创新药强势反弹，科创创新药ETF（589720）、创新药ETF（517110）均涨超2%。 近期，创新药板块波动较大，调整更多源于市场风格切换、资金短期流动等资金面因素。 （风险提示：提及个股仅供参考，不作为股票推荐，不构成投资建议和承诺。指数/个股短期涨跌 仅供参考，不代表未来表现。观点随市场环境变化，不构成投资建议。提及基金风险收益水平各不相 同，请选择与自身风险偏好匹配的产品，谨慎投资。如涉及基金收益分配原则详见基金法律文件） 每日经济新闻 （责任编辑：董萍萍 ） 【免责声明】本文仅代表作者本人观点，与和讯网无关。和讯网站对文中陈述、观点判断保持中立，不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。邮箱： news_center@staff.hexun.com 展望后市，创新药板块仍以交易BD预期为主，BD重新落地预计仍是刺激板块重新修复的关键。根 据数据统计每年四季度BD占比约占全年40%，此外大单品等仍具有预期。ESMO大会或有重要数据发 布。近期调整为看好创新药长期赛道的投资者提供了较好的布局窗口。 创新药ETF国泰（517110）覆盖三地优 ...

Market Performance - The pharmaceutical and biotechnology index declined by 1.66% from October 6 to October 10, underperforming the Shanghai Composite Index by 0.72 percentage points, marking three consecutive weeks of underperformance [1] - The innovative drug sector (BK1106) also fell by 1.09% during the same period, continuing its three-week downward trend [1] IPO Trends - A surge in IPO applications from innovative drug companies has been observed in Hong Kong, with notable companies like Betta Pharmaceuticals, Changchun High-tech, Baillie Gifford, and Borui Pharmaceuticals expected to achieve "A+H" listings [2] - The influx of A-share companies listing in Hong Kong is attributed to multiple factors, including policy support and improved market liquidity [2] - The Hong Kong Stock Exchange has relaxed public shareholding restrictions for "A+H" companies, which has created opportunities for A-share companies to list in Hong Kong [2] Clinical Trials - From October 6 to October 10, the National Medical Products Administration (NMPA) disclosed 85 clinical trial registration information, with 29 of these being new registrations for innovative drugs in Phase II or above [3] - Following the National Day and Mid-Autumn Festival holidays, the innovative drug sector experienced a significant downturn, with the Hong Kong innovative drug index dropping sharply [3] Business Development (BD) Trends - BD transactions have been a highlight for domestic innovative drugs this year, with total transaction amounts reaching $60.8 billion in the first half of the year, exceeding the total for the entire year of 2024 by $3.7 billion [3] - The market has shown a tendency for stock prices to decline following BD transactions, attributed to market expectations being overly optimistic [3] - The upcoming European Society for Medical Oncology (ESMO) annual meeting in Berlin will feature 23 research projects from China, indicating ongoing innovation in the sector [3] New Drug Approvals - The first IL-36R monoclonal antibody, HB0034, developed by Huazhong Tai Biological, has been submitted for market approval to treat adult generalized pustular psoriasis (GPP) [4] - GPP is a rare and potentially life-threatening skin disease, and currently, only one drug has been approved globally for its treatment [4] Industry Insights - The innovative drug sector is experiencing a return to a bubble-like state, with significant fluctuations in stock prices driven by BD news [4] - The founder of InnoCare Pharma expressed optimism about the industry's future, envisioning a time when Chinese companies will be recognized for their contributions to global health rather than just for their pipeline sales [4]

Market Performance - The pharmaceutical and biotechnology index declined by 1.66% from October 6 to October 10, underperforming the Shanghai Composite Index by 0.72 percentage points, marking three consecutive weeks of underperformance [1] - The innovative drug index (BK1106) fell by 1.09% during the same period, also experiencing three weeks of decline [1] - The Hang Seng Healthcare Index dropped by 6.33%, the largest weekly decline since the second half of 2025 [1] - The Hong Kong innovative drug ETF (513120) decreased by 3.98% [1] IPO Trends - A surge in IPO applications from innovative pharmaceutical companies has been observed in Hong Kong, including notable firms like Betta Pharmaceuticals, Changchun High-tech, Baillie Gifford, and Borui Pharmaceuticals, which are expected to achieve "A+H" listings [2] - The increase in A-share companies listing in Hong Kong is attributed to policy support and improved market liquidity, with the Hong Kong Stock Exchange relaxing public holding restrictions for "A+H" companies [2] - The AH share premium index has narrowed, providing opportunities for A-share companies to list in Hong Kong, with the index at 118.33, a low for the past year [2] Clinical Trials - From October 6 to October 10, the National Medical Products Administration (NMPA) disclosed 85 clinical trial registration information, with 29 related to innovative drugs in Phase II or above, focusing on autoimmune diseases and tumors [4] Business Development (BD) Trends - Following the National Day and Mid-Autumn Festival holidays, the innovative drug sector experienced a significant downturn, with the Hong Kong innovative drug index dropping by 5.84% and 3.13% on October 9 and 10, respectively [5] - The high volume of BD transactions has been a catalyst for the recent bull market in Hong Kong's innovative drug sector, with total transaction amounts reaching $60.8 billion in the first half of the year, a 129% year-on-year increase [5][6] - Market expectations have been tempered, with analysts suggesting a shift in focus from BD transactions to fundamental revenue and profit growth [6] New Drug Approvals - The first domestic IL-36R monoclonal antibody, HB0034, developed by Huaotai Biopharmaceutical, has been submitted for market approval for treating adult generalized pustular psoriasis (GPP) [7] - GPP is a rare and potentially life-threatening skin disease, and the urgency for effective treatment methods is critical [8] Industry Insights - The CEO of InnoCare Pharma expressed that the presence of valuation bubbles in the industry is not necessarily negative, viewing BD as a means rather than an end [9] - The innovative drug sector is expected to evolve, with hopes for the emergence of top-tier ADC companies in China over the next decade [9]

Core Insights - Chinese innovative drugs are becoming "scarce assets" that multinational pharmaceutical companies are eager to acquire, leading to high-value business development (BD) transactions as a result of decades of development in the Chinese pharmaceutical industry [1][4] Group 1: Milestone Payments and Clinical Trials - The recent milestone payment of $250 million triggered by the IZABRIGHT-Breast01 clinical trial marks the largest milestone payment for a single ADC asset in a domestic innovative drug transaction [1][2] - This payment structure is tied to clinical development milestones, indicating international partners' endorsement of the company's research execution and global competitiveness [2][3] - The total potential transaction value with BMS could reach $8.4 billion, setting a record for ADC licensing agreements globally [3][4] Group 2: Trends in BD Transactions - The number of Chinese projects in global innovative drug BD transactions has increased from 3% in 2019 to 13% in 2024, with monetary share rising from 1% to 28% [4] - The total amount of License-out transactions for Chinese innovative drugs is expected to approach $66 billion in the first half of 2025, surpassing the total for 2024 [4] Group 3: Drivers Behind Increased Interest - The impending "patent cliff" is a significant driver for multinational companies to seek Chinese innovative drug assets, as it may lead to substantial revenue declines for these companies [5][6] - The cost-effectiveness of Chinese innovative drugs is also a key factor, as valuations are currently low, making it an opportune time for foreign companies to acquire these assets [6] Group 4: Challenges and Future Directions - Chinese innovative drug companies face the challenge of transitioning from a reliance on upfront payments to achieving full transaction values through successful clinical outcomes [7][8] - To ensure sustainable growth, companies should focus on differentiated pipelines, deepen global clinical collaborations, and explore diverse BD models beyond traditional License-out agreements [8][9] - The shift from short-term reliance on upfront payments to long-term value realization is essential for the internationalization of Chinese pharmaceutical companies and the overall upgrade of the industry [9]

将投中网设为"星标⭐"，第一时间收获最新推送 港股发行新规成政策东风。 作者丨 海若镜 来源丨 36氪Pro 港交所门口，排满了等待上市的创新药企。 9月28日，小核酸药企靖因药业递表港股IPO，上轮投后2.5亿美元。9月15日至今两周间，已有爱 科百发、新元素药业、先为达等六家创新药企加入港股IPO冲刺队伍。 今年4月映恩生物上市以来，沉寂多时的港股创新药板块，被高频的BD交易、汹涌的IPO热潮激活。 维立志博、银诺医药新股公开发售部分都获得超3000倍认购，出现上市首日股价翻一倍、两倍的表 现，扭转了此前三年药企到港股"上市即破发"的窘境。 "边走边看，祈祷行情可以持续，"一家近期递表药企的IR负责人说道。待上市药企，普遍渴望能抓 住这一波上市机会。 "现在大家都觉得很紧迫。因为市场很热，发行窗口难得，谁也不确定等自家通过聆讯时，行情是什 么样。"科律律师事务所上海办事处主管合伙人刘毅铭表示，"另外，当前创新药横向竞争也比较激 烈，像代谢领域，已有多家开发GLP-1靶点的药企上市，还有几家正在推进中。市场上能看懂创新 药的二级市场投资人，本身就有限，如果他投了竞品，可能不一定有胃口再投同赛道的另一家企 业 ...

Core Viewpoint - The Hong Kong Stock Connect innovative drug sector experienced a rebound after five days of adjustment, with the Hong Kong Stock Connect Innovative Drug ETF (520880) rising by 1.77% on September 22, 2023, recovering its five-day moving average and achieving a total trading volume of 331 million yuan [1][3]. Group 1: Market Performance - The innovative drug ETF (520880) opened high and reached a peak increase of 2.57% during the day, closing in the green with a trading volume of 331 million yuan [1]. - Among the 37 constituent stocks, MIRXES-B surged by 27.68%, while major stocks like Innovent Biologics and Kintor Pharmaceutical rose by 2.88% and over 1%, respectively [1]. - The ETF has attracted nearly 680 million yuan over 14 consecutive days, indicating strong investor interest [3]. Group 2: Policy Impact - The National Healthcare Security Administration released the 11th batch of centralized drug procurement documents on September 20, emphasizing principles such as "stabilizing clinical use, ensuring quality, preventing collusion, and avoiding internal competition" [5]. - The fund manager of the innovative drug ETF interpreted the new procurement policy as a continuous support for innovation in the industry, allowing companies to ensure quality while avoiding a sole focus on low prices [6]. Group 3: Future Outlook - The innovative drug sector is expected to see a peak in business development transactions in October and November, with no significant impact from potential U.S. policies [6]. - The ETF's index has shown a cumulative increase of 119.75% year-to-date, indicating strong performance compared to other innovative drug indices [7]. - The ETF focuses exclusively on innovative drug research and development, excluding CXO companies, which is anticipated to enhance its performance during market rallies [7].

Core Viewpoint - The collaboration between Haizheng Pharmaceutical and Aixin Dawei marks a significant step in China's innovative drug development, reflecting the rapid growth of China's innovative drug business development (BD) transactions from less than 1% of the global share in 2016 to nearly 35% today [1][4]. Company Summary - Haizheng Pharmaceutical has entered into a partnership with Aixin Dawei to introduce a potential first-in-class small molecule conjugate drug, HSE-001 (AST-3424), with a total investment of up to 240 million yuan [1][2]. - The drug AST-3424 targets the AKR1C3 enzyme in tumor cells, selectively activating and releasing a potent DNA damaging agent, showing low toxicity to normal tissues [2]. - This partnership allows Haizheng to fill a gap in its pipeline for innovative drugs targeting solid tumors, enhancing its transition from a generic drug leader to an innovative pharmaceutical company [2][6]. Industry Summary - The innovative drug BD landscape in China is evolving, with a notable increase in the number of BD transactions, reaching 95 by September 2025, which represents 11% of global BD transactions, up from 2% in 2016 [4][5]. - The total transaction value of China's innovative drug BD events reached $89 billion by 2025, accounting for 33% of the global total, a significant increase from less than 1% in 2016 [5]. - The number of heavyweight BD transactions in China has also surged, with 21 transactions by 2025, representing 28% of global heavyweight BD transactions, compared to 0% in 2016 [5]. - The collaboration trend indicates a shift in the pharmaceutical industry from a "large and comprehensive" model to a "specialized and precise" approach, with biotech firms focusing on early-stage research and traditional pharmaceutical companies leveraging their commercialization capabilities [7][8]. - China's biopharmaceutical market is projected to grow significantly, reaching $2,911 billion by 2026 and $3,732 billion by 2030, with approximately 30% of global innovative drugs under development [8].

Investment Rating - The industry rating is "stronger than the market" indicating that the overall return of the industry is expected to exceed the market benchmark index by more than 5% in the next 6 months [6][75]. Core Insights - The report analyzes the impact of the "Biological Safety Act" on the CXO industry and concludes that the BD policies will not have a substantial effect on the innovative drug sector [4][28]. - The CXO companies have shown resilience, with stock prices recovering and reaching new highs despite the changes in the Biological Safety Act [4][17]. - The report emphasizes the advantages of China's innovative drug industry, including talent resources, research efficiency, and cost-effectiveness, which are expected to mitigate the impact of external policies [4][28]. Summary by Sections Market Review - During the week of September 8-12, 2025, the CITIC Pharmaceutical Index fell by 0.3%, underperforming the CSI 300 Index by 1.7 percentage points, ranking 28th among CITIC's primary industry classifications [3][30]. - Year-to-date, the CITIC Pharmaceutical and Biotechnology Index has risen by 27.8%, outperforming the CSI 300 Index by 12.9 percentage points, ranking 8th among CITIC's industry classifications [3][30]. - The top five performing stocks for the week included: Zhend Medical (+41.3%), Haooubo (+28%), Jimin Medical (+25.9%), Kangwei Century (+23.2%), and Ao Jing Medical (+20.5%) [3][44]. Impact of the Biological Safety Act - The report details the evolution of the Biological Safety Act since December 30, 2023, noting that the stock price reactions of representative CXO companies have become desensitized over time, with current prices surpassing levels from December 29, 2023 [4][17]. - The performance of CXO companies in the U.S. market has remained strong, with significant growth in orders and revenue despite the act's implications [24][28]. Investment Focus - The report suggests focusing on three main areas in the innovative drug and its supply chain: companies with revenue and commercialization capabilities, potential BD opportunities based on technological trends, and exploring cutting-edge technologies such as gene therapy and CAR-T [5][28]. - The medical device sector is also highlighted as a key area for investment, with expectations of a policy turning point and improving fundamentals [5][28]. Stock Recommendations - The report recommends a focus on specific stocks including Kangfang Biotech, Baiji Shenzhou, Xinda Biotech, Enhua Pharmaceutical, and others for the upcoming month [5][12].

Core Viewpoint - The Trump administration is preparing a new executive order targeting the Chinese pharmaceutical industry, particularly focusing on the licensing-out (BD) of innovative drugs, which may restrict U.S. pharmaceutical companies from importing new drugs from China and impose stricter reviews on drug licensing transactions and clinical data from China [1][3]. Group 1: Impact on the Market - Following the news, shares of innovative drug companies in both A-shares and H-shares fell, with companies like BeiGene and Rongchang Bio experiencing declines, while the Hang Seng Biotechnology Index saw a significant drop [1]. - Despite initial declines, the innovative drug sector showed signs of recovery, with a partial rebound observed on September 12 [1]. Group 2: Details of the Proposed Executive Order - The draft executive order includes four main points: limiting U.S. pharmaceutical companies from importing in-development drugs from China, requiring licensing transactions to undergo mandatory review by the Committee on Foreign Investment in the United States (CFIUS), enhancing FDA scrutiny on projects using Chinese clinical data, and promoting domestic drug production in the U.S. [3][5]. - The proposed restrictions are seen as a response to the increasing trend of U.S. pharmaceutical companies acquiring Chinese innovative drug pipelines, which has raised concerns among some U.S. investors [3][4]. Group 3: Industry Reactions and Feasibility - Industry insiders express skepticism about the feasibility of the executive order due to the complex interests involved, suggesting that even if the order is implemented, it may only affect the most sensitive areas like cell therapy and human genetic resources, while allowing other transactions to proceed normally [2][6]. - The potential impact of the order on U.S. pharmaceutical companies is significant, as it could limit their access to innovative drugs and hinder their development capabilities [6][7]. Group 4: Economic Implications - The executive order is perceived as a move that could harm both U.S. and Chinese companies, as it may restrict BD transactions that are crucial for innovation and collaboration in the pharmaceutical sector [2][6]. - The financial stakes in BD transactions are substantial, with the potential for significant profits for multinational companies, as evidenced by BioNTech's recent acquisition and subsequent sale of a Chinese innovative drug [7].

Core Viewpoint - The article discusses the significant fluctuations in stock prices of innovative pharmaceutical companies, highlighting both the successes and failures in the market, particularly focusing on the performance of companies that reached historical highs in 2025 and those that have experienced substantial declines. Group 1: Performance of Innovative Pharmaceutical Companies - As of September 11, 2025, 90% of Hong Kong and STAR Market innovative pharmaceutical companies have seen significant stock price increases since the beginning of the year [6] - A total of 17 companies reached historical highs in stock price and market capitalization in 2025, with notable companies including BeiGene (688235.SH) and Innovent Biologics (01801.HK) [7][10] - Among these 17 companies, 12 have entered or are about to enter the commercialization phase, establishing stable revenue sources [7] Group 2: Key Events and Financial Performance - BeiGene and Innovent Biologics achieved their first profits in the first half of 2025, with BeiGene reporting a net profit of approximately 450 million yuan, a significant turnaround from a loss of 2.877 billion yuan in the same period last year [10] - Innovent Biologics reported a net profit of 834 million yuan, benefiting from the growth of PD-1 and other oncology drugs in the domestic market [10] - Other companies like Kintor Pharmaceutical (06990.HK) and Rongchang Biologics (688331.SH) have also made significant progress through BD transactions and drug approvals [11] Group 3: Declining Companies and Market Challenges - Despite the successes, 50% of innovative pharmaceutical companies still have stock prices below their initial offering prices, with 31 out of 55 Hong Kong 18A innovative pharmaceutical stocks experiencing declines [14][15] - Companies like Tengsheng Bo Pharmaceutical (02137.HK) and Akeso (09939.HK) have seen significant drops in stock prices, with some losing over 90% of their value since their IPOs [20][21] - The article notes that many of these declining companies faced challenges such as failed drug trials or adverse market conditions, leading to substantial losses [20][21] Group 4: Recent Trends and Future Outlook - Three companies, including Tongyuan Kang Pharmaceutical (02410.HK), have seen stock price declines of 70% or more since the beginning of the year, indicating ongoing volatility in the sector [25] - The article emphasizes the importance of BD transactions and successful drug approvals as key factors for recovery and growth in the innovative pharmaceutical market [12][22]