Core Viewpoint - The domestic innovative pharmaceutical industry in China is transitioning from a "catch-up" phase to an "exceeding" phase, driven by ongoing drug review reforms, engineering talent, abundant clinical resources, and supportive policies [1] Group 1: Industry Trends - The number of clinical trials initiated by Chinese innovative drug companies has significantly increased, with Chinese firms now accounting for over 50% of global R&D projects [1] - The Hang Seng Biotechnology ETF by Fuguo Fund, which focuses on core pharmaceutical assets in Hong Kong, is set to close its fundraising on December 19 [1] Group 2: Index Characteristics - The Hang Seng Biotechnology Index emphasizes high-growth sectors such as innovative drugs and CXO (Contract Research Organization), with over 90% weight in these two areas [1] - The index employs a unique discount coefficient design, reducing the weight of drug distribution stocks to better reflect the growth potential of high R&D investment companies [1] - The index's quarterly rebalancing mechanism optimizes constituent stocks while maintaining stability and representativeness [1] Group 3: Performance Metrics - The top ten constituents of the Hang Seng Biotechnology Index include leading companies across the pharmaceutical value chain, such as WuXi Biologics and BeiGene [2] - The index has shown strong performance, with a year-to-date increase of 68.41% as of December 16, outperforming the Hang Seng Healthcare Index and the Hang Seng Index [2] - Since its inception on December 31, 2013, the index has achieved a cumulative increase of 45.19%, significantly surpassing the 9.37% increase of the Hang Seng Healthcare Index [2] - The current P/E ratio of the index is below 28, indicating attractive valuation compared to the 15.96% percentile over the past three years [2] Group 4: Fund Management - The proposed fund manager for the Hang Seng Biotechnology ETF is Cai Kaer, who has over 12 years of experience in securities and more than 8 years in investment management [3] - The quantitative investment team led by Dr. Li Xiaowei provides robust support for the fund's operations, having accumulated extensive experience in index quantitative investment [3] Group 5: Market Opportunities - The launch of the Hang Seng Biotechnology Index futures enhances liquidity and strategy diversity for related assets [3] - The ongoing development of China's biopharmaceutical industry, particularly since the 14th Five-Year Plan, presents significant market opportunities for innovative drug development [3]

Core Insights - The Chinese biopharmaceutical industry has undergone a significant transformation over the past decade, shifting from a focus on generic drugs to a strong emphasis on innovative drug development, with domestic innovative drugs accounting for 93% of new approvals in the first half of 2025, a 59% year-on-year increase [1][7] - The industry faces geopolitical challenges, particularly from the U.S. government, which has implemented tariffs and regulatory barriers that could hinder the growth of China's biopharmaceutical sector [2] - The future positioning of China's biopharmaceutical industry will involve a "dual circulation" strategy, focusing on both domestic and international markets, with an emphasis on innovation and collaboration [3] Industry Development - The reform of the drug review and approval system initiated in 2015 has been a key driver of transformation, significantly shortening the approval cycle for innovative drugs [4][5] - By 2025, the approval time for clinical trial applications has been reduced to 30 working days, reflecting the ongoing policy support for the industry [5] - The shift from a model of "combination of imitation and innovation" to "source innovation" has been marked by increased R&D investment and a focus on original drug development [6][7] Capital Market Dynamics - The capital market has experienced volatility, with a "capital winter" affecting the biopharmaceutical sector since 2022, leading to reduced financing and cash flow pressures for many companies [8][9] - There is a need for "patient capital" to support the long-term nature of biopharmaceutical investments, which could be facilitated by relaxing investment restrictions for long-term capital sources [9] - The integration of national support for innovative drugs with capital market mechanisms is essential for creating a resilient ecosystem [9][10] Technological Advancements - The application of artificial intelligence (AI) in drug development has become a critical factor in addressing industry challenges, enhancing efficiency in clinical trials and drug discovery [11][12] - AI can streamline patient recruitment and optimize drug repurposing, thereby improving the overall drug development process [12] - The integration of AI in the payment system is crucial for balancing drug pricing, patient affordability, and sustainable healthcare financing [12] Future Outlook - The transition from a generic drug powerhouse to a leader in innovative drugs requires ongoing collaboration among policymakers, industry leaders, researchers, and capital markets [13] - Emphasizing clinical value and adopting a global perspective will be vital for providing innovative therapies to patients worldwide [13]

Core Insights - The A-share market has shown a fluctuating upward trend since 2025, with the pharmaceutical and biotechnology sector performing exceptionally well, dominating the top ten stock fund rankings in the first half of the year [2] - Jin Xiaofei, a representative mid-generation fund manager at Penghua Fund, has achieved remarkable performance with his managed funds, utilizing a unique "dual-line resonance" framework to navigate crowded sectors [2][3] Investment Performance - Jin Xiaofei has been with Penghua Fund since July 2012, accumulating a tenure of 9 years and 174 days, managing assets totaling 5.375 billion yuan, with a best-term return of 239.59% [3] - The Penghua Medical Technology Stock A fund, under Jin's management, has shown significant excess returns, with a total return of 74.19% since its inception on June 2, 2015, and a return of 73.03% this year [5] - The Penghua Innovation Upgrade Mixed A fund has also performed well, with a year-to-date return of 88.72% and a one-year return of 74.60% [15] Investment Strategy - Jin's investment strategy is centered on "fundamental trend investing," integrating a dual-dimensional analysis framework that focuses on both visible driving factors and market sentiment [3][4] - The "bright line" strategy emphasizes significant industry changes, while the "dark line" strategy identifies undervalued opportunities through reverse analysis of market emotions and capital flows [4] - Jin's approach includes a three-dimensional decision-making framework that considers long-term, mid-term, and short-term performance metrics to ensure robust investment logic [14][16] Stock Holdings and Performance - The fund has made strategic purchases in various stocks, including: - 1,126,260 shares of Nuocheng Jianhua, which saw a price increase of 213% during the holding period [7] - 217,760 shares of Dizhe Pharmaceutical, with a price increase of 90.49% [9] - 119,040 shares of Baijishenzhou, which appreciated by 257% [11] - 211,230 shares of Rongchang Bio, with a price increase of 121% [13] - The fund's holdings in stocks like Hailan Pharmaceutical and Zexing Pharmaceutical also demonstrated significant price increases during their respective holding periods [18][20] Market Outlook - Jin Xiaofei anticipates a new investment cycle in the pharmaceutical sector, with institutional holdings recovering from historical lows, and emphasizes the importance of beta opportunities in the current market [5][16] - The need for continuous optimization of risk control systems is highlighted, as the industry faces increasing competition and innovation [25]

Group 1 - The Hang Seng Index opened down 0.32%, while the Hang Seng Tech Index fell by 0.56%. Pharmaceutical stocks were active, with BeiGene rising nearly 3%, while tech stocks experienced the largest declines [1] Group 2 - Guotai Junan Securities believes that the short-term adjustment of the Hong Kong stock market will open up space for a rise in 2026. In November, southbound funds net inflow into the Hong Kong stock market exceeded 110 billion RMB. This reflects the ample liquidity of mainland funds and their strong willingness to position in Hong Kong stocks at low levels [2] - CITIC Securities predicts that in 2026, the Hong Kong stock market will benefit from internal "14th Five-Year Plan" catalysts and external major economies' "fiscal + monetary" easing. With macroeconomic improvement, the performance of Hong Kong stocks is expected to transition from "earnings recovery" to "revenue expansion," creating a sustainable trend of revenue and profit resonance [2] - Dongwu Securities anticipates that the Hong Kong stock market will continue to rebound next year for several reasons: expected continued interest rate cuts by the Federal Reserve in 2026, a phase of easing in China-U.S. relations, synchronized deepening of domestic monetary and fiscal policies, further improvement in corporate earnings, sustained inflow of southbound funds due to "profit-making effects," and potential additional contributions from overseas funds [2]

Core Viewpoint - The inclusion of 19 drugs in the first version of the commercial health insurance innovation drug directory marks a significant step towards improving access and affordability of innovative drugs, particularly high-cost CAR-T therapies, while presenting challenges for insurance companies in product development and risk management [1][4][10]. Group 1: Policy and Implementation - The National Medical Security Work Conference emphasized the support for the development of commercial health insurance and the establishment of a multi-tiered medical security system, with a focus on the implementation of the commercial health insurance innovation drug directory by January 1, 2026 [1][2]. - The first version of the commercial health insurance innovation drug directory includes 19 drugs, focusing on high-cost and innovative treatments, including five CAR-T products and drugs for rare diseases [2][4]. Group 2: Challenges for Insurance Companies - Insurance companies face significant challenges in translating the drug directory into viable insurance products, including issues related to pricing, risk control, and compliance [4][5]. - Accurate pricing for insurance products relies on detailed data regarding potential patient populations, disease incidence, treatment cycles, and real-world efficacy, which are primarily held by pharmaceutical companies and hospitals [4][5]. Group 3: Risk Management and Compliance - The inclusion of Alzheimer's disease treatments raises concerns about adverse selection risks, as these drugs have high costs and long treatment durations, necessitating strict eligibility criteria for insurance coverage [5][6]. - Establishing transparent and compliant financial flows between insurance companies and pharmaceutical firms is crucial for effective collaboration [5][6]. Group 4: Data Sharing and Integration - The "医保+商保" one-stop clearing and settlement model aims to break down data silos, enhancing the efficiency of claims processing and improving patient experiences [6][8]. - Successful implementation of data sharing initiatives in regions like Shanghai and Beijing indicates potential for nationwide adoption, which could facilitate better integration of commercial health insurance with innovative drug offerings [8][10]. Group 5: Investment in Innovative Drugs - The policy encourages insurance funds to invest in the upstream of the pharmaceutical industry, positioning them as "patient capital" for innovative drug development [10][11]. - Major insurance companies are already investing in health industry funds, supporting numerous innovative drug companies and enhancing the overall funding environment for drug development [10][11]. Group 6: Future Outlook - Despite the potential for increased investment in innovative drugs, insurance companies remain cautious due to the high risks and costs associated with drug development, which may lead to a preference for established pharmaceutical firms over smaller, innovative companies [12].

Core Viewpoint - The Hong Kong innovation drug sector is experiencing a significant decline, with the Hong Kong Innovation Drug ETF (520880) hitting a five-month low, prompting potential "bottom-fishing" activities from investors [1][7]. Market Performance - The Hong Kong Innovation Drug ETF (520880) fell by 2.77%, marking a new low in five months, with leading stocks like CanSino Biologics dropping over 5% and BeiGene falling more than 6% [1][7]. - Despite the downturn, there has been a strong buying interest, as evidenced by a net inflow of over 136 million yuan in the past week, with five consecutive days of net purchases [1][7]. Industry Outlook - The sentiment in the innovation drug sector has shown volatility, but the long-term outlook remains positive, with expectations for increased global competitiveness and successful commercialization by Q1 2026 [3][9]. - The National Healthcare Security Administration emphasized the importance of implementing commercial insurance for innovative drugs, encouraging the inclusion of reasonable medical expenses outside the basic insurance catalog [3][9]. ETF Characteristics - The Hong Kong Innovation Drug ETF (520880) is the largest in its category, with a total size of 2.142 billion yuan and an average daily trading volume of 458 million yuan since its inception [5][10]. - The index tracked by the ETF, the Hang Seng Hong Kong Innovation Drug Select Index, has a significant concentration in leading companies, with the top ten stocks accounting for over 72% of the index weight [5][10]. Risk Management - The ETF employs a strategy to mitigate risks associated with less liquid stocks by enforcing a forced reduction in weight for these components, thereby controlling tail risks [4][9].

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 第一条 百济神州有限公司（BeOne Medicines Ltd.，以下简称"公司"）根 据《上海证券交易所科创板股票上市规则》（以下简称"《科创板 上市规则》"）等法律、法规、规范性文件的规定，结合《百济神 州有限公司（BeOne Medicines Ltd.）之组织章程细则》（经不时修 订及重列，以下简称"《公司章程》"）、《百济神州有限公司（BeOne Medicines Ltd.）组织条例》（经不时修订及重列，以下简称"《组 织条例》"）《Related Person Transaction Policy（关联交易政策）》 《Connected Transaction Management Policy（关连交易管理政策）》 及公司实际情况，制定本关联交易管理制度（以下简称"本制度 ...

百济神州有限公司 内部审计章程 目的 百济神州有限公司及其关联公司设置内部审计职能（"内部审计"）的目的是通过向审计委员 会和管理层提供独立的、基于风险的、客观的鉴证、建议、洞察与前瞻性观点，以增强公司 在价值创造、保护和维持方面的能力。 内部审计增强了公司的： 当以下条件得到满足时，内部审计可以最有效发挥其作用： 遵守全球内部审计标准的承诺 公司的内部审计将遵守国际内部审计师协会的国际职业实践框架的各项要求，包括全球内部 审计标准和专项要求。首席审计师（CAE）将每年向审计委员会和高级管理层报告内部审计 对以上标准和专项要求的遵守情况，并将通过质量保障与改进计划（QAIP）进行评估。 • 成功实现其目标的能力； • 治理、风险管理和控制流程； • 决策和监督； • 与利益相关者交流时的声誉与信誉； • 服务公众利益的能力。 • 内部审计由符合资格的专业人士按照国际内部审计师协会（IIA）为公共利益制定 的全球内部审计标准执行； • 内部审计独立设置，并对审计委员会直接负责； • 内部审计人员不受不当影响，并致力于做出客观评估。 • 充分且无限制地访问所有与执行内部审计职责相关的部门、数据、记录、信息、 实物 ...

第二条 公司实施关联交易应当遵循以下基本原则： （一）平等、自愿、等价、有偿的原则； （二）公平、公正、公开的原则；及 （三）不损害公司及公众投资者合法权益的原则。 第三条 公司的关联方具体包括： （一）直接或者间接控制公司的自然人、法人或其他组织； （二）直接或间接持有公司 5%以上股份的自然人； （三）公司董事、高级管理人员； （四）与本条第（一）项、第（二）项和第（三）项所述关联自然 人关系密切的家庭成员，包括配偶、年满 18 周岁的子女及 其配偶、父母及配偶的父母、兄弟姐妹及其配偶、配偶的兄 弟姐妹、子女配偶的父母； （五）直接持有公司 5%以上股份的法人或其他组织及其一致行动 人； 百济神州有限公司 A 股关联交易管理制度 第一章 总 则 第一条 百济神州有限公司（BeOne Medicines Ltd.，以下简称"公司"）根 据《上海证券交易所科创板股票上市规则》（以下简称"《科创板 上市规则》"）等法律、法规、规范性文件的规定，结合《百济神 州有限公司（BeOne Medicines Ltd.）之组织章程细则》（经不时修 订及重列，以下简称"《公司章程》"）、《百济神州有限公司（BeOne Me ...