Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 21, 2025 [1] Core Insights - The trend of Chinese innovative drugs going global is a significant industry trend, with a notable increase in License-out transactions in the first half of 2025, surpassing the total number for 2024 by over half and increasing transaction amounts by 16% [2] - The report highlights the importance of structural opportunities within the industry, emphasizing the need to select high-quality companies amidst the competitive landscape [2] - The report notes that while the trend of innovative drugs going abroad continues, concerns have arisen due to fewer major transactions and proposed U.S. regulations affecting Chinese drug licensing [2] - The report identifies significant breakthroughs in small nucleic acid drugs, particularly in chronic disease areas such as hypertension, with notable partnerships and potential milestone payments [3] - The report discusses promising clinical data from Chinese ADCs presented at the World Lung Cancer Conference, showcasing competitive advantages in efficacy and safety [4] - The report mentions the advancements in GLP-1 analogs for weight loss, with ongoing developments from both multinational corporations and domestic companies [5] - The CXO sector is expected to gradually recover, driven by an increase in orders and favorable policy changes [6] - The report outlines the completion of expert reviews for the 2025 medical insurance negotiation and commercial insurance innovative drug directories, indicating potential impacts on participating companies [7] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry index has underperformed compared to the CSI 300 index, with a recent weekly decline of 2.07% [22] - Over the past month, the industry has lagged behind the CSI 300 index by 7.79 percentage points [23] 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical industry index is 39.77, above the five-year historical average of 31.50 [48] 3. Recent Research Achievements - The report includes various recent research outputs, highlighting the ongoing focus on innovative drug development and market opportunities [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Medical Insurance Administration regarding drug directory adjustments and the implications for the industry [52][54]

经济观察报面向27位Biotech负责人和10位一级市场投资人 开展了问卷调查和访谈。在受访者中，60%的人认为，创新药 一级市场已经走出谷底，但仍然不够理想；33%的人认为没有 太大变化，一级市场仍处在资本寒冬之中。 作者： 刘晓诺 封图：图虫创意 导读 壹 || 有67%的Biotech受访者认为，融资时遇到的主要困难是"专业壁垒高，投资人不理解创 新药的逻辑"，52%的Biotech受访者认为主要困难是"融资条件苛刻，如对赌协议等"。 贰 || 2025年，投资人最关注的就是药物能否出海，包括在国外开临床、做BD、在海外上市 等，这往往意味着药物即将带来明确的回报。 叁 || 一级市场的股权投资有募、投、管、退几个环节。通过退出实现收益，无疑是一次投资 活动的终点与目标。 肆 || 在10位受访的投资人中，有9位表示目前投资环境有一定好转，但他们仍保持谨慎。受访 者普遍认为，创新药在二级市场的热度，还需要时间传递到一级市场。 神曦生物的创始人陈功注意到，2025年以来，有更多合伙人级别的投资人来看创新药项目、参加 行业会议了。而去年，参加圆桌论坛的很多是投资经理。 不过，投资人虽然开始走动，但当前融资依 ...

Core Viewpoint - The Chinese innovative drug industry is gradually catching up with Europe and the United States in terms of technology, with some targets and technical pathways already leading globally. The number and value of new drugs authorized for overseas markets continue to increase, leading to world-class pricing and non-linear investment elasticity. The domestic market is experiencing strong growth in demand, with domestic new drug sales continuing to rise, and several innovative pharmaceutical companies have turned losses into profits, entering a stable growth phase [2]. Group 1: Innovative Drugs - The innovative drug sector is witnessing a significant increase in sales driven by strong domestic demand, with a number of innovative companies achieving profitability [2]. - The trend of domestic innovative drugs going overseas is accelerating, with increasing numbers and values of new drug authorizations [2]. - The pricing power of innovative drugs is improving, reflecting the global competitiveness of Chinese pharmaceutical companies [2]. Group 2: High-Value Medical Consumables - The orthopedic sector is expected to see mild price reductions due to continued domestic substitution and accelerated overseas business progress [2]. - The neurosurgery and neurointervention fields are experiencing stable growth post-collection, with new products being launched [2]. - The high-value consumables market is expected to benefit from ongoing domestic replacement and the introduction of new products [2]. Group 3: Medical Devices - The medical device sector is seeing a recovery in bidding prices, with ongoing high-speed growth in bidding data this year [2]. - Companies are entering a phase of inventory reduction, with performance expected to improve in the second half of the year [2]. - The low-value consumables sector is experiencing product upgrades and accelerated expansion into overseas markets [2]. Group 4: Blood Products - The supply side of the blood products industry is concentrating on central state-owned enterprises, gradually clearing the competitive landscape [2]. - The demand side is expected to see continuous upgrades to new products, with industry sentiment gradually improving [2]. Group 5: API (Active Pharmaceutical Ingredients) - The API sector is benefiting from the end of a capital expenditure peak, with three growth logic points driving upward trends: new high-end market products, integrated consolidation and overseas expansion, and cost-leading CDMO [2]. - Leading companies in the API sector are expected to see explosive growth in revenue and profits [2]. Group 6: CXO (Contract Research Organization) - The CXO sector is witnessing a recovery in A+H financing activity, with multiple significant business developments enhancing market confidence [2]. - The focus is on optimizing the supply-side landscape and increasing market share for leading CRO companies [2]. Group 7: Traditional Chinese Medicine and Retail Pharmacy - The traditional Chinese medicine sector is showing signs of recovery, with friendly pricing for new drugs and ongoing observation of collection progress [2]. - The retail pharmacy sector is influenced by the pace of supply-side clearing and business model upgrades, with expectations of increased store closures in the second half of 2025 [2]. Group 8: Research and Development Services - The domestic innovative drug business development is heating up, likely driving downstream demand recovery [2]. - The overseas market presents significant growth opportunities for domestic companies, leveraging cost-effectiveness and service differentiation [2].

Market Overview - In the recent trading period from September 12 to September 18, major indices showed mixed performance, with the Shanghai Composite Index declining by 1.13% and the ChiNext Index increasing by 1.38% [2] - The trading volume increased, with a total of 12.65 trillion yuan traded, averaging 2.53 trillion yuan per day, which is an increase of 278.79 billion yuan compared to the previous five trading days [2] Economic Data - From January to August, fixed asset investment grew by 0.5% year-on-year, reflecting a marginal decline of 1.1 percentage points [3] - The total retail sales of consumer goods from January to August increased by 4.6% year-on-year, which is a decrease of 0.2 percentage points compared to July [3] Policy Developments - Recently, the Ministry of Commerce and eight other departments issued measures to expand service consumption, proposing 19 measures focused on promoting consumption and expanding domestic demand [3] - The policy measures indicate a proactive approach to stimulate service consumption in light of the need to boost consumer demand [3] International Developments - On September 18, the Federal Reserve lowered the federal funds rate by 25 basis points, bringing the target range to 4.00% to 4.25%, aligning with market expectations [3] - The Fed's forecast for the policy rate in 2025 has been adjusted down to 3.6%, suggesting a potential for an additional 50 basis points of rate cuts within the year, indicating a trend towards further easing of overseas liquidity [3] Investment Strategy - The A-share market is exhibiting strong structural characteristics, with a focus on stabilizing the overall market while the technology-driven sectors are showing active performance [3] - The continuation of liquidity inflow will be crucial for maintaining the current structural market trends [3] Industry Focus - Investment opportunities are identified in the TMT sector due to the promotion of domestic alternatives in computing power and the upcoming peak season for smart terminal releases [4] - Other sectors with potential investment opportunities include pharmaceuticals, power equipment, non-ferrous metals, and machinery, driven by factors such as innovative drug exports, high demand for energy storage, and the anticipated mass production of robots [4]

Core Insights - The conference highlighted the growing global competitiveness of Chinese innovative drugs, particularly in areas like ADC and bispecific antibodies, while emphasizing the need for improvement in original innovation capabilities [1][5][6] - There is a consensus among industry leaders that "going global" is essential for the future of Chinese innovative drugs, with calls for more supportive policies to facilitate this process [1][7][9] Group 1: Current State of Chinese Innovative Drugs - Chinese innovative drugs have reached a global competitiveness level from "1 to 10," especially in engineering fields, but still need to enhance original innovation from "0 to 1" [1] - The quality of projects is crucial for international expansion, as highlighted by industry leaders who stress that strong data and comprehensive packages are essential for success [2][3] - The past decade has seen significant development in the Chinese innovative drug ecosystem, with a complete industrial chain now in place, particularly in cities like Shanghai [4] Group 2: Challenges and Opportunities - The domestic market's limitations are pushing companies to explore international markets, with a focus on countries involved in the Belt and Road Initiative [7] - There is a need for policy reforms regarding listing standards to support innovative drug companies that face long development cycles and high R&D costs [7][9] - The current pricing of innovative drugs in international markets is still influenced by domestic prices, which poses challenges for global competitiveness [9] Group 3: Future Directions and Innovations - The industry is witnessing a surge in various therapeutic areas, including small molecules, antibodies, peptides, RNA, and gene therapies, indicating a diverse landscape of innovation [10] - The potential for small nucleic acids and other novel therapies is recognized as a significant opportunity for Chinese companies to lead in the global market [10] - Industry leaders express confidence in the future of Chinese innovative drugs, anticipating that with time, more companies will emerge as global players [11]

作为科创板迈向"新高地"暨"硬科硬客"2025年会的重要内容之一，9月10日，君实生物（688180.SH）、 皓元医药（688131.SH）、药康生物（688046.SH）、美迪西（688202.SH）、迈威生物（688062.SH） 等科创板创新药领域龙头上市公司高管，逾50家机构投资者参与了创新药产业链的高层次闭门研讨会。 会议围绕中国创新药出海的核心能力、国际竞争力现状及未来发展方向进行深入研讨。 与会嘉宾认为，中国创新药已具备从"1到10"的全球竞争力，尤其在ADC、双抗等工程化领域国际领 先，但在"0到1"的原始创新方面仍需努力。出海，成为行业共识，企业呼吁政策进一步支持破解"出 海"难题。 "君实生物是最早把国际化当作自己重要战略的本土企业之一，特瑞普利单抗也是第一个获得美国FDA 批准上市的中国自研自产PD-1产品，目前已经在40个国家和地区获批。"李鑫坦言，产品出海是高成本 的事情，需要满足国际上未被满足的需求，同时要应对FDA等海外监管机构的严格审评，包括临床和生 产端。 皓元医药董事长兼总经理郑保富从产业链角度分析："创新药是我们CRO（定制研发机构）、CDMO （医药合同定制研发生产企 ...

2024年中国药企完成超90笔海外授权交易，总交易金额超519亿美元，参与了全球约三分之一的大型授权交易。今年上半年，中国创新药 授权出海交易已超过50起，总金额超过660亿美元。近年来，中国生物医药产业快速崛起并在这两年进入收获期，中国药企和科研机构正展现 出国际前沿的原始创新能力。 和黄医药临床开发高级副总裁范颂华称："从中国产业融合来讲，确实这十年的发展或者二十年的发展也让中国诞生了越来越多具有国际 视野的中国研究者，并且中国产生的数据也越来越得到美国FDA（食品药物管理局）的认证。" 央视网消息：今年以来，中国创新药"出海"步伐持续加快。数据显示，2025年上半年创新药对外授权总金额已超过660亿美元，超过2024 年全年519亿美元的交易总额，其中多笔交易金额超过10亿美元，展现出中国创新药实力的显著提升和全球化进程的提速。 近日，在上海张江生物医药创新基地，恒瑞医药与英国葛兰素史克公司完成包含5亿美元首付款、潜在120亿美元里程碑付款及销售分成的 合作交易，这是今年以来中国第100笔对外授权交易。 江苏恒瑞医药股份有限公司总裁冯佶称："中国的研发已经得到了全球的认可，很多大公司都在中国看什么样的产 ...

Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].

Group 1 - The Hang Seng Hong Kong Stock Connect Innovative Drug Select Index increased by 0.38%, with notable gains from companies such as Hengrui Medicine (+5.42%) and Junshi Biosciences (+3.48%) [2] - The Hong Kong Innovative Drug Select ETF (520690) rose by 0.97%, with a current price of 1.04 yuan, and has accumulated a total increase of 4.15% since its inception [2] - The trading activity for the Hong Kong Innovative Drug Select ETF was robust, with a turnover rate of 35.03% and a transaction volume of 132 million yuan [2] Group 2 - In the first half of 2025, the total amount of overseas licensing for Chinese innovative drugs approached 66 billion USD, nearing the total for the entire year of 2024 [3] - The acceleration of innovative drug research and development is expected due to policy support, which will help companies complete clinical trials faster and bring products to market sooner [3] - The global pharmaceutical transaction volume reached 456 deals, a 32% year-on-year increase, with upfront payments totaling 11.8 billion USD, a 136% increase [4] Group 3 - The top ten weighted stocks in the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index account for 78.87% of the index [5][6] - The recent net inflow of funds into the Hong Kong Innovative Drug Select ETF was 3.076 million yuan, with a total of 14.35 million yuan net inflow over the past five trading days [4]

Core Viewpoint - The Chinese innovative drug industry is gradually catching up with Europe and the United States in terms of technology, with some targets and technical pathways already leading globally. The number and value of new drugs authorized for overseas markets continue to increase, leading to world-class pricing and non-linear investment elasticity. The domestic market is experiencing strong growth in demand, with domestic new drug sales continuing to rise, and several innovative pharmaceutical companies have turned losses into profits, entering a stable growth phase [2]. Group 1: Innovative Drugs - The innovative drug sector is witnessing a significant increase in sales driven by strong domestic demand, with a number of innovative companies achieving profitability [2]. - The trend of domestic innovative drugs going overseas is accelerating, with increasing numbers and values of new drug authorizations [2]. - The industry is positioned for a "Davis double" effect, where both performance and valuation are expected to improve [2]. Group 2: High-Value Medical Consumables - The orthopedic sector is expected to see mild price reductions, while domestic replacements continue to grow, and overseas business progresses rapidly [2]. - The neurosurgery and neurointervention fields are stabilizing after centralized procurement, with new products expected to contribute to growth [2]. Group 3: Medical Devices - The medical device sector is experiencing a high-speed growth in bidding data, with companies entering a destocking phase, which is expected to improve performance in the second half of the year [2]. - The low-value consumables sector is seeing continuous product upgrades and accelerated expansion into overseas markets [2]. Group 4: Blood Products - The supply side of the blood products industry is increasingly concentrated among state-owned enterprises, leading to a clearer competitive landscape [2]. - The demand side is expected to upgrade towards new products, gradually improving the industry's overall health [2]. Group 5: API (Active Pharmaceutical Ingredients) - The industry is at an upward turning point due to the end of a capital expenditure peak, combined with three growth drivers: new high-end market products, integrated consolidation and overseas expansion, and cost-leading CDMO [2]. - Leading companies are expected to see explosive growth in revenue and profits in the medium term [2]. Group 6: CXO (Contract Research Organization) - The CXO sector is seeing a revival in A+H financing activity, with multiple significant business developments enhancing market confidence [2]. - The focus is on optimizing the supply-side landscape and increasing market share for leading CRO companies [2]. Group 7: Traditional Chinese Medicine and Retail Pharmacy - The traditional Chinese medicine sector is showing signs of recovery, with friendly pricing for new drugs, while the retail pharmacy sector is influenced by supply-side adjustments and business model upgrades [2]. - The performance of offline pharmacies is expected to improve in the second half of 2025, with leading chains like YaoXingTang making progress in store upgrades [2]. Group 8: Research Reports - A series of in-depth research reports on various companies and sectors within the pharmaceutical and medical device industries have been published, highlighting their growth potential and market positioning [3][4].