21世纪经济报道记者季媛媛 2025年，中国生物医药行业一扫前几年的阴霾，呈现出一系列活跃信号：创新药对外授权（License- out）交易频传捷报，一级市场融资活动回暖，一度沉寂的海外基石投资者重新出现在港股生物科技 （18A）公司的IPO名单中。投融资的"暖意"似乎正在驱散资本寒冬的记忆。 然而，这是否表明长达数年的周期性深度调整已然彻底结束？当前的复苏究竟是可持续的"新常态"的开 端，还是阶段性的情绪修复？步入2026年，驱动行业前行的核心力量究竟是什么？企业与投资者又该如 何辨识真正的机遇与潜在的泡沫呢？ 针对这些问题，安永大中华区生命科学与医疗健康行业联席主管合伙人吴晓颖接受了21世纪经济报道记 者的专访。基于其对行业的长期深耕与一线观察，吴晓颖认为，市场正从前几年的"极致压缩"回归"相 对正常"，但尚未进入全面繁荣。新一轮的上升通道正在形成，其底层支撑是结构性变化而非短期刺 激。在这个过程中，分化与理性将成为关键词。 "其实，这两年我们所看到的投融资变化，更多是从前几年的极致压缩状态，回归到了一个相对正常的 状态。"吴晓颖开门见山地指出，市场情绪与投融资活动均在修复恢复，但这更像是有质量的复苏， ...

Market Performance - The CSI Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index increased by 0.5% at midday, while the Hang Seng Hong Kong Stock Connect Innovative Drug Index rose by 0.3%. The CSI Biotechnology Theme Index and the CSI 300 Pharmaceutical and Health Index both saw a 0.1% increase, whereas the CSI Innovative Drug Industry Index declined by 0.2% [1]. Company Developments - Recently, CloudTop New Medicine announced that the U.S. FDA has approved its cardiovascular product, Lurepirdine injection, for lowering low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. The company plans to submit a listing application in the Greater China region in the first half of 2026, which is expected to boost market confidence in the internationalization prospects of innovative drugs [1].

Core Viewpoint - The launch of the Chinese Drug Price Registration System (referred to as "Drug Registration System") is expected to accelerate the internationalization of China's innovative drugs by providing a global, authoritative, standardized, and transparent market price registration platform [1][2]. Group 1: Overview of the Drug Registration System - The Drug Registration System is a national-level price registration platform independent of the medical insurance network, offering services such as price registration, price inquiry, price comparison, and notarization for drug marketing authorization holders [1]. - Pharmaceutical companies can autonomously declare and register drug prices based on their development needs, taking responsibility for the authenticity of the submitted information, while the operating unit only processes registration applications without intervening in pricing [1]. Group 2: Impact on the Pharmaceutical Industry - The establishment of the Drug Registration System is seen as a key measure to address the structural shortcomings in the pricing system, which has become a core bottleneck for companies seeking to internationalize [2]. - The platform aims to create a "one drug, one file" database covering innovative drugs and other registered varieties, providing authoritative support for companies to establish a consistent pricing system in domestic and international markets [2]. - Analysts believe that the Drug Registration System will promote the healthy development of China's pharmaceutical innovation ecosystem and facilitate high-quality internationalization, presenting long-term investment opportunities in the innovative drug sector [2].

12月2日，中国药品价格登记系统正式上线，药企可在此平台登记药品价格，并面向全球公开。 对于药品价格登记，我国既往有各省级医药采购平台。这一新平台与各省医药采购平台有何区别？登记 的药品价格如何确定？是否会影响到药价？医保部门进行了答疑。 中国药品价格登记系统上线，价格向全球公开 追问2 国内药物价格是否受影响？ 我国现已存在各省级医药采购平台，新上线的中国药登与其的关系是什么？企业登记的价格是否会对居 民购药价格产生影响？ 该平台服务方式分为线上和线下两种，线上服务是依托"线上系统网站"，实现药品价格登记和查询等基 础服务，线下服务依托"线下服务中心"，线下服务中心设在北京市西城区，设立专门国资企业，配备专 业团队，提供现场登记指导、电子版或纸质凭证打印等服务，提升服务便捷性。为满足医药企业多样化 需求，后续将逐步增加有针对性的收费性增值服务。 追问1 为何上线该系统？ 国家医保局价格招采司负责人介绍，近年来，我国医药产业创新能力显著增强，中国创新药出海已经从 一个可选项变成了许多药企的必选项和生存发展之道。在创新药国际化进程中，中国市场的终端价格参 考价值日益凸显。国家医保局发起建设中国药品价格登记系统， ...

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **innovative drug industry** in China, focusing on the **2026 outlook** and the ongoing **internationalization** of Chinese pharmaceutical companies [1][3][5][8]. Core Insights and Arguments - **Healthcare Negotiations**: Ongoing negotiations in healthcare are emphasizing tumor drugs, with innovative drugs receiving support but at potentially lower price reductions. The average price reduction for drugs is stabilizing around **60%** [2][4]. - **Commercial Insurance Directory**: The establishment of a commercial insurance directory for innovative drugs provides a second payment pathway for high-value drugs, benefiting CAR-T and ADC therapies [1][2]. - **Internationalization Phase 2.0**: Chinese pharmaceutical companies are entering the **2.0 phase** of internationalization, with a **60%** year-on-year increase in business development transactions, totaling **$88.26 billion** [3][5]. - **Focus on Innovative Technologies**: Key areas of focus include **ADC**, **I/O (immunotherapy)**, and **small nucleic acids**. Notable products and data releases are anticipated in these fields [1][6][7]. - **GLP-1 Market Potential**: The GLP-1 market is expected to grow significantly, with major companies like Eli Lilly, Roche, and AstraZeneca set to release critical clinical data in cardiovascular, diabetes, and obesity sectors [1][7]. Additional Important Content - **Collective Procurement Policies**: The latest round of collective procurement has introduced new focus areas such as maintaining clinical stability and ensuring quality, with price reductions stabilizing [4]. - **CRO Industry Recovery**: The CRO industry is experiencing a recovery, with significant growth in biopharmaceutical investments, particularly in the CDMO sector, which is benefiting from strong commercial demand [9][10]. - **Upstream Supply Chain and Equipment**: The domestic upstream supply chain and pharmaceutical equipment sectors are seeing improvements in profitability due to increased localization and technological upgrades [13]. - **Research Reagents Market**: The demand for research reagents is strong, driven by increased funding for research, with domestic brands improving in quality and responsiveness [14]. - **Impact of Global Expansion**: Local companies are leveraging global expansion strategies to alleviate domestic price pressures and enhance their competitive positioning in the international market [15]. This summary encapsulates the key points discussed in the conference call, providing insights into the current state and future outlook of the innovative drug industry in China.

Group 1 - The innovative pharmaceutical sector is experiencing three major trends: deepening internationalization 2.0, unprecedented policy support, and continuous technological breakthroughs [1] - By 2025, the number of license-out transactions is expected to reach 103, with upfront payments hitting a record high of $8.45 billion, benefiting companies that expand internationally [1] - The CXO industry adjustment is nearly complete, with stable overseas demand and a rebound in domestic investment and financing, focusing on CDMO companies with strong overseas capabilities and leading clinical CROs [1] Group 2 - The Chinese pharmaceutical industry is enhancing its competitiveness despite increasing external challenges, leveraging advantages in population, domestic demand, manufacturing, and supply chains [1] - The policy outlook indicates a shift towards high-quality growth, with a focus on optimizing drug and consumable procurement policies and diversifying payment and medical service pricing reforms by the second half of 2025 [2] - The industry is witnessing a transformation with an emphasis on supply chain security, innovation, and the integration of new technologies such as AI and brain-machine interfaces [2]

Group 1 - The report highlights the "engineer dividend" period for China's innovative drug industry, indicating that local innovations have gained full recognition from multinational corporations (MNCs) [4][5][53] - The report emphasizes the strong performance of various Chinese biotech stocks, with notable price increases observed in companies like Rongchang Biopharmaceutical (+199%) and Mawei Biopharmaceutical (+124%) in the A-share market [4][16] - The report identifies a significant increase in the number of first-in-class (FIC) drugs entering clinical trials in China, from only 9 in 2015 to an expected 120 in 2024, with China's global share of FIC drugs exceeding 30% [4][22] Group 2 - The report discusses the leading position of Chinese companies in the antibody-drug conjugate (ADC) sector, with over 50% global pipeline share in key targets such as HER2 and TROP2 [25][32] - It notes that two Chinese ADC drugs have entered the top ten global upfront payment rankings, indicating strong valuation potential for local innovations [30][31] - The report highlights the anticipated growth in bispecific antibodies (bsAbs), with Chinese companies dominating the top five global upfront payments for related assets [37][41] Group 3 - The report recommends several companies with significant global single product potential, including Kolon Biotech and Innovent Biologics, while also highlighting others like 3SBio and BeiGene as companies to watch [6][52] - It emphasizes the potential for substantial global pricing power for assets, particularly for companies like Rongchang Biopharmaceutical and Zai Lab, which are expected to see continued clinical data readouts [6][52] - The report suggests that companies like Innovent Biologics and Rongchang Biopharmaceutical are likely to turn profitable, with expectations of improved financial performance in the coming years [6][52]

Core Viewpoint - The overall revenue growth rate of the chemical pharmaceutical industry is projected to be -2.1% for Q1-Q3 2025, while the net profit margin (excluding non-recurring items) is expected to be 12.5%, indicating short-term revenue pressure but continuous improvement in profitability [1][2]. Group 1: Industry Performance - The pharmaceutical industry is experiencing a decline in revenue growth, with a rate of -2.1% for Q1-Q3 2025, but profitability is on the rise, as indicated by a net profit margin of 12.5% [1]. - Research and development (R&D) expenditure is increasing, with an R&D expense ratio of 9.6% for the first three quarters of 2025, up by 0.7 percentage points year-on-year [1]. - The financial data of 18 A-share biotech companies shows a revenue of 10 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 17.3%, while the net loss (excluding non-recurring items) has narrowed by 25.2% [1]. Group 2: Internationalization and Innovation - The internationalization of domestic pharmaceutical companies is crucial for innovation upgrades, with a total transaction amount of 93.7 billion USD for Q1-Q3 2025, matching the total amount of foreign transactions [2]. - The number of transactions reached 230, with upfront payments totaling 5 billion USD, both figures surpassing the total for the entire year of 2024, indicating a growing emphasis on independent R&D capabilities [2]. Group 3: Investment Opportunities - The domestic pharmaceutical industry is expected to benefit from a new product cycle driven by innovation and internationalization, presenting medium to long-term investment opportunities [3]. - The implementation of the "Full Chain Support for Innovative Drug Development" plan clarifies the industry's development direction, emphasizing continuous quality improvement in innovation [3]. Group 4: Recommended Stocks - Recommended stocks in the innovative drug sector include: 恒瑞医药 (600276.SH), 科伦博泰生物-B (06990), 百利天恒-U (688506.SH), and others [4]. - In the specialty drug sector, recommended stocks include: 人福医药 (600079.SH), 恩华药业 (002262.SZ), and 东诚药业 (002675.SZ) [4].

Group 1 - The National Medical Products Administration of China has approved 2 innovative drugs and 2 innovative medical devices for market entry since November, indicating a shift from being a "technology follower" to a "technology leader" with 4,804 innovative drugs in the pipeline, ranking second globally [1] - In 2025, negotiations for the national basic medical insurance drug catalog and commercial insurance innovative drug catalog pricing have been completed, with 120 companies participating, including 127 drugs for basic medical insurance and 24 for commercial insurance [1] Group 2 - The Hong Kong innovative drug ETF (SH520700) has shown a 2.13% increase, reflecting a clear trend of innovation going global, with ongoing benefits from drug review reforms and supportive policies [2] - The Chinese innovative drug industry has entered its 2.0 era, transitioning from "importing and imitating" to "innovative output," with various forms of internationalization such as license out and new co [2] - The ETF tracks the CSI Hong Kong Stock Connect Innovative Drug Index, which includes leading companies like BeiGene, Innovent Biologics, and WuXi AppTec, focusing on innovative drug development, production, and services in the Hong Kong market [2]

Market Overview - A-shares experienced a slight decline with the Shanghai Composite Index closing at 4000.14 points, down 0.07%, while the Shenzhen Component Index and the ChiNext Index fell by 0.36% and 0.39% respectively [1] - The Hong Kong market saw the Hang Seng Index rise over 1% during the session [1] Sector Performance Banking and Insurance - The banking and insurance sectors showed strength, with Agricultural Bank of China rising over 3% to reach a historical high, and major insurance stocks like China Life and New China Life also posting gains [9][10] - Analysts suggest that the economic recovery is injecting new growth momentum into the financial sector, with insurance products gaining traction due to low interest rates and regulatory guidance [9] Storage Chip Sector - The storage chip sector remained active, with companies like Xiangnan Chip and Demingli seeing significant gains of 10.47% and 6.06% respectively [5] - Global supply chain issues have led to a tight balance in the storage chip market, with SanDisk raising NAND flash contract prices by 50% [5][7] - Analysts predict that the storage chip price increase will continue through 2026, driven by a structural demand surge and limited supply [7] Pharmaceutical Sector - The pharmaceutical sector was notably active, with stocks like Kaineng Health and Sanmian Gene hitting the daily limit up of 20% and over 12% respectively [12] - The domestic innovative drug industry is showing long-term growth potential, with increased licensing deals expected to enhance global market commercialization [14] Solar Industry - The solar industry faced a significant downturn, with stocks like Aters falling over 14% and Longi Green Energy dropping more than 6% [16] - The China Photovoltaic Industry Association issued a statement refuting false information circulating online, emphasizing the need for careful decision-making [16]