Core Viewpoint - The announcement indicates that the company has received acceptance from the National Medical Products Administration (NMPA) for its application of a new drug, which is a significant step towards potential market entry for the treatment of specific lung cancer patients [1] Group 1: Company Information - The company, Betta Pharmaceuticals (stock code: 300558), has announced that it received an acceptance notice from the NMPA for its application of the drug, Enasidenib Hydrochloride Capsules (brand name: Baimena®) [1] - The drug is intended for postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC) at stages IB to IIIB, who have previously undergone surgical resection [1] - The decision for patients to receive or not receive adjuvant chemotherapy will be made by their physicians [1] Group 2: Industry Context - The acceptance of the drug application by NMPA represents a crucial regulatory milestone in the pharmaceutical industry, particularly for oncology treatments [1] - The focus on ALK-positive NSCLC highlights the ongoing advancements and targeted therapies being developed within the cancer treatment sector [1]

Investment Rating - The investment rating for the company is "Buy" [5] Core Insights - The company reported a revenue of 2.717 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 15.90%. However, the net profit attributable to the parent company decreased by 23.86% to 317 million yuan, while the net profit excluding non-recurring items fell by 6.74% to 337 million yuan [1][5] - The overseas commercialization of Ensartinib is progressing smoothly, with the product approved for sale in Macau in June 2025 and the first prescription issued in the United States in August 2025. The first prescription in Macau was issued in October 2025 [2] - The company has achieved significant milestones in its innovative ecosystem, including the nationwide sales launch of Trastuzumab injection in July 2025 and the approval of a new indication for a strategic investment project in July 2025 [3] Financial Forecasts - Revenue projections for 2025-2027 are estimated at 3.55 billion, 4.37 billion, and 5.31 billion yuan, with year-on-year growth rates of 22.8%, 23.1%, and 21.5% respectively. The net profit attributable to the parent company is expected to reach 573 million, 721 million, and 856 million yuan, with growth rates of 42.3%, 25.8%, and 18.8% respectively [3][4]

Group 1 - The core point of the article is that Beida Pharmaceutical (300558.SZ) plans to issue overseas listed shares (H-shares) and apply for listing on the Hong Kong Stock Exchange to enhance its capital strength and competitiveness while advancing its internationalization process [2] - Beida Pharmaceutical will consider the interests of existing shareholders and the conditions of domestic and foreign capital markets when selecting the appropriate timing and issuance window for the listing [2] - The company has previously attempted to list in Hong Kong, submitting its prospectus in February 2021 and again in December 2021, but both attempts were unsuccessful [2] Group 2 - Beida Pharmaceutical, founded in 2003, focuses on innovative drug research and development with independent intellectual property rights, and has eight drugs currently on the market [3] - The company was listed on the Shenzhen Stock Exchange on November 7, 2016, and as of September 10, 2025, its total market capitalization is approximately 30.259 billion RMB [3][4] - The company's notable products include various cancer treatment drugs, such as the hydrochloride erlotinib tablets (Kaimena®) and the hydrochloride ensartinib capsules (Beimana®) [3]

Core Insights - The announcement highlights the approval of a clinical trial for ensartinib (Baimena®) as a postoperative adjuvant treatment for ALK-positive non-small cell lung cancer (NSCLC) by the National Medical Products Administration (NMPA) [1] - The interim analysis by the Independent Data Monitoring Committee (IDMC) showed positive results, achieving the primary endpoint with significant statistical significance and important clinical benefits [1] - Detailed data from the study will be presented at a major international academic conference later this year [1] - The company is preparing to submit a New Drug Application (NDA) for the new indication as soon as possible [1] Product Development - Ensartinib is a next-generation ALK inhibitor developed collaboratively by the company and its subsidiary, Xcovery Holdings, Inc. [1] - The drug was previously approved for use in patients with ALK-positive locally advanced or metastatic NSCLC who had progressed after or were intolerant to crizotinib in November 2020 (second-line indication) [1] - In March 2022, ensartinib received approval for a first-line indication for ALK-positive locally advanced or metastatic NSCLC patients [1] Market Impact - The positive interim data from the postoperative adjuvant clinical trial represents a significant achievement for the company, demonstrating the competitive strength of ensartinib [2] - The potential approval of the new indication is expected to enhance product coverage and benefit more patients [2]

Core Viewpoint - Betta Pharmaceuticals has made significant progress in the clinical research of Ensartinib for postoperative adjuvant therapy in ALK-positive non-small cell lung cancer (NSCLC), with positive interim results from an independent data monitoring committee [1] Group 1: Clinical Trial Progress - The clinical trial for Ensartinib (Baimena®) was approved by the National Medical Products Administration (NMPA) in April 2022 for use in postoperative treatment of ALK-positive NSCLC [1] - The interim analysis of the clinical trial has shown positive results, achieving the primary research endpoint with significant statistical significance and important clinical benefits [1] - Detailed data from this study will be presented at a major international academic conference later this year [1] Group 2: Future Implications - The positive interim results of the postoperative clinical trial reflect the company's focus on resource allocation and development, showcasing the competitive strength of Ensartinib [1] - The approval of the new indication is expected to enhance product coverage and benefit more patients [1] - The company is preparing to submit the NDA application for the new indication as soon as possible [1]