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。 派林生物（000403）(000403.SZ)发布公告，近日，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。 ...

智通财经APP讯，派林生物(000403.SZ)发布公告，近日，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。 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。 ...

Core Viewpoint - The company, Weiguang Biological, has announced a plan to raise up to 1.5 billion yuan through a private placement to fund the construction of a new intelligent factory with an annual capacity of 1,200 tons for blood products, addressing the urgent need for capacity expansion in the context of increasing market demand and competition in the blood products industry [1][2]. Group 1: Company Overview - Weiguang Biological specializes in blood products and operates nine wholly-owned or controlled plasma collection stations, with its product range including human serum albumin, immunoglobulin, and coagulation factors [1]. - The company’s existing production line, established in 2013, has a design capacity of 400 tons per year, which has been upgraded to 650 tons, indicating limited potential for further expansion without new facilities [1]. Group 2: Investment Plan - The company plans to allocate 1.2 billion yuan of the raised funds to build a new factory capable of producing various blood products, including human serum albumin and immunoglobulin, which will help alleviate supply-demand imbalances in the industry and enhance market share [1]. - An additional 300 million yuan will be used to supplement working capital [1]. Group 3: Industry Context - The blood products industry is experiencing consolidation, with leading companies rapidly expanding their production capacities. Notable competitors include Tiantan Biological, Hualan Biological, and others, who have established or are in the process of establishing large-scale production bases [3]. - The industry is witnessing a "Matthew Effect," where stronger companies are becoming more dominant, making it crucial for Weiguang Biological to successfully implement its fundraising plan to maintain competitiveness [2][3].