2025 年 4 月 28 日 证券研究报告/公司研究 化学制剂/化学制药/医药生物 艾力斯 688578.SH 基础数据： 截至 2025 年 4 月 27 日 huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 weiyuqi@gwgsc.com 执业证书编号：S0200123060002 联系电话：010-68099389 富层大厦 17 楼 伏美替尼维持高增长态势，戈来雷塞获批上市在即 事件： 公司发布2024年报及2025年第一季度报告：2024年公司实现营收35.58 亿元，同比增长76.29%，其中药品销售收入35.06亿元，同比增长77.27%； 归母净利润14.30亿元，同比增长121.97%；扣非归母净利润13.61亿元， 同比增长124.51%；经营活动现金净流量15.66亿元，同比增长132.12%； 研发投入4.82亿元，同比增长53.81%，研发投入占营收比例为13.53%。 2025年第一季度公司实现营收10.98亿元，同比增长47.86%；归母净利 润4.10亿元，同比增长34.13%；扣非归母净利润3.96亿元 ...

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][9] Core Views - The company achieved a revenue of 2.892 billion yuan in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to the parent company was 403 million yuan, up 15.67% year-on-year, while the non-recurring net profit reached 410 million yuan, marking a significant increase of 55.92% [4][11] - The company is expanding the clinical value and evidence of its products, Kai Mei Na and Sai Mei Na, and has successfully included them in the national medical insurance catalog, enhancing patient accessibility [5][6] - The successful overseas launch of Bei Mei Na, which received FDA approval for first-line treatment indications, is expected to further open up market opportunities for the company [5][6] - The company is continuously enriching its pipeline with ongoing research and development, including the acceptance of NDA for its self-developed CDK4/6 inhibitor BPI-16350 [6][7] - The company is actively expanding its innovative ecosystem and has made significant progress in strategic collaborations, including projects related to plant-derived recombinant human serum albumin and stem cell therapy for diabetes [7] Financial Data and Forecast - The company forecasts net profits attributable to the parent company for 2025, 2026, and 2027 to be 534 million, 604 million, and 739 million yuan respectively, with corresponding EPS of 1.28, 1.44, and 1.77 yuan [8][11] - The current stock price corresponds to a PE ratio of 39, 35, and 28 times for the years 2025, 2026, and 2027 respectively [8][11]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][9] Core Views - The company achieved a revenue of 2.892 billion yuan in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to the parent company was 403 million yuan, up 15.67% year-on-year, while the non-recurring net profit reached 410 million yuan, marking a significant increase of 55.92% [4][11] - The company is expanding the clinical value and evidence of its products, particularly focusing on the domestic market for EGFR-TKI. Both Kai Mei Na and Sai Mei Na have been included in the national medical insurance directory, enhancing patient accessibility [5][6] - The successful overseas launch of Bei Mei Na, which received FDA approval for first-line treatment indications, is expected to further open up market opportunities for the product [5][6] - The company is continuously enriching its pipeline with ongoing research and development, including the acceptance of NDA for its self-developed CDK4/6 inhibitor BPI-16350 [6][7] - The company is actively expanding its innovation ecosystem and strategic partnerships, achieving significant progress in projects such as plant-derived recombinant human serum albumin and stem cell therapy for diabetes [7] Financial Data and Forecast - The company forecasts net profits attributable to the parent company for 2025, 2026, and 2027 to be 534 million, 604 million, and 739 million yuan respectively, with corresponding EPS of 1.28, 1.44, and 1.77 yuan [8][11] - The projected revenue growth rates for 2025, 2026, and 2027 are 20.61%, 17.06%, and 18.22% respectively, indicating a robust growth trajectory [11]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [1][3][8] Core Views - The company achieved a historical high in performance, with 2024 revenue reaching 41.906 billion yuan, a year-on-year increase of 3.16%, and a net profit attributable to shareholders of 3.512 billion yuan, up 23.72% year-on-year [3][8] - The pharmaceutical industry is identified as the core growth engine, with the pharmaceutical manufacturing segment showing a net profit of 2.876 billion yuan, a 29.04% increase year-on-year [3][4] - The company has accelerated the launch of innovative products, with 133 ongoing research projects, including 94 innovative products and biosimilars [3][4] Financial Performance Summary - For 2024, the company reported a comprehensive gross margin of 33.21%, an increase of 0.81 percentage points year-on-year, and a net profit margin of 8.34%, up 1.33 percentage points year-on-year [3][4] - The revenue breakdown by segment includes: pharmaceutical commerce at 27.092 billion yuan (0.41% growth), pharmaceutical manufacturing at 13.811 billion yuan (13.05% growth), medical aesthetics at 2.326 billion yuan (-4.94% decline), and industrial microbiology at 711 million yuan (43.12% growth) [3][4] - The company expects net profits for 2025-2027 to be 4.028 billion, 4.559 billion, and 5.120 billion yuan respectively, with corresponding EPS of 2.30, 2.60, and 2.92 yuan [8][10] Research and Development - The company invested 2.678 billion yuan in R&D for the pharmaceutical manufacturing segment in 2024, a 16.77% increase year-on-year, with direct R&D expenses accounting for 12.91% of the segment's revenue [3][4] - Several innovative products have been approved for market launch, including CAR-T product and biosimilars, indicating a strong pipeline and ongoing commitment to innovation [3][4][5] Market Performance - The total market capitalization of the company is 68.985 billion yuan, with a circulating market value of 68.904 billion yuan [1][3] - The company is positioned to benefit from the recovery of domestic and international consumer markets, particularly in the medical aesthetics segment, which is expected to stabilize and grow with new product approvals [5][6]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [1][3][8] Core Views - The company achieved record high performance in 2024, with operating revenue of 41.906 billion yuan, a year-on-year increase of 3.16%, and a net profit attributable to shareholders of 3.512 billion yuan, up 23.72% year-on-year [3][8] - The pharmaceutical industry is identified as the core growth engine, with the pharmaceutical manufacturing segment achieving a net profit of 2.876 billion yuan, a year-on-year increase of 29.04% [3][4] - The company has accelerated the launch of innovative products, with significant R&D investment in the pharmaceutical sector reaching 2.678 billion yuan, a 16.77% increase year-on-year [3][4] Summary by Sections Financial Performance - In 2024, the company reported operating revenue of 41.906 billion yuan, with a gross margin of 33.21% and a net margin of 8.34% [3][10] - The pharmaceutical commercial, industrial, aesthetic medicine, and industrial microbiology segments generated revenues of 27.092 billion, 13.811 billion, 2.326 billion, and 711 million yuan respectively, with growth rates of 0.41%, 13.05%, -4.94%, and 43.12% [3][4] R&D and Innovation - The company has 133 ongoing pharmaceutical projects, with 94 being innovative products and biosimilars [3][4] - Several innovative products were approved for market launch in 2024, including CAR-T product and biosimilar injections [4][5] Market Outlook - The company expects net profits for 2025-2027 to be 4.028 billion, 4.559 billion, and 5.120 billion yuan respectively, with corresponding EPS of 2.30, 2.60, and 2.92 yuan [8][10] - The company is focusing on expanding its international market presence and enhancing its product development capabilities [5][6]

Investment Rating - The investment rating for the industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index experienced a decline of 4.47%, ranking 14th among 31 primary industries, underperforming the CSI 300 index which fell by 4.21% [6][17] - The PE (TTM overall method, excluding negative values) for the pharmaceutical and biotechnology industry as of April 11, 2025, is 25.83x, down from 27.06x, indicating a downward trend in valuation [22] - The report highlights that 26 listed companies in the pharmaceutical and biotechnology sector had a net reduction of 295 million yuan in shareholder holdings during the reporting period [6] Industry Review - The report notes that blood products and offline pharmacies had the highest gains, with increases of 3.99% and 2.70% respectively, while medical research outsourcing and in vitro diagnostics faced the largest declines of -20.32% and -9.68% respectively [6][17] - The top three sub-industries in terms of PE (TTM overall method, excluding negative values) are diagnostic services (85.87x), hospitals (38.62x), and medical consumables (32.82x), with the lowest valuation in pharmaceutical circulation at 15.21x [22] Important Industry News - Beijing and Shenzhen have introduced supportive policies for innovative drugs, focusing on accelerating innovation in the pharmaceutical and healthcare industry, optimizing approval processes, and enhancing financial support [9] - The NMPA has issued a draft for public consultation regarding the import of commercially scaled batches of drugs approved overseas, aiming to facilitate the early use of innovative drugs in clinical settings [29][30] Investment Recommendations - The report suggests continuous attention to pharmaceutical and medical device companies with original innovation capabilities and overseas expansion potential, especially those with performance exceeding expectations during the earnings disclosure period [9]

Investment Rating - Investment Rating: Positive [1] Core Viewpoints - The pharmaceutical and biotechnology industry index experienced a decline of 4.47%, ranking 14th among 31 primary industries, underperforming the CSI 300 index, which fell by 4.21% [6][17] - The industry valuation as of April 11, 2025, is a PE (TTM overall method, excluding negative values) of 25.83x, down from 27.06x, indicating a downward trend and below the mean and negative one standard deviation [6][22] - The report highlights that 26 listed companies in the pharmaceutical and biotechnology sector had a net reduction of 295 million yuan in shareholder holdings during the reporting period [6] Industry Review - The report notes that blood products and offline pharmacies showed the highest gains, with increases of 3.99% and 2.70%, respectively, while medical research outsourcing and in vitro diagnostics faced significant declines of -20.32% and -9.68% [6][17] - The top three sub-industries in terms of PE (TTM overall method, excluding negative values) are diagnostic services (85.87x), hospitals (38.62x), and medical consumables (32.82x), with the lowest valuation in pharmaceutical circulation at 15.21x [6][22] Important Industry News - Beijing and Shenzhen have introduced supportive policies for innovative drugs, focusing on accelerating innovation in the pharmaceutical and healthcare industry, optimizing approval processes, and enhancing financial support [9] - The NMPA has solicited opinions on a draft announcement regarding the import of commercially scaled batches of drugs approved overseas before they are granted approval in China [8][29] - The report emphasizes that innovation and international expansion remain core investment themes in the pharmaceutical and biotechnology sector, particularly for companies with original innovation capabilities and those exceeding performance expectations [9] Company Dynamics - The report tracks 500 pharmaceutical and biotechnology companies, with 130 disclosing their 2024 performance. Among them, 11 companies reported a net profit growth rate of 100% or more, and 21 companies had growth rates between 30% and 100% [7] - Notable approvals include AbbVie’s "Upadacitinib" for treating giant cell arteritis, marking it as the first JAK inhibitor approved for this condition [8][39] - The report also highlights the approval of the first domestic gene therapy for hemophilia B, "Bopida Keg," by Xinnian Pharmaceutical, which is a significant milestone in the industry [8][40]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [2][3] Core Insights - The company achieved a revenue of 1.009 billion yuan in 2024, representing a year-on-year growth of 36.68%, with drug sales revenue reaching 1.006 billion yuan, up 49.74% [3] - The net profit attributable to shareholders was a loss of 440 million yuan, narrowing by 30% [3] - The first commercialized product, the BTK inhibitor Obutinib, saw sales exceed 1 billion yuan in 2024, growing by 49.14% year-on-year, driven by multiple factors including its inclusion in the national medical insurance catalog [4] - The company is advancing its self-developed ADC platform, with the first IND submission expected within the year [2][4] Financial Performance and Forecast - Revenue forecasts for 2025, 2026, and 2027 are projected at 1.411 billion yuan, 1.702 billion yuan, and 2.058 billion yuan respectively, with net profits expected to be losses of 427 million yuan, 355 million yuan, and 235 million yuan [9][11] - The company is expected to continue benefiting from the growth of Obutinib and the anticipated approval of Tafasitamab, which is expected to contribute to revenue in 2025 [9][11] Clinical Development - The company has initiated a registration Phase III clinical trial for ICP-248 in combination with Obutinib for the treatment of 1L CLL/SLL, with promising clinical data reported [5] - The company is also exploring multiple indications in the autoimmune field, with ongoing clinical trials for Obutinib in treating PPMS, SPMS, and ITP [6] - The second-generation TRK inhibitor ICP-723 has shown a high overall response rate of 85.5% in clinical trials and is expected to submit an NDA soon [8] Market Position and Future Prospects - The company is positioned to expand its market presence with the anticipated approval of Tafasitamab and the ongoing development of its ADC platform targeting difficult-to-treat solid tumors [4][9] - The strong commercial capabilities and the positive clinical outcomes of its products are expected to drive future growth [4][9]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [2][3]. Core Insights - The company achieved a revenue of 1.009 billion yuan in 2024, representing a year-on-year growth of 36.68%, with drug sales revenue reaching 1.006 billion yuan, up 49.74% [3]. - The net profit attributable to shareholders was a loss of 444 million yuan, narrowing by 30% [3]. - The company’s first commercialized product, the BTK inhibitor Acalabrutinib, saw sales exceed 1 billion yuan in 2024, with a growth rate of 49.14% [4]. - The company is advancing its ADC platform and plans to submit its first IND application within the year [4][8]. Financial Performance - The company forecasts revenues of 1.411 billion yuan, 1.702 billion yuan, and 2.058 billion yuan for 2025, 2026, and 2027 respectively, with net profits expected to be losses of 427 million yuan, 355 million yuan, and 235 million yuan [9][11]. - The company’s R&D expenses for 2024 were 815 million yuan, reflecting a year-on-year increase of 7.57% [3]. Product Pipeline and Clinical Trials - The company is progressing with multiple clinical trials, including a Phase III trial for ICP-248 in combination with Acalabrutinib for 1L CLL/SLL, which has shown promising clinical data [5]. - Tafasitamab is expected to be approved in the first half of 2025, contributing to the company's growth trajectory [4]. - The company is also exploring Acalabrutinib's potential in autoimmune diseases, with several clinical trials underway [6]. Market Position and Future Outlook - The company is well-positioned with its core product Acalabrutinib and the anticipated approval of Tafasitamab, which is expected to enhance its revenue streams [9]. - The ADC platform is expected to target hard-to-treat solid tumors, indicating a strategic expansion into new therapeutic areas [8].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The pharmaceutical and biotechnology industry index experienced a decline of 0.44%, outperforming the CSI 300 index which fell by 2.28% [5][15] - The industry is seeing a shift in policy focus from cost control to encouraging innovation, with significant developments in drug approvals and market dynamics [7][38] - The report highlights three main investment themes: innovative drug companies with global clinical capabilities, quality generic companies under easing procurement pressures, and innovative drug licensing opportunities abroad [7] Industry Review - The pharmaceutical and biotechnology industry PE (TTM, excluding negative values) as of March 28, 2025, is 27.06x, down from 27.31x in the previous period, indicating a downward trend in valuation [5][19] - Among the sub-industries, diagnostic services, hospitals, and raw materials have the highest PE ratios, while pharmaceutical distribution has the lowest [19] Important Industry News - The National Financial Regulatory Administration released a plan for the high-quality development of pension finance [23] - The State Council issued guidelines to enhance the quality of traditional Chinese medicine and promote the high-quality development of the industry [29] - The NMPA approved the first-in-class anti-tumor drug "Hydrobromide Tazemetostat" for market entry [49] - AstraZeneca announced a $2.5 billion investment plan to establish its sixth global R&D center in Beijing [6] Company Dynamics - A total of 26 listed companies in the pharmaceutical and biotechnology sector reported a net reduction of 937 million yuan in shareholder holdings during the reporting period [5] - Eight companies reported a net profit growth rate of over 100% for 2024, while 16 companies had growth rates between 30% and 100% [6] Investment Recommendations - The report suggests focusing on leading companies with innovative drugs and international capabilities, particularly in oncology and autoimmune fields [7] - It emphasizes the importance of structural opportunities arising from recent policy changes and advancements in drug development [7]