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].

Group 1 - The core viewpoint is that the medical innovation sector is experiencing a phase of differentiation, with a focus on innovative drugs and performance-driven stocks [2] - The Medical Innovation ETF (516820) has seen a net inflow of 57.86 million yuan recently, indicating positive market sentiment towards the sector [1] - The industry is expected to continue stable and sustainable growth in healthcare spending, with innovation and high-end manufacturing being key drivers for future investment opportunities [3] Group 2 - The report suggests that innovative drugs remain the most promising sub-industry within the pharmaceutical sector, with a clear upward trend and growth potential [2] - There is a recommendation to actively invest in high-performing segments such as CRO&CDMO, GLP-1, and specialty raw materials, which are expected to show improvement [2] - The CS Pharmaceutical Innovation Index, which the Medical Innovation ETF tracks, uses objective quantitative indicators to select stocks in high-growth areas, making it a unique investment vehicle in the market [2]

Core Viewpoint - The Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index has shown strong performance, with significant increases in constituent stocks, indicating a positive trend in the biopharmaceutical sector [1][3]. Market Performance - As of July 11, 2025, the Biopharmaceutical Index rose by 1.23%, with notable gains from stocks such as Yifang Biotech (+10.31%), Shouyao Holdings (+8.34%), and Te Bao Biotech (+7.18%) [1]. - The Jiashi Science and Technology Medicine ETF (588700) also increased by 1.14%, marking its third consecutive rise [1]. Liquidity and Trading Volume - The Jiashi Science and Technology Medicine ETF recorded a turnover rate of 9.54% and a trading volume of 21.11 million yuan [3]. - Over the past month, the ETF has maintained an average daily trading volume of 33.32 million yuan, ranking first among comparable funds [3]. Fund Growth and Performance - In the last two weeks, the Jiashi Science and Technology Medicine ETF's scale increased by 17.56 million yuan, leading among comparable funds [3]. - The ETF's net value has risen by 37.70% over the past year, with a maximum single-month return of 23.29% since its inception [3]. Top Holdings - As of June 30, 2025, the top ten weighted stocks in the Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare, BeiGene, and Huatai Medical [3][5]. Policy Support and Market Outlook - Recent policy documents have been released to support the high-quality development of innovative drugs, highlighting government backing for the sector [6]. - The number of innovative drugs in development in China has reached over 4,000, representing approximately 30% of the global total [5][6].

Group 1 - The core viewpoint highlights the significant growth and performance of the Kexin Pharmaceutical ETF managed by Jiashi, with a notable increase in trading volume and fund size [2] - As of July 9, the Kexin Pharmaceutical ETF achieved a daily average trading volume of 34.95 million yuan over the past month, ranking first among comparable funds [2] - The fund's size increased by 16.76 million yuan in the past two weeks, also ranking first among comparable funds [2] - The ETF saw a total inflow of 12.84 million yuan over the last ten trading days, indicating strong investor interest [2] - The net value of the Kexin Pharmaceutical ETF rose by 36.83% over the past year, showcasing its strong performance [2] Group 2 - The top ten weighted stocks in the Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index account for 50.3% of the index, with leading companies including United Imaging Healthcare and BeiGene [2][4] - On July 9, Shanghai Pharmaceuticals announced an expected net profit of 4.45 billion yuan for the first half of 2025, representing a year-on-year increase of approximately 52% [4] Group 3 - Short-term market expectations for overseas transactions in innovative drugs are high, leading to a continuous rise in valuations [5] - China's innovative drug research and development capabilities are competitive globally, and the trend of innovative drugs going overseas is expected to persist [5] - The commercial health insurance sector in China is anticipated to see significant growth in premium income and payout rates, becoming an important source of funding for innovative drugs [5]

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].