Core Viewpoint - The company is actively preparing to submit a New Drug Application (NDA) for a new indication of Ensatinib [2] Group 1 - The company team is accelerating the preparation of submission materials [2] - The NDA application for the new indication of Ensatinib is expected to be submitted soon [2]

Group 1 - The core point of the article is that Betta Pharmaceuticals has successfully commercialized its product Ensartinib in the United States and is actively advancing its sales efforts [2] - The company has established the necessary teams in accordance with regional regulations and business practices for sales operations [2] - Betta Pharmaceuticals will promptly disclose any significant commercial cooperation matters through announcements or its public platform [2]

Group 1 - The company announced that its overseas subsidiary Xcovery is leading a global multicenter Phase III clinical study for Ensartinib, accumulating valuable experience [2] - The company has established a deep strategic partnership with He Yuan Bio, an important collaborator in the innovative ecosystem [2] - The company will provide strong support for the global clinical research of plant-derived recombinant human albumin [2]

Core Insights - As of October 31, 2025, the total number of common shareholders for the company in the A-share market is 34,761 [2] Company Summary - The company, Betta Pharmaceuticals, provided an update on its shareholder count in response to investor inquiries on November 6 [2]

证券日报网讯贝达药业11月6日在互动平台回答投资者提问时表示，公司定期报告对报告期的经营状 况、财务数据等已进行真实、准确、完整的记录和核算。2025年前三季度，公司实现营业收入27.17亿 元，同比增长15.90%；公司息税折旧摊销前利润（EBITDA）达到8.6亿元，同比增长20.15%，因影响 净利润的还有折旧、摊销等因素，净利润未同步增长。未来随着药品推广策略的落地，公司的营收将持 续改善，对财务指标也会产生积极影响。 （文章来源：证券日报） ...

Group 1 - The company emphasizes the importance of collaboration with partners and has been communicating regarding milestone payments [2] - The company maintains smooth communication with partners regarding daily operational matters and aims to handle issues pragmatically [2]

（文章来源：证券日报） 证券日报网讯贝达药业11月6日在互动平台回答投资者提问时表示，本次发行所募集资金在扣除发行费 用后全部用于公司，可能包括（但不限于）用于在研管线的研发活动提供支持、为开拓管线而进行的潜 在的收购以及进一步开拓创新生态圈、营销网络建设及重点治疗领域市场拓展、营运资金及其他一般公 司用途。 ...

Core Viewpoint - Betta Pharmaceuticals (300558.SZ) has reported positive interim data analysis from clinical trials of Ensartinib for postoperative adjuvant treatment of ALK-positive NSCLC, achieving the predefined primary research endpoint [1] Group 1 - The company is accelerating the preparation of submission materials for the new indication [1] - The company plans to submit a New Drug Application (NDA) as soon as possible [1]

Group 1 - The company has established a dedicated marketing team for overseas promotion, specifically in the United States [2] - The product Ensartinib has been officially commercialized in the U.S. market [2] - The sales team has been organized according to regional regulations and business practices, and sales activities are progressing smoothly [2]

Core Viewpoint - The company is actively preparing to submit the NDA application for the new indication of Ensartinib, aiming to expedite the process to potentially meet the timeline for next year's national discussions [2]. Group 1 - Investors have inquired about the delay in submitting the post-operative adjuvant indication for Ensartinib [2]. - The company has confirmed that its team is working diligently to prepare the submission materials [2].