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》。 2、继发性免疫球蛋白缺陷病，如重症感染、新生儿败血症等。3、自身免疫性疾病，如原发性血小板减 少性紫癜、川崎病等。静注人免疫球蛋白(10%)采用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优势，将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。 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 ...

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静注 人免疫球蛋白药品补充申请《受理通知书》。此次申请涉及三种规格的静注人免疫球蛋白药品：2.5g/ 瓶（10%，25ml）、5g/瓶（10%，50ml）和10g/瓶（10%，100ml）。药品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和自身免疫性疾病。此次受理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。 ...

图源InCephalo 瑞士生物科技公司InCephalo成立于2021年，公司致力于研发能局部作用于胶质母细胞瘤的生物制剂。该制剂基于公司专有的C-Lock技术，可提升药物在大 脑中枢神经系统中的停留时间与浓度，并在发生药物全身扩散时及时体内降解，实现对胶质母细胞瘤的安全治疗。 InCephalo由Carlo Bertozzi与Johannes vom Berg 共同创立。Carlo Bertozzi为公司首席执行官，拥有苏黎世大学生物博士学位，曾创办多家生物科技企业，并 担任Innosuisse生命科学辅导专家。Johannes vom Berg为公司首席科学官，拥有苏黎世大学博士后学位，目前担任苏黎世大学脑癌局部免疫疗法研究组组 长。 图源SwissCore InCephalo是2025年《瑞士创新100强》（TOP100 Swiss Startups）上榜企业。《瑞士创新100强》汇聚了最佳"瑞士制造"的初创及成长期科技创新 企业，是瑞士科技创新领域最具国际影响力的标杆榜单。自2011年以来，该榜单每年在瑞士全国范围内评选出100家最具开创性和市场前景的瑞 士创新企业和25家最具独角兽潜力的瑞士成长期 ...

Core Viewpoint - The company Hualan Biological (002007.SZ) has received approval from the National Medical Products Administration for clinical trials of a new drug, HL08, which is aimed at improving weight control in obese patients in addition to its original indication for type 2 diabetes management [1] Group 1 - The drug HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The original indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - The newly approved indication expands its use to include weight control in obese patients [1]

Core Viewpoint - The company Hualan Biological (002007.SZ) has received approval from the National Medical Products Administration for a new drug clinical trial, expanding the indications for its drug HL08 to include weight control in obese patients in addition to its original indication for improving blood glucose control in type 2 diabetes patients [1] Group 1 - The drug HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The original indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - The newly approved indication aims to assist in weight control for obese patients [1]

Core Viewpoint - The company, Hualan Biological (002007.SZ), has received approval from the National Medical Products Administration for its drug, HL08, a new generation GLP-1 receptor agonist developed in-house [1] Group 1: Drug Development - HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The active ingredient of HL08 is a recombinant Exendin-4-Fc fusion protein, which combines Exendin-4 with the Fc fragment of IgG2 antibody [1] - The drug significantly extends the biological half-life while retaining the natural physiological functions of Exendin-4, enhancing medication convenience and therapeutic efficacy [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for a new drug, HL08, which is a recombinant Exendin-4-Fc fusion protein injection aimed at treating type 2 diabetes and obesity [1] Group 1: Drug Approval Details - The approval notification was issued on February 2, 2026, under the notification number 2026LP00310 [1] - HL08 is classified as a Class 1 therapeutic biological product and is categorized as a new drug [1] Group 2: Drug Characteristics - HL08 is a next-generation GLP-1 receptor agonist developed by the company [1] - The active ingredient is a recombinant Exendin-4-Fc fusion protein, which combines Exendin-4 with the Fc fragment of IgG2 antibody [1] - This fusion significantly extends the biological half-life of the drug, enhancing convenience and sustained efficacy in treatment [1] Group 3: Indications - The original approved indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - An additional indication has been approved for improving weight control in obese patients [1]

智飞生物2月3日公告，公司全资子公司安徽智飞龙科马生物制药有限公司研发的带状疱疹mRNA疫苗获 得国家药品监督管理局药物临床试验批准通知书，同意开展用于预防带状疱疹的临床试验。公司带状疱 疹mRNA疫苗临床试验申请获得批准对公司近期业绩不会产生重大影响，但有利于公司夯实研发技术， 加强在研管线储备。该项目后续临床试验进度、结果及产品上市情况存在不确定性，公司将根据研发进 展情况及时履行信息披露义务。 ...

格隆汇2月3日丨智飞生物(300122.SZ)公布，近日获悉，由全资子公司安徽智飞龙科马生物制药有限公 司（简称"智飞龙科马"）研发的带状疱疹mRNA疫苗获得国家药品监督管理局药物临床试验批准通知书 （通知书编号：2026LP00326），同意开展用于预防带状疱疹的临床试验。 ...

智通财经APP讯，智飞生物(300122.SZ)公告，公司子公司安徽智飞龙科马生物制药有限公司(简称"智飞 龙科马")研发的带状疱疹mRNA疫苗获得国家药品监督管理局药物临床试验批准通知书，同意开展用于 预防带状疱疹的临床试验。 ...