医药 2025 年 12 月 30 日 基石药业-B（2616.HK） 以临床开发为引擎、稳健迈入研发2.0阶段，创新布局前沿管线及领域 推荐（首次） 股价：5.51 港元 主要数据 | 行业 | 医药 | | --- | --- | | 公司网址 | www.cstonepharma.com | | 大股东/持股 | Wuxi Healthcare Ventures/11.84% | | 总股本(百万股) | 1475.98 | | 流通 A 股(百万股) | 0 | | 流通 B/H 股(百万股) | 1475.98 | | 总市值（亿港元） | 81.3 | | 每股净资产(元) | 0.23 | | 资产负债率(%) | 73.57 | 行情走势图 证券分析师 | 投资咨询资格编号 | | --- | | S1060524030001 | | HEMINXIU894@pingan.com.cn | | 投资咨询资格编号 | | S1060519060002 | | hanmengmeng005@pingan.com.cn | | 叶寅 投资咨询资格编号 | | S1060514100001 | | B ...

天风证券今年8月发布的研报指出，预计普拉替尼纳入医保后有望加速放量。基石药业的临床前管线包 括多特异性抗体、ADC等超过九个潜在候选药物，专注于FIC/BIC研究，涵盖肿瘤学、自身免疫和炎症 性疾病等多个治疗领域。公司创新的内部ADC技术平台，以优化专有连接子为特色，改善肿瘤选择性 有效载荷的释放。平台支持管线2.0多个ADC产品，有望为公司未来发展提供持续动力。 本文源自：智通财经网 消息面上，基石药业近日宣布，公司RET抑制剂普吉华®（普拉替尼胶囊，100 mg）被成功纳入中国国 家医疗保障局公布的最新版《国家基本医疗保险、生育保险和工伤保险药品目录》，该目录将于2026年 1月1日起正式实施。截至目前，基石药业已成功推进4款创新药获批上市，其中3款由基石药业在中国完 成临床试验及注册获批上市的产品，已被纳入国家医保目录。 智通财经获悉，基石药业-B(02616)涨超5%，截至发稿，涨5.57%，报6.07港元，成交额2270.42万港 元。 ...

天风证券今年8月发布的研报指出，预计普拉替尼纳入医保后有望加速放量。基石药业的临床前管线包 括多特异性抗体、ADC等超过九个潜在候选药物，专注于FIC/BIC研究，涵盖肿瘤学、自身免疫和炎症 性疾病等多个治疗领域。公司创新的内部ADC技术平台，以优化专有连接子为特色，改善肿瘤选择性 有效载荷的释放。平台支持管线2.0多个ADC产品，有望为公司未来发展提供持续动力。 智通财经APP获悉，基石药业-B(02616)涨超5%，截至发稿，涨5.57%，报6.07港元，成交额2270.42万港 元。 消息面上，基石药业近日宣布，公司RET抑制剂普吉华®（普拉替尼胶囊，100 mg）被成功纳入中国国 家医疗保障局公布的最新版《国家基本医疗保险、生育保险和工伤保险药品目录》，该目录将于2026年 1月1日起正式实施。截至目前，基石药业已成功推进4款创新药获批上市，其中3款由基石药业在中国完 成临床试验及注册获批上市的产品，已被纳入国家医保目录。 ...

Group 1 - The core viewpoint of the article is that China Galaxy has issued a "recommend" rating for Elysium (688578.SH) based on its steady sales growth and clinical value enhancement of Vomeletin [1] - The report highlights the commercialization of Golaires and the localization of production for Pralsetinib as significant developments for the company [1] Group 2 - The report emphasizes the steady growth in sales of Vomeletin, indicating a positive trend in the company's performance [1] - The initiation of commercialization for Golaires is noted as a key milestone for the company, potentially impacting its market position [1] - The transition of Pralsetinib to local production is seen as a strategic move that may enhance operational efficiency and market responsiveness [1]

Investment Rating - The report assigns a "Buy" rating for the company, indicating a potential increase in stock price relative to the market index over the next six months [12][13]. Core Insights - The company is advancing its research pipeline into the 2.0 era, with key products expected to catalyze growth soon [7]. - CS2009 has shown good safety and tolerability in Phase I clinical trials, with promising anti-tumor activity and a high disease control rate (DCR) [7]. - The company has initiated Phase II dose expansion studies for CS2009 in specific tumor types, aiming to optimize dosing regimens and gather more data for regulatory submissions [7]. - CS5001 is under investigation for both monotherapy and combination therapy in hematological and solid tumors, with ongoing global multi-center clinical trials [7]. - Strategic collaborations are expanding the international reach of the company's products, particularly for Shugli monoclonal antibody, which is expected to cover multiple indications [7]. Financial Projections - The company forecasts revenues of RMB 2.2 billion, RMB 5.1 billion, and RMB 8.6 billion for the years 2025, 2026, and 2027 respectively [9]. - The projected revenue breakdown includes contributions from various products, with significant growth anticipated for Shugli monoclonal antibody starting in 2026 [8][9]. - The company expects to achieve a positive net profit of RMB 165.95 million by 2027, following substantial losses in the preceding years [2][10]. Revenue and Profitability Metrics - The report outlines a projected revenue decline of 12.21% in 2024, followed by a significant recovery with growth rates of 131.82% and 68.63% in 2026 and 2027 respectively [2][9]. - The earnings per share (EPS) is expected to turn positive by 2027, indicating a turnaround in profitability [2][9]. - The net asset return rate (ROE) is projected to improve significantly, reaching 304.32% by 2027 after a period of negative returns [2][10].

Core Insights - Hainan Boao Lecheng International Medical Tourism Pilot Zone is becoming a crucial link between rare disease drug companies and patients through policy iterations, insurance collaboration, and multi-dimensional empowerment [1] Policy Iteration - The policy framework for rare disease drug assurance in Lecheng has evolved through three versions: - Version 1.0 focuses on introducing licensed drugs and devices to allow some patients to access urgently needed medications [2] - Version 2.0 allows the use of real-world data from rare disease drugs for expedited domestic approval [2] - Version 3.0 expands the coverage to include special medical foods, health products, and new biomedical technologies [2] Special Drug Insurance - Lecheng has launched a special drug insurance plan to significantly reduce the financial burden on patients, with premiums starting at 49 yuan and coverage up to 2 million yuan for 120 types of global special drugs and 10 types of imported devices [3] Future Initiatives - Lecheng aims to strengthen the connection between rare disease drug companies and patients by leveraging special drug policies and introducing more special medical foods [4] - The zone has received approval for biomedical new technology policies, allowing clinical research and application transformation for technologies that have completed Phase II trials [4] - The initiative includes collaboration with the National Medical Products Administration and the National Healthcare Security Administration to expedite drug registration and insurance access [4]

Investment Rating - The investment rating for the company is "Buy" and is maintained [6]. Core Views - The company reported a total revenue of 2.374 billion yuan for the first half of 2025, representing a year-on-year increase of 50.57%. The net profit attributable to shareholders was 1.051 billion yuan, up 60.22% year-on-year, while the net profit after deducting non-recurring items was 905 million yuan, reflecting a 39.92% increase year-on-year. The company's performance is strong, indicating robust sustainable development momentum [2][4][10]. Summary by Sections Financial Performance - In the first half of 2025, the company achieved total revenue of 2.374 billion yuan, a 50.57% increase year-on-year. The net profit attributable to shareholders was 1.051 billion yuan, marking a 60.22% year-on-year growth. The net profit after deducting non-recurring items was 905 million yuan, which is a 39.92% increase year-on-year. The company’s financial health is solid, providing a strong foundation for sustainable growth [2][4][10]. Research and Development - The company invested 297 million yuan in R&D during the reporting period, a significant increase of 126.00% year-on-year, accounting for 12.50% of total revenue. This increase is attributed to the steady progress of ongoing projects and milestone payments for clinical projects of introduced products [10]. Product Development - The company is focusing on three main products: 1. **Vomecitin**: The company is deepening research on Vomecitin, expanding its clinical value and market competitiveness. The IND for a Phase III clinical trial was approved in January 2025, and a marketing application was accepted in July 2025 [10]. 2. **Goralesib**: The product received conditional approval for second-line monotherapy for KRAS G12C mutation in advanced NSCLC in May 2025, with promising clinical data [10]. 3. **Pralsetinib**: The domestic production application has been approved, expected to enhance supply chain resilience and product accessibility starting in 2026 [10]. Profit Forecast - The company’s net profit attributable to shareholders is projected to be 1.737 billion yuan in 2025, 2.105 billion yuan in 2026, and 2.521 billion yuan in 2027, with corresponding EPS of 3.86 yuan, 4.68 yuan, and 5.60 yuan respectively. The "Buy" rating is maintained based on these forecasts [10].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1][6] Core Views - The company achieved a revenue of 2,018 million in 2023, with a year-on-year growth of 155%, and is projected to reach 5,088 million by 2025, reflecting a growth rate of 43% [1] - The net profit attributable to the parent company is expected to grow significantly, from 644 million in 2023 to 1,808 million in 2025, indicating a growth rate of 26% [1] - The report highlights the strong performance of the drug Vomeletin, which is expected to drive revenue growth and profitability [4][5] Financial Performance Summary - The company reported a revenue of 2,374 million in the first half of 2025, a year-on-year increase of 50.57%, and a net profit of 1,051 million, up 60.22% [2] - The earnings per share (EPS) are projected to increase from 3.18 in 2024 to 4.02 in 2025, and further to 4.78 in 2026 [1][5] - The company's gross margin is expected to remain stable at 96% from 2024 to 2027 [5] Pipeline and Product Development - The company is transitioning from a single product operation to a product matrix management phase, with multiple drugs in the pipeline [4] - Vomeletin has shown promising results in clinical trials, particularly for patients with brain metastases, and is expected to expand its indications [4] - The company is collaborating with international partners to accelerate the development of Vomeletin for various NSCLC mutations [4] Market Position and Strategy - The report emphasizes the differentiated advantages of Vomeletin, including its safety profile and efficacy across various mutation types, which are expected to enhance its market value [4] - The company is preparing for the commercialization of other products, such as Pralsetinib, which is anticipated to be launched in 2026 [4] - The overall strategy focuses on leveraging strong clinical evidence to support the long product lifecycle and maintain competitive advantages in the market [4]

Group 1 - China Galaxy issued a report on August 29, recommending Elysium (688578.SH, latest price: 114 yuan) based on strong revenue and profit growth, driven by the rapid market penetration of Vomeprazole [1] - The commercialization of Golai Reza has commenced, and the local production of Platinib is accelerating [1] - Increased R&D investment and smooth progress in overseas clinical trials are highlighted as positive factors for the company [1] Group 2 - Nvidia's stock price has experienced a significant drop, resulting in a market value loss of 1.28 trillion yuan [1] - Investors expressed concerns over a $200 million earnings gap, leading to panic in the market [1]

Core Insights - The report highlights that Ailis has achieved significant revenue and profit growth in the first half of 2025, driven by the rapid sales increase of its core product, Vomeitin [2][4] - The company has received a "Buy" rating from analysts, indicating strong confidence in its future performance [1][4] Financial Performance - In H1 2025, Ailis reported revenue of 2.374 billion yuan, a year-on-year increase of 50.57%, and a net profit of 1.051 billion yuan, up 60.22% [2] - For Q2 2025, the company achieved revenue of 1.275 billion yuan, reflecting a 52.99% year-on-year growth, and a net profit of 641 million yuan, which is an 83.02% increase [2] - The operating cash flow for H1 2025 was 1.093 billion yuan, indicating strong cash generation capabilities [2] Product and Market Development - The rapid growth in revenue and profit is primarily attributed to the strong market performance of Vomeitin, with the sales team expanding to over 1,400 personnel covering more than 5,000 hospitals across 31 provinces [2][4] - The company is also advancing its commercialization efforts for other products, such as Goleirese and Pralsetinib, with Goleirese recently receiving NMPA approval for commercialization [3][4] Research and Development - Ailis increased its R&D investment to 297 million yuan in H1 2025, a 126% year-on-year increase, representing 12.5% of its revenue [4] - The company is progressing with its clinical trials, including the NMPA acceptance of Vomeitin for NSCLC treatment and ongoing Phase III trials for Goleirese [4] Investment Outlook - Analysts project Ailis' net profit to reach 1.856 billion yuan in 2025, with growth rates of 29.79%, 20.34%, and 20.32% for the years 2025 to 2027 [4] - The current stock price corresponds to a PE ratio of 27.5, 22.8, and 19.0 for the years 2025 to 2027, indicating a favorable valuation for potential investors [4]