Human normal immunoglobulin(Takeda)

摘要：             新药获批上市GSK：针对特定类型哮喘的德莫奇单抗注射液获国家药监局批准上市 新药临床试验 长春高新：拟用于胃癌的GenSci128片获得美国FDA孤儿药资格认定 诺思兰德：拟用于缓解因轻微眼部刺激引起的眼睛发红的酒石酸溴莫尼定滴眼液获临床试验批准 科兴制药：拟用于红斑狼疮的GB19注射液获美国FDA新药临床试验许可 悦康药业：拟用于治疗与预防人偏肺病毒感染的YKYY018雾化吸入剂治疗与预防人偏肺病毒感染的适应症获FDA临床试验批准 恒瑞医药：拟用于心血管疾病的HRS9531注射液获得药物临床试验批准 康弘药业：拟用于晚期实体瘤的注射用KHN922收到药物临床试验批准 卫光生物：皮下注射人免疫球蛋白收到药物临床试验批准 华东医药：拟用于晚期实体瘤的注射用HDM2024获药物临床试验批准 健康元：拟用于精神分裂症的注射用布瑞哌唑微球获得药物临床试验批准 健康元：拟用于支气管哮喘的新一代糖皮质激素获得药物临床试验批准 信立泰：拟用于个MASH的SAL0145获得临床试验批准 以岭药业：拟用于慢阻肺相关问题的中药新药“芪龙定喘片”获批药物临床试验         万泰生物：重组三价轮状病毒亚单位疫苗（大肠埃希菌）获得临床试验批准 报告分享： 《2025中国创新药械多元支付白皮书》 书籍介绍：Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust 有问题，问星光智能体！ 人类基地：那个爱跑马拉松的中年男人猝死了！他们不是在跑步，是在“越狱” 星际微光数据资源 （背景图片：Wallpaper） 哈哈 第1部分 The first story 白 1 新药动向 ~ 新药获批上市 ~ GSK：针对特定类型哮喘的德莫奇单抗注射液获国家药监局批准上市 近日，国家药品监督管理局批准GlaxoSmithKline Trading Services Limited申报的德莫奇单抗注射液（商品名：易适来）上市，该品种用于成人和12岁及以上青少年重度嗜酸性粒细胞性哮喘的维持治疗。该品种的上市为相关患者提供了新的治疗选择。作为一款针对特定类型哮喘的创新生物制剂，该药旨在帮助患者有效控制病情、减少急性发作，并改善长期生活质量。 ~ 新药临床试验 ~ 长春高新：拟用于胃癌的GenSci128片获得美国FDA孤儿药资格认定 证券代码：000661  证券简称：长春高新  公告编号：2026-014 近日，长春高新技术产业（集团）股份有限公司子公司——长春金赛药业有限责任公司收到美国食品药品监督管理局（FDA）通知，授予 GenSci128 片孤儿药资格认定（OrphanDrug Designation,ODD），用于胃癌的治疗。 一、药品的基本情况 产品名称：GenSci128 片 申请事项：FDA 孤儿药资格认定 申请编号：DRU-2025-11348 申请人：长春金赛药业有限责任公司 适应症：胃癌的治疗 二、药品的其它情况 GenSci128片属治疗用化药 1 类新药，在美国新药注册类别“505b1”，是针对 TP53 Y220C 突变的选择性重激活剂，拟用于治疗携带 TP53 Y220C 突变的局部晚期或转移性实体瘤，涵盖胰腺癌、胃癌、卵巢癌、乳腺癌、结直肠癌等。 TP53是人类癌症中最常发生突变的基因。TP53 基因编码的 p53 蛋白作为转录因子，具有抑制肿瘤的功能。TP53 基因突变导致 p53 蛋白失活，是肿瘤发生的关键步骤，其中，TP53 Y220C 突变约占 TP53 突变的 1.8%。临床上尚无获批的靶向TP53 Y220C 突变的治疗手段，对于标准治疗失败的具有 TP53 Y220C 突变的患者，仍存在未被满足的医疗需求。胃癌是全球第五大常见癌症和第五大癌症死因。多数患者在诊断时已进展为转移性疾病，其 5 年生存率不足 10%，因此一直是临床治疗的重大挑战。 GenSci128片旨在选择性地与 TP53 Y220C 突变蛋白的口袋结合，从而恢复TP53 Y220C 突变蛋白的正常构象，增加稳定性，恢复转录和抑制肿瘤的功能。临床前数据表明 GenSci128 片具有较好的疗效和安全性。 此前，GenSci128 片已在中国、美国获批开展用于携带 TP53 Y220C 突变的局部晚期或转移性实体瘤的临床试验，其用于胰腺癌治疗的适应症已获得 FDA 孤儿药资格认定。金赛药业正按照有关要求和法律法规，有序开展相关多中心临床试验工作。 三、对公司的影响 本次获得FDA 孤儿药资格认定，有助于 GenSci128 片用于胃癌的治疗在美国的后续研发和审评过程中获得一定的政策支持，包括但不限于：临床试验费用的税收抵免、免除新药申请费、上市后享有 7 年的市场独占权且不受专利的影响。若子公司后续临床试验进展顺利，将有利于公司拓宽业务结构、优化产品结构，并丰富完善战略领域产品线布局、提升公司核心竞争力。 诺思兰德：拟用于缓解因轻微眼部刺激引起的眼睛发红的酒石酸溴莫尼定滴眼液获临床试验批准 证券代码：920047  证券简称：诺思兰德  公告编号：2026-011 近日，北京诺思兰德生物技术股份有限公司子公司北京汇恩兰德制药股份有限公司化药仿制药研发项目“酒石酸溴莫尼定滴眼液”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》。 一、该临床试验的基本情况 产品名称：酒石酸溴莫尼定滴眼液 注册分类：化学药品3类 受理号：CYHL2600008、CYHL2600009 规格：0.025%（0.4ml:0.1mg）、0.025%（7.5ml:1.875mg） 申请的适应症：缓解因轻微眼部刺激引起的眼睛发红 申请事项：临床试验 申请人：北京汇恩兰德制药股份有限公司 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，2026 年1月12日受理的酒石酸溴莫尼定滴眼液符合药品注册的有关要求，同意开展临床试验。 二、对公司的影响 子公司“酒石酸溴莫尼定滴眼液”研发项目后续仍需按照国家临床试验的要求组织开展临床试验，待相关工作完成后向国家药品监督管理局申报临床研究相关资料及生产上市申请，获批后方可上市。 科兴制药：拟用于红斑狼疮的GB19注射液获美国FDA新药临床试验许可 证券代码：688136  证券简称：科兴制药  公告编号：2026-017 近日，科兴生物制药股份有限公司全资子公司深圳科兴药业有限公司收到美国食品药品监督管理局（FDA）的通知，深圳科兴自主研发的创新药GB19注射液药品临床试验申请已获得FDA批准，可在美国开展临床试验，适应症为治疗皮肤型红斑狼疮（CLE）、系统性红斑狼疮（SLE）。 一、许可基本情况 药品名称：GB19 注射液 申请事项：美国境内开展临床试验 申请编号：IND 180417 审评结论：本药品临床试验申请获得美国FDA 批准，同意本药品按照提交的方案开展临床研究。 二、药品相关介绍 GB19注射液项目靶向浆细胞样树突状细胞（pDC）表面特异性表达的 BDCA2 靶点，其作用机制与现有靶向 B 细胞通路的临床药物存在显著差异； GB19 通过与 BDCA2 特异性结合，可抑制 pDC 细胞产生 I 型干扰素，从而干预先天性免疫与适应性免疫间的异常活化环路。GB19 临床前研究展现出良好的体外活性、免疫原性，生物利用度高，对靶点抑制时间维持超 90 天，安全性表现优异，如研发成功有望为多种干扰素通路异常相关的 CLE、SLE、SSc 等自身免疫性疾病患者提供新的治疗选择。 三、对公司的影响 本次GB19 注射液美国临床试验获批对公司近期的财务状况、经营业绩不会产生重大影响。 截至本公告披露日，公司GB19 注射液先后获得国家药品监督管理局和美国 FDA 的临床试验批准，是公司基于自主技术平台在单抗药物研发领域扎实积淀的成果，也是公司推进创新药全球化布局的重要举措。若该药品研发未来实现成功上市，能够为满足市场需求提供更加多元的产品，有利于丰富公司产品布局，进一步提高公司市场竞争力。 悦康药业：拟用于治疗与预防人偏肺病毒感染的YKYY018雾化吸入剂治疗与预防人偏肺病毒感染的适应症获FDA临床试验批准 证券代码：688658  证券简称：悦康药业  公告编号：2026-020 悦康药业集团股份有限公司全资子公司北京悦康科创医药科技股份有限公司于近日获得美国食品药品监督管理局（FDA）关于同意 YKYY018 雾化吸入剂用于人偏肺病毒治疗与预防的临床试验申请的函告（Study May Proceed Letter，IND 编号：180432）。 一、函告主要内容： 药品名称：YKYY018 雾化吸入剂 IND编号：180432 申请适应症：治疗与预防人偏肺病毒的感染 申请人：北京悦康科创医药科技股份有限公司 申报阶段：临床试验 审批结论：YKYY018 雾化吸入剂临床试验申请获得美国 FDA 批准，同意本品按照提交的方案开展临床试验。 二、其他情况 1、关于人偏肺病毒 人偏肺病毒（hMPV）是肺炎病毒科偏肺病毒属的单股、非节段负链 RNA 病毒，主要通过飞沫和密切接触传播，也可通过接触被病毒污染的物品间接传播。hMPV 是婴儿和 5 岁以下儿童上呼吸道感染的常见原因，婴儿、老年人以及患有免疫抑制、慢性阻塞性肺病和哮喘等疾病的人患严重疾病的风险更高。 2、关于YKYY018 雾化吸入剂 YKYY018雾化吸入剂是公司依托全流程 AI 平台自主开发的一款国际原创的膜融合抑制剂药物，该产品已于 2025 年 11 月和 12 月分别获得美国食品药品监督管理局（FDA）和国家药品监督管理局（NMPA）核准签发的关于YKYY018雾化吸入剂用于预防和治疗呼吸道合胞病毒感染进行临床试验的函告，具体内容详见《悦康药业集团股份有限公司关于自愿披露子公司 YKYY018 雾化吸入剂获得 FDA 临床试验批准的公告》（公告编号：2025-049）、《悦康药业集团股份有限公司关于自愿披露子公司 YKYY018 雾化吸入剂获得国家药品监督管理局临床试验批准的公告》（公告编号：2025-050）。YKYY018 项目针对呼吸道合胞病毒（RSV）感染的临床Ⅰ期研究正在稳步推进中，本次获批人偏肺病毒治疗与预防适应症，标志着该管线布局从单一病毒向重要呼吸道病毒谱全面拓展，为婴幼儿、老年人等高风险人群提供更全面的防治选择。 本产品具有全新的作用机制，能够与呼吸道合胞病毒和人偏肺病毒融合前F 蛋白（pre-F）F1 亚基的七肽重复序列区 1（HR1）特异性结合，抑制病毒自身 HR1 与 HR2 结构域之间同源 6-HB 的形成，阻断病毒与宿主细胞的融合过程，实现抗病毒效果，兼具治疗和预防的双重功能。公司已获得该产品的核心专利授权，并拥有其全球独占权益。 临床前研究结果显示，该产品对多种呼吸道合胞病毒毒株和人偏肺病毒均表现出显著的抑制效果；在棉鼠的预防和治疗模型药效试验中，YKYY018 雾化吸入剂均能显著降低病毒滴度；安全性方面，在 Sprague-Dawley 大鼠和 Beagle 犬的试验中，YKYY018 未对呼吸功能产生明显影响，所有受试动物的一般状况、体重及摄食量、血液学及血生化指标、T 淋巴细胞亚群、尿液及眼科检查、脏器重量及系数、大体解剖观察及组织病理学检查等均未见与药物相关的异常改变，表明其安全性和耐受性良好。 恒瑞医药：拟用于心血管疾病的HRS9531注射液获得药物临床试验批准 证券代码：600276  证券简称：恒瑞医药  公告编号：临2026-054 近日，江苏恒瑞医药股份有限公司子公司福建盛迪医药有限公司收到国家药品监督管理局核准签发关于HRS9531注射液的《药物临床试验批准通知书》，将于近期开展临床试验。 一、药物的基本情况 药物名称：HRS9531注射液 剂        型：注射剂 申请事项：临床试验 受 理 号：CXHL2600039、CXHL2600040、CXHL2600041 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，2026 年1月7日受理的HRS9531注射液临床试验申请符合药品注册的有关要求，同意本品开展临床试验。 申请的适应症：用于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险。 二、药物的其他情况 HRS9531注射液是以HRS9531为主要活性成分，具有全球自主知识产权的新型靶向抑胃肽受体（GIPR）和胰高血糖素样肽-1受体（GLP-1R）的双激动剂，可在体内调节糖脂代谢、抑制食欲和增强胰岛素敏感性，从而起到改善血糖和减轻体重的效果。对于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险适应症，HRS9531有望通过减重降糖间接、或直接实现心血管获益。针对此适应症，全球范围内暂无同类药物获批上市。截至目前，HRS9531相关项目累计研发投入约63,150万元（未经审计）。 康弘药业：拟用于晚期实体瘤的注射用KHN922收到药物临床试验批准 证券代码：002773  证券简称：康弘药业  公告编号：2026-012 近日，成都康弘药业集团股份有限公司全资子公司成都康弘生物科技有限公司收到国家药品监督管理局签发的《药物临床试验批准通知书》。 一． 药品基本信息 药品名称：注射用KHN922 剂型：注射剂 适应症：晚期实体瘤 注册分类：治疗用生物制品1类 受理号：CXSL2600077 审批结论：同意本品单药在晚期实体瘤中开展临床试验。 二． 产品简介 注射用KHN922是康弘生物自主研发的一种具有抗耐药潜力的靶向人表皮生长因子3（HER3）的新型双载荷（dual-payload）抗体偶联药物（ADC），其双载荷能实现同时在RNA水平和DNA水平对肿瘤细胞的抑制，具有双效协同机制。此外，还能降低P-gp和HSP70蛋白的表达，克服耐药，增加细胞对化疗药物的敏感性。KHN922在多个瘤种的CDX模型和PDX模型中，均表现出优异的抗肿瘤活性。双载荷设计有望使KHN922具有更优的人体抗肿瘤应答，为晚期肿瘤患者提供新的治疗选择。 卫光生物：皮下注射人免疫球蛋白收到药物临床试验批准 证券代码：002880  证券简称：卫光生物  公告编号：2026-010 深圳市卫光生物制品股份有限公司于近日收到国家药品监督管理局下发的《药物临床试验批准通知书》（通知书编号：2026LP00795）。 一、药品基本情况 药品名称：皮下注射人免疫球蛋白 申请事项：临床试验 受理号：CXSL2501109 适应症：原发性免疫缺陷病（PID），如X联锁低免疫球蛋白G血症，常见变异性免疫缺陷病，免疫球蛋白G亚类缺陷病等。 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，2025 年 12 月 22 日受理的皮下注射人免疫球蛋白符合药品注册的有关要求，同意本品开展用于治疗原发性免疫缺陷病（PID）的临床试验。 皮下注射人免疫球蛋白（SCIG）含有广谱抗病毒、细菌或其他病原体的人免疫球蛋白G（IgG），可提高患者体内IgG水平，中和毒素、协同杀灭细菌、病毒和其他病原体，增强机体的抗感染能力和免疫调节功能。 二、同类产品市场情况 目前国内尚无皮下途径给药的SCIG产品获批，海外已有多款SCIG产品批准上市，代表性产品主要有CSL Behring公司的HIZENTRA®、Takeda公司的CUVITRU®、Grifols公司的XEMBIFY®等。 华东医药：拟用于晚期实体瘤的注射用 HDM2024获药物临床试验批准 证券代码：000963  证券简称：华东医药  公告编号：2026-011 2026年 03 月 25 日，华东医药股份有限公司全资子公司杭州中美华东制药有限公司收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》（通知书编号：2026LP00950），由中美华东申报的注射用HDM2024临床试验申请获得批准。 一、该药物基本信息 药物名称：注射用HDM2024 注册分类：治疗用生物制品1 类 受理号：CXSL2600084  适应症：晚期实体瘤 申请事项：临床试验 申请人：杭州中美华东制药有限公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2026 年 1 月 14 日受理的注射用 HDM2024 临床试验申请符合药品注册的有关要求，同意本品开展晚期实体瘤的临床试验。 二、该药物研发及注册情况 注射用HDM2024 是由中美华东研发并拥有全球知识产权的 1 类生物新药，是一款靶向表皮生长因子受体 1（Epidermal growth factorreceptor，EGFR/HER1）和人表皮受体 3（Human epidermal receptor 3，HER3）的新型双特异抗体药物偶联物（Bispecific antibody-drug conjugate，Bs-ADC）。HDM2024 由靶向 EGFR/HER3 的双抗分子，可裂解的连接子及 DNA 拓扑异构酶 1 抑制剂细胞毒性分子组成。 HDM2024 可同时阻断 EGFR/HER3 信号通路，能够有效的阻断肿瘤细胞增殖信号，同时向肿瘤细胞内释放毒素载荷，发挥肿瘤杀伤作用。临床前研究已证明HDM2024在靶点不同表达水平的多种实体瘤药效模型中显示出强大的抗肿瘤活性，具有良好的成药性和安全性。 HDM2024的临床前研究成果将在2026年美国癌症研究协会（AACR）年会上进行展示。 此外，2026 年 03 月，注射用 HDM2024 晚期实体瘤适应症的Ⅰ期临床试验申请获得美国食品药品监督管理局批准。 三、对上市公司的影响 本次注射用HDM2024 中国临床试验获批，是该款产品研发进程中的又一重要进展，将进一步提升公司在肿瘤治疗领域的核心竞争力。 健康元：拟用于精神分裂症的注射用布瑞哌唑微球获得药物临床试验批准 证券代码：600380  证券简称：健康元  公告编号：临 2026-012 近日，健康元药业集团股份有限公司控股子公司丽珠医药集团股份有限公司全资子公司珠海市丽珠微球科技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》（通知书编号：2026LP00935），同意丽珠集团申报的注射用布瑞哌唑微球开展用于成人精神分裂症的临床试验。 一、药品基本情况 药物名称：注射用布瑞哌唑微球 剂型：注射剂 注册分类：化学药品2.2 类改良型新药 申请适应症：用于成人精神分裂症的治疗 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，2026年 1 月 7 日受理的注射用布瑞哌唑微球符合药品注册的有关要求，同意开展用于成人精神分裂症的临床试验。 二、药品研发及相关情况 注射用布瑞哌唑微球为丽珠集团自主研发的缓释微球制剂，是新一代精神分裂症的治疗药物。本品通过对多巴胺D2、5-HT1A 受体的部分激动以及对去甲肾上腺素等受体的拮抗协同起效，与同代其他药物相比，在多项安全性指标上表现更优。本品采用长效缓释设计，拟定给药方式为每月一次肌肉注射，可提升患者用药依从性，降低复发风险，解决精神分裂症患者治疗依从性低、复发率高的临床痛点，契合临床长期维持治疗需求。目前，布瑞哌唑口服制剂已在全球获批多项精神类疾病适应症，尚无布瑞哌唑长效制剂获批上市，本品为填补该临床空白研发的改良型新药。 截至本公告披露日，注射用布瑞哌唑微球累计直接投入的研发费用约为人民币752.64万元。 三、药品的市场情况 根据国家药监局药品审评中心网站显示，截至本公告披露日，国内尚无布瑞哌唑长效制剂药物获批上市。 健康元：拟用于支气管哮喘的新一代糖皮质激素获得药物临床试验批准 证券代码：600380  证券简称：健康元  公告编号：临 2026-011 近日，健康元药业集团股份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》，同意本公司的新一代糖皮质激素（ICS）开展临床试验。 一、药物临床试验批准通知书的主要内容 药物名称：JKN2404 吸入混悬液 剂型：吸入混悬剂 申请事项：临床试验申请 注册分类：化学药品1 类 申请人：健康元药业集团股份有限公司 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，2026 年 1 月 14 日受理的 JKN2404 吸入混悬液符合药品注册的有关要求，同意开展支气管哮喘的临床试验。 二、药品研发及相关情况 JKN2404吸入混悬液为本公司自主研发的新一代局部作用、高选择性的小分子糖皮质激素（ICS）创新药，拟用于支气管哮喘等呼吸系统疾病的治疗。本品通过作用于糖皮质激素受体（Glucocorticoid Receptor，GR），调节与炎症相关的基因转录，抑制炎性因子表达，并对免疫细胞增殖发挥调控作用，从而达到抗炎治疗效果。 临床前研究结果显示，本品在体内外药效模型中表现出与现有主流ICS 药物相当或更优的抗炎活性；在药代动力学及安全性方面，本品表现出“高局部抗炎效用、低全身毒副作用”特征。与同靶点已上市药物相比，本品拥有更高的安全窗，有望降低传统 ICS 长期使用下带来的下丘脑-垂体-肾上腺（HPA）轴抑制及儿童生长迟缓等全身性不良反应风险。本品将进一步丰富公司在呼吸系统疾病治疗领域的创新产品布局。 截至本公告披露日，JKN2404 吸入混悬液累计直接投入的研发费用约为人民币2,258.39 万元。 三、药品的市场情况 吸入性糖皮质激素（ICS）作为目前有效控制气道炎症药物，已广泛应用于支气管哮喘、慢性阻塞性肺疾病等呼吸系统疾病的临床治疗。目前，布地奈德、氟替卡松等相关产品已在国内外上市销售，具有较为成熟的临床应用基础。根据抽样统计估测数据，2025 年国内吸入性糖皮质激素（ICS）类药物终端销售金额约为人民币 46.58 亿元。随着呼吸系统疾病患者人数持续增加，临床对疗效强、安全性更优（系统暴露低）且全人群依从性良好的新型吸入制剂仍存在迫切且持续的未满足需求。 信立泰：拟用于个MASH的SAL0145获得临床试验批准 证券代码：002294  证券简称：信立泰  编号：2026-024 近日，深圳信立泰药业股份有限公司收到国家药品监督管理局核准签发的《临床试验批准通知书》，同意公司自主研发的创新药物SAL0145 注射液（项目代码：SAL0145）开展 MASH 适应症的临床试验。 SAL0145是公司研发的具有自主知识产权的 siRNA 药物。临床前研究显示，其具有治疗 MASH 的潜力。若能研发成功并获批上市，将有望为更多患者提供新的用药选择，满足未被满足的临床需求，并进一步丰富公司慢病领域的创新产品管线。 以岭药业：拟用于慢阻肺相关问题的中药新药“芪龙定喘片”获批药物临床试验 证券代码：002603  证券简称：以岭药业  公告编号：2026-012 石家庄以岭药业股份有限公司于2026 年 3 月 26 日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》。 一、临床试验申请及批准通知书主要内容 药物名称：芪龙定喘片 注册分类：中药新药1.1 类 适应症：慢性阻塞性肺疾病稳定期心肺气虚、痰瘀阻滞证 剂 型：片剂 申请事项：新药临床试验 受理号：CXZL2600002  通知书编号：2026LP00945 申请人：石家庄以岭药业股份有限公司 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，2026 年 01 月 07 日受理的芪龙定喘片临床试验申请符合药品注册的有关要求，在进一步完善临床试验方案的基础上，同意本品开展用于慢性阻塞性肺疾病稳定期心肺气虚、痰瘀阻滞证的临床试验。 芪龙定喘片相关情况芪龙定喘片是在中医络病理论指导下，应用肺络病证治理论研发而成的治疗慢性阻塞性肺疾病（COPD）的中药创新药。其拟定功能主治为：益气活血通络，化痰止咳平喘。用于慢性阻塞性肺疾病稳定期心肺气虚、痰瘀阻滞证，症见气短喘息，动则加重，咳嗽，咳痰质黏，伴乏力，懒言，胸闷，心悸，自汗，恶风，易感冒，舌质淡或淡暗，舌苔白，寸脉沉细或沉弱。 万泰生物：重组三价轮状病毒亚单位疫苗（大肠埃希菌）获得临床试验批准 证券代码：603392 证券简称：万泰生物 公告编号：2026-011 2025年 12 月，北京万泰生物药业股份有限公司全资子公司厦门万泰沧海生物技术有限公司收到国家药品监督管理局行政许可文书《受理通知书》，公司申报的“重组三价轮状病毒亚单位疫苗（大肠埃希菌）”临床试验申请已获得受理。 近日，万泰沧海收到国家药监局核准签发的重组三价轮状病毒亚单位疫苗（大肠埃希菌）的《药物临床试验批准通知书》。 一、药品基本信息 产品名称：重组三价轮状病毒亚单位疫苗（大肠埃希菌） 申请事项：境内生产药品注册临床试验 通知书编号：2026LP00936 规格：每瓶0.5ml  剂型：注射剂 审批结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》及有关规定，经审查，2025 年 12 月 25 日受理的重组三价轮状病毒亚单位疫苗（大肠埃希菌）符合药品注册的有关要求，同意开展预防轮状病毒胃肠炎的临床试验。 二、药品研究情况 重组三价轮状病毒亚单位疫苗（大肠埃希菌）由厦门大学、万泰沧海联合研制，系采用基因工程重组技术、以大肠埃希菌表达系统生产的重组蛋白疫苗。其主要活性成分为自主开发的截短的轮状病毒刺突蛋白VP4。临床前数据显示，本品安全性良好，且可在小鼠、大鼠、食蟹猴等多种动物体内诱导产生轮状病毒的中和抗体应答。 哈哈 第2部分 The second story 白 1 报告分享 报告 今日报告： 《2025中国创新药械多元支付白皮书》 在公众号内回复“7777”获得报告原文（有效期7天） 如需下载历史分享报告和更多报告，请扫以下二维码加入社群： 哈哈 第3部分 The third story 白 1 书籍介绍 Every Living Creature——How Xenotransplantation Will Change Our Lives 每个生灵 ——异种移植将如何改变我们的生活 本书作者是一位屡获殊荣的器官移植外科医生。他带我们走进一个既神奇又充满温度的科学世界。 在美国，有超过十万个病人正排队等着做器官移植救命。可问题是，如果非得用一个人的死去换另一个人的新生，那器官短缺这个坎儿就永远过不去。但是，办法其实已经近在眼前了——这就是“异种移植”，也就是把一种生物的器官移植到另一种生物身上。听起来像是天方夜谭？作者偏偏就把这个曾经的“不可能”讲得清清楚楚。 故事得从上世纪六十年代讲起，那时候人们开始试着用黑猩猩、狒狒的器官来救人。这一路走得可不顺，既碰到一堆伦理上的纠结，也有现实的失败和挫折。但科学从来不会就此止步。后来，克隆羊多莉的成功，让大家重新燃起了希望。再后来，基因编辑技术CRISPR-Cas9横空出世，终于打开了通向人类异种移植的大门——用经过基因改造的小猪，当器官的供体。 这本书的主角们，跟书里写的科学一样让人惊叹。 有个跨性别的梦想家，她是全球收入最高的女CEO，一心只为了让自己的女儿活下去； 有位外科医生，自己就是靠一场风险极高的心脏移植捡回了命，从此他深信，猪的器官就是未来； 还有一位才华横溢又敢闯敢拼的外科医生兼科学家兼企业家，为了把异种移植做成真，押上了所有身家。 每个人都在拼尽全力，促成一件了不起的事——说到底，这是一个奇迹的故事。而且正如书里说得清清楚楚，这不是等来的上天回应，而是咱们亲手培育出来的奇迹。 作者：Joshua D. Mezrich 出版：2026.4.7 哈哈 第4部分 The fourth story 白 1 猜猜看 问题 人类为什么不是“夜行”动物？（已知早期哺乳动物祖先曾是夜行性的） 大家猜猜看 答案是什么 可直接下方留言 或者后台回复 明天揭晓答案哦 上期答案 《Nature Microbiology》：耶鲁大学研究团队发现，HIV 会产生一种此前未知的环状RNA——circHIV。研究表明，circHIV 不仅存在于感染细胞中，也可在感染者血浆中检测到；它通过与HIV 的Tat 蛋白结合，增强病毒基因转录并促进复制。降低circHIV 水平会削弱HIV 活性，增加其水平则会增强病毒活性，提示它可能成为新的治疗靶点。 这项研究也揭示，稳定的环状RNA 在病毒生物学中可能具有重要而长期被忽视的作用。 问题请见上期文章：医周政见 l 国家医保局等八部门：印发《加快建立长期护理保险制度实施方案》－第458期 已完成的项目 星际微光已完成的项目（截至2023.9，仍在继续......）  圆满中秋 | 星际微光七年完成100个咨询项目 咨询、调研、PR、投资、融资、营销、技术转化项目需求请扫码联系我们： Copyright © 2016-2026 Interstellar Firefly Ltd. All rights reserved  星际微光（北京）咨询顾问有限公司 版权所有 点击“阅读原文”，看看：GLP-1制造黑幕

Short seller’s Characterization of ASCENIV’s Competitive Position Reflects Blatant Misunderstanding of ADMA’s Business and Its Role as Late-line Therapy for Patients Who are Immune Compromised and Therefore, May Not Respond to Vaccines Highlights that Demand for – and Utilization of – ASCENIV Has Grown Steadily Over Past Two Years and is at Record High Details that Stocking Levels Maintained by ADMA’s Distributors Align with Industry Standards and Reflect the Long Production Cycle for ASCENIV RAMSEY, N.J. and BOCA RATON, Fla., March 27, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today responded to a report issued on March 24, 2026 by short seller Culper Research (the “Short Report”). Following a detailed review of the Short Report, ADMA wishes to refute key allegations to alleviate confusion in the marketplace concerning the Company’s business practices and operations. ADMA believes that by providing, on a non-recurring basis, additional details concerning the Company’s immune globulin product portfolio – including inventory days on hand at its distribution partners and direct customers, and end user demand pull-through data – it refutes the key false and misleading allegations contained in the Short Report. Specifically: Demand for ASCENIV is real and growing. As shown through data provided directly from ADMA’s distribution partners and direct customers, end-user demand for ASCENIV has increased over the past two-plus years. Allegations of channel stuffing illustrate a misunderstanding of the commercial dynamics of the IVIG market. Distributors must maintain a level of safety stock to ensure the continuity of care for immune compromised patients who require IG therapy every 21-28 days.ADMA’s distributors and direct customers typically stock above contractually required minimum levels to have supply on hand for immediate administration and to mitigate any potential supply chain, manufacturing, testing or regulatory disruptions.The Company’s distributors provide inventory and pull through sales data to ADMA on an ongoing basis.As shown through data provided directly from ADMA’s distribution partners and direct customers, the graphs entitled “Distributor Inventory Days of Coverage Above Safety Stock” illustrates, as of January 5, 2026 and March 22, 2026, an average of 84 and 48 days on hand, respectively, for ASCENIV, and an average of 87 and 51 days on hand, respectively, for BIVIGAM, in excess of the distributors’ minimum requirements. These data are calculated using each distributor’s run rate for the previous month, demonstrating that ADMA’s immune globulin products are continuing to pull through the channel. Note: Due to year end calendar and fixed reporting schedules, January 5, 2026 is the closest available data for December 31, 2025.As shown through data provided directly from ADMA’s distribution partners and direct customers, graphs entitled “Distributor Inventory Days of Coverage”, as of January 5, 2026 and March 22, 2026, illustrate the average of 128 and 90 days of inventory on hand, respectively, for ASCENIV, and 129 and 92 days of inventory on hand, respectively, for BIVIGAM, by ADMA’s distribution partners and direct customers, including the mutually agreed upon safety stock levels of ADMA’s immune globulin products. Note: Due to year end calendar and fixed reporting schedules, January 5, 2026 is the closest available data for December 31, 2025.The Company believes that these inventory levels are consistent with industry peers and are appropriately sized to ensure the cold-chain shipping, storage and handling of such products and to mitigate any potential supply chain or production disruptions. The Short Report misrepresents and conflates ASCENIV’s utility and competitive positioning in the IVIG market. ASCENIV is positioned as a late-line therapy for immune compromised individuals who are refractive to standard IG treatments, have comorbidities and suffer from chronic and persistent infections.As a late line therapy for patients who have failed standard IG, ASCENIV is in a different category and commands premium pricing. The Short Report’s citation of new launches of normal course immune globulin products as creating competitive pressure for ASCENIV utilization is grossly misguided. ADMA has received unqualified opinions in its audits for FY 2024 and FY2025. ADMA has filed its Annual Reports on Form 10-K for the years ended December 31, 2024 and 2025 with reports from a Big Four accounting firm that expressed unqualified opinions on the effectiveness of the Company’s internal control over financial reporting and an assessment that the Company’s consolidated financial statements are presented fairly, in all material respects, in conformity with U.S. generally accepted accounting principles (GAAP) for such periods.The Company’s prior accounting firm resigned in late 2024 in advance of being acquired by a private equity firm. There have never been any undisclosed related party transactions in violation of U.S. securities laws. No entity owned or controlled by Jerrold Grossman, Adam Grossman or the Grossman family has ever distributed, taken title to or otherwise possessed any of ADMA’s immune globulin or other products, whether for resale or otherwise. ADMA confirms that it has never sold any of its immune globulin products or other products to any entity controlled by the Grossman family or other related parties. ADMA is committed to leading a new age of manufacturing, marketing, and commercializing specialty biologic products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections, and creating long-term value for its stockholders. To receive accurate information about the Company, all investors are encouraged to review materials filed by ADMA with the U.S. Securities and Exchange Commission, which can also be accessed by visiting the Company’s website www.admabiologics.com. About ASCENIV™ ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes such as bacteria and viruses that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company’s website at www.admabiologics.com. Additional Important Safety Information About ASCENIV™ WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients.Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. ASCENIV™ Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. ASCENIV™ Warnings and Precautions: IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1] Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4] In patients at risk of developing acute renal failure. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9] Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5] Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6] Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7] Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ASCENIV™ Adverse Reactions: The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About BIVIGAM® BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies. Certain data and other information about BIVIGAM® or ADMA Biologics and its products can be found on the Company’s website at www.admabiologics.com. Additional Important Safety Information About BIVIGAM® WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. BIVIGAM® Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. BIVIGAM® Warnings and Precautions: Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available immediately to treat any acute severe hypersensitivity reactions. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure. Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. Hemolytic anemia can develop subsequent to treatment with IGIV products. Monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. BIVIGAM® Adverse Reactions: The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia. ADMA manufactures its immune globulin products and product candidates at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products and product candidates. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “position us,” “positioned,” “support,” “should,” “could,” “would,” “may,” “potential,” “opportunity” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about Short Report, including but not limited to the Company’s inventory levels and days on hand and product utilization. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto. INVESTOR RELATIONS CONTACT: Argot Partners | 212-600-1902 | ADMA@argotpartners.com MEDIA CONTACT: Longacre Square Partners | ADMABiologics@longacresquare.com Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fa2ef727-67b9-47b9-8903-3327560f7723 https://www.globenewswire.com/NewsRoom/AttachmentNg/1c4170ed-8dfa-46dc-87d2-4dc69bd58671 https://www.globenewswire.com/NewsRoom/AttachmentNg/cc3886f3-76e6-4df6-a915-1e5106dad222 https://www.globenewswire.com/NewsRoom/AttachmentNg/52920050-f97e-4b6f-aaec-4234d158f7ce https://www.globenewswire.com/NewsRoom/AttachmentNg/c2e4dfc0-94d2-4de6-8ca0-8e790ba8a1ee