艾力斯 20250822 摘要 伏美替尼进入医保后销售额大幅增长，2023 年 Q1 至 Q2 环比增长显著， 体现了创新药的巨大潜力，销售费用率、研发和管理费用率均下降，规 模效应显现，2024 年净利率达 40%，预计 2025 年保持良好。 艾力斯围绕伏美替尼在 EGFR 突变领域深入布局，经典突变一二线适应 症已获批，辅助治疗预计 2026 年申请上市，20 号外显子和 PAX 突变 二线适应症已递交申请，一线适应症预计明年初完成三期临床并递交上 市申请。 伏美替尼安全性数据优于同类药物，可加量使用，公司探索与其他药物 联合用药，包括 PL1 小分子、MET ADC、FACT 抑制剂等，并与康宁杰 瑞合作开发双抗 ADC 药物，旨在提升疗效并拓展应用空间。 艾力斯积极引进和开发新的肺癌管线，如加克斯公司的 K84 和 SIX2 管 线梯队，与基石合作获得 RET 抑制剂 Platinum 销售权，K2G 产品 Gallacy 已获批用于 KRAS G12C 突变非小细胞肺癌二线治疗。 华亭产品已同时申报医保和商保目录，普拉替尼是首个完成地产化生产 的产品，成本控制具优势。公司布局与伏美替尼赛道契合的四 ...

公司近况跟踪 艾力斯(688578) 证券研究报告 化学制药 / 公司跟踪研究报告 / 2025.08.20 投资评级:增持(维持) | 基本数据 | 2025-08-19 | | --- | --- | | 收盘价(元) | 89.99 | | 流通股本(亿股) | 4.50 | | 每股净资产(元) | 12.53 | | 总股本(亿股) | 4.50 | 最近 12 月市场表现 -27% -4% 18% 41% 63% 86% 艾力斯 沪深300 上证指数 化学制药 请阅读最后一页的重要声明！ 1. 《公司近况跟踪》 2025-08-14 2. 《研发顺利突进》 2024-08-22 3. 《核心产品持续放量》 2024-05-13 ❖ 伏美替尼用于 EGFR 20 外显子插入突变 NSCLC 的二线治疗适应症已获得 CDE 突 破性治疗品种的认定。2021 年 7 月，公司与 ArriVent 合作开展伏美替尼对比含铂化 疗一线治疗 EGFR 20 外显子插入突变的局部晚期或转移性 NSCLC 患者的疗效和安 全性的国际、III 期、随机、多中心研究，该研究已于今年年初完成全部患者入组，目 前处于患者 ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

Core Viewpoint - The company Ailis (688578.SH) announced plans for a share reduction by its employee stock ownership platforms due to funding needs, potentially affecting up to 3% of its total shares, corresponding to a maximum value of over 1.2 billion yuan based on recent market capitalization [1][3]. Group 1: Share Reduction Announcement - Ailis plans to reduce up to 13,500,000 shares, representing no more than 3.00% of its total share capital, starting from September 1, 2025 [1]. - The company's market capitalization was reported at 42.5 billion yuan as of August 8, 2023 [1]. Group 2: Employee Stock Ownership Platforms - The shares held by the employee stock ownership platforms were acquired through equity incentives before the IPO, resulting in significant appreciation in value [3]. - The Shanghai Aixiang platform held 10.11% of Ailis prior to the IPO, with an initial investment of 59.57 million yuan, which has appreciated substantially [3]. Group 3: Key Shareholders - Jeffery Yang Guo, a core founder's son, holds 25.6236 million shares valued at approximately 2.422 billion yuan, making him the largest shareholder [3]. - Chairman and General Manager Du Jinhao holds 10.8 million shares valued at around 1.021 billion yuan, ranking him second among shareholders [4]. Group 4: Market Trends - There is a growing trend of share reductions by employee stock ownership platforms in the market, with other companies like United Imaging Healthcare also announcing similar plans [4]. - The stock market has shown positive trends, prompting many companies to liquidate shares through employee platforms [4]. Group 5: Financial Performance - Ailis reported revenues of 790 million yuan, 2.018 billion yuan, and 3.558 billion yuan for the years 2022, 2023, and 2024, respectively, with net profits of 131 million yuan, 644 million yuan, and 1.43 billion yuan [6]. - In Q1 of the current year, Ailis achieved a revenue of 1.098 billion yuan, a 48% year-on-year increase, and a net profit of 410 million yuan, a 34% increase [7]. Group 6: Product Dependency and Competition - Ailis heavily relies on its lung cancer drug, Vomeletinib, which has captured over 80% of the market share in its category, but faces increasing competition from other EGFR TKI products [8][9]. - The competitive landscape includes several other approved products, with Ailis's Vomeletinib projected to generate around 4.5 billion yuan in 2025 [8].

Summary of Key Points from Conference Call Records Industry Overview - The discussion primarily revolves around the **innovative drug industry**, focusing on valuation methods, market dynamics, and the competitive landscape in China and the U.S. [1][8][10] Core Insights and Arguments 1. **Valuation Methodology**: - Innovative drug valuation requires detailed breakdowns of indications, market assessment, and product positioning, integrating both objective data and subjective judgment [1][3][4] - The peak sales calculation must consider diagnosis rates, treatment rates, market share, duration of treatment (DOT), and pricing, confirmed with expert opinions [7][8] 2. **Sales Performance**: - The sales of **Fumetinin** exceeded expectations, with an increase in DOT from 1.1 years to 1.3 years, although market share fluctuated due to competition and patent issues [5][6] - The first-year sales of major drugs entering the insurance list often exceed 1 billion RMB, with subsequent years showing significant growth [12][13] 3. **Market Dynamics**: - The Chinese market for innovative drugs has a longer commercialization ramp-up period compared to the U.S., with a typical annual growth rate of around 15% for many drugs [8] - The market is highly concentrated, with the top two players often holding 60%-70% market share in their respective categories [11] 4. **Pricing Strategies**: - In China, the first-year pricing for innovative drugs typically caps at 150,000 RMB, reflecting a balance between affordability and market acceptance [10] - Pricing is influenced by negotiations with health insurance and collective procurement policies, leading to annual price fluctuations [6][9] 5. **Risk Assessment**: - Risk adjustment values for marketed indications are set at one, while those in clinical phases may be discounted significantly (e.g., 80% discount for phase III indications) [6][7] - The success rates for drug development vary significantly by disease type, with hematological malignancies showing higher success rates compared to solid tumors [15][16] Additional Important Insights 1. **Commercialization Advantages**: - Early market entrants often capture significant market share, emphasizing the importance of first-mover advantages in the commercialization process [12][14] - The average gross margin for small molecules is around 95%, with sales expenses in China ranging from 30% to 40% [14] 2. **Market Sentiment**: - Market sentiment plays a crucial role in the valuation of innovative drug companies, with positive sentiment leading to higher valuations for early-stage products [21][23] - The current financing environment has improved, allowing companies with early-stage products to secure funding and advance their development [24][25] 3. **Comparative Success Rates**: - The success rates for drug approval differ across disease categories, with blood cancers having a notably higher success rate compared to cardiovascular and CNS diseases [16][19] 4. **Future Outlook**: - The innovative drug sector is characterized by a self-reinforcing cycle where favorable market conditions lead to increased funding and development, while adverse conditions can stifle progress [25][26] This summary encapsulates the essential points discussed in the conference call, providing a comprehensive overview of the innovative drug industry's current landscape and future prospects.

Core Insights - The article highlights the significant achievement of Ailis in the Chinese pharmaceutical industry, particularly with its drug Fumetinib, which has won the highest honor in intellectual property in China [1][2] - Ailis has successfully commercialized Fumetinib, establishing itself as a representative of innovation in the pharmaceutical sector, achieving a remarkable revenue growth and market capitalization increase [1][6] - Despite its success, Ailis faces challenges due to its heavy reliance on a single product, prompting the company to seek new growth opportunities [1][4][11] Group 1: Company Achievements - Ailis was founded in 2004 and has become a significant player in the pharmaceutical industry, particularly with the success of Fumetinib [3][4] - Fumetinib's sales revenue skyrocketed from 5.3 billion yuan in 2021 to 35.58 billion yuan in 2024, with a compound annual growth rate of 88.6% [4][6] - The company's stock price increased from 14.16 yuan to nearly 100 yuan, representing a growth of over 586%, leading to a market capitalization exceeding 40 billion yuan [6][7] Group 2: Market Dynamics - The EGFR inhibitor market in China reached a sales scale of 204.4 billion yuan in 2024, with a year-on-year growth of 19.5% [7][8] - Fumetinib's market share increased to 14.3% in 2024, while competitors like Osimertinib and Amivantamab faced challenges, allowing Ailis to capture market share [7][8] - The competitive landscape is intensifying with the entry of multiple new third-generation EGFR inhibitors and the development of fourth-generation drugs, posing a threat to Fumetinib's market position [8][9] Group 3: Strategic Responses - Ailis is focusing on deepening the development of Fumetinib through various clinical studies to expand its indications and market potential [11][12] - The company is pursuing a dual strategy of "independent research and development + collaborative partnerships" to build a diverse product portfolio [12][14] - Despite the ongoing growth, Ailis's revenue growth rate is showing signs of slowing down, indicating the need for new growth drivers beyond Fumetinib [12][14]

Summary of the Earnings Call for Ailis Company Company Overview - Ailis Company is focused on the development and commercialization of targeted therapies for cancer, particularly in the area of non-small cell lung cancer (NSCLC) with EGFR mutations and KRAS mutations [2][3]. Key Products and Market Performance - **Fumetinib**: - Approved for multiple indications, including first-line and second-line treatments for EGFR mutation-positive NSCLC [2][3]. - Projected sales for 2024 are 3.5 billion RMB, representing a 77% year-over-year growth [2][5]. - Clinical data shows superior progression-free survival (PFS) and objective response rates (ORR) compared to Osimertinib [2][6]. - In patients with brain metastases, the ORR is 66%, with a disease control rate of 100% and a significant reduction in the risk of disease progression or death by 60% [2][9]. - Demonstrated efficacy in treating EGFR 20 exon insertion mutations, with ORR of 78% and 46% in different dosing groups [2][10]. - **KRAS G12C Inhibitor (Glarasertib)**: - Approved in May 2025, showing an ORR of 77.9% in second-line treatment and a disease control rate exceeding 86% [2][12]. - Currently in clinical trials for first-line treatment in combination with SHIP2 inhibitors [2][12]. - **Pralsetinib**: - Recently introduced and has achieved local production, which is expected to lower costs and prices, facilitating entry into health insurance negotiations [3][4][14]. - Recommended in multiple treatment guidelines, indicating a positive sales outlook [4][14]. Financial Performance - Ailis Company reported a strong financial performance with projected revenues of 3.5 billion RMB for 2024, a nearly 80% increase year-over-year [4][5]. - Net profit is expected to reach 1.4 billion RMB, reflecting a 120% increase, with a net profit margin of 40% [4][5]. Market Dynamics - The market for EGFR mutation-positive NSCLC is expanding, with approximately 250,000 new patients annually in China [6]. - EGFR mutations account for 30% of all NSCLC cases, with a significant portion being adenocarcinoma [6]. - The introduction of third-generation TKIs like Fumetinib addresses resistance issues seen with earlier generations, enhancing patient outcomes [6][7]. Clinical Insights - Fumetinib has shown a median PFS of 20.8 months, surpassing Osimertinib's 19 months, and a high ORR of 85% [6][7]. - The drug's safety profile is favorable, with lower rates of severe adverse reactions compared to Osimertinib [7]. Future Outlook - Ailis Company is optimistic about its growth trajectory, with potential for market expansion both domestically and internationally [15]. - The product pipeline, particularly Fumetinib, is expected to drive significant revenue growth in the coming years [15].

Investment Rating - The report maintains a "Buy" rating for the company [4] Core Viewpoints - Fumetinib at a dosage of 240mg achieved a median progression-free survival (mPFS) of 16 months, significantly outperforming existing therapies [2] - The current first-line treatments for EGFR PACC mutation NSCLC have mPFS ranging from 7.5 to 10 months, indicating Fumetinib's potential as a superior therapy [2] - The global Phase III trial for Fumetinib targeting first-line EGFR PACC mutation NSCLC is expected to enroll its first patient in the second half of 2025, addressing a significant unmet clinical need [3] Financial Projections - The company's projected revenues for 2025, 2026, and 2027 are 45.3 billion, 55.4 billion, and 66.2 billion CNY, respectively, with year-on-year growth rates of 27.4%, 22.1%, and 19.6% [4] - The net profit attributable to the parent company is expected to be 17.7 billion, 20.9 billion, and 25.0 billion CNY for the years 2025, 2026, and 2027, reflecting growth rates of 23.5%, 18.1%, and 19.7% [4] - The company is expected to maintain a relatively low price-to-earnings (PE) ratio compared to its peers, with PE ratios of 25, 21, and 18 for the years 2025, 2026, and 2027 [4] Market Context - The report highlights that approximately 12.5% of all EGFR mutation NSCLC cases are due to PACC mutations, with an annual incidence of 87,000 globally and 54,000 in China, indicating a substantial market opportunity [3]

Core Insights - The establishment of the Sci-Tech Innovation Board (STAR Market) has enabled 20 innovative biopharmaceutical companies to list under the fifth set of listing standards, reshaping China's biopharmaceutical landscape [1] - The China Securities Regulatory Commission (CSRC) has introduced measures to enhance the STAR Market's support for high-growth, unprofitable tech companies, emphasizing the importance of "hard technology" [1][3] - The fifth set of listing standards allows unprofitable innovative companies to raise funds, breaking traditional capital market constraints and facilitating financing for R&D-focused firms [1][2] Industry Developments - Since its inception, the STAR Market has seen 20 innovative biopharmaceutical companies adopt the fifth set of listing standards, with significant fundraising efforts directed towards advanced technologies such as antibody drugs and ADCs [1] - In 2024, these 20 companies collectively achieved revenue of 14.21 billion yuan, a year-on-year increase of 44.17%, with several companies projected to exceed 1 billion yuan in revenue soon [1] - Companies like Dizhe Pharmaceutical have reported substantial revenue growth, with a 294.24% increase to 360 million yuan, driven by innovative drug development [2] Company Performance - Companies such as Junshi Biosciences have successfully raised over 8 billion yuan through the STAR Market, significantly advancing their clinical projects and R&D initiatives [2][3] - Ailis, which listed under the fifth set of standards, achieved commercialization of its core product within 2 years and 5 months, demonstrating the effectiveness of the STAR Market in supporting innovative firms [3] - ShenZhou Cell has transitioned from having no products or revenue at the time of listing to achieving 2.51 billion yuan in revenue, marking a successful turnaround [5] Innovation Ecosystem - The STAR Market has fostered an innovation-driven ecosystem, enhancing the flow of resources and increasing recognition of innovative technologies within the capital market [3][4] - Companies are increasingly focusing their resources on R&D, maintaining high levels of investment intensity, and establishing a virtuous cycle of research and development [6] - The introduction of the STAR Market has led to a fundamental shift in the development logic of listed companies, prioritizing quality over scale and fostering collaborative ecosystems [6]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [10][12]. Core Viewpoints - The company, Ailis, is a representative enterprise in the Biotech sector, focusing on innovative cancer drug development, particularly with its core product, Fumetinin, which shows significant clinical data advantages for treating EGFR-sensitive mutation NSCLC [3][6]. - Fumetinin is expected to enhance its market penetration due to its excellent efficacy and safety profile, with sales projected to reach 3.506 billion yuan in 2024, accounting for over 99% of the company's total revenue [7][28]. - The company is expanding its product pipeline through a dual strategy of "self-research + introduction," focusing on high-barrier targets like KRAS G12C and RET, which broadens its growth potential [6][9]. Summary by Sections Company Overview - Ailis has successfully transitioned from a Biotech to a Biopharma company, leveraging the commercial potential of Fumetinin, which was approved for clinical trials in 2016 and launched in 2022 [20][28]. Product and Market Potential - Fumetinin has shown superior efficacy and safety in treating EGFR mutation-positive NSCLC, with ongoing clinical trials aimed at expanding its indications to include brain metastases and rare mutations [7][8]. - The company is collaborating with ArriVent to advance global clinical studies for rare mutations, which could significantly enhance its market presence [8]. Financial Performance - The company reported a revenue of 3.558 billion yuan in 2024, a 76% year-on-year increase, with a net profit of 1.424 billion yuan, reflecting a 121% growth [28][30]. - Revenue forecasts for 2025-2027 are projected at 4.987 billion yuan, 5.768 billion yuan, and 6.896 billion yuan, respectively, with corresponding net profits of 1.737 billion yuan, 2.105 billion yuan, and 2.521 billion yuan [10]. Research and Development - The company maintains a strong focus on innovation, with increasing R&D investments that are expected to remain stable relative to revenue, ensuring a balance between innovation and sustainable growth [32][34].