二、药品其他相关情况 1 证券代码：688578 证券简称：艾力斯 公告编号：2025-015 上海艾力斯医药科技股份有限公司 自愿披露关于甲磺酸伏美替尼片 EGFR 20 外显子插入 突变 NSCLC 二线治疗适应症拟纳入优先审评程序的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 上海艾力斯医药科技股份有限公司（以下简称"公司"）产品甲磺酸伏美替 尼片（以下简称"伏美替尼"）拟用于"既往经含铂化疗治疗时或治疗后出现疾 病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR） 20 外显子插入突变的局部晚期或转移性 NSCLC 成人患者的治疗"的药品上市许 可申请近日被国家药品监督管理局药品审评中心（CDE）纳入拟优先审评品种公 示名单，公示期为 2025 年 7 月 8 日至 2025 年 7 月 15 日。 由于药品优先审评程序认定在公示期存在被提出异议的风险，且药品新增适 应症上市申请尚需经过审评、药品临床试验现场检查和审批等环节，药品注册批 件取得时间和结果均具有不确定性。敬 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 5.30%, outperforming the CSI 300 index which rose by 3.52% during the reporting period [3][14] - The PE ratio (TTM, excluding negative values) for the pharmaceutical and biotechnology industry as of July 4, 2025, is 28.52x, up from 27.28x in the previous period, indicating an upward trend in valuation [3][19] - Notable sub-industries include "Other Biological Products" and "Medical R&D Outsourcing," which saw increases of 11.20% and 9.37% respectively, while "Medical Equipment" and "Blood Products" lagged with increases of only 0.98% [3][14] Industry Trends - The report highlights significant policy measures from the National Healthcare Security Administration and the National Health Commission aimed at supporting the high-quality development of innovative drugs [5][6] - The introduction of a commercial health insurance innovative drug directory is a key breakthrough, facilitating better pricing and reimbursement mechanisms for high-value drugs [6] - The report emphasizes the importance of the innovative drug industry chain, particularly focusing on platform pharmaceutical companies, clinical CROs, and high-barrier CDMOs [6] Important Industry News - The approval of several innovative drugs, including "ZEGFROVY" by Dize Pharmaceutical and "TQG203" by Zhengda Tianqing, marks significant advancements in the industry [41][42][46] - The report notes that the global number of hemophilia patients is expected to increase by 25% by 2025, highlighting the growing market for innovative treatments [42] - The approval of "Mastrudep" by Innovent Biologics for weight management in adults showcases the expanding therapeutic applications of GLP-1R/GCGR dual agonists [49][50] Investment Recommendations - Continuous attention is recommended for the innovative drug industry chain, particularly for companies that can navigate the new dual directory system and have international expansion capabilities [6] - The report suggests that the recent policy changes and the successful IPO of a biotech company signal a positive outlook for the innovative drug sector [6]

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]

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.93% as of July 1, 2025, with notable gains from stocks such as Rongchang Biopharmaceutical (688331) up 7.21% and Shanghai Yizhong (688091) up 3.61% [1] - Starting July 1, 2025, a new policy mandates that all drug sales must include a verification code for medical insurance reimbursement, with full traceability of drug codes required by January 1, 2026, which is expected to enhance drug circulation regulation and impact the entire pharmaceutical industry chain [1] - The current bull market in innovative drugs is driven by the improvement of China's pharmaceutical innovation capabilities, with a trend towards international collaboration in new drug development expected to enhance profitability and market potential for Chinese pharmaceutical companies [2] Group 2 - As of June 30, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare (688271) and BeiGene (688235) [3] - The Sci-Tech Biopharmaceutical ETF closely tracks the performance of the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which includes 50 large-cap companies in various biopharmaceutical sectors [2]

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].

Core Viewpoint - The innovative pharmaceutical sector is experiencing a resurgence, driven by improved fundamentals, supportive policies, and increased market interest, particularly in the A-share and Hong Kong markets [1][3][12]. Group 1: Market Performance - The pharmaceutical sector has shown strong performance this year, with a notable rebound starting from April 9, despite recent pullbacks [1]. - The innovative drug segment in A-shares and Hong Kong stocks has continued to strengthen, indicating a recovery after four years of adjustment [1][3]. - The total amount of business development (BD) transactions for innovative drugs is projected to rise significantly, from $8.4 billion in 2020 to $51.9 billion in 2024 [4]. Group 2: Policy and Industry Trends - The policy environment has shifted from cost control to encouraging innovation, providing strong support for the development of innovative drugs [3]. - The number and quality of innovative drug products in China have significantly improved, leading to increased interest from foreign pharmaceutical companies [3][5]. - The penetration rate of innovative drugs in China is expected to rise, with current levels at around 20%, compared to 70%-80% in the U.S. [5]. Group 3: Investment Opportunities - Fund managers are optimistic about the future of innovative drugs, emphasizing the importance of technology and growth attributes in the sector [6]. - Investment strategies include focusing on high-quality companies, innovative drug leaders, and traditional pharmaceutical companies transitioning to innovative drugs [7][8][9]. - Investors can consider actively managed pharmaceutical funds or industry-themed ETFs to gain exposure to the innovative drug market [10][12]. Group 4: Fund Performance - Several funds managed by 工银瑞信 have demonstrated strong performance, ranking highly in their respective categories over various time frames [13][15]. - The 工银港股通创新药ETF has seen significant inflows, reflecting market preference for innovative drug companies [11].

Group 1 - The China Securities Regulatory Commission (CSRC) Chairman announced plans to enhance the STAR Market's demonstration effect, including the establishment of a STAR Market Growth Tier and the reintroduction of the fifth listing standard for unprofitable companies [1] - The STAR Market Growth ETF (588110) saw a strong increase of 1.20% as of June 18, 2025, with notable gains in constituent stocks such as Shengyi Electronics (688183) up 16.63% and Tiande Yu (688252) up 9.28% [1] - The STAR Market Growth ETF has experienced a significant increase in trading volume, with a turnover rate of 4.74% and a daily average transaction of 15.45 million yuan over the past week [1] Group 2 - The STAR Market Growth ETF has achieved a net value increase of 38.29% over the past year, ranking 185 out of 2854 index equity funds, placing it in the top 6.48% [2] - The ETF's highest monthly return since inception was 25.02%, with an average monthly return of 7.25% during the months it increased [2] Group 3 - The management fee for the STAR Market Growth ETF is 0.50%, and the custody fee is 0.10%, making it one of the lowest in its category [3] - The STAR Market Growth Index consists of 50 high-growth companies selected based on revenue and net profit growth rates, reflecting the overall performance of high-growth stocks on the STAR Market [3] - The top ten weighted stocks in the STAR Market Growth Index account for 53.67% of the index, including companies like Haiguang Information (688041) and Hengen Technology (688608) [3] Group 4 - The introduction of new indices in the STAR Market is positively impacting domestic index investment development by enriching the investment target pool and providing more diverse underlying assets for ETFs [4] - The emergence of thematic and industry indices is guiding investors to accurately allocate resources in emerging industries, enhancing the capital market's effectiveness in serving new productive forces [4]

Core Insights - The "Eight Articles" of the Sci-Tech Innovation Board have revitalized the capital market ecosystem, with significant growth in M&A activities and IPOs for unprofitable companies [1] - Since the release of the "Eight Articles," there have been 106 new M&A transactions on the Sci-Tech Innovation Board, with 60 completed and a total transaction value exceeding 140 billion yuan [1] - Institutional innovations are strengthening the connection between "hard tech" companies and the capital market, enhancing the flexibility of capital to promote technological advancements [1] Group 1: Company Responses to "Eight Articles" - Baili Tianheng's chairman highlighted that the "Eight Articles" have deepened reforms and increased support for high-quality development of unprofitable companies, allowing for successful IPOs even before profitability [1] - Jinghe Integrated's chairman noted that the "Eight Articles" have improved financing efficiency and innovation mechanisms, enabling the company to issue 2 billion yuan in technology innovation bonds [2] - Chip Origin's chairman mentioned that the "Eight Articles" support refinancing for R&D, allowing the company to accelerate its strategic layout in Chiplet technology [3] Group 2: Recommendations for Future Reforms - Tianyue Advanced's chairman expressed the need for more long-term capital to focus on outstanding Sci-Tech Innovation Board companies and suggested enhancing the inclusivity of capital operations for hard tech companies [7] - Du Jinhao from Ailis proposed increasing liquidity by attracting more long-term funds and promoting international connectivity for quality Sci-Tech enterprises [7] - The emphasis on improving corporate governance and enhancing profitability through cash dividends was also highlighted as a key area for development [4]

Core Viewpoint - The performance of the Sci-Tech Innovation Pharmaceutical Index ETF has shown significant growth in both trading volume and scale, indicating strong investor interest and confidence in the sector [3][5][6]. Liquidity - The Sci-Tech Innovation Pharmaceutical Index ETF had an intraday turnover of 9.12%, with a transaction volume of 20.17 million yuan. Over the past week, the average daily transaction volume reached 50.98 million yuan, ranking first among comparable funds [3]. Scale - In the past year, the Sci-Tech Innovation Pharmaceutical Index ETF's scale increased by 143 million yuan, achieving notable growth and ranking first among comparable funds [3]. Shares - The ETF's shares grew by 120 million in the past year, also ranking first among comparable funds [3]. Top Holdings - As of May 30, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index accounted for 51.6% of the total weight. The leading stocks include: - United Imaging Healthcare (8.97%) - BeiGene (7.05%) - Huaitai Medical (5.85%) - Aierx (4.91%) - Baillie Tianheng (4.77%) - Zai Lab (4.75%) - BGI Genomics (4.17%) - Junshi Biosciences (4.15%) - Aibo Medical (3.33%) - Teva Biopharma (3.25%) [5]. Market Response - Following the American Society of Clinical Oncology (ASCO) annual meeting, there has been a positive market response, highlighting the competitiveness and innovation of Chinese pharmaceutical companies in new drug development [5][6]. Innovation Pipeline - The proportion of domestic companies' innovative drug data presented at ASCO has been increasing, with 73 studies selected for oral presentations in 2025, indicating a strong focus on innovation within the industry [6]. Investment Opportunities - Investors without stock accounts can access opportunities in the Sci-Tech Innovation Board biopharmaceutical sector through the Sci-Tech Biopharmaceutical ETF linked fund (021061) [6].