in 2024 [23] Future Opportunities and Challenges - The aging population and the demand for innovative drugs in oncology and chronic diseases are expected to continue growing [69] - The industry faces challenges such as geopolitical tensions, regulatory tightening, and high-risk characteristics of drug development, which typically takes over 10 years and requires substantial investment [71][72]