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） ...

（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，公司一贯重视与合作伙伴的协作关 系，目前双方已就里程碑付款进行相关的沟通和交流。对于该类日常经营事项，双方一直保持顺畅的沟 通，会实事求是、妥善处理。 ...

（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。 ...

格隆汇11月6日丨贝达药业(300558.SZ)在投资者互动平台表示，恩沙替尼用于ALK阳性NSCLC术后辅助 治疗的药物临床试验期中数据分析显示阳性结果，达到预设的主要研究终点，公司团队正加紧准备申报 材料，尽快递交新增适应症的NDA申请。 ...

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]

（文章来源：每日经济新闻） 每经AI快讯，有投资者在投资者互动平台提问：请问恩莎替尼的术后辅助适应症为何迟迟没有提交上 市？按这个节奏能否赶上明年的国谈？ 贝达药业（300558.SZ）11月6日在投资者互动平台表示，公司团队正加紧准备申报材料，尽快递交恩沙 替尼新增适应症的NDA申请。 ...