（文章来源：每日经济新闻） 贝达药业（300558.SZ）12月2日在投资者互动平台表示，MRX-2843属于一个具有探索性靶点的新药， 目前该项目仍在进行转化医学探索研究，从而发现精准适应症的人群。如有重大进展公司会及时公开披 露。 每经AI快讯，有投资者在投资者互动平台提问：MRX-2843项目引进已经5年以上，临床看不到任何进 度，是暂停还是失败了？ ...

Group 1 - The core point of the article is that BeiGene (300558.SZ) is currently conducting translational medicine exploratory research on its new drug MRX-2843, which targets an exploratory target and aims to identify precise patient populations for its indications [1] Group 2 - The company has stated that it will promptly disclose any significant progress related to the MRX-2843 project [1]

Group 1 - The company, BeiGene (300558.SZ), has stated on its investor interaction platform that it currently has no project collaboration with Huahao Biotech [1]

Core Insights - The company has established a positive cycle of "R&D-commercialization-reinvestment," leading to steady revenue growth and cash flow reserves that meet operational needs and support the orderly advancement of its R&D pipeline [1] Group 1: Financial Performance - The company has achieved stable revenue increments and cash flow reserves, ensuring daily operational needs are met [1] Group 2: R&D Strategy - The company employs a dynamic project evaluation mechanism to select research projects, focusing on those with higher clinical value and market potential [1] - This strategy allows for efficient allocation of R&D resources and optimization of the pipeline [1] Group 3: Product Development - In the field of lung cancer treatment, the company is currently advancing the CFT8919 and MCLA-129 projects [1]

Core Viewpoint - The company has stated that there are currently no global multicenter clinical plans for Beifu Tini and Tairisili, and any significant collaborations or transactions will be disclosed in a timely manner [1] Group 1 - The company is actively engaging with investors through an interactive platform [1] - The company emphasizes transparency regarding major collaborations or transactions [1]

证券代码：300558 证券简称：贝达药业 公告编号：2025-074 贝达药业股份有限公司（以下简称"贝达药业"或"公司"）于 2024 年 12 月 4 日召开第四届董事会第二十次会议及第四届监事会第十七次会议，审议通过了 《关于使用部分闲置募集资金暂时补充流动资金的议案》，同意在不影响公司募集 资金投资计划正常进行的前提下，使用不超过 2.5 亿元人民币的闲置募集资金暂时 补充流动资金，使用期限自董事会审议通过之日起不超过 12 个月。具体情况详见 公司披露在巨潮资讯网（http://www.cninfo.com.cn）上的《关于使用部分闲置募集 资金暂时补充流动资金的公告》（公告编号：2024-093）。 在使用此部分闲置募集资金暂时补充流动资金期间，公司严格遵守《上市公司 募集资金监管规则》《深圳证券交易所创业板股票上市规则》及《深圳证券交易所 上市公司自律监管指引第 2 号——创业板上市公司规范运作》的相关规定，仅用于 与主营业务相关的生产经营使用，资金使用安排合理，不存在变相改变募集资金用 途或者影响募集资金投资项目的正常进行，不存在损害股东利益的情况。 截至 2025 年 12 月 1 日，公 ...

Investment Rating - The report maintains an "Outperform" rating for the industry [2]. Core Insights - The third-generation EGFR TKI has become the first-line standard therapy for advanced EGFR mutation NSCLC, significantly extending median progression-free survival (mPFS) to 18.9-22.1 months compared to earlier generations [4][24]. - The domestic EGFR TKI market is expected to exceed 20 billion CNY in 2024, with third-generation EGFR TKIs accounting for 88% of the market share [4][30]. - There is an urgent need to address resistance mechanisms following third-generation EGFR TKI treatment, with ongoing exploration of fourth-generation TKIs, bispecific antibodies, and antibody-drug conjugates (ADCs) [5][32]. Summary by Sections 1. High Incidence of Lung Cancer in China - Lung cancer is the most common malignant tumor globally, with approximately 2.6 million new cases expected in 2024, including about 1.15 million in China [8]. - Non-small cell lung cancer (NSCLC) accounts for around 85% of lung cancer cases, with adenocarcinoma and squamous cell carcinoma being the most prevalent subtypes [8]. 2. Third-Generation EGFR TKI as First-Line Therapy - The third-generation EGFR TKI has established itself as the first-line treatment for advanced EGFR mutation NSCLC, with significant improvements in mPFS compared to first and second generations [4][16][24]. - The report highlights the efficacy of third-generation TKIs in overcoming common mutations and their favorable safety profile [4][24]. 3. Exploration of Resistance Mechanisms - The report discusses the complexity of resistance mechanisms to third-generation EGFR TKIs, including both EGFR-dependent and independent pathways [5][32]. - Current research focuses on developing fourth-generation TKIs targeting specific mutations and exploring combination therapies with bispecific antibodies and ADCs [5][32][39]. 4. Investment Recommendations - The report emphasizes the growth potential of third-generation EGFR TKIs and suggests monitoring companies like Hansoh Pharma and Eli Lilly for market penetration and sales growth [51]. - It also highlights the progress of ADCs and bispecific antibodies in clinical trials, indicating a robust pipeline for future treatments [51][52].

Policy Developments - The National Healthcare Security Administration exposed a healthcare fraud industry chain in Shanghai, leading to the prosecution of an individual for fraud, resulting in significant losses to the national healthcare fund [1] - The crackdown on healthcare fraud has become more systematic and normalized in recent years, highlighting the importance of protecting the healthcare fund [1] Drug and Device Approvals - Anglicon received a drug registration certificate for Ertugliflozin Metformin Extended-Release Tablets, aimed at improving blood sugar control in adults with type 2 diabetes [2] - Betta Pharmaceuticals announced that its application for the marketing authorization of Ensartinib Capsules for treating ALK-positive non-small cell lung cancer has been accepted by the European Medicines Agency [3] - Innovent Biologics received approval for its IL-23p19 monoclonal antibody for the treatment of moderate to severe plaque psoriasis in adults [4] - Warner Pharmaceuticals obtained a drug registration certificate for Formoterol Fumarate Inhalation Solution, intended for the maintenance treatment of COPD [5] - Shanghai Pharmaceuticals announced that its Tramadol Hydrochloride Injection passed the consistency evaluation for generic drugs, which may enhance its market competitiveness [6] Major Industry Events - Biontech received a milestone payment of $250 million from Bristol-Myers Squibb related to the Iza-bren project, with potential for additional payments based on future milestones [7] - Jining Pharmaceutical plans to invest 893 million yuan in a hospital expansion project to meet the growing health demands in the region [8] - Maiwei Biotech completed Phase IIa clinical trials for its innovative drug 9MW1911 in COPD patients, showing significant reductions in acute exacerbation rates [9] Shareholder Actions - Sanofi Biotech announced plans for shareholders to reduce their holdings by a total of 0.0240% of shares due to personal financial needs [10] Management Changes - Sinopharm Holdings announced management changes, including the resignation of several executives and the appointment of new leadership, which will take effect upon shareholder approval [11]

Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The innovative drug sector is experiencing rapid growth, with several new drugs being quickly incorporated into the medical insurance directory as of October 2025 [3][20] - The report highlights significant increases in the number of drugs entering hospitals, particularly those newly included in the insurance directory, indicating strong market demand [3][19] Weekly New Drug Market Review - From November 24 to November 30, 2025, the top five performing new drug companies were: Frontline Bio (+23.12%), Yifang Bio (+15.74%), Rongchang Bio (+15.39%), Kangfang Bio (+14.86%), and Jakes (+14.18%). The five companies with the largest declines were: Yongtai Bio (-4.11%), Nothland (-3.33%), Junshengtai (-2.78%), Boan Bio (-2.09%), and Dongyao Pharma (-1.11%) [1][14] Suggested Focus Stocks - The report suggests focusing on several companies with promising catalysts, including: 1. Companies with MNC certification and high overseas sales potential: Sanofi, Lianbang Pharma, and Kelun Biotech 2. Companies with overseas data catalysts: Betta Pharma, Hutchison China MediTech, and Yimeng Bio 3. Potential heavyweights for overseas MNC licensing: Fuhong Hanlin, Shiyao Group, and Yifang Bio 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18] New Drug Industry Key Analysis - The National Healthcare Security Administration updated the data on innovative drugs included in the insurance directory as of October 2025, showing rapid hospital entry for several newly included domestic innovative drugs. Notable drugs with fast entry rates include: - Hengrui Medicine's Tazobactam - Innovent Biologics' Toripalimab - Haisco's Alogliptin and Clopidogrel - Sinopharm's Aliskiren and Amlodipine - Shanghai Yizhong's Paclitaxel polymer micelles - Kangfang Bio's Ivoris monoclonal antibody [3][19] New Drug Approval and Acceptance Status - This week, 11 new drugs or new indications received approval for market entry, while 13 new drugs or new indications were accepted for review [4][24] New Drug Clinical Application Approval and Acceptance Status - This week, 54 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [8][27]

Group 1 - The core point of the article is that Xcovery Holdings, a subsidiary of Betta Pharmaceuticals, has submitted a marketing authorization application for ensartinib capsules to the European Medicines Agency (EMA) for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] - The drug is a novel, potent, and highly selective ALK inhibitor that has already been approved for second-line and first-line indications in China [1] - The FDA is expected to approve the drug for market launch in the United States by December 2024, and the EMA has officially accepted the application for marketing authorization [1]