10月21日，港股通创新药板块震荡回暖，100%创新药研发标的——港股通创新药ETF（520880）午后 稳定涨势，场内收涨1.21%终结两连跌。成份股荣昌生物、云顶新耀涨超4%，权重股石药集团、翰森制 药跌1%有所拖累。 值得关注的是，520880早尾盘震荡区间均涌现溢价，收盘溢价率更是超过1%，显示买盘尤为强劲。资 金面上，昨日3945万元逢跌净申购，近10日维度，累计超1.58亿元进场。 9月中旬以来，港股通创新药震荡走低，而创新药产业的态度和动作，成为波动行情中的"定心丸"。一 方面，美国第一药企辉瑞公司首席执行官直言，中国的生物医药生态系统"令人瞩目"，美国应少关注如 何拖慢中国，而更多思考如何适应新的竞争。另一方面，上周行业出现久违的BD"小高潮"，一天内三 个中国药企BD落地。 当下创新药怎么投？港股通创新药ETF（520880）基金经理丰晨成认为，创新药行情已经从"鸡犬升 天"的普涨行情，逐步过渡到关注"质量因子"的第二阶段。只有真正能落地、临床数据优异并具有商业 化能力的创新药龙头，才能取得财务的成功，并实现对于海外业务的"戴维斯双击"。 【创新药"新势力"——港股通创新药ETF（52088 ...

Core Viewpoint - The A-share and Hong Kong stock markets have experienced significant gains, with the Hong Kong Stock Connect Innovative Drug ETF (159570) seeing a nearly 2% increase and a trading volume approaching 2 billion yuan, indicating strong investor interest and liquidity in the innovative drug sector [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (159570) has a current scale exceeding 21 billion yuan, leading its peers in both scale and liquidity [1]. - As of October 20, the ETF has seen a net inflow of over 1.7 billion yuan in the past 20 days [1]. - Major stocks within the ETF, such as Innovent Biologics, CanSino Biologics, and 3SBio, have shown positive performance, with increases exceeding 2% [3]. Group 2: Business Development (BD) Trends - The innovative drug sector continues to thrive, with five business development (BD) deals totaling $4.266 billion reported over two days [3]. - Notable transactions include Hansoh Pharmaceutical with a total deal amount of $1.53 billion and Prigen with $1.64 billion [3]. - The total number of license-out transactions in China from January 1 to October 17, 2025, reached 135, with upfront payments totaling $4.976 billion and total deal amounts reaching $102.996 billion, reflecting strong international interest in Chinese innovative drug assets [5]. Group 3: Upcoming Catalysts - The fourth quarter is expected to see an acceleration in BD activities, with a focus on data from the ESMO conference [5]. - Chinese scholars are leading 23 LBA studies at the 2025 ESMO, showcasing various innovative drugs and highlighting China's growing influence in the global pharmaceutical landscape [7]. - The anticipated release of clinical data from the ESMO conference may lead to a revaluation of Chinese innovative drug pipelines and their corresponding stocks [7]. Group 4: Global Pricing Dynamics - Recent agreements between Pfizer and AstraZeneca with the U.S. government on Most Favored Nation (MFN) pricing have exceeded expectations, potentially impacting global sales forecasts for innovative drugs [8][9]. - Pfizer's agreements cover aspects such as pricing for existing and new drugs, direct sales, and tariff exemptions, which could enhance the market potential for innovative drugs [9][10]. - If MFN pricing trends continue, the peak global sales forecast for innovative drugs, including those licensed out from China, may significantly increase [10].

Group 1 - The core viewpoint indicates that the innovative drug sector in Hong Kong is showing clear signs of bottoming out, supported by several factors [1] - BD (Business Development) transactions have started to recover since October, with historical data showing that transactions from October to January account for over 50% of the annual total, and transaction amounts can reach 60% to 70% of the yearly total [1] - Positive data from ESMO (European Society for Medical Oncology) has emerged, with several important clinical studies, such as AK112 and 3SB707, showing promising results, which is expected to catalyze further trading and stock price increases [1] - The valuation of innovative drugs has reached an absolute bottom, with some companies having little room for further decline [1] Group 2 - As of October 21, 2025, the National Securities Hong Kong Stock Connect Innovative Drug Index (987018) shows mixed performance among its constituent stocks, with notable gainers including CloudTop New Drug (01952) up 5.29% and Zai Lab (09688) up 1.80%, while major decliners include Juno Therapeutics-B (02617) down 6.82% [2] - The Hong Kong Innovative Drug ETF (159286) closely tracks the National Securities Hong Kong Stock Connect Innovative Drug Index and has seen a slight increase of 0.22%, with the latest price at 0.93 yuan [2] - As of September 30, 2025, the top ten weighted stocks in the National Securities Hong Kong Stock Connect Innovative Drug Index account for 71.83% of the index, including companies like BeiGene (06160) and Innovent Biologics (09926) [2]

Core Insights - China Biopharmaceutical announced the interim analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules, presented at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy for HR+/HER2- advanced breast cancer [1] Group 1 - Kumosili is a novel oral CDK2/4/6 inhibitor with varying degrees of inhibition on CDK2, CDK4, and CDK6, showing strong selectivity against CDK4, which may help delay clinical resistance and reduce bone marrow suppression [2] - The China National Medical Products Administration (NMPA) accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer in July 2024, with a second indication application expected in July 2025 [2] - The company is actively advancing a Phase III clinical trial for Kumosili in adjuvant therapy for breast cancer, having completed patient enrollment, with plans to submit a marketing application in the next two years [2] Group 2 - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Insights - China Biologic Products (01177) announced the mid-analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules (CDK2/4/6 inhibitor), for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy in HR+/HER2- advanced breast cancer [1] - Kumosili shows selective inhibition of CDK4 kinase, which may help delay clinical resistance and reduce bone marrow suppression, potentially positioning it as a Best-in-Class therapy [1] Regulatory Developments - The Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer, expected to be reviewed by July 2024 [2] - A second indication for initial endocrine treatment in HR+/HER2- locally advanced or metastatic breast cancer is also under review, with an expected decision by July 2025 [2] - The company is advancing a Phase III clinical trial for Kumosili in adjuvant therapy, with all participants enrolled and a marketing application anticipated within the next two years [2] Market Potential - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

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，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 庫莫西利聯合氟維司群一線治療晚期乳腺癌III期研究數據在ESMO 2025公佈 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團已 在2025年歐洲腫瘤內科學大會(ESMO)上以最新重磅摘要(LBA)的形式，公佈了國家1類創新藥庫莫西 利膠囊（CDK2/4/6抑制劑）用於一線治療HR+/HER2-晚期乳腺癌的III期臨床研究(CULMINATE-2)期 中分析結果。 CULMINATE-2是全球首個口服CDK2/4/6抑制劑聯合內分泌治療用於HR+/HER2-晚期一線乳腺癌取 得陽性結果的III期臨床試驗。這項隨機、雙盲、多中心平行對照研究，旨在評估庫莫西利聯合氟維 司群（試驗組）對比安慰劑聯合氟維司群（對照組）在內分泌初治的HR+/HER2 ...

Core Insights - The acquisition of Akero Therapeutics by Novo Nordisk for $5.2 billion marks a significant move into the FGF21 space, indicating the growing importance of metabolic disease treatments, particularly for metabolic dysfunction-associated steatotic liver disease (MASH) [2][12] - FGF21 is rapidly becoming a key target in the treatment of metabolic diseases, with major pharmaceutical companies like GSK and Roche also making substantial investments in similar assets, reflecting a competitive landscape reminiscent of the GLP-1 market boom [3][19] - The market for MASH is projected to reach $32.2 billion by 2030, driven by the increasing prevalence of obesity and type 2 diabetes, highlighting the commercial potential of FGF21 therapies [13][19] Company Strategies - Novo Nordisk's acquisition of Akero Therapeutics is part of a broader strategy to enhance its portfolio in the metabolic disease sector, especially after facing competitive pressures [16][18] - GSK's acquisition of Boston Pharmaceuticals' FGF21 asset aims to fill gaps in its MASH treatment offerings and is expected to complement its existing therapies [15][18] - Roche's acquisition of 89bio's FGF21 drug pegozafermin is intended to strengthen its position in cardiovascular and metabolic disease markets, showcasing a trend of major companies consolidating their portfolios through strategic acquisitions [16][18] Market Dynamics - The FGF21 target is emerging as a lucrative opportunity, with the potential to replicate the success seen with GLP-1 drugs, which have transformed into leading treatments for metabolic disorders [19][23] - The unique ability of FGF21 therapies to address late-stage liver disease (F4) provides a competitive edge over existing treatments, which are limited to earlier disease stages [13][19] - The ongoing trend of mergers and acquisitions in the FGF21 space is expected to intensify, driven by the substantial market size and the need for innovative therapies in metabolic diseases [22][23] Clinical Developments - Akero's Efruxifermin has shown promising clinical results, with nearly 50% improvement in liver fibrosis for F2-F3 MASH patients after 96 weeks of treatment, indicating its potential as a leading therapy in this area [11][19] - The advancements in protein engineering have allowed FGF21 drugs to overcome previous limitations, such as short half-lives, enabling less frequent dosing and enhancing their commercial viability [9][19] - Chinese pharmaceutical companies are also making strides in the FGF21 space, focusing on multi-target agents that could provide synergistic effects in treating metabolic disorders [20][21]

Core Insights - The A-share pharmaceutical sector is showing signs of recovery, with significant inflows into representative ETFs, particularly in the CXO segment, indicating strong buying interest [1][7] - The Hong Kong innovation drug ETF (520880) has been trading at a high premium, reflecting robust buying activity, with over 125 million yuan entering the market for low absorption last week [5][7] - The pharmaceutical sector is experiencing mixed performance, with some stocks like Kelun Pharmaceutical and Baillie Gifford rising over 2%, while others like Pianzihuang faced pressure post-earnings [3][5] Group 1: Market Performance - The A-share medical sector is rebounding, with notable gains in CXO stocks, exemplified by WuXi AppTec's 3% rebound and the largest medical ETF (512170) seeing a peak premium of 1% during trading [1][3] - The only drug ETF in the market (562050) is stabilizing near water level, with frequent premiums observed in the market [3] - The Hong Kong innovation drug ETF (520880) opened over 1% higher but quickly fell below water before recovering, with major stocks like BeiGene rising over 3% while others like CanSino Biologics dropped over 2% [5][7] Group 2: Investment Strategies - Analysts suggest that the innovation drug sector may be entering a configuration window, with multiple catalysts expected in Q4, including major industry conferences and positive Q3 earnings expectations [7] - Investment strategies are focusing on two main lines: identifying stocks with strong Q3 earnings and continuing to explore innovative drugs in preparation for a potential market rebound [7][8] - The Hong Kong innovation drug ETF (520880) is characterized by 100% investment in innovative drug companies, while the largest medical ETF (512170) includes a mix of medical devices and services [8][9]

Core Viewpoint - The Chinese asset market is experiencing a significant adjustment, with A-shares and Hong Kong stocks declining sharply, particularly in high-tech sectors, while the healthcare sector shows signs of resilience and potential investment opportunities [1][3][4]. A-shares and ETFs Performance - A-shares saw all three major indices decline, with the Shenzhen Component Index and the ChiNext Index both dropping over 3%, while the largest medical ETF (512170) fell by 2.39% but showed strong buying interest with a trading volume increase of 30% to 687 million yuan [1][3]. - The only drug ETF in the market (562050) outperformed the market with a decline of only 1.56%, indicating strong buying momentum as it traded at a premium throughout the day [3]. Hong Kong Stocks and Innovation Drugs - The Hong Kong innovation drug sector has faced volatility, with the Hong Kong Stock Connect Innovation Drug ETF (520880) dropping 2.53% after two consecutive days of gains, while 33 out of 37 covered companies saw declines [3][4]. - Despite the downturn, the Hong Kong innovation drug ETF has also been trading at a premium, with a net inflow of over 128 million yuan in the past five days, suggesting continued investor interest [3][4]. Market Trends and Investment Strategies - The market is shifting from high-tech assets to dividend-paying assets, with healthcare ETFs and innovation drug ETFs attracting significant capital inflows [3][4]. - Analysts predict a potential rebound for the innovation drug sector in the fourth quarter, driven by multiple catalysts such as industry conferences, favorable quarterly earnings, and upcoming national healthcare negotiations [4][5]. Investment Recommendations - Investment strategies focus on identifying companies with strong quarterly earnings, particularly in the CXO sector, and balancing portfolios between innovation drugs and other healthcare segments [4][5]. - The medical ETF (512170) is noted for its high cost-performance ratio, with a current PE valuation of 35.1 times, lower than 60% of the past decade, indicating a favorable entry point for investors [3][4].

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [3] Core Viewpoints - The report emphasizes that the fourth quarter is expected to see a rebound in innovative drugs, driven by a concentration of business development (BD) activities and upcoming events such as the ESMO conference and medical insurance negotiations [4][16] - The Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs significantly opening new growth avenues for Chinese pharmaceutical companies [16][35] - The report suggests that the demand for healthcare will continue to rise due to an aging population, and the payment side is also expected to grow steadily, supported by the development of a multi-tiered payment system [35] Summary by Sections 1. BD + ESMO - The number of license-out transactions in China has been increasing, with 135 transactions occurring from January 1, 2025, to October 17, 2025, totaling $10.2996 billion [8][9] - The report highlights that the international pharmaceutical industry recognizes the value of Chinese innovative drug assets, which are characterized by high quality and low cost [8][9] - The ESMO conference will showcase 23 studies led by Chinese scholars, indicating a significant increase in international recognition of Chinese innovation [12][13] 2. Industry Perspective - The report maintains that innovative drugs will remain the main focus for the year, with attention on manufacturing, overseas expansion, and aging-related consumption [16][35] - The pharmaceutical index has shown a decline of 2.48% in the past week, but an increase of 18.85% year-to-date, indicating a mixed performance [16] - The report lists several companies to watch, including innovative drug manufacturers and those involved in the supply chain [38]