创新药行情持续火热，建议关注 PD-1/L1 双抗及多抗 [Table_Industry] 医药生物行业周报 [Table_ReportTime] 2025 年 7 月 6 日 证券研究报告 行业研究 [Table_ReportType] 行业周报 医药生物 医药生物 投资评级 看好 上次评级 看好 [Table_A 唐爱金 uthor 医药首席分析师 ] 执业编号：S1500523080002 邮 箱：tangaijin@cindasc.com 贺鑫 医药行业分析师 执业编号：S1500524120003 邮 箱：hexin1@cindasc.com 曹佳琳 医药行业分析师 执业编号：S1500523080011 邮 箱：caojialin@cindasc.com 章钟涛 医药行业分析师 执业编号：S1500524030003 邮 箱：zhangzhongtao@cindasc.com 赵丹 医药行业分析师 执业编号：S1500524120002 邮 箱：zhaodan@cindasc.com 信达证券股份有限公司 CINDA SECURITIES CO.,LTD 北京市西城区宣武门西大街甲127号金隅大厦 ...

Core Insights - The company, Haili Biological (603718.SH), reported a significant net profit increase of 172.28% in 2024, with non-recurring gains accounting for 93.82% of net profit, despite a revenue decline in Q1 2025 [2][5][8] - Haili Biological has transitioned from animal health products to human health products, leading to a substantial restructuring of its business model [2][9] Financial Performance - In 2024, Haili Biological's net profit reached approximately 1.71 billion yuan, with a notable increase attributed to asset disposals and acquisitions [4][5] - The company achieved an investment return exceeding 1 billion yuan from the sale of a 30% stake in WuXi Vaccines, which had previously generated low returns [5][6] - The sale of Yangling Jinhai at a nominal price of 1 yuan was a strategic move to eliminate ongoing losses, with the company recovering all debts owed by Yangling Jinhai [6][8] Asset Management - Haili Biological completed the acquisition of a 55% stake in Shaanxi Ruisheng Biotechnology, which is focused on oral tissue repair and regeneration materials, resulting in a goodwill of approximately 782 million yuan [9][10] - The company has prioritized finding quality projects in the oral and IVD sectors following the restructuring, although it acknowledges the challenges in identifying such opportunities [3][9] Market Dynamics - The oral vaccine market, particularly for foot-and-mouth disease, is facing increased competition and declining profitability, prompting Haili Biological to divest from Yangling Jinhai [7][8] - The revenue from Ruisheng Biotechnology in 2024 was approximately 265 million yuan, slightly below expectations, but the net profit exceeded targets [11]

Core Viewpoint - The company reported a revenue of 297 million yuan for 2024, representing a year-on-year growth of 22.26%, with significant variations across different product lines and services [3][4][6]. Revenue and Gross Margin Analysis - The revenue breakdown shows that CHO culture media revenue increased by 62.83%, while CDMO service revenue declined by 25.66% [3][16]. - The gross margin for domestic CDMO services dropped significantly, while the gross margin for culture media remained relatively stable [24][25]. Product Sales Performance - CHO culture media sales in the domestic market reached 126.05 million yuan, a 33.01% increase, driven by ongoing customer projects [11][12]. - The sales volume of 293 culture media decreased by 16.28% in the domestic market due to lower demand in related application fields [12][13]. - Other products, including contract manufacturing and vaccine culture media, saw a notable increase in revenue due to stable orders from overseas clients [13][15]. CDMO Business Challenges - The CDMO business faced a significant decline in revenue, attributed to a tightening financing environment in the biopharmaceutical industry, leading to reduced project initiation and progression [35]. - The number of high-value orders (over 5 million yuan) significantly decreased, impacting overall revenue [17][35]. - The company reported a negative gross margin for CDMO services in 2024, primarily due to increased material costs and operational expenses from the new commercial production platform [35][36]. Customer and Market Dynamics - The company’s top five overseas clients contributed significantly to revenue growth, with notable increases in sales to key customers [20][22]. - The overall customer base remained stable, but the number of high-value clients decreased, reflecting a challenging market environment [7][35]. - The company continues to focus on providing high-quality CDMO services despite facing increased competition and cost pressures [35].

Core Viewpoint - The Hang Seng Healthcare Index (HSHCI) has shown strong performance, with significant gains in constituent stocks, indicating a positive trend in the healthcare sector [3]. Group 1: Market Performance - As of July 4, 2025, the HSHCI rose by 1.19%, with notable increases in stocks such as Huahao Zhongtian Pharmaceutical-B (02563) up 16.34% and Kangfang Biotech (09926) up 8.67% [3]. - The Hang Seng Healthcare ETF (513060) increased by 0.86%, with a latest price of 0.59 yuan, and has seen a cumulative increase of 3.57% over the past week [3]. - The ETF recorded a turnover rate of 18.66% during the trading session, with a transaction volume of 1.516 billion yuan, indicating active market participation [3]. Group 2: Investment Opportunities - Huatai Securities suggests that AI is expected to reshape drug development and healthcare service delivery, with increasing applications in the medical field, highlighting potential investment opportunities by 2025 [4]. - The Hang Seng Healthcare ETF has seen a significant growth in scale, with an increase of 191 million yuan over the past week, ranking in the top third among comparable funds [4]. - Leveraged funds are actively investing, with the latest financing buy-in amounting to 291 million yuan and a financing balance of 277 million yuan [4]. Group 3: Performance Metrics - The Hang Seng Healthcare ETF has achieved a net value increase of 18.78% over the past two years, with a maximum monthly return of 28.34% since inception [4]. - The ETF has outperformed its benchmark with an annualized excess return of 1.73% over the past year, and a Sharpe ratio of 1.85 as of June 27, 2025 [4]. - The ETF has the lowest drawdown among comparable funds, with a relative drawdown of 0.45% year-to-date [4]. Group 4: Fee Structure and Valuation - The management fee for the Hang Seng Healthcare ETF is 0.50%, and the custody fee is 0.15% [5]. - The ETF's tracking error over the past year is 0.069%, the highest tracking precision among comparable funds [5]. - The latest price-to-earnings ratio (PE-TTM) for the HSHCI is 27.68, indicating a valuation below 90.41% of the historical data over the past three years, suggesting it is at a historical low [5]. Group 5: Index Composition - The top ten weighted stocks in the HSHCI account for 58.46% of the index, including companies like Innovent Biologics (01801) and BeiGene (06160) [5].

Core Viewpoint - The pharmaceutical sector is experiencing significant movements, particularly with AstraZeneca exploring a potential $15 billion deal with SMMT, indicating strong interest in the PD(L)1*VEGF market, which is expected to grow substantially by 2030 [1][2]. Group 1: Market Performance - As of July 4, 2025, the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Composite Index (930965) shows mixed performance among its constituent stocks, with Kangfang Biotech (09926) leading with a 3.86% increase [1]. - The Hong Kong Pharmaceutical ETF (159718) has seen a net value increase of 67.88% over the past year, currently priced at 0.86 yuan [1]. - The CSI Pharmaceutical and Medical Device Innovation Index (931484) has risen by 0.01%, with notable gains from stocks like Baillie Gifford (688506) and Kanghong Pharmaceutical (002773) [5][10]. Group 2: AstraZeneca's Strategic Moves - AstraZeneca is in discussions with SMMT regarding a potential $15 billion transaction, reflecting its strong positioning in the oncology sector and the need for a quality IO asset [1]. - The company is expected to generate 14 billion yuan in operating cash flow by 2025, with half available for business development and acquisitions, indicating a robust financial position to pursue significant transactions [1]. Group 3: PD(L)1*VEGF Market Insights - The PD(L)1*VEGF market is projected to reach $100 billion by 2030, with 42 approved indications, primarily in lung, stomach, kidney, bladder, liver, and head and neck cancers [2]. - Companies like Kangfang Biotech and Promis Biotech are exploring additional indications in China, suggesting a broadening of the PD(L)1*VEGF market [2]. - Other multinational corporations (MNCs) such as MSD, BMS, PFE, and ABBV are also likely to enter the PD(L)1*VEGF space, indicating a competitive landscape similar to the early days of PD(L)1 monoclonal antibodies [3].

Group 1 - The core viewpoint of the news highlights a significant rise in the innovative drug sector, with the Hang Seng Biotechnology ETF (513280) increasing by 3.5% and showing net inflows for 3 out of the last 5 days, making it the only ETF in its index with positive growth in shares this year [1][3] - The A-share innovative drug sector also saw gains, with the Biopharmaceutical ETF (159839) rising by 1.72% [1] - Notable stock performances include Kangfang Biotech rising over 14%, and other companies like Innovent Biologics and CSPC Pharmaceutical Group also showing significant increases [3] Group 2 - Kangfang Biotech announced the completion of the first patient enrollment in the Phase Ia clinical study for its dual-target ADC drug AK146D1, which targets Trop2 and Nectin4 for treating advanced solid tumors [3][4] - AK146D1 is the first dual-target ADC drug to enter clinical stages for Kangfang Biotech, having received approvals from the FDA, TGA, and the National Medical Products Administration for clinical trials [4] - The drug aims to enhance efficacy and reduce resistance and toxicity by targeting both Trop2 and Nectin4, which are promising tumor targets [4] Group 3 - New policies have been introduced to support the development of innovative drugs, including measures from the National Healthcare Security Administration and the National Health Commission aimed at enhancing the quality of innovative drug development [4][5] - The introduction of a commercial health insurance directory for innovative drugs is expected to expand market opportunities and incentivize pharmaceutical companies to increase R&D efforts [5][6] - The measures include optimizing drug directory access policies and promoting the global market development of innovative drugs [5] Group 4 - The Hang Seng Biotechnology ETF (513280) is noted for its high proportion of innovative drugs and is the only ETF in its category to have net inflows this year, with a year-to-date share change of 11.40% [7] - The ETF is also recognized for having the lowest management fees among Hong Kong pharmaceutical ETFs, making it an attractive option for investors [7] - The Biopharmaceutical ETF (159839) focuses on leading companies in the sector, emphasizing a higher concentration and potential for growth [7]

Group 1 - The Hang Seng Index Company announced adjustments to the calculation methods of several indices, including the Hang Seng Hong Kong Stock Connect Innovative Drug Index, Hang Seng Innovative Drug Index, Hang Seng Biotechnology Index, and Hang Seng Hong Kong-US Biotechnology Index [1] - The adjustments aim to enhance the focus on pure innovative drug companies by excluding companies primarily engaged in the CXO industry, which includes Contract Research Organizations (CRO), Contract Manufacturing Organizations (CMO), and Contract Development and Manufacturing Organizations (CDMO) [2][4] - The changes will result in a more concentrated index composition, with the top five constituents of the Hang Seng Hong Kong Stock Connect Innovative Drug Index shifting to companies like Innovent Biologics, BeiGene, and others, while the previous weight of excluded companies was approximately 18.1% [3] Group 2 - The Hang Seng Biotechnology Index will see a reduction in the number of constituents from 50 to a fixed number of 30, along with new trading qualification requirements under the Stock Connect program [6] - The Hang Seng Hong Kong-US Biotechnology Index will also reduce its constituent count from 60 to a fixed number of 40, indicating a significant decrease in the number of stocks included [9] - The adjustments to the indices will take effect on June 30, 2025, with the changes in constituent stocks implemented on September 8, 2025 [9]

Company Overview - Beihai Kangcheng Pharmaceutical Co., Ltd. (stock code 01228.HK) is a leading global biopharmaceutical company in China, focusing on rare diseases and dedicated to the research, development, and commercialization of innovative therapies [2] - The company has a portfolio of 10 drug assets with significant market potential, including 2 approved products and 8 in development, targeting common rare disease indications such as Hunter syndrome and other lysosomal storage diseases, complement-mediated diseases, hemophilia A, metabolic disorders, rare cholestatic liver diseases, and neuromuscular diseases [2] Research and Development - The company is developing new and potentially curative gene therapies for rare genetic diseases, including Pompe disease, Fabry disease, Duchenne muscular dystrophy (DMD), and other neuromuscular diseases at its next-generation gene technology R&D center [2] - Beihai Kangcheng collaborates with leading researchers and biotechnology companies globally, including Apogenix, GCPharma, Mirum, WuXi Biologics, Privus, Washington University School of Medicine, and ScriptrGlobal [2] Management Team - The company is led by a management team with extensive experience in the rare disease sector, covering R&D, clinical development, regulatory affairs, business development, and commercialization [3] - 42% of the employees hold PhDs and/or MDs, and over 70% have experience working in multinational biopharmaceutical companies [3] - The management team has a strong track record of successfully obtaining approvals and commercializing rare disease therapies in major markets, including China and the United States [3] Industry Context - As of the latest data, the average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is 3.78 times, with a median of 6.52 times [1] - Beihai Kangcheng's P/E ratio is -0.28 times, ranking 155th in the industry, indicating a significant undervaluation compared to peers such as Jingxin Pharmaceutical (0.85 times) and King’s Ray Biotechnology (1.44 times) [1]

Group 1: Market Performance - A-shares' three major indices collectively rose, with the Shanghai Composite Index reaching a new high for the year, closing up 0.18% [1] - The Shenzhen Component Index increased by 1.17%, and the ChiNext Index rose by 1.90%, with total trading volume exceeding 1.3 trillion yuan [1] Group 2: Innovation Drug Sector - The Hong Kong innovation drug sector demonstrated significant elasticity, with multiple ETFs rising over 4% following the release of new policies to support high-quality development of innovative drugs [2][3] - The new policies introduced by the National Healthcare Security Administration and the National Health Commission aim to address industry challenges and promote the growth of the innovative drug market, which is expected to exceed 1.3 trillion yuan in 2024, with a growth rate of 12%-15% anticipated for 2025 [3] Group 3: Investment Trends - Southbound funds have significantly increased their investment in Hong Kong stocks, with a net purchase amount reaching 725.973 billion HKD in the first half of 2025, surpassing the previous year's level [4] - Major companies like Tencent, Alibaba, and Xiaomi have seen their market values increase by over 10 billion HKD due to strong performance and improved liquidity in the market [4] Group 4: ETF Activity - The Hong Kong innovation drug ETF (513120) recorded the highest trading volume among stock products, reaching 9.712 billion yuan, while other bond ETFs also showed strong trading activity [5] - The turnover rate for the benchmark national debt ETF (511100) was notably high at 827.90%, indicating strong trading interest in the sector [6] Group 5: New ETF Launch - The Huaxia Hong Kong Stock Connect Medical ETF (520510) is set to begin fundraising, focusing on core enterprises in the medical field within the Hong Kong Stock Connect range [7] - The index tracks 50 selected stocks, primarily in medical services and innovative drug sectors, highlighting significant coverage of the pharmaceutical outsourcing and innovative drug industry chain [7]

Group 1 - The core viewpoint of the news highlights the recent measures introduced by the National Healthcare Security Administration and the National Health Commission to support the high-quality development of innovative drugs, which includes 16 specific measures aimed at enhancing R&D support, integrating innovative drugs into basic medical insurance, and improving clinical application and payment capabilities [1][2] - There has been a significant increase in multinational pharmaceutical companies purchasing innovative drug patents from China, with the procurement amount from January to May nearing the total for the entire year of 2024, indicating the competitive strength of Chinese innovative drugs in the international market [2] - The Hang Seng Innovative Drug ETF (520500) saw a nearly 4% increase in early trading, tracking the Hang Seng Innovative Drug Index, with a current scale of approximately 700 million [2][5] Group 2 - The Hong Kong Stock Connect Medical ETF (159506) rose by 3.5% in early trading, tracking the Hang Seng Hong Kong Stock Connect Healthcare Index, with a scale of 2.27 billion [2] - Other ETFs such as the Hong Kong Stock Connect Innovative Drug ETF (159217), Hong Kong Innovative Drug ETF (159567), and Hong Kong Stock Connect Innovative Drug ETF (159570) also showed positive performance, with scales exceeding 3 billion, and the latter reaching 8.518 billion [2][5] - The CSI Hong Kong Innovative Drug Index selects up to 50 listed companies involved in innovative drug R&D from the Hong Kong Stock Connect range, reflecting the overall performance of innovative drug companies in the market [7][8]