Core Viewpoint - The approval of Enasidenib capsules (brand name: Beimingna) by the Macao Drug Regulatory Authority marks a significant milestone for the company in treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development and Approvals - Enasidenib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery [1] - The drug received approval for second-line indications from the National Medical Products Administration of China in November 2020 [1] - In March 2022, the first-line indication was approved, followed by the approval for clinical trials of postoperative adjuvant therapy in April 2022, with ongoing Phase III clinical research [1] Group 2: Market Access and Insurance Inclusion - Enasidenib was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023) with an agreement valid until December 31, 2025 [1] - The first-line indication is expected to receive approval from the U.S. Food and Drug Administration in December 2024 [1] Group 3: Competitive Landscape - As of the announcement date, other ALK inhibitors available in Macao include Crizotinib, Ceritinib, Alectinib, Brigatinib, and Lorlatinib [1]

Core Viewpoint - The company has submitted a drug registration application for Ensartinib capsules to the Macau Drug Administration, aiming to treat patients with locally advanced or metastatic non-small cell lung cancer who are positive for anaplastic lymphoma kinase (ALK) [1] Group 1 - The drug, marketed as Baimena, is a new generation ALK inhibitor developed in collaboration with the company's subsidiary, Xcovery [1] - Ensartinib has already received marketing approval in China and the United States, and the company is advancing the application process in Europe [1] - The company will continue to monitor the review progress, and the short-term impact of this application on the company's operating performance is not expected to be significant [1]

东风已来，在政策支持与市场需求的共同推动下，深市一批医药生物企业正乘"数"而行、提"智"增效。 积极推进数智化转型 医药行业是关系国计民生的重要产业，是培育发展战略性新兴产业的重点领域，也是我国国民经济的重 要组成部分。 近日，工业和信息化部、商务部、国家卫生健康委等七部门联合印发《医药工业数智化转型实施方案 （2025—2030年）》，释放出"推动新一代信息技术与医药产业链深度融合"的积极信号。 2024年，多个"十四五"规划类文件出台，《深化医药卫生体制改革2024年重点工作任务》等一系列重大 的产业支持政策相继发布，首次将创新药列为新兴产业关键环节和新质生产力重要组成部分，持续鼓励 医药行业向高质量、创新驱动方向转型，聚焦医药、医疗、医保协同发展和治理，三医联动协同发展促 进行业的规范化与高效化。 人工智能等前沿技术加持，医药生物产业迎来哪些变化呢？ 创新成果驱动业绩增长 原创性技术产品和颠覆性研发成果持续涌现，深市医药企业实现了持续的业绩增长。 贝达药业是一家以自主知识产权创新药物研究与开发为核心，集研发、生产、市场营销于一体的国家级 高新技术企业。公司深耕肿瘤创新药二十多年，构建了覆盖表皮生长因子受 ...

Core Viewpoint - Beida Pharmaceutical reported a revenue growth of 17.74% year-on-year to 2.892 billion yuan in 2024, with a net profit of 403 million yuan, marking a 15.67% increase, and a significant turnaround in profitability with a 55.92% rise in non-net profit [1][2] Financial Performance - The company achieved a revenue of 2.892 billion yuan in 2024, approaching the 3 billion yuan mark, with a net profit of 403 million yuan [1] - The non-net profit reached 410 million yuan, indicating a strong recovery from previous years where revenue growth did not translate into profit [1] - Historical revenue figures from 2021 to 2023 were 2.246 billion yuan, 2.377 billion yuan, and 2.456 billion yuan, with net profits fluctuating significantly [1] Product Portfolio - Beida Pharmaceutical currently has five new drugs in the oncology treatment field, including the first-generation EGFR inhibitor, Alectinib (Kaimena®), and the ALK inhibitor, Ensartinib (Beimina®) [1][2] - The company has expanded its product lineup from a single product to five through independent research and strategic partnerships [2] - Alectinib has generated over 1 billion yuan in annual revenue since its inclusion in the national medical insurance directory in 2017 [2] Market Expansion and Pipeline - The company has one innovative drug under review for market approval and over 20 projects in development, indicating potential for future growth [2][6] - The sales forecast for Beimina in 2024 is expected to approach 800 million yuan, while Kaimena's sales are projected to be between 1.2 billion and 1.4 billion yuan [4][5] - Beida's research and development investment has consistently been high, with R&D expenditures from 2020 to 2024 being 742 million yuan, 861 million yuan, 977 million yuan, 1 billion yuan, and 717 million yuan, respectively [7] Leadership and Strategic Moves - The return of Professor Mao Li as the Chief R&D Officer is a significant development for the company, as he previously held key positions within Beida and has extensive experience in the industry [8][9]