"创新药第一股"贝达药业（300558）于8月20日交出了一份增收不增利的半年报，公司上半年净利下降 至1.4亿元，降幅达到37.53%。贝达药业把业绩下滑归因于计入当期损益的折旧摊销等费用升高。报告 期内，公司销售费用、管理费用和财务费用均出现上升。值得关注的是，在三大费用攀升的同时，贝达 药业的研发投入却不增反降，同比下降超20%。此外，贝达药业拖欠益方生物的1.8亿元里程碑款项已 出现逾期，更进一步暴露其资金压力。在业内人士看来，这可能会影响贝达药业的商业信誉与未来的合 作前景。 净利下滑吓崩股价 一季度尚且实现净利增长的贝达药业，上半年净利出现了明显下滑，公司股价因此盘中一度重挫逾 10%。 财务数据显示，贝达药业上半年实现营业收入17.31亿元，同比增长15.37%；归属净利润1.4亿元，同比 下降37.53%。这是公司自2022年之后，首次在半年报出现净利润同比下滑现象 在研发投入下降的同时，贝达药业销售费用出现持续攀升。今年上半年，贝达药业销售费用约为5.94亿 元，同比增长13.34%。2022—2024年期间，贝达药业半年度销售费用分别为4.4亿元、4.58亿元、5.24亿 元。 此外，今年 ...

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]