证券代码：300558 证券简称：贝达药业 公告编号：2026-008 贝达药业股份有限公司 关于股东股份质押变动的公告 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。 贝达药业股份有限公司（以下简称"公司"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 一、股东股份质押基本情况 1、凯铭投资股份新增质押情况 | | 是否为控 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 股股东或 | 本次质押 | 占其所 | 占公司 | 是否为 | 是否为 | 质押 | 质押 | | 质押 | | 名称 | 第一大股 | 数量 | 持股份 | 总股本 | 限售股 | 补充质押 | 起始日 | 到期日 | 质权人 | 用途 | | | 东及其一 | （股） | 比例 | 比例 | | | | | | | | | 致行动人 | | ...

Core Insights - The anti-tumor drug industry is crucial for treating malignant tumors, with a shift from traditional chemotherapy to precision-targeted therapies driven by high cancer incidence globally and in China [1][2][5] Industry Overview - Anti-tumor drugs, also known as anti-cancer drugs, are designed to inhibit tumor cell growth and proliferation, playing a central role in systemic treatment for malignant tumors [2][3] - The industry is characterized by a transition towards innovative therapies such as immunotherapy and antibody-drug conjugates (ADCs), reflecting a global trend towards precision medicine [1][6] Development Background in China - China's cancer incidence and mortality rates are on the rise, with lung cancer, gastric cancer, and liver cancer being the most prevalent, creating a strong clinical demand [5][6] - The government has introduced various policies to support the development of the anti-tumor drug industry, including optimizing clinical trial approvals and enhancing drug accessibility through insurance [5][6] Current Market Analysis - The global anti-tumor drug market is projected to grow from $167 billion in 2020 to $295 billion by 2025, representing a cumulative growth of 76.7% [6][7] - In China, the anti-tumor drug market is expected to increase from 185.8 billion yuan in 2020 to 318.7 billion yuan by 2025, with a growth rate of 71.5% [8][9] Competitive Landscape - The Chinese anti-tumor drug industry features a competitive landscape where multinational companies lead in high-end markets while domestic firms are rapidly emerging [7][9] - Key domestic players like Heng Rui Medicine and BeiGene are making significant strides in core segments such as PD-1 inhibitors and small molecule targeted drugs [8][9] Future Trends - The industry is expected to focus on innovation, with a shift from generic drugs to original innovations and differentiated breakthroughs in areas like ADCs and cell therapies [10][11] - Domestic companies will continue to enhance their market share through policy support and cost advantages, while also working towards self-sufficiency in critical supply chains [11][12] - The regulatory environment will evolve to improve drug accessibility and quality, fostering a competitive ecosystem that prioritizes clinical value and patient affordability [12]

Core Viewpoint - The article reports that BeiGene (300558.SZ) has received a drug registration certificate from the National Medical Products Administration (NMPA) for the launch of its biosimilar drug, Perjeta (pertuzumab injection), in collaboration with Hangzhou Bozhrui Biopharmaceutical Co., Ltd. [1] Group 1 - The NMPA has approved the market launch of the biosimilar pertuzumab injection, branded as Bezetin® [1] - Bezetin® is developed by Bozhrui Biopharmaceutical, a wholly-owned subsidiary of Zhejiang Bozhrui Biopharmaceutical Co., Ltd. [1] - The drug is indicated for the treatment of early-stage breast cancer and metastatic breast cancer [1]

Core Viewpoint - The company has received a drug registration certificate from the National Medical Products Administration for its collaboration with Hangzhou Bozhi Rui Biopharmaceutical Co., Ltd. to market the biosimilar drug Pertuzumab injection (brand name: Bezetin®) for early and metastatic breast cancer patients [1] Group 1 - The drug Bezetin® is a biosimilar of Pertuzumab, independently developed by Bozhi Rui Biopharmaceutical [1] - The approval allows the company to advance the commercialization efforts for Bezetin® [1] - Bezetin® is indicated for the treatment of early breast cancer and metastatic breast cancer [1]

剂型：注射剂 证券代码：300558 证券简称：贝达药业 公告编号：2026-007 贝达药业股份有限公司 关于国家药品监督管理局批准帕妥珠单抗注射液上市的公告 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。 今日，贝达药业股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）签发的《药品注册证书》（药品批准文 号：国药准字 S20260009），国家药监局批准公司与杭州博之锐生物制药有 限公司（浙江博锐生物制药股份有限公司之全资子公司，以下统称"博锐生 物"）合作的帕妥珠单抗注射液（商品名：贝泽汀®，以下简称"贝泽汀®"） 上市，现将具体情况公告如下： 一、申请注册药品的基本情况 药物名称：帕妥珠单抗注射液 规格：420 mg（14ml）/瓶 药品注册分类：治疗用生物制品 3.3 类 申请事项：药品上市许可申请 适应症：本品适用于早期乳腺癌及转移性乳腺癌患者。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品基本情况及同类药品市场状况 贝泽汀®是由公 ...

Group 1 - The company, BeiGene, stated that its operations are normal and there are no regulatory requirements to issue a performance forecast [2] - The company has scheduled the disclosure of its 2025 annual report for April 23, 2026 [2]

Group 1 - The company has indicated that it expects to disclose its 2025 annual report on April 23, 2026, based on the progress of its business operations [2] - The company is currently operating normally, and any information related to its 2025 performance will be disclosed publicly [2]

Group 1 - The company stated that the disclosure time for its annual report is determined based on the scheduling arrangements of the Shenzhen Stock Exchange, along with the company's actual situation, audit progress, and internal review procedures [2] - The company will complete the preparation and disclosure of the annual report within the scheduled deadline [2]

Group 1 - The core viewpoint of the article highlights that Beida Pharmaceutical (300558) is experiencing steady sales growth for its eight listed drugs and is gradually expanding into overseas markets [1] - The company is concentrating resources on the development of key projects and is increasing its investment in new targets and technologies to expedite the launch of new products [1]

Core Viewpoint - The company has not yet initiated any self-developed ADC product projects and is focusing on collaborating with ecosystem partners for ADC product initiatives [2] Group 1 - The company responded to an investor inquiry regarding its ADC product strategy on an investor interaction platform [2] - The company will actively monitor ADC product projects through partnerships rather than developing its own products at this stage [2] - The company commits to timely disclosure of any significant developments related to ADC projects in the future [2]