9月15日晚间，白云山（600332）发布公告，公司旗下分公司白云山制药总厂研发的选择性RET小分子 抑制剂BYS10片收到国家药品监督管理局药品审评中心(CDE)的反馈意见，同意BYS10片未来采用Ⅱ期 单臂临床试验申请上市。这也意味着BYS10片进入关键注册临床试验阶段。 公告显示，BYS10片是白云山制药总厂自主研发的高选择性RET抑制剂，制剂规格为25mg、100mg，其 适应症为非小细胞肺癌、甲状腺髓样癌等晚期实体瘤。白云山制药总厂于2022年1月获得国家药品监督 管理局签发的《药物临床试验批准通知书》，2022年4月，BYS10片临床试验首次在CDE公示，2023年1 月，第一例受试者签署知情同意书。截至2025年8月，该项目已投入研发费用近1.5亿元。 BYS10片I期临床试验数据显示，BYS10片具有强效、持久的抗肿瘤活性，在RET基因突变的多种实体 瘤如晚期非小细胞肺癌（NSCLC）、甲状腺癌（TC）、甲状腺髓样癌（MTC）等患者中表现出良好的 临床活性和耐受性。基于阶段Ⅰ期的安全性和有效性数据，近日CDE同意BYS10片未来采用Ⅱ期单臂临 床试验申请上市。 当前，中国每年新发RET突变肿瘤 ...

Core Viewpoint - The company is committed to enhancing operational quality and core competitiveness while protecting the legitimate rights and interests of all investors, particularly small and medium-sized investors, through its "Quality Improvement, Efficiency Enhancement, and Return Focus" action plan for 2025 [1] Group 1: Business Development - The company focuses on the development of innovative anti-tumor drugs and related products, supported by a team of high-tech talents with backgrounds in polymer materials, drug formulation, and biology [1] - The company has achieved significant improvements in operational quality and efficiency, with core product marketing maintaining a steady performance [2] - The company has completed approvals for its products in over 200 key hospitals nationwide, enhancing drug accessibility and patient affordability [2] Group 2: Production Expansion - The company is implementing a project to produce 5 million injections of paclitaxel polymer micelles annually, with construction progressing smoothly and on schedule [3] - The cleanroom construction and production equipment preparations are underway, ensuring alignment with future market demand [3][4] Group 3: Clinical Research - The company is actively conducting clinical research for multiple cancer indications, with Phase II trials for ovarian, esophageal, and nasopharyngeal cancers progressing as planned [5] - Phase III trials for breast and pancreatic cancers have been initiated at over 20 research centers nationwide, with research progress meeting expectations [5] Group 4: Talent Acquisition - The company has successfully recruited 252 individuals in the first half of 2025, including 23 high-educated talents and 99 fresh graduates, enhancing its research and professional capabilities [6] Group 5: Innovation and R&D - The company is developing two new drugs: a multifunctional monoclonal antibody and a fourth-generation EGFR-TKI, both currently in preclinical research [6] - The focus for the year will be on advancing these new drugs through critical experiments to validate their efficacy and safety [6] Group 6: Investor Returns - The company emphasizes sustainable profitability and has implemented a cash dividend policy, distributing 0.3 yuan per share, totaling 43,166,400 yuan, which is 30.22% of the net profit attributable to shareholders [7][8] - The company has repurchased 1,274,307 shares, amounting to 37,240,964.92 yuan, reinforcing its commitment to maintaining long-term investment value [8] Group 7: Investor Communication - The company has enhanced its investor communication by expanding channels and improving the quality of information disclosure, thereby increasing investor confidence [9] - Regular training for key personnel has been conducted to ensure accurate and timely information disclosure, reflecting the company's investment value [9] Group 8: Corporate Governance - The company is continuously improving its governance structure and internal control systems to ensure stable operations and enhance financial management [10] - The company has revised key governance documents to clarify the responsibilities of its management team, aligning their performance with shareholder interests [10] Group 9: Future Outlook - The company will continue to focus on its main business development and maintain a stable and resilient long-term profitability, ensuring the protection of all shareholders' rights [11]

Core Investment Logic - The impact of the national procurement of Lefuyin is gradually diminishing, and with the launch and promotion of new products, the company's performance is expected to return to a growth trajectory [1][2] - The company is firmly advancing its innovation transformation, introducing the ALK-N001 (DXd) which opens up new possibilities. ALK-N001 is a tumor-responsive prodrug designed based on the TMEA platform, which has shown significant efficacy and safety trends compared to existing first-line chemotherapy regimens in phase 3 trials of its first drug, Legu Bixin [1][3] Business Overview - Established in 2001, the company has over 20 years of experience in the pharmaceutical field, transitioning from generic to innovative drugs. It primarily engages in the R&D, production, and sales of chemical raw materials, chemical preparations, pharmaceutical excipients, and specialty intermediates [1] - The company has a significant advantage in cardiovascular preparations, oral cephalosporin raw materials, alpha-keto acid raw materials, inhalation anesthetics, anti-androgen intermediates, and plant-derived cholesterol products [1] Financial Performance and Forecast - The company expects a revenue of 1.54 billion in 2024, a year-on-year decrease of 5%. The decline in performance is mainly due to the impact of the Lefuyin product, particularly from the eighth batch of national procurement [2] - The company anticipates a rebound in performance driven by the approval and promotion of new products, including the "light-foot" compound alpha-keto acid tablets and the cooperative product Ediguanol soft capsules [2] - Profit forecasts for 2025-2027 are projected at 132 million, 170 million, and 216 million respectively, with year-on-year growth rates of 64%, 29%, and 27% [4] New Growth Areas - The company is expanding into new fields such as plant cholesterol and animal health, aiming to create new growth drivers. The acquisition of Keri Bio in 2023 is expected to provide stable cash flow, with a projected net profit margin of 40% in 2024 [2] - The company's animal health business focuses on pet medications, with a target to double the sales of isoflurane by 2025, and numerous ongoing projects in pet medications that could become new growth points [2] Drug Development and Innovation - ALK-N001 is a tumor-responsive prodrug designed to achieve targeted delivery in the tumor microenvironment, aiming for high efficacy and low toxicity. The TMEA-SMDC platform has been validated through positive phase 3 trial results of Legu Bixin [3] - The company has reached an agreement with Affinity for the authorization of ALK-N001/QHL-1618, obtaining all rights in Greater China. ALK-N001 is expected to be a strong candidate for tumor treatment due to its enhanced cytotoxicity [3]