PLBIO(000403)

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派林生物(000403) - 关于全资子公司获得新增适应症临床试验批准通知书的公告
2025-04-07 08:15
派斯双林生物制药股份有限公司 关于全资子公司获得新增适应症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。 2024 年 5 月 23 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:2024LP01236),同意广东双林开 展静注人免疫球蛋白(10%)适应症为原发免疫性血小板减少症(ITP)的临床试验,具 体内容请详见公司于 2024 年 5 月 23 日在巨潮资讯网(www.cninfo.com.cn)披露的《关 于全资子公司获得药物临床试验批准通知书的公告》(公告编号:2024-035)。近日,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: 2025LP00983),同意广东双林开展静注人免疫球蛋白(10%)新增适应症为治疗慢性炎 性脱髓鞘性多发性神经根神经病(CIDP)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(1 ...
血制品概念股拉升,派林生物、博雅生物涨幅居前
Cai Jing Wang· 2025-04-07 06:46
Group 1 - The blood products sector is experiencing growth, with companies like Shijiazhuang Yiling Pharmaceutical, Palin Bio, Boya Bio, and Tiantan Bio seeing stock price increases [1] - Shanxi Securities reported strong demand for immunoglobulin and albumin, with a projected market share of 6.5% and 2.5% for the company in 2023, respectively [1] - The domestic market for immunoglobulin is expanding, and the company is expected to benefit from the launch of new generation immunoglobulin products [1] Group 2 - Boya Bio aims to achieve a plasma collection of 630.6 tons in 2024, representing a year-on-year growth of 10.4%, with its main facility collecting 522.04 tons, up 11.7% [1][2] - The company is committed to compliance and operational efficiency, expecting double-digit growth in plasma collection by 2025 [1][2] - The blood products industry has not yet been included in national centralized procurement, but local and regional procurement initiatives have begun since January 2022 [2] Group 3 - Boya Bio is focusing on international expansion through product registration and technical cooperation, aiming to increase market share for immunoglobulin and factor VIII products [2] - The company is advancing innovative treatments for rare diseases, including small nucleic acids and gene therapies, to enhance its global presence [2] - The company’s president emphasized a focus on optimizing plasma utilization and enhancing product structure to improve profitability [3]
医药行业周报:贸易冲突加剧,关注供给变化-2025-04-07
Huaxin Securities· 2025-04-07 04:51
Investment Rating - The industry investment rating is "Recommended" [1] Core Insights - The report highlights the impact of escalating trade conflicts on the supply chain of pharmaceuticals, particularly regarding the exemption of certain drugs from tariffs, which reflects the U.S.'s reliance on global pharmaceutical supply chains [3] - The report emphasizes the importance of international markets for Chinese pharmaceutical exports, with a projected export value of $107.96 billion in 2024, indicating a growth of 5.9% year-on-year [4] - The report discusses the potential changes in the supply landscape for blood products due to new tariffs, which may accelerate domestic substitution opportunities [6] - The report notes the ongoing evolution of raw material applications, particularly in the nicotine sector, as companies explore new production avenues [8] - The report indicates that the optimization of centralized procurement policies may alleviate pricing pressures on traditional pharmaceutical companies [10] - The report outlines advancements in CAR-T cell therapies, with significant sales growth and the potential for cost reductions in the future [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.57 percentage points in the past week, ranking third among 31 primary industry indices [23] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's index has shown a 3.15% increase over the past month, outperforming the CSI 300 index by 4.20 percentage points [40] - The current PE (TTM) for the pharmaceutical sector is 31.25, which is below the historical average of 32.95 [45] 3. Recent Research Achievements - The report lists various deep-dive studies conducted by the research team, focusing on supply and demand dynamics in the blood products sector and the impact of policy support on inhalation drug markets [49] 4. Important Industry Policies and News - Recent policy updates include the release of the 2025 edition of the Pharmacopoeia of the People's Republic of China, which will take effect on October 1, 2025 [52] - Significant industry news includes the approval of new drug applications by major pharmaceutical companies, indicating ongoing innovation and market activity [54][55]
血制品概念拉升,派林生物、卫光生物涨停,博雅生物涨超10%
Zheng Quan Shi Bao Wang· 2025-04-07 03:27
血制品概念7日盘中集体上扬,截至发稿,博晖创新(300318)涨超12%,博雅生物(300294)涨超 10%,派林生物(000403)、卫光生物(002880)涨停,天坛生物(600161)涨近9%,华兰生物 (002007)涨超5%。 该机构表示,血制品生产涉及国家生物安全且具备资源品属性,由于政策限制,目前行业内仅存较少厂 商,形成了以天坛生物、上海莱士(002252)、华兰生物、派林生物等为主的寡头格局,产业链自主可 控,受海外地缘政治风险影响较小。随着血制品行业内多个企业股东实力的持续提升,优质血制品资产 的竞争力将持续提升,战略发展路径将更加清晰,未来中国有望出现多个具备全球竞争力的血制品巨 头。在贸易摩擦背景下,血制品行业具备内循环性质,外部贸易政策对我国血制品行业自身发展负面影 响较小,看好其长远发展。 机构表示,血制品市场需求较为刚性,加征关税可能会造成短期进口白蛋白价格上涨,利好国产企业。 光大证券指出,血制品可治疗多种疾病,需求端受经济周期影响小,呈现刚性需求属性,贸易摩擦对需 求影响有限。另外,血制品具备资源属性,受上游原材料血浆供应影响,整体市场供给有限。我国约有 60%以上的人血白 ...
派林生物与晶泰控股达成战略合作 推动智能战略升级
Zheng Quan Shi Bao Wang· 2025-03-30 12:28
Core Viewpoint - The strategic cooperation agreement between Palin Bio (000403) and XtalPi Holdings Limited aims to enhance innovation and quality management in the blood products industry through collaboration in product development and intelligent management solutions [1][2]. Group 1: Strategic Cooperation Details - The cooperation focuses on three main areas: drug research and optimization, intelligent management of drug production and quality, and protein structure and function research [1]. - The partnership will leverage Palin Bio's expertise in blood products and XtalPi's strengths in artificial intelligence to align with national strategies for integrating AI with the real economy and enhancing regulatory oversight in the blood products sector [2]. Group 2: Impact on Financials - The signing of the framework agreement is not expected to have a significant impact on the current financial status and operating performance of Palin Bio, with future effects dependent on the implementation of specific cooperation projects [2].
派林生物(000403) - 关于签订《战略合作协议》的公告
2025-03-30 07:48
证券代码:000403 证券简称:派林生物 公告编号:2025-011 派斯双林生物制药股份有限公司 二、协议对方基本情况 公司名称:XtalPi Holdings Limited 关于签订《战略合作协议》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 特别提示: 1、本次公司与合作方签署的战略合作协议属于框架性协议,在具体实施过程中 尚存在不确定性,敬请广大投资者谨慎决策,注意投资风险。 2、本次签署的战略合作协议对公司本年度经营业绩不会构成重大影响,对公司 未来年度经营业绩的影响将视公司与合作方后续具体合作项目的实施情况确定。 3、公司不存在最近三年披露的框架协议无进展或进展未达预期的情况。 一、协议签署概述 派斯双林生物制药股份有限公司(以下简称"公司")与XtalPi Holdings Limited (晶泰控股有限公司,以下简称"XtalPi")基于良好的信任,出于双方长远发展战 略上的考虑,双方遵守"优势互补、互利互惠、诚实守信、长期合作"的原则,经 双方友好协商,于近日签署了战略合作协议。 本协议的签署不构成关联交易,亦不构成《上市公司重 ...
派林生物: 关于公司部分董监高及核心管理人员增持公司股份计划时间过半的进展公告
Zheng Quan Zhi Xing· 2025-03-28 09:37
证券代码:000403 证券简称:派林生物 公告编号:2025-010 派斯双林生物制药股份有限公司 关于公司部分董监高及核心管理人员 增持公司股份计划时间过半的进展公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 特别提示: 级市场集中竞价或相关法律法规允许的其他方式增持公司股份,合计拟增持金额不 低于人民币500万元。 司股份183,500股,增持金额合计人民币3,867,383.00元。 划实施时间内增持公司股份。 一、本次增持计划的基本情况 英、董事兼副总经理司文彬、董事兼副总经理叶兰、监事左超、董事会秘书赵玉林、 财务总监王晔弘,公司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")总经理闫晨。 景的信心以及对公司价值的高度认可,为促进公司健康稳定长远发展,维护广大股 东利益,增强投资者信心,计划自 2024 年 12 月 28 日起 6 个月内,通过二级市场集 中竞价或相关法律法规允许的其他方式增持公司股份,拟合计增持金额不低于人民 币 500 万元,拟增持具体情况如下: | 增持主体 | 职务 | 计划增持金额下限 | | --- ...
派林生物(000403) - 关于公司部分董监高及核心管理人员增持公司股份计划时间过半的进展公告
2025-03-28 09:15
证券代码:000403 证券简称:派林生物 公告编号:2025-010 派斯双林生物制药股份有限公司 关于公司部分董监高及核心管理人员 增持公司股份计划时间过半的进展公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 3、本次增持计划尚未实施完毕,增持主体将继续按照相关增持计划,在增持计 划实施时间内增持公司股份。 1、公司部分董监高及核心管理人员计划自2024年12月28日起6个月内,通过二 级市场集中竞价或相关法律法规允许的其他方式增持公司股份,合计拟增持金额不 低于人民币500万元。 特别提示: 一、本次增持计划的基本情况 1、增持主体:公司现任总经理荣先奎、监事会主席郭麾、董事兼副总经理黄晓 英、董事兼副总经理司文彬、董事兼副总经理叶兰、监事左超、董事会秘书赵玉林、 财务总监王晔弘,公司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")总经理闫晨。 2、增持计划主要内容:公司部分董监高及核心管理人员基于对公司未来发展前 景的信心以及对公司价值的高度认可,为促进公司健康稳定长远发展,维护广大股 东利益,增强投资者信心,计划自 2024 年 1 ...
派林生物(000403):浆站采浆量稳步提升,新品种提供长期增长动力
Shanxi Securities· 2025-03-26 06:19
Investment Rating - The report assigns a "Buy-B" rating for the company, marking its first coverage [5]. Core Insights - The company has shown significant growth in revenue and profit, with a compound annual growth rate (CAGR) of 22.1% in revenue from 860 million yuan to 2.33 billion yuan from 2018 to 2023, and a CAGR of 50.2% in net profit from 80 million yuan to 610 million yuan during the same period [3][19]. - The company is expanding its plasma collection capacity and product offerings, which are expected to drive long-term growth [4][19]. - The domestic market for immunoglobulin and blood products is growing, with the company positioned to capture a larger market share due to increasing demand and limited domestic supply [4][51]. Summary by Sections 1. Company Growth and Resource Expansion - The company has rapidly expanded its plasma collection stations and resources through mergers and acquisitions, particularly with the integration of subsidiaries Guangdong Shuanglin and Paisfiko [16][19]. - The company has a diverse product portfolio with 11 blood product varieties, ranking it among the top in the industry [40][69]. 2. Market Demand and Product Development - There is a strong demand for immunoglobulin and albumin products, with significant room for domestic product substitution as the market is currently dominated by imports [4][47]. - The company is actively developing new products, including the fourth-generation immunoglobulin and various coagulation factor products, which are expected to enhance its market position [4][71]. 3. Financial Projections and Valuation - Revenue projections for 2024-2026 are estimated at 2.91 billion yuan, 3.32 billion yuan, and 3.81 billion yuan, respectively, with corresponding net profits of 760 million yuan, 860 million yuan, and 980 million yuan [5][6]. - The company is expected to maintain a favorable price-to-earnings (P/E) ratio, projected at 21.1, 18.6, and 16.4 for the years 2024, 2025, and 2026, respectively [5][6].
派林生物:浆站采浆量稳步提升,新品种提供长期增长动力-20250326
Shanxi Securities· 2025-03-26 06:00
生物医药Ⅲ 派林生物(000403.SZ) 买入-B(首次) 浆站采浆量稳步提升,新品种提供长期增长动力 2025 年 3 月 26 日 公司研究/深度分析 公司近一年市场表现 投资要点: | 市场数据:2025 年 | 月 3 | 日 25 | | | --- | --- | --- | --- | | 收盘价(元): | | | 22.00 | | 总股本(亿股): | | | 7.31 | | 流通股本(亿股): | | | 7.27 | | 流通市值(亿元): | | | 159.93 | | 年 月 基础数据:2024 9 | 日 30 | | | --- | --- | --- | | 每股净资产(元): | | 10.67 | | 每股资本公积(元): | | 6.54 | | 每股未分配利润(元): | | 3.01 | | 资料来源:最闻 | | | 分析师: 静丙、白蛋白需求旺盛,在研第四代静丙、凝血因子新品种提供长期增 长动力。狂免和破免是公司长期优势产品,2023 年公司在静丙、白蛋白国内 市场占比 6.5%、2.5%,国内进口人血白蛋白占比 64.4%,国产替代空间巨大; 国内静丙市 ...