交银国际研究 消息快报 中国内地生物类似药集采启动在即，或涉及多个大品种 丁政宁 Ethan.Ding@bocomgroup.com (852) 3766 1834 诸葛乐懿 Gloria.Zhuge@bocomgroup.com (852) 3766 1845 此报告最后部分的分析师披露、商业关系披露和免责声明为报告的一部分，必须阅读。 下载本公司之研究报告，可从彭博信息：BOCM 或 https://research.bocomgroup.com 医药 2025 年 8 月 4 日 中国内地生物类似药集采即将启动：安徽省医药集中采购平台发布《关于 开展部分单抗类生物制剂信息填报收集工作的通知》，针对 8 款单抗类生 物药的销售情况、产能、获批适应症等信息，要求生产企业进行填报。今 年 1 月，安徽省医保工作会议曾提出，要牵头全国生物药品联盟集采，我 们认为此次信息填报标志着集采工作正式启动。按照过往化学仿制药集采 的经验，信息填报到正式开标需要 1-2 个月的时间，但鉴于此次是中国内 地第一次生物类似药集采，我们预计：1）信息整理、规则制定可能需要 更长时间，建议关注最终纳入品种和竞标规则的出台；2）竞标 ...

Core Insights - The Chinese life sciences industry is undergoing rapid transformation driven by policy relaxation, technological innovation, the rise of domestic companies, and the development of specialized real estate ecosystems [9][18][39] - The report "Trends in China's Life Sciences" provides a comprehensive overview of current market dynamics, regulatory changes, and future development directions [9] Policy Environment - Nationally, China has relaxed foreign investment restrictions in gene and cell therapy, allowing foreign-owned hospitals in major cities [10][20] - Local governments in cities like Beijing, Shanghai, and Shenzhen are offering targeted subsidies and fast-track approval processes to support biotechnology development [10][27] Industry Innovation and Company Growth - Chinese life sciences companies are shifting from generic drug production to innovative therapies, with firms like CanSino Biologics and BeiGene leading in CAR-T cell therapy and bispecific antibodies [11][29] - These companies are attracting international investment and licensing agreements, enhancing China's position in the global life sciences sector [11][39] Real Estate Development and Regional Hubs - Innovation hubs such as Suzhou BioBay and Shanghai Zhangjiang Hi-Tech Park provide end-to-end support, including shared laboratories and GMP-compliant facilities [12][35] - Second-tier cities like Chengdu and Ningbo are emerging as new growth centers, expanding the life sciences ecosystem [12][35] Owner Perspective - Real estate developers are adapting to industry-specific needs through light-asset models and flexible leasing arrangements [14][45] - While first-tier cities face saturation, demand remains robust in central and western regions, with a focus on sustainability and compliance [14][45] Tenant Perspective - Life sciences tenants are responding to regulatory reforms and increased compliance requirements, seeking flexibility and proximity to talent and infrastructure [15][46] - The highest demand is for GMP-certified laboratories and modular production facilities, emphasizing location advantages and sustainability certifications [15][46] Future Outlook - Growth opportunities lie in AI-driven drug development, personalized medicine, and advanced therapies, supported by government policies [16][39] - Life sciences real estate is evolving from generic parks to specialized, digitally-enabled facilities with high compliance and flexibility [16][39]

Company Overview - Legend Biotech Corporation's shares increased by 6% to close at $42.13, with a notable trading volume compared to normal sessions, and a total gain of 13.9% over the past four weeks [1][2] Product Performance - The rise in stock price is attributed to investor optimism regarding the strong sales of Carvykti, a therapy for relapsed or refractory multiple myeloma, developed in partnership with Johnson & Johnson [2] Financial Expectations - The company is projected to report a quarterly loss of $0.18 per share, reflecting a year-over-year decline of 260%, while revenues are expected to reach $233.67 million, marking a 25.3% increase from the previous year [3] - The consensus EPS estimate for the upcoming quarter has been revised 4.1% higher in the last 30 days, indicating a potential for price appreciation [4] Industry Context - Legend Biotech is categorized within the Zacks Medical - Biomedical and Genetics industry, where Vanda Pharmaceuticals, another company in the same sector, has also shown a 1% increase in its stock price recently [4] - Vanda's consensus EPS estimate remains unchanged at -$0.34, representing a 325% decline from the previous year [5]

Market Performance - The S&P 500 and Nasdaq indices reached new all-time highs, driven by strong retail data and a decrease in initial jobless claims [1] - The Dow Jones Industrial Average rose by 0.52% to 44,484.49 points, while the Nasdaq increased by 0.75% to 20,885.65 points, and the S&P 500 gained 0.54% to 6,297.36 points [1] Economic Data - U.S. retail sales increased by 0.6% month-over-month in June, surpassing market expectations of 0.1% and reversing a 0.9% decline in May [2] - Core retail sales, excluding automobiles, gasoline, building materials, and food services, grew by 0.5% in June, up from a downwardly revised 0.2% in May [2] - Ten out of thirteen major retail categories experienced growth, with auto sales rebounding after two months of decline [2] Inflation and Employment - The Consumer Price Index (CPI) rose by 0.3% month-over-month and 2.7% year-over-year in June, aligning with market expectations [3] - Initial jobless claims fell to 221,000, marking a decrease of 7,000 and the lowest level since mid-April, indicating a resilient job market [3] Cryptocurrency Legislation - The U.S. House of Representatives passed three significant cryptocurrency bills, including the "Genius Act" aimed at major regulatory reforms for cryptocurrencies [4] - The "Clarity Act" was also passed, which seeks to establish a broader regulatory framework for digital assets [4] - President Trump is expected to sign an executive order to open alternative investments, including cryptocurrencies, to the $9 trillion U.S. retirement market [4] Commodity Prices - International oil prices rose due to positive U.S. economic data and ongoing geopolitical risks in the Middle East, with WTI crude oil futures increasing by $1.16 to $67.54 per barrel [5] - Gold futures fell by 0.41% to $3,345.40 per ounce, while silver futures rose by 0.83% to $38.44 per ounce [5]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the Chinese innovative pharmaceutical industry, particularly focusing on PD-1 drugs and their market dynamics, as well as the medical device sector and CDMO companies [1][4][5]. Core Insights and Arguments PD-1 Drug Market - The core patent for PD-1 immunotherapy drugs is expected to expire in 2032, with a potential global market size reaching $100 billion, facing competition from biosimilars [4]. - Investment strategies include extending patents through ADC combinations (e.g., Bai Li Tian Heng) and identifying next-generation immunotherapies (e.g., Innovent Biologics' interleukin-2), which have significant potential in both cold and hot tumor markets [1][4]. Medical Device Sector - Companies in the medical device sector, such as United Imaging, may face pressure in Q2 but are expected to maintain growth [5]. - The IVD sector experienced a decline in the first half of the year due to centralized procurement but is anticipated to see a turnaround in Q3 and Q4 [5]. - The orthopedic sector is entering a performance release phase post-centralized procurement [5]. - Long-term focus on leading companies like Mindray and United Imaging, as well as the home medical device sector, which has shown strong performance due to government subsidies [5]. CDMO Companies - CDMO companies have seen a significant increase in overseas orders, with order value growth rates reaching 15%-20%, leading to a recovery in revenue and profit growth [10]. - Recommendations include companies with low valuations and strong fundamentals, such as those reporting nearly 20% revenue growth and a net profit margin of 33% in Q2 [10]. Traditional Chinese Medicine and Biopharmaceuticals - Investment recommendations focus on innovative drug layouts in traditional Chinese medicine, highlighting companies like Tasly and Kangyuan, which have underappreciated innovative drug assets [7]. - OTC products are recovering in retail pharmacies, with companies like Mayinglong and Lingrui showing stable performance [7]. Market Trends and Economic Impact - The service and pharmacy sectors are expected to face pressure in the first half of 2025, with growth slowing due to their close correlation with the economic cycle [6]. - The domestic innovation research and development investment is entering a new cycle, with BD upfront payments becoming a primary funding source [11]. Additional Important Insights - The "borrowing ship" and "building ship" models for Chinese innovative drugs are discussed, with the former involving patent licensing and the latter focusing on independent overseas market entry [15][16]. - Successful cases of the "building ship" model include BeiGene's BTK inhibitor and Legend Biotech's CAR-T therapy, indicating a shift towards independent innovation in the Chinese pharmaceutical sector [17][18]. - The cultivation medium business of Aopumai has shown strong growth, with over 50% revenue increase in Q2, benefiting from domestic substitution trends [12]. Conclusion - The Chinese innovative pharmaceutical industry is poised for significant growth, driven by patent expirations, innovative therapies, and expanding overseas markets. The medical device sector and CDMO companies also present promising investment opportunities amidst evolving market dynamics.

Investment Rating - The report maintains a "Positive" investment rating for the healthcare industry [9]. Core Insights - Chinese pharmaceutical companies are increasingly enhancing their original research capabilities, leading to a surge in high-quality innovative products gaining international recognition. This trend is facilitating the acceleration of domestic innovative drugs entering global markets through two primary pathways: "building ships" and "borrowing ships" [2][6]. - The total value of license-out transactions from China reached over $43 billion in 2024, accounting for nearly 20% of the global total, indicating a significant shift in the global pharmaceutical landscape as Chinese innovative drugs gain traction [6][17]. Summary by Sections Innovative Drug Globalization - Chinese innovative drug companies are transitioning from "following overseas" to "independent innovation," with a notable increase in original research capabilities. The number of Chinese companies participating in major international conferences like AACR and ASCO has reached historical highs, with 126 companies presenting nearly 300 new drug research results at the 2025 AACR conference [17][18]. - The number of original innovative drugs approved in China has increased from 11 in 2015 to 92 in 2024, with the proportion of globally developed first-in-class (FIC) drugs rising from 9% to 24% during the same period [21][22]. "Building Ships" and "Borrowing Ships" Models - "Building ships" refers to domestic companies independently conducting overseas clinical trials and obtaining market approvals. Notable examples include BeiGene's BTK inhibitor, which achieved over $2.6 billion in global sales, and Legend Biotech's CAR-T therapy, which reached $963 million in global sales in 2024 [25][26]. - "Borrowing ships" involves leveraging partnerships for international development and commercialization. The total value of license-out transactions in the Chinese innovative drug sector reached $51.9 billion in 2024, with over 50 transactions reported in the first half of 2025, totaling $48.4 billion [27][28]. Investment Perspective - The report emphasizes that the ongoing transformation in the healthcare sector, driven by innovative drug globalization, presents significant investment opportunities. Companies with strong cash flow, innovative capabilities, and established research platforms are particularly well-positioned for growth [43].

CARVYKTI® Performance and Market Position - CARVYKTI® demonstrates superior Overall Survival (OS) compared to Standard of Care (SoC) in Multiple Myeloma[15, 25] - CARVYKTI® has a strong launch with a 79% Net Trade Sales Compound Annual Growth Rate (CAGR) since launch, leading the industry[15] - CARVYKTI® Net Trade Sales grew by 135% in Q1 2025 compared to Q1 2024[34] - Outpatient treatment represents up to approximately 48% of CARVYKTI® volume in the U S [44] Manufacturing and Supply - The company aims to achieve 10,000 annualized doses of CARVYKTI® exiting 2025 and 20,000 annualized doses exiting 2027[58] - Commercial production at the Tech Lane facility in Belgium is targeted to initiate in the second half of 2025[58] Pipeline and R&D - The company has 11 pipeline programs in Hematologic Malignancies, Solid Tumors, and Autoimmune Diseases[11] - Legend Biotech and Novartis have an exclusive agreement to advance DLL3-targeted CAR-T therapies, including LB2102 for small cell lung cancer[74] - LB2102 targets DLL-3, which is approximately 80% positive in Small Cell Lung Cancer (SCLC)[80] Multiple Myeloma Market - Multiple Myeloma accounts for 10% of all hematologic cancers[17] - There were 187,952 new cases of Multiple Myeloma worldwide in 2022[18]

Investment Rating - The industry investment rating is maintained at "Outperform the Market" [3][82]. Core Viewpoints - The report emphasizes the significant progress of Chinese innovative drugs, highlighting their emergence as a global force in the pharmaceutical industry, supported by a solid industrial foundation, policy backing, and capital support [4][5]. - The gap between Chinese and global innovative drugs has narrowed significantly, with the time to market for first-in-class drugs reduced from over 10 years to within 1-5 years [4]. - The report indicates that Chinese companies now account for over 30% of global clinical trials, with more than 60% of popular targets being pursued by Chinese firms [35][38]. Summary by Sections Breakthrough Therapies - The development of innovative drugs in China is underpinned by a robust industrial base, supportive policies, and substantial capital investment, leading to rapid growth in the ADC market and next-generation therapies [4][12]. - Key drugs such as Keytruda and Semaglutide are projected to generate sales of $29.482 billion and $29.296 billion respectively in 2024, showcasing the potential of innovative therapies [4][12]. Achievements - Chinese innovative drugs have made significant strides, with the clinical trial participation rate increasing from 9.7% in 2016 to 28.2% in 2023 [35]. - The report notes that the number of Chinese companies involved in clinical trials for oncology drugs has risen from 15% in 2016 to 35.5% in 2023, indicating a strong focus on cancer therapies [35]. Leading Trends - The rapid growth of License Out transactions has provided substantial cash flow for innovative drug companies, facilitating their expansion into international markets [5][66]. - The report highlights that the Chinese market is still dominated by foreign patented drugs, but there is significant potential for domestic innovative drugs to capture market share, especially as many foreign drugs face expiration of patents [70][72].

Investment Rating - The industry rating is maintained at "Outperform" [3] Core Insights - Breakthrough therapies (BTD) are defined as drugs that demonstrate significant and reliable clinical significance, aimed at accelerating the treatment of severe diseases or conditions that critically affect survival quality [4][6] - As of June 4, 2025, a total of 126 domestic innovative drugs have been approved for BTD by CDE, with a trend of expanding from traditional targets like PD-1 and HER2 to emerging targets such as PD-1/IL-2 and BCL2 [4][13] - The potential for overseas expansion of BTD drugs is notable, with 25% of domestic BTD molecules having achieved international market entry, compared to only 1% of all domestic molecules [28][29] Summary by Sections Breakthrough Therapy Overview - Breakthrough therapies were introduced in China in 2020 to expedite the development of innovative drugs for severe diseases [4] - The dynamic shift in breakthrough therapies shows a diversification of targets and companies involved, with emerging biotech firms gaining traction alongside established pharmaceutical companies [4][5] Market Dynamics - The CDE has approved 171 BTD products, with a significant portion being domestic innovations, indicating a robust pipeline for future drug development [13] - The distribution of BTD approvals shows that traditional chemical drugs and monoclonal antibodies dominate, while new molecular types like ADCs are gaining prominence [14][17] Company Performance - Leading companies in BTD approvals include Heng Rui Medicine with 17 approvals, followed by Innovent with 10 and CSPC with 8 [17] - Emerging biotech firms such as Shuyou and Legend Biotech are also highlighted for their potential in the BTD landscape [17] Clinical Progress and Global Expansion - Domestic innovative drugs are progressing steadily in clinical trials, with 13 products approved overseas and 60 in clinical stages as of June 4, 2025 [13] - The report identifies several domestic drugs with high potential for international expansion based on their clinical progress and BTD certification [31][32]

Market Performance - The three major U.S. stock indices closed lower, with the Dow Jones down 0.25% at 42,319.74 points, the S&P 500 down 0.53% at 5,939.3 points, and the Nasdaq down 0.83% at 19,298.45 points [1] - Most large tech stocks declined, with Tesla dropping over 14%, Apple down more than 1%, Nvidia down over 1%, and Facebook down 0.48%. In contrast, Google rose 0.1%, Amazon increased 0.33%, and Microsoft gained 0.82% [1] Chinese Stocks - Most Chinese stocks saw gains, with Zhihu Group rising nearly 13%, Kingsoft Cloud up over 7%, Lotus Technology increasing over 5%, and GDS Holdings up over 4%. However, some stocks like Linklogis and Bawang Tea fell over 9% [1] European Indices - European major indices showed mixed results, with Germany's DAX index up 0.19% at 24,323.58 points, reaching a new historical high, while France's CAC40 index fell 0.18% to 7,790.27 points, and the UK's FTSE 100 index rose 0.11% to 8,811.04 points [1] Commodity Prices - International precious metal futures closed mixed, with COMEX gold futures down 0.68% at $3,376.1 per ounce, while COMEX silver futures rose 3.31% to $35.795 per ounce [1] - International oil prices increased across the board, with WTI crude oil main contract up 0.64% at $63.25 per barrel and Brent crude oil main contract up 0.66% at $65.29 per barrel [1] Currency and Bond Yields - The U.S. dollar index fell 0.07% to 98.74, while the offshore RMB against the U.S. dollar dropped 38.5 basis points to 7.1755 [1] - U.S. Treasury yields rose across the board, with the 2-year yield up 6.19 basis points to 3.924%, the 3-year yield up 6.82 basis points to 3.894%, the 5-year yield up 7.13 basis points to 3.995%, the 10-year yield up 3.93 basis points to 4.395%, and the 30-year yield up 0.61 basis points to 4.883% [1] - European bond yields also generally increased, with the UK 10-year yield up 1 basis point to 4.614%, France's 10-year yield up 4.7 basis points to 3.248%, Germany's 10-year yield up 5.2 basis points to 2.576%, Italy's 10-year yield up 3.5 basis points to 3.524%, and Spain's 10-year yield up 4 basis points to 3.155% [1]