Core Viewpoint - The announcement highlights the successful prescription of a new innovative drug, Ensartinib, by Betta Pharmaceuticals and its subsidiary Xcovery Holdings, marking a significant milestone in the development of targeted therapies for lung cancer [1] Company Summary - Betta Pharmaceuticals has developed Ensartinib (brand name: Baimena), a novel and highly selective next-generation ALK inhibitor [1] - The drug has received FDA approval for market entry in December 2024, making it the first small molecule targeted innovative drug led by a Chinese company to be launched globally [1] Industry Summary - Ensartinib represents a significant advancement in the field of targeted cancer therapies, particularly for lung cancer, which is a major area of focus in oncology [1] - The successful prescription at the Martin O'Neill Cancer Center in California indicates the drug's entry into the competitive U.S. market, potentially enhancing the company's position in the global pharmaceutical landscape [1]

贝达药业股份有限公司 关于盐酸恩沙替尼胶囊在美国开出首张处方单的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 证券代码：300558 证券简称：贝达药业 公告编号：2025-057 近日，贝达药业股份有限公司（以下简称"公司"）和控股子公司 Xcovery Holdings, Inc.共同开发的自主创新药盐酸恩沙替尼胶囊（贝美纳®，以下简称"恩 沙替尼"）在美国加利福尼亚州 Martin O'Neill 癌症中心正式开出首张处方 单。现将相关情况公告如下： 以上事项具体情况详见公司披露在巨潮资讯网（http://www.cninfo.com.cn）上 的相关公告（公告编号：2020-135、2021-121、2022-026、2023-017、2023-102、 2024-010、2024-088、2024-096、2025-006、2025-037、2025-047、2025-056）。 截至本公告披露日，共有 6 款用于 ALK 阳性肺癌患者治疗的药物在美国 获批上市，分别是克唑替尼、塞瑞替尼、阿来替尼、布格替尼、洛拉替尼和 恩沙替尼。 一、药品基 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company has shown steady revenue growth, with a total revenue of 1.731 billion yuan in H1 2025, representing a year-on-year increase of 15.37%. However, the net profit attributable to the parent company decreased by 37.53% to 140 million yuan due to increased depreciation and amortization expenses [6][7] - The company has successfully commercialized eight drug products, with significant sales growth expected for its key products, including Enasidenib and Bevacizumab, following their inclusion in medical insurance [6][7] - The company is expanding its product pipeline with ongoing clinical trials for new treatments, including its first self-developed CDK4/6 inhibitor, which was approved in June 2025 [6][7] - The revenue forecast for 2025-2027 has been adjusted, with expected revenues of 3.611 billion yuan, 4.228 billion yuan, and 5.082 billion yuan, respectively, and net profits of 471 million yuan, 589 million yuan, and 747 million yuan [6][7] Summary by Sections Financial Performance - Total revenue for 2022 was 2.377 billion yuan, with a growth rate of 5.82%. The forecast for 2023 is 2.456 billion yuan, with a growth rate of 3.35%. The revenue is expected to reach 3.611 billion yuan in 2025, reflecting a growth rate of 24.87% [3][7] - The net profit attributable to the parent company was 145 million yuan in 2022, with a significant increase of 139.33% in 2023, reaching 348 million yuan. The forecast for 2025 is 471 million yuan, with a growth rate of 17.08% [3][7] Valuation Metrics - The earnings per share (EPS) for 2022 was 0.35 yuan, expected to rise to 1.12 yuan in 2025, with a corresponding price-to-earnings (P/E) ratio decreasing from 210.54 in 2022 to 64.96 in 2025 [3][7] - The price-to-book (P/B) ratio is projected to decline from 6.31 in 2022 to 5.28 in 2025, indicating a potential improvement in valuation [3][7] Market Position and Strategy - The company is focusing on expanding its market presence in oncology, with successful launches and sales of new products, including its first self-developed drug for breast cancer treatment [6][7] - The company has invested 299 million yuan in research and development in H1 2025, indicating a commitment to innovation and product development [6][7]

Core Viewpoint - The clinical trial for Ensartinib (also known as "Baimena") for postoperative adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC) has received approval from the National Medical Products Administration (NMPA) and has shown positive interim results, achieving the primary research endpoint with significant statistical and clinical benefits [1]. Group 1: Drug Information - Ensartinib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery Holdings, Inc. [1] - The drug was approved for use in patients with locally advanced or metastatic NSCLC who progressed after crizotinib treatment or were intolerant to it 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]. - The drug was included in the National Basic Medical Insurance Directory in December 2023, and the European marketing application for the first-line indication was initiated in February 2025 [1]. Group 2: Impact on the Company - The positive interim data from the postoperative adjuvant clinical trial represents a significant achievement for the company, demonstrating the competitive strength of Ensartinib [1]. - The approval of the new indication is expected to enhance product coverage and benefit more patients [1].

Group 1 - The chemical pharmaceutical sector increased by 2.53% on August 25, with Shutaishen leading the gains [1] - The Shanghai Composite Index closed at 3883.56, up 1.51%, while the Shenzhen Component Index closed at 12441.07, up 2.26% [1] - Notable gainers in the chemical pharmaceutical sector included: - Buzoushen (300204) with a closing price of 61.00, up 16.17% and a trading volume of 445,500 shares [1] - Haichen Pharmaceutical (300584) with a closing price of 58.95, up 13.61% and a trading volume of 217,200 shares [1] - Changshan Pharmaceutical (300255) with a closing price of 53.25, up 12.84% and a trading volume of 683,900 shares [1] Group 2 - The chemical pharmaceutical sector experienced a net outflow of 426 million yuan from institutional investors, while retail investors saw a net inflow of 509 million yuan [2] - The top stocks by net inflow from retail investors included: - Anglikang (002940) with a net inflow of 163 million yuan, representing 22.87% of its trading volume [3] - Haichen Pharmaceutical (300584) with a net inflow of 132 million yuan, representing 10.90% of its trading volume [3] - Lingkang Pharmaceutical (603669) with a net inflow of 64.68 million yuan, representing 37.53% of its trading volume [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]

Group 1 - The core viewpoint of the news is that 贝达药业 (Bida Pharmaceutical) has shown fluctuations in stock performance and financial metrics, indicating both growth and challenges in its operations [1][2] Group 2 - As of August 25, 贝达药业's stock price increased by 2.06% to 66.38 CNY per share, with a total market capitalization of 27.93 billion CNY [1] - The company has experienced a year-to-date stock price increase of 23.54%, but a recent decline of 3.80% over the last five trading days [1] - The main business revenue composition is 99.10% from drug sales and 0.90% from other sources [1] Group 3 - For the first half of 2025, 贝达药业 reported a revenue of 1.73 billion CNY, reflecting a year-on-year growth of 15.37%, while the net profit attributable to shareholders decreased by 37.53% to 140 million CNY [2] - The number of shareholders increased by 9.97% to 32,100, while the average circulating shares per person decreased by 9.08% to 13,064 shares [2] Group 4 - The company has distributed a total of 669 million CNY in dividends since its A-share listing, with 184 million CNY distributed over the past three years [2] - Notable institutional holdings include 易方达创业板ETF (E Fund ChiNext ETF) as the fifth largest shareholder, holding 6.37 million shares, a decrease of 107,600 shares from the previous period [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]

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 2022 年 4 月，贝达药业股份有限公司（以下简称"公司"）申报的盐酸 恩沙替尼胶囊（贝美纳®，以下简称"恩沙替尼"）用于间变性淋巴瘤激酶（ALK） 阳性的非小细胞肺癌（NSCLC）术后辅助治疗的药物临床试验（以下简称"该 临床试验"）获国家药品监督管理局（以下简称"NMPA"）批准开展。近 日，经临床试验独立数据监查委员会（IDMC）评估，该临床试验期中分析显 示阳性结果，达到研究预设的主要研究终点，具有显著统计学意义和重要临 床获益。本研究详细数据将于今年在重要国际学术会议上公布。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。现将具体情况公告如 下： 证券代码：300558 证券简称：贝达药业 公告编号：2025-056 贝达药业股份有限公司 关于恩沙替尼术后辅助适应症临床研究进展的公告 二、对公司的影响及风险提示 一、药品基本情况 恩沙替尼是一种新型强效、高选择性的新一代 ALK 抑制剂，是公司和控股子 公司 Xcovery Holdings, Inc.共同开发的自主创新药。2020 ...

Core Viewpoint - The company, Betta Pharmaceuticals, provided an update on its dual-target antibody product MCLA-129, which targets both EGFR and c-Met to inhibit tumor growth and survival [1] Group 1: Product Development - MCLA-129 is currently undergoing multiple clinical studies for both monotherapy and combination therapy indications [1] - In January, the I/II phase study of MCLA-129 entered the parallel cohort expansion phase and completed the enrollment of the first subject, targeting wild-type colorectal cancer [1] - In July, a Phase II study of MCLA-129 in lung cancer related to driver gene positivity and MET amplification completed the enrollment of its first patient [1] Group 2: Combination Therapy Trials - Clinical trials for MCLA-129 in combination with Bevacizumab are progressing [1] - The application for clinical trials of MCLA-129 in combination with Ensartinib has recently been accepted by the NMPA [1] Group 3: Communication and Disclosure - The company will timely disclose any significant progress in the aforementioned clinical studies [1]