法律意见书 浙江天册律师事务所 关于 浙江省杭州市杭大路 1 号黄龙世纪广场 A 座 11 楼 310007 电话：0571-87901111 传真：0571-87901500 法律意见书 浙江天册律师事务所 关于贝达药业股份有限公司 2023 年限制性股票激励计划 首次授予部分第一个归属期归属条件成就及部分限制性股票作废 贝达药业股份有限公司 2023 年限制性股票激励计划 首次授予部分第一个归属期归属条件成就 及部分限制性股票作废的 法律意见书 编号：TCYJS2025H0784 号 的法律意见书 致：贝达药业股份有限公司 浙江天册律师事务所（以下简称"本所"）接受贝达药业股份有限公司（以 下简称"公司"或"贝达药业"）的委托，指派于野律师、孔舒韫律师（以下简 称"本所律师"或"经办律师"），依据《中华人民共和国公司法》（以下简称 "《公司法》"）、《中华人民共和国证券法》（以下简称"《证券法》"）、 《上市公司股权激励管理办法》（以下简称"《管理办法》"）等有关法律、法 规和规范性文件及《贝达药业股份有限公司章程》（以下简称"《公司章程》"）、 《贝达药业股份有限公司 2023 年限制性股票激励计划（草 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-040 贝达药业股份有限公司 关于 2023 年限制性股票激励计划首次授予部分第一个归属期 符合归属条件的公告 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。 重要内容提示： 一、本次激励计划实施情况概要 （一）本次激励计划主要内容 公司于 2023 年 11 月 17 日召开的第四届董事会第十次会议以及于 2023 年 12 月 5 日召开的 2023 年第一次临时股东大会，审议通过了《贝达药业股份有限 公司 2023 年限制性股票激励计划（草案）》（以下简称"《2023 年激励计划 （草案）》"）等相关议案，主要内容如下： 1、激励工具：第二类限制性股票。 1 1、本次符合归属条件的激励对象共 479 人，拟归属的第二类限制性股票数 量为 289.7827 万股，占目前公司股本总额 41,848.5885 万股的 0.6925%。 2、本次第二类限制性股票的归属价格为 41.00 元/股，归属股票来源为公司 向激励对象定向发行的 A 股普通股股票。 3、本次拟归属的第二类限制性股票在相关手续办 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-043 贝达药业股份有限公司 董事会薪酬与考核委员会 关于 2023 年限制性股票激励计划相关事项的核查意见 本公司及董事会薪酬与考核委员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。 根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中华人 民共和国证券法》（以下简称"《证券法》"）、《上市公司股权激励管理办 法》（以下简称"《管理办法》"）、《深圳证券交易所创业板股票上市规则》 （以下简称"《上市规则》"）、《深圳证券交易所创业板上市公司自律监管 指南第 1 号——业务办理：第二章公司治理第二节股权激励》及《贝达药业股 份有限公司 2023 年限制性股票激励计划（草案）》（以下简称"《2023 年激 励计划（草案）》"）的规定，贝达药业股份有限公司（以下简称"公司"） 第四届董事会薪酬与考核委员会对公司 2023 年限制性股票激励计划（以下简 称"本次激励计划"）的相关事项进行了核查，认真审阅了相关资料，并发 表核查意见如下： 一、关于 2023 年限制性股票激励计划首次授予部分第一个归属期符合归 ...

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]

贝达药业股份有限公司 关于向澳门药物管理局递交盐酸恩沙替尼胶囊药品上市申请的公告 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。 近日，贝达药业股份有限公司（以下简称"公司"）向中华人民共和国 澳门特别行政区药物监督管理局（以下简称"ISAF"）递交盐酸恩沙替尼胶 囊（商品名：贝美纳®，以下简称"恩沙替尼"）"拟用于间变性淋巴瘤激酶 （ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗"（即 一线适应症）的药品上市申请。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：2025-037 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.（以下简称"Xcovery"）共同开发的自主创新药。2020 年 11 月，恩沙替尼"适用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不 耐受的 ALK 阳性的局部晚期或转移性 NSCLC 患者的治疗"（即二线适应症）获 得国家药品监督管理局（以下简称"NMPA"）批准上市；2022 年 3 月，恩沙替 尼一线 ...

Summary of the Conference Call Industry Focus - The report focuses on the pharmaceutical industry, specifically highlighting innovative drugs and contract research organizations (CXO) Core Insights and Arguments - Continuous recommendation of innovative drugs with positive growth outlook, including: - 恒瑞医药 (Hengrui Medicine) - 华东医药 (East China Pharmaceutical) - 翰森制药 (Hansoh Pharmaceutical) - 贝达药业 (Betta Pharmaceuticals) - 信立泰 (Sinopharm) - 科伦药业 (Kelun Pharmaceutical) - 百利天恒 (Baili Tianheng) - 荣昌生物 (Rongchang Biopharmaceutical) - 科伦博泰生物 (Kelun Biotech) - 石药集团 (Shijiazhuang Pharmaceutical Group) [1][1][1] - Recommendation of CXOs showing signs of profit growth turning points, including: - 药明生物 (WuXi Biologics) - 药明康德 (WuXi AppTec) [1][1] - Positive outlook on domestic replacement of innovative medical devices, specifically: - 惠泰医疗 (Huitai Medical) [1] - Anticipation of recovery in consumer healthcare, particularly: - 爱尔眼科 (Aier Eye Hospital) [1] Other Important Points - The report emphasizes the ongoing trend of recommending companies that are positioned well within the pharmaceutical sector, particularly those that are expected to benefit from market dynamics and growth opportunities - The focus on innovative drugs and CXOs indicates a strategic approach to capitalize on emerging trends in the healthcare market - The mention of domestic replacements in medical devices suggests a shift towards local production and innovation, which could impact market competition and supply chains - The recovery in consumer healthcare points to potential growth areas as the market stabilizes post-pandemic

Investment Rating - The report maintains a rating of "Buy" for the industry, indicating an expected relative performance increase of over 15% compared to the benchmark index within the next 6 to 12 months [5][50]. Core Viewpoints - The report emphasizes that the industry is expected to see a bottoming out and gradual improvement, with a continued focus on innovation and AI as key growth drivers. The performance of the pharmaceutical sector has shown resilience, with a year-to-date return of 1.2%, outperforming the Shanghai Composite Index by 3.4% [7][12]. - The report suggests that the innovation trend in pharmaceuticals is likely to persist, with specific recommendations for companies such as Changchun High-tech, Sanofi, and Betta Pharmaceuticals, among others [7][12]. - The report highlights the potential of AI in pharmaceuticals and healthcare, indicating that this sector is just beginning to unfold, with opportunities in drug development, diagnostic assistance, and chronic disease management [8][13]. Summary by Sections Industry Overview - The pharmaceutical industry comprises 498 listed companies with a total market capitalization of 62,240.01 billion yuan and a circulating market value of 55,873.42 billion yuan [2][5]. Market Performance - The report notes that the Shanghai Composite Index rose by 2.00% while the pharmaceutical sector increased by 1.01%, ranking 26th among 31 sub-industries. Various sub-sectors, including medical devices and traditional Chinese medicine, also experienced gains [7][12]. Investment Opportunities - The report identifies several key areas for investment: 1. **Innovation Growth**: Focus on innovative drugs with strong technological attributes and ongoing policy support [7][12]. 2. **AI in Healthcare**: Emphasizing the emerging opportunities driven by AI in diagnostics and drug research [8][13]. 3. **Recovery in Distressed Sectors**: Highlighting potential recovery in CRO&CDMO and specialty raw materials due to improved industry policies and global order recovery [8][13]. Key Company Recommendations - The report recommends a focus on companies such as: - Changchun High-tech - Sanofi - Betta Pharmaceuticals - WuXi AppTec - Daan Diagnostics - Others in the AI and healthcare sectors [7][8][12][13].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [4] Core Insights - The innovative drug sector is expected to continue its growth, supported by strong technological attributes and favorable policies, with commercial insurance and Class B medical insurance providing further catalysts [6][11] - The AI-driven medical and pharmaceutical industry is just beginning, with potential investment opportunities emerging in drug development, assisted diagnosis, and chronic disease care [6][11] - The report highlights a recovery in performance for certain segments, including CRO&CDMO and specialty APIs, driven by improved industry policies and global order recovery [6][11] Summary by Sections May Industry Investment Outlook - The innovative growth of drugs is supported by strong technology and ongoing policy support, with recommendations for companies like Changchun High-tech and Three Life Pharmaceuticals [11] - AI in medicine is expected to create numerous investment opportunities, particularly in diagnostics and medical services [11] - Recovery is anticipated in segments like CRO&CDMO, with companies such as WuXi AppTec and Tianyu Co. being highlighted for their potential [11] April Review and Analysis - The pharmaceutical sector saw a decline of 2.1% in April, outperforming the Shanghai Composite Index, which fell by 3.0% [12] - The report notes that innovative drugs are leading the market, with a positive outlook for the remainder of the year [12] - The report anticipates a gradual improvement in performance across various sub-sectors, with some beginning to show signs of recovery [12] Key Recommendations - The report recommends focusing on companies such as WuXi AppTec, Changchun High-tech, and Three Life Pharmaceuticals for potential growth [13] - It emphasizes the importance of monitoring the performance of companies in the AI and medical sectors, including Dian Diagnostics and Meinian Health [11][13] Financial Performance Overview - In 2024, the pharmaceutical sector is projected to see a revenue decline of 0.8% and a profit drop of 9.9%, with a further decline in Q1 2025 [16] - The report indicates that while some segments are under pressure, the innovative drug industry is thriving, with significant growth in exports and BD opportunities [16] - The overall cash flow for the pharmaceutical sector is expected to decline, with notable variations across different segments [24][25]

国浩律师（杭州）事务所 贝达药业 2024 年年度股东大会法律意见书 国浩律师（杭州）事务所 关于 贝达药业股份有限公司 2024 年年度股东大会的法律意见书 致：贝达药业股份有限公司 国浩律师（杭州）事务所（以下简称本所）接受贝达药业股份有限公司（以 下简称公司）的委托，指派律师列席公司 2024 年年度股东大会（以下简称本次 股东大会），并依据《中华人民共和国公司法》（以下简称《公司法》）、《中 华人民共和国证券法》（以下简称《证券法》）、中国证券监督管理委员会（以 下简称中国证监会）发布的《上市公司股东会规则》（以下简称《股东会规则》）、 《上市公司治理准则》（以下简称《治理准则》）和深圳证券交易所发布的《深 圳证券交易所上市公司股东会网络投票实施细则》（以下简称《网络投票实施细 则》）等法律、行政法规、规范性文件及现行有效的《贝达药业股份有限公司章 程》（以下简称《公司章程》）、《贝达药业股份有限公司股东大会议事规则》 （以下简称《股东大会议事规则》）的规定，就本次股东大会的召集、召开程序、 出席大会人员资格、会议表决程序等事宜出具本法律意见书。 为出具本法律意见书，本所律师列席了公司本次股东大会，审 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-036 本次股东大会由公司董事会召集，董事长丁列明先生主持本次股东大会。公 司董事、监事、高级管理人员、公司聘请的见证律师等相关人士出席了本次会议。 会议的召集、召开与表决程序符合《中华人民共和国公司法》（以下简称"《公 贝达药业股份有限公司 2024 年度股东大会决议公告 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。 特别提示： 1、本次股东大会没有出现否决议案的情形； 2、本次股东大会没有涉及变更前次股东大会决议。 一、会议召开和出席情况 贝达药业股份有限公司（以下简称"公司"）2024 年度股东大会会议通知于 2025 年 4 月 18 日以公告形式发出，现场会议于 2025 年 5 月 8 日（星期四）14:30 在公司行政大楼一楼会议室召开，通过深圳证券交易所交易系统进行网络投票的 具体时间为 2025 年 5 月 8 日的交易时间，即 9:15-9:25、9:30-11:30、13:00-15:00；通 过深圳证券交易所互联网投票系统进行投票的具体时间为 2025 年 5 月 8 日 ...