登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：000403 证券简称：派林生物 公告编号：2025-058 派斯双林生物制药股份有限公司 关于全资子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容的真实、准确和完整，没有虚假记载、误导性陈述或者重 大遗漏。 近日，派斯双林生物制药股份有限公司（以下简称"公司"）之全资子公司广东双林生物制药有限公司 （以下简称"广东双林"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》（通知书编 号：2025LP03518），同意广东双林开展静注人免疫球蛋白（pH4）生产工艺变更后的临床试验。现将 有关情况公告如下： 一、药品基本情况 药物名称：静注人免疫球蛋白（pH4） 剂型：注射剂 申请事项：药品注册临床试验 申请人：广东双林生物制药有限公司 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，2024年11月21日受理的静注人免 疫球蛋白（pH4）为生产工艺变更后申请临床试验的补充申请。申请人提交的临床试验方案名称：评价 静注人免疫球蛋白（pH4）在成人及青少年中治疗原发免疫性血小板减少症（ITP）有效性和 ...

证券日报网讯 12月23日，派林生物发布公告称，公司之全资子公司广东双林生物制药有限公司收到国 家药品监督管理局核准签发的《药物临床试验批准通知书》，同意广东双林开展静注人免疫球蛋白 （pH4）生产工艺变更后的临床试验。 （文章来源：证券日报） ...

欧科亿：股东拟减持不超过1.89%公司股份 12月23日晚，欧科亿(688308)发布公告称，股东袁美和因自身资金需求，拟通过集中竞价或大宗交易方 式减持不超过300万股，即不超过公司总股本的1.89%。 天创时尚：筹划控制权变更事项 股票继续停牌 12月23日晚，天创时尚(603608)发布公告称，公司控股股东泉州禾天投资合伙企业（普通合伙）及实控 人李林正在筹划公司控制权变更事宜，目前正在积极推动此次重大事项的各项工作，公司预计无法在12 月24日复牌。公司股票、可转债债券以及可转债转股将于12月24日继续停牌，预计继续停牌时间不超过 3个交易日。 中国电建：前11月新签合同额10317.55亿元 同比下降1.65% 12月23日晚，中国电建(601669)发布公告称，公司2025年1月至11月新签项目7382个，新签合同金额合 计10317.55亿元，同比下降1.65%。 派林生物：全资子公司药物临床试验获得批准 12月23日晚，派林生物(000403)发布公告称，全资子公司广东双林收到国家药监局核准签发的《药物临 床试验批准通知书》，同意广东双林开展静注人免疫球蛋白（pH4）生产工艺变更后的临床试验。 ...

格隆汇12月23日丨派林生物(000403.SZ)公布，公司之全资子公司广东双林生物制药有限公司（简称"广 东双林"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》（通知书编号： 2025LP03518），同意广东双林开展静注人免疫球蛋白（pH4）生产工艺变更后的临床试验。 公司获得静注人免疫球蛋白（pH4）的生产工艺变更临床试验批准通知书后，须按照批件内容进行临床 研究并经国家药品监督管理局药品审评中心审评及国家药品监督管理局审批后方可上市。 本次静注人免疫球蛋白（pH4）生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多 步层析精制纯化工艺，在产品质量、病毒安全性等方面，特别是产品收率方面有显著的提高，同时有助 于提升临床用药安全性及便捷性，使国内产品工艺水平与国际接轨，将进一步提升公司第四代静注人免 疫球蛋白产品市场竞争力。 ...

人民财讯12月23日电，派林生物(000403)12月23日公告，全资子公司广东双林收到国家药监局核准签发 的《药物临床试验批准通知书》，同意广东双林开展静注人免疫球蛋白（pH4）生产工艺变更后的临床 试验。 转自：证券时报 ...

格隆汇12月23日丨派林生物(000403.SZ)公布，公司之全资子公司广东双林生物制药有限公司（简称"广 东双林"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》（通知书编号： 2025LP03518），同意广东双林开展静注人免疫球蛋白（pH4）生产工艺变更后的临床试验。 本次静注人免疫球蛋白（pH4）生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多 步层析精制纯化工艺，在产品质量、病毒安全性等方面，特别是产品收率方面有显著的提高，同时有助 于提升临床用药安全性及便捷性，使国内产品工艺水平与国际接轨，将进一步提升公司第四代静注人免 疫球蛋白产品市场竞争力。 公司获得静注人免疫球蛋白（pH4）的生产工艺变更临床试验批准通知书后，须按照批件内容进行临床 研究并经国家药品监督管理局药品审评中心审评及国家药品监督管理局审批后方可上市。 ...

派林生物公告，全资子公司广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》，同意其开展静注人免疫球蛋白（pH4）生产工艺变更后的临床试验。该药品为注射剂，规格为 2.5g/瓶（5%，50ml），申请事项为药品注册临床试验，申请人提交的临床试验方案名称为评价静注人 免疫球蛋白（pH4）在成人及青少年中治疗原发免疫性血小板减少症（ITP）有效性和安全性的单臂、 开放、多中心临床研究。 ...

Core Viewpoint - The company is actively expanding its international market presence and enhancing its product offerings while addressing pricing strategies and production efficiency to meet annual targets [1][2]. Group 1: International Expansion and Product Development - The company has established an International Cooperation Department to focus on international market development and registration preparations, successfully exporting several immunoglobulin products [1]. - The company is advancing its key products towards international certification and registration, aiming to become a globally influential blood product enterprise [1]. Group 2: Pricing Strategy and Market Position - In response to investor concerns about declining gross margins due to falling prices of blood products, the management indicated that product prices have stabilized in 2025, although there was a decrease compared to the full year of 2024 [1]. - The company plans to implement multiple measures to achieve its annual goals, including increasing market share, boosting sales, and reducing inventory [1]. Group 3: Research and Development Progress - The company maintains a leading level of R&D investment in the industry, with over ten products under research, including blood products and gene-recombinant products [2]. - Two products have completed Phase III clinical trials and have submitted applications for marketing authorization, while others are progressing well in clinical trials [2]. Group 4: Production Capacity and Facility Development - The Yunnan project has completed key product registration inspections and is currently addressing inspection deficiencies, with plans to accelerate production site transfer for major products [2]. - The Yunnan facility is expected to commence production in 2026, focusing on human albumin, intravenous immunoglobulin, and prothrombin complex products [2].

Core Viewpoint - The company reported a decline in revenue and net profit for the first half of 2025, primarily due to ongoing capacity expansion efforts at its subsidiaries, which are expected to enhance product supply in the latter half of the year [2][3] Group 1: Financial Performance - The company achieved operating revenue of 986 million yuan, a year-on-year decrease of 13.18% [2] - The net profit attributable to shareholders was 236 million yuan, down 27.89% year-on-year [2] - The net profit after deducting non-recurring items was 215 million yuan, reflecting a decline of 27.63% compared to the previous year [2] Group 2: Business Operations - The company specializes in the research, development, production, and sales of blood products, with a total of 11 products and 38 collection stations, ranking third in the industry [2] - The company’s plasma collection volume exceeded 770 tons in the first half of 2025, representing an approximate year-on-year growth of 11% [3] - The company’s total annual production capacity is set to exceed 3,000 tons following the successful completion of capacity expansions at its subsidiaries [2][3] Group 3: Industry Outlook - The blood products industry in China is characterized by strict regulatory controls and a relative supply shortage, with the annual plasma collection volume accounting for only about 18% of the global total [3] - The market size for blood products in China is projected to reach 60 billion yuan in 2024 and is expected to grow to 95 billion yuan by 2030, indicating significant growth potential [3] - The industry is experiencing increasing concentration through mergers and acquisitions, with leading companies gaining more advantages over smaller firms [4] Group 4: International Cooperation - The company’s subsidiary, Guangdong Shuanglin, signed a framework cooperation agreement with BRAINFARMA to promote overseas sales, but the agreement was terminated due to changes in market trends and regulatory policies [4][5] - The company plans to continue seeking opportunities for overseas regulatory registration and export of its products, including immunoglobulin [5]

Core Viewpoint - The company has decided to abandon the acquisition opportunity of Palin Biotech due to potential competition with its core business and strategic considerations [1][2][3] Summary by Sections Overview of Abandonment of Business Opportunity - The company received a notification from its controlling shareholder, China National Biological, regarding the investment opportunity in Palin Biotech, which constitutes a 21.03% stake held by its controlling shareholder, Shengbang Yinghao [1][2] - The decision to abandon the acquisition was made after careful analysis, considering the competitive nature of the blood products business [2][3] Related Party Introduction - China National Biological is the controlling shareholder of the company [3] - The company has not engaged in any significant transactions with the same related party in the past 12 months, aside from routine transactions [2][3] Basic Information of the Target Company - Palin Biotech's main business involves the research, development, production, and sales of blood products, with significant production capabilities across various product lines [4][5] - As of December 31, 2024, Palin Biotech reported a revenue of approximately 2.65 billion yuan and a net profit of approximately 745 million yuan [5] Reasons for Abandoning the Business Opportunity - The acquisition timeline is tight, and the company would face significant regulatory hurdles and potential delays in completing the acquisition [6] - There are concerns regarding the integration risks associated with Palin Biotech's complex history and organizational structure, which could adversely affect minority shareholders [6][7] Impact of Abandoning the Business Opportunity - The company believes that abandoning the acquisition aligns with its operational needs and protects investor interests, ensuring no adverse effects on its operations [7][8] - China National Biological will proceed with the acquisition and address any new competition issues that arise, with commitments to be disclosed in due course [7][8] Required Review Procedures - The decision has been approved by the independent directors and will be submitted for shareholder approval, with related shareholders abstaining from voting [8]