Core Viewpoint - Palin Biopharma (000403) announced that its wholly-owned subsidiary, Guangdong Shuanglin Biopharmaceutical Co., Ltd., received the approval notice for the marketing registration of human coagulation factor IX from the National Medical Products Administration [1] Group 1 - The approved drug, human coagulation factor IX, is indicated for the treatment of patients with congenital factor IX deficiency, specifically those with hemophilia B, or patients with low levels of factor IX due to other reasons [1] - The drug is expected to significantly increase the levels of human coagulation factor IX in the blood, thereby achieving the goal of preventing and treating bleeding [1]

派林生物（000403）(000403.SZ)公告，公司全资子公司广东双林生物制药有限公司(称"广东双林")收到 国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知书》。 ...

智通财经APP讯，派林生物(000403.SZ)公告，公司全资子公司广东双林生物制药有限公司(称"广东双 林")收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知书》。 ...

格隆汇2月4日丨派林生物(000403.SZ)公布，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人凝血因子IX药品注册上市许可《受理通知书》。人凝血因子IX 适应症：对于治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因其它原因引起的人凝血因子Ⅸ含量低 下的患者，可显著提升其血液中人凝血因子Ⅸ的水平，从而达到预防和治疗出血的目的。乙型血友病属 罕见病，长期临床用药紧缺，现有治疗用药活性回收率待提升。公司长期以患者为中心，将致力于研发 高回收率的血源性药品。 ...

药物名称：人凝血因子 IX 剂型：注射剂 证券代码：000403 证券简称：派林生物 公告编号：2026-002 派斯双林生物制药股份有限公司 关于全资子公司获得药品注册上市许可受理通知书的公告 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人 凝血因子IX药品注册上市许可《受理通知书》（受理号：XCSS2600002），现将有关情 况公告如下： 一、药品基本情况 公司获得人凝血因子 IX 药品注册上市许可《受理通知书》，对公司当期业绩不会产 生影响，长期将进一步丰富公司产品线，有利于优化公司产品结构，有利于提升公司原 料血浆综合利用率和盈利能力，进一步提升公司的核心竞争力。 规格：500IU/瓶，复溶后 10ml 申请事项：境内生产药品注册上市许可 申请人：广东双林生物制药有限公司 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定 予以受理。 二、药品研发及相关情况 人凝血因子IX适 ...

派林生物公告，近日，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人凝 血因子IX药品注册上市许可《受理通知书》（受理号：XCSS2600002）。人凝血因子IX适应症：对于 治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因其它原因引起的人凝血因子Ⅸ含量低下的患者，可 显著提升其血液中人凝血因子Ⅸ的水平，从而达到预防和治疗出血的目的。 ...

（文章来源：证券日报） 证券日报网讯 2月3日，派林生物发布公告称，近日，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静注人免疫球蛋白药品补充申请《受理通知书》。 ...

北京商报讯(记者王寅浩宋雨盈)2月3日，派林生物（000403）发布公告称，公司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静注人免疫球蛋白药品补充申请《受理通知书》， 2.5g/瓶、5g/瓶和10g/瓶的静注人免疫球蛋白的境内生产药品补充申请获受理。 根据公告，静注人免疫球蛋白主要适应症包括原发性免疫球蛋白缺乏症、继发性免疫球蛋白缺陷病以及 自身免疫性疾病。目前国内拥有静注人免疫球蛋白(5g/瓶，10%，50ml)上市批件的企业包括成都蓉生药 业有限责任公司、贵州泰邦生物制品有限公司以及华润博雅生物（300294）制药集团股份有限公司。 ...

Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]

1、原发性免疫球蛋白缺乏症，如X联锁低免疫球蛋白血症，常见变异性免疫缺陷病，免疫球蛋白G亚型 缺陷病等。 格隆汇2月3日丨派林生物(000403.SZ)公布，近日，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静注人免疫球蛋白药品补充申请《受理通知书》。 静注人免疫球蛋白主要适应症包括： 经查询，目前国内拥有静注人免疫球蛋白(5g/瓶，10%，50ml)上市批件的企业包括成都蓉生药业有限责 任公司、贵州泰邦生物制品有限公司以及华润博雅生物制药集团股份有限公司。 2024年5月，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；2025年4月，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；2025年12 月，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》，同意广东双林开展静 注人免疫球蛋白(pH4)生产工艺变更后 ...