Core Insights - The new medical insurance directory has entered a substantial implementation phase, with several innovative drugs, including Tislelizumab and Fuzhengzhu, being prescribed under insurance in various hospitals, indicating a reduction in access barriers for patients [1] - The adjustment includes 114 new drugs and introduces a commercial health insurance directory for innovative drugs, marking a significant shift towards a multi-tiered insurance system [1][5] - The rapid inclusion of innovative drugs in the insurance directory reflects increased support for "true innovation" with high clinical value [5] Group 1: New Drug Inclusion - The new medical insurance directory has added 124 unique products, including Tislelizumab, the first targeted drug for thyroid eye disease, and Fuzhengzhu, a biological agent for psoriasis [5] - Heng Rui Medicine is a major beneficiary, with 20 products and indications adjusted, including 10 new drugs entering the directory for the first time [5][6] - Other biotech companies like BeiGene and Innovent Biologics have also benefited, with multiple products included in the new directory, enhancing their commercialization prospects [7] Group 2: Commercial Health Insurance Directory - The introduction of the commercial health insurance directory provides a secondary market for high-value innovative drugs, with price reductions ranging from 15% to 50%, which is less severe than the basic insurance cuts [9] - The directory aims to improve accessibility for high-priced drugs while ensuring adequate returns for pharmaceutical companies [9] - Notable CAR-T therapies have been included in the commercial directory, overcoming previous barriers to entry, with prices for these therapies exceeding 1 million yuan [8][10] Group 3: Market Dynamics and Drug Exits - The adjustment process has also seen the removal of 29 drugs from the insurance directory, including Benarutide, which faced competition from more effective alternatives [12][14] - The dynamic adjustment mechanism emphasizes the need for drugs to demonstrate clinical value, reinforcing a "can enter, can exit" policy [14] - Companies are encouraged to shift from "me-too" products to genuine innovations, focusing on high-value areas such as oncology and rare diseases [10][14]

内容概要：目前双特异性抗体药物主要应用于肿瘤的免疫治疗、自身免疫疾病和感染类疾病的治疗，在 组织再生和临床诊断领域也有应用。以其"双向靶向"的独特优势，双特异性抗体已成为肿瘤治疗的重要 力量，尤其在血液肿瘤中展现出改写预后的潜力。近年来，全球双特异性抗体药物市场快速扩张，2025 年全球双特异性抗体药物市场规模有望增至191亿美元，中国双特异性抗体药物市场规模约为8亿美元， 约占全球4.19%；预计2026年，全球双特异性抗体药物市场规模有望增至268亿美元，中国双特异性抗 体药物市场规模约为15亿美元，约占全球5.60%。从治疗领域来看，双抗药物的治疗领域主要抗癌产品 居多，近80%的管线集中在癌症领域，其中实体瘤最为热门。除了癌症，炎症性疾病也一直是双抗药物 的研发重点。 上市企业：康方生物[09926]、康宁杰瑞制药-B[09966]、信达生物[01801.HK]、智翔金泰-U[688443]、百 济神州[06160] 相关企业：罗氏公司、Xencor公司、MacroGenics公司、ABLBio公司、安进公司、再生元制药公司、强 生公司、阿斯利康公司Teneobio公司、艾伯维公司、F-starThe ...

来源：龙谈价值2023 大家好，我是龙哥。 2025年的创新药大行情，总体围绕创新药海外BD交易展开，市场对BD交易的预期从一个极端走向另一 个极端——从已经BD出去的要看到比较明确的临床推进才愿意给部分估值，到大多创新药公司的管线 都被拉出来用放大镜看一圈、只要有潜力BD出去的就炒一把。经过自10月份以来的多个BD交易落地或 海外资产被并购后反而股价暴跌的市场表现，3个月的行情、情绪、关注度的退潮，很多A股和H股的小 公司股价腰斩，市场情绪趋于理性，创新药行业2026年的驱动逻辑被市场重新理解和认知。 2026年行业靠什么驱动？我们此前文章已经多次讲过，淡化一过性的BD交易，后续要靠实实在在的海 外临床推进、海外商业化确定性的提升来驱动，到现在市场对该认知已经逐渐理解，创新药行业β也再 次显现，行业龙头和优质二线公司以及此前讲过的持仓比较纯粹的520880港股通创新药ETF都陆续企稳 向上。 本文我们来讨论一下2026年海外注册临床会有明确进展的公司，所谓的进展既包括新开全球多中心注册 临床，也包括临床数据的读出，我们在此抛砖引玉的列举一部分公司，也欢迎大家的补充。 1、行业影响巨大的两个肿瘤药 首先我们要 ...

Market Overview - The Hong Kong stock market experienced its first decline of the year on January 7, with the Hang Seng Index closing at 26,458.95 points, down 251.50 points, a decrease of 0.94% [1][2]. - The Hang Seng Tech Index also fell, closing at 5,738.52 points, down 86.74 points, a decline of 1.49% [2]. Sector Performance - The pharmaceutical and biotechnology sector saw significant gains, with Rongchang Biologics (HK09995) rising over 12%, and other companies like Kailaiying (HK06821) and Tigermed (HK03347) increasing by over 8% [5]. - Rongchang Biologics announced positive clinical trial data for its PD-1/VEGF bispecific antibody RC148, which showed promising efficacy and safety for treating non-small cell lung cancer [5]. - Kangfang Biologics received approval for an important update on its PD-1/VEGF bispecific antibody, indicating significant clinical benefits in treating advanced non-small cell lung cancer [7]. Investment Trends - Southbound funds continued to significantly increase their holdings in Hong Kong stocks, with a net purchase exceeding 9.1 billion HKD by the end of the trading day [8]. - Research from CICC suggests that the Hong Kong stock market is entering a recovery phase, driven by a weaker US dollar and improved domestic liquidity, with a positive outlook for the first half of 2026 [12]. - Guotai Junan Securities anticipates a second round of valuation recovery and performance resurgence in the Hong Kong market in 2026, recommending focus on technology, healthcare, and consumer sectors [12]. Analyst Ratings - Credit Lyonnais maintained a "Outperform" rating for WuXi AppTec, raising the target price to 143.4 HKD, citing expected growth from outsourcing demand and reduced policy uncertainty [10].

Market Overview - The Hong Kong stock market indices experienced a decline, with the Hang Seng Index falling by 1.01% to 26,439.68 points, the Hang Seng Tech Index down by 1.65%, and the National Enterprises Index decreasing by 1.11% [1][9]. Technology Sector - Technology stocks faced widespread losses, with Alibaba dropping over 4%, Bilibili down more than 3%, and Kuaishou, NetEase, and Meituan each declining by over 2% [1][9]. Biopharmaceutical Sector - The biopharmaceutical sector continued its upward trend, highlighted by Kangfang Biopharmaceutical's stock rising over 6%. The company announced an important update regarding its PD-1/VEGF bispecific antibody, which has shown statistically significant and clinically meaningful benefits in treating advanced non-squamous non-small cell lung cancer [2][11]. Metals Sector - The metals sector showed strength, with Luoyang Molybdenum rising over 5%. Citigroup raised its short-term copper price target to $14,000 per ton, although it warned that the price increase may be nearing its peak [5][14]. Oil Sector - Oil stocks weakened, with PetroChina falling over 3%. This decline follows an announcement regarding the transfer of 30 to 50 million barrels of oil from the Venezuelan interim government to the U.S., which will be sold at market prices [5][16]. Automotive Sector - The automotive sector saw significant declines, with NIO dropping over 3%. Reports indicate that the Chinese auto market may experience a 7% decline in sales in 2026, marking the first anticipated annual drop since 2020. A price war has begun, involving over 76 models from various manufacturers [6][16].

消息面上，康方生物宣布，国家药品监督管理局已批准公司自主研发的全球首创PD-1/VEGF双特异性抗 体依沃西(商品名：依达方)说明书的一项重要更新：更新纳入了AK112-301/HARMONi-A研究的最终分 析数据，即依沃西联合疗法治疗EGFR-TKI治疗后进展的局部晚期或转移性非鳞状非小细胞肺癌(nsq- NSCLC)取得的具有统计学显著性和临床意义的无进展生存期(PFS)和总生存期(OS)双重获益。 本次更新的核心意义在于，HARMONi-A研究是全球首个在EGFR-TKI耐药nsq-NSCLC治疗领域，同时 在PFS和OS两个核心终点上均取得具有临床意义和统计学显著性获益的免疫疗法III期临床试验，也是首 个取得PFS和OS双阳性结果的随机、双盲III期临床试验，再次验证了依沃西作为全球首个肿瘤免疫+抗 血管生成机制双抗的突破性临床价值。 康方生物(09926)再涨超6%，截至发稿，涨6.15%，报127.8港元，成交额7.89亿港元。 ...

本次更新的核心意义在于，HARMONi-A研究是全球首个在EGFR-TKI耐药nsq-NSCLC治疗领域，同时 在PFS和OS两个核心终点上均取得具有临床意义和统计学显著性获益的免疫疗法III期临床试验，也是首 个取得PFS和OS双阳性结果的随机、双盲III期临床试验，再次验证了依沃西作为全球首个肿瘤免疫+抗 血管生成机制双抗的突破性临床价值。 智通财经APP获悉，康方生物(09926)再涨超6%，截至发稿，涨6.15%，报127.8港元，成交额7.89亿港 元。 消息面上，康方生物宣布，国家药品监督管理局已批准公司自主研发的全球首创PD-1/VEGF双特异性抗 体依沃西（商品名：依达方）说明书的一项重要更新：更新纳入了AK112-301/HARMONi-A研究的最终 分析数据，即依沃西联合疗法治疗EGFR-TKI治疗后进展的局部晚期或转移性非鳞状非小细胞肺癌 （nsq-NSCLC）取得的具有统计学显著性和临床意义的无进展生存期（PFS）和总生存期（OS）双重获 益。 ...

资讯所属栏目还有更多独家策划、专家专栏，免费查阅>> 1月7日，沪深两市窄幅震荡涨跌互现，通信、电子、综合板块涨幅靠前。截至10点50分，恒生生物科技 ETF(159615.SZ)涨2.82%，康方生物涨6.56%。华泰证券认为，生物医药领域具有政策支持和需求刚性 特征，港股生物科技板块汇聚了众多创新药企，研发管线丰富、国际化程度高。在全球对生物科技研发 投入持续增加的背景下，创新药、医疗器械等细分领域展现出较大的发展潜力。当前港股生物科技企业 估值具备吸引力，在政策支持下，行业景气度有望进一步提升。与此同时，港股科技板块前期受美联储 加息等因素压制，估值处于历史低位。随着美国十年期国债收益率趋稳，市场对流动性改善的预期增 强，板块估值修复动力上升。我国经济回升向好的态势明确，科技领域政策支持力度持续加大，为港股 科技板块提供了坚实的基本面支撑。在此背景下，恒生生物科技ETF(159615.SZ)作为港股生物科技板块 的重要配置工具，紧密跟踪该板块，覆盖创新药、医疗器械等领域，具备较好的投资价值。 风险提示：基金有风险，投资需谨慎。 ...

Group 1: Market Performance - Hong Kong's innovative drug ETF (159570) surged by 3%, with a trading volume exceeding 1.5 billion yuan, following a net inflow of over 62 million yuan today after a previous inflow of 430 million yuan [1][3] - As of January 6, the latest scale of the Hong Kong innovative drug ETF reached over 23.3 billion yuan, leading its peers in the same category [1] Group 2: Economic Signals - Federal Reserve Governor Milan indicated that upcoming economic data may support further interest rate cuts, with expectations of a reduction exceeding 100 basis points this year [3] - Wall Street analysts suggest that if the U.S. unemployment rate rises to 4.7% by December 2025, the Fed may cut rates by 25 basis points this month [3] Group 3: Company Developments - Brain-computer interface "unicorn" Strong Brain Technology completed a financing round of 2 billion yuan, second only to Musk's Neuralink [3] - AI pharmaceutical company Insilico Medicine announced a long-term collaboration with Siveya for anti-tumor drug development, with a total deal value of 888 million USD [3] Group 4: New Drug Approvals - On January 6, BeiGene announced that its self-developed BCL2 inhibitor, Baiyueda® (sotucumab), received conditional approval from the National Medical Products Administration [3] - Shiyao's SYS6017 has initiated Phase II clinical trials for the prevention of shingles [3] Group 5: Investment Insights - Zhongtai Securities predicts that the pharmaceutical sector's opportunities in 2025 will focus on innovation and industry upgrades, with investment strategies continuing into 2026 [5] - The report emphasizes the importance of "innovative drugs and industry chains, demand recovery, and AI" as key investment dimensions [5] Group 6: J.P. Morgan Healthcare Conference - The 44th J.P. Morgan Healthcare Conference is set to take place from January 12 to 15, 2026, in San Francisco, attracting over 8,000 global participants [6] - The conference will feature over 500 listed companies and thousands of startups, focusing on "capital + strategy" discussions [6] Group 7: Industry Trends - Three major trends are highlighted for 2026: the continued rise of gene and cell therapies, deep integration of AI in pharmaceuticals, and the emergence of new market forces [7] - The report notes that over 20 gene editing companies will showcase breakthroughs in CAR-T and base editing at the conference [7] Group 8: MNC Engagement - Multinational corporations (MNCs) are willing to pay higher prices for innovative drugs from China, with the average total package for drugs purchased from China being 2.76 billion USD, compared to 1.29 billion USD for those from overseas [8] - The willingness of MNCs to pay a premium for Chinese innovations is driven by the need to fill significant pipeline gaps due to impending patent expirations [8] Group 9: Investment Focus - Investment strategies should focus on companies with strong clinical development capabilities and those in popular therapeutic areas such as ADCs, GLP-1, and dual antibodies [11] - Companies that can produce high-quality late-stage clinical assets are likely to attract MNC interest [11] Group 10: Key Therapeutic Areas - The report identifies key therapeutic areas for investment, including ADCs, GLP-1, dual antibodies, and neuroscience, emphasizing the need for innovative platforms and clinical data superiority [12]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09926 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 ...