本报告版权属于国投证券股份有限公司，各项声明请参见报告尾页。 1 2026 年 01 月 04 日 生物医药Ⅱ 新药周观点：2025 年约 101 款创新药 国内获批上市，行业蓬勃发展 本周新药行情回顾： 2025 年 12 月 29 日-2026 年 1 月 4 日，新药板块涨幅前 5：友芝友 （+12.45%）、艾迪药业（+8.07%）、永泰生物（+6.72%）、开拓药业 （+6.25%）、亚虹医药（+4.07%）；跌幅前 5：加科思（-15.53%）、 云顶新耀（-15.06%）、科笛（-11.73%）、歌礼制药（-8.64%）、康宁 杰瑞（-8.06%）。 本周建议关注标的： 考虑板块后续仍有多个催化值得期待，包括学术会议、数据读出、 多个 BD 兑现等，仍建议关注： 1）已获 MNC 认证未来海外放量确定性高的品种：三生制药、联邦制 药、科伦博泰等； 2）存在海外数据催化的品种：贝达药业、和黄医药、映恩生物等； 3）下一个可能海外授权 MNC 的重磅品种：复宏汉霖、石药集团、益 方生物等； 4）新的创新药技术突破领域：小核酸、体内 CAR-T、减脂增肌、自 免 CAR-T/双抗、基因疗法等。 本周国 ...

Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The innovative drug sector is experiencing rapid growth, with several new drugs being quickly incorporated into the medical insurance directory as of October 2025 [3][20] - The report highlights significant increases in the number of drugs entering hospitals, particularly those newly included in the insurance directory, indicating strong market demand [3][19] Weekly New Drug Market Review - From November 24 to November 30, 2025, the top five performing new drug companies were: Frontline Bio (+23.12%), Yifang Bio (+15.74%), Rongchang Bio (+15.39%), Kangfang Bio (+14.86%), and Jakes (+14.18%). The five companies with the largest declines were: Yongtai Bio (-4.11%), Nothland (-3.33%), Junshengtai (-2.78%), Boan Bio (-2.09%), and Dongyao Pharma (-1.11%) [1][14] Suggested Focus Stocks - The report suggests focusing on several companies with promising catalysts, including: 1. Companies with MNC certification and high overseas sales potential: Sanofi, Lianbang Pharma, and Kelun Biotech 2. Companies with overseas data catalysts: Betta Pharma, Hutchison China MediTech, and Yimeng Bio 3. Potential heavyweights for overseas MNC licensing: Fuhong Hanlin, Shiyao Group, and Yifang Bio 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18] New Drug Industry Key Analysis - The National Healthcare Security Administration updated the data on innovative drugs included in the insurance directory as of October 2025, showing rapid hospital entry for several newly included domestic innovative drugs. Notable drugs with fast entry rates include: - Hengrui Medicine's Tazobactam - Innovent Biologics' Toripalimab - Haisco's Alogliptin and Clopidogrel - Sinopharm's Aliskiren and Amlodipine - Shanghai Yizhong's Paclitaxel polymer micelles - Kangfang Bio's Ivoris monoclonal antibody [3][19] New Drug Approval and Acceptance Status - This week, 11 new drugs or new indications received approval for market entry, while 13 new drugs or new indications were accepted for review [4][24] New Drug Clinical Application Approval and Acceptance Status - This week, 54 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [8][27]

Core Viewpoint - The innovative drug sector is experiencing significant growth, driven by favorable policies, internationalization, and technological breakthroughs, with the Hong Kong Stock Connect Innovative Drug ETF (159570) showing a remarkable increase of over 109% year-to-date, outperforming other pharmaceutical indices [1][5][10]. Group 1: ETF and Index Changes - The Hong Kong Stock Connect Innovative Drug Index will undergo a revision to exclude contract research organizations (CXO), ensuring a 100% purity in innovative drug representation [1][2]. - The revision changes the sample selection criteria from "companies involved in innovative drug development" to "companies whose main business involves innovative drug development, excluding CXO" [2]. - The sample stock adjustment frequency will shift from semi-annual to quarterly, effective August 12, 2025 [2]. Group 2: Importance of 100% Innovative Drug Index - The purity of the index is crucial for maximizing industry gains and avoiding dilution effects from unrelated components, allowing for a more direct capture of returns [3]. - CXO's business model differs fundamentally from innovative drugs, as CXOs provide outsourced services and do not share in the patent revenues from successful drug commercialization [3]. Group 3: Growth Drivers for Innovative Drugs - The rise of Chinese innovative drugs is characterized by a transition from "Me-too" and "Me-better" strategies to achieving "Best-in-Class" (BIC) and "First-in-Class" (FIC) innovations [4]. - The innovative drug sector is propelled by three main drivers: accelerated internationalization, supportive policies, and technological advancements [5][10]. - Internationalization is evidenced by increasing participation of domestic innovative drug data in international conferences and rising transaction volumes in out-bound business development (BD) [5]. - Policy support includes a series of measures aimed at enhancing the innovative drug industry, with significant potential for growth in the reimbursement space [10][12]. - Technological breakthroughs in areas such as ADC, GLP-1, and immunotherapy are leading the industry innovation [10][12]. Group 4: Market Outlook - The innovative drug sector is expected to enter a profitability phase in 2025, marking a transition to a stage of business model validation and systematic valuation increase [6]. - The market perception of innovative drug companies is shifting from continuous financing to a focus on profitability, indicating a positive outlook for the sector [6].

Core Insights - The Hong Kong innovative drug ETF (513120) has gained significant attention, with its net asset value reaching a historical high of over 14 billion yuan and a one-year return exceeding 109%, ranking first among all stock funds in the market [1][2] - The performance is attributed to the anticipated interest rate cuts by the Federal Reserve, which have improved the financing environment for the innovative drug sector, alongside notable advancements in Chinese innovative pharmaceutical companies [1] - The innovative drug industry, characterized by high R&D costs and long development cycles, is highly dependent on the financing environment, which has recently improved due to the Fed's easing policies [1][2] Industry Analysis - Chinese innovative pharmaceutical companies are increasingly competitive globally, with their share of multinational pharmaceutical companies' upfront payments in business development transactions rising from less than 5% four years ago to 40% [1][2] - Recent successful Phase III clinical trials for dual-antibody ADC drugs indicate that Chinese companies are developing "First In Class" capabilities, marking a significant milestone in the industry [1] - The Hong Kong Monetary Authority's liquidity injections have provided essential support for the innovative drug sector, despite recent marginal tightening of liquidity [2] ETF Performance - The Hong Kong innovative drug ETF closely tracks the CSI Hong Kong Innovative Drug Index (CNY), which focuses on no more than 50 listed companies involved in innovative drug R&D [3] - The index has shown a one-year return of 109.8% with a price-to-earnings ratio (PE TTM) of 38, placing it in the 41st percentile of valuation since its inception [3] - The ETF is recommended for investors looking to gain exposure to the innovative drug sector, with specific connection fund codes provided for further investment options [2]