Core Viewpoint - MicuBio (688321.SH) announced the final top-line analysis data from its pivotal Phase III clinical trial (DEB study) for its self-developed drug, Sidanbamide, which significantly outperformed the control group in terms of event-free survival (EFS), achieving the primary endpoint of the study [2][4] Group 1: Product and Market Information - Sidanbamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor and belongs to the class of epigenetic regulators [4] - The drug received conditional approval for DLBCL indications from the National Medical Products Administration (NMPA) in April 2024 and is set to be included in the national medical insurance catalog by the end of 2024, making it the only oral innovative drug for first-line DLBCL within the insurance coverage [4] - DLBCL is the most common type of lymphoma in China, with approximately 60,000 to 80,000 new cases reported annually, and the incidence rate is gradually increasing [4] Group 2: Clinical Trial and Regulatory Information - The company previously received conditional approval based on interim analysis data, requiring completion of clinical trials within two years to obtain complete clinical data [4] - The announcement of the final results signifies an expansion of the existing indication range for the product, positively impacting the company [4] - Conditional approval allows for accelerated market entry of urgently needed drugs with significant clinical value, even before completing full clinical research [5] Group 3: Competitive Landscape - The treatment field for DLBCL has seen recent breakthroughs, including the approval of Tafasitamab, a CD19 monoclonal antibody for relapsed/refractory DLBCL, which does not directly compete with Sidanbamide as it is used for second-line or later treatments [5] Group 4: Financial Performance - The company reported a revenue of 658 million yuan for 2024, a year-on-year increase of 25.63%, but faced a net loss of 115 million yuan, a significant decline of 228.97% [6] - In the first quarter of 2025, revenue was 162 million yuan, up 24.24% year-on-year, but the net loss was 19 million yuan, a decrease of 4.64% compared to the previous year [6]

国家药品监督管理局7月8日消息，心神宁胶囊经组织论证和审核，已由处方药转换为非处方药。相关药 品上市许可持有人须在2026年4月1日前，依据《药品注册管理办法》向省级药品监督管理部门备案说明 书修订事项，并通知医疗机构等单位；自补充申请备案日起生产的药品不得使用原说明书，非处方药说 明书范本内容外其他事项保留原批准证明文件。 药械审批 国家药品监督管理局7月8日消息，国家药监局综合司再次公开征求对《药品附条件批准上市申请审评审 批工作程序（试行）（修订稿征求意见稿）》及相关政策解读的意见，以进一步完善药品附条件批准上 市申请审评审批制度。 心神宁胶囊转换为非处方药 徐诺药业口服癌症新药艾贝司他拟纳入优先审评 近日，中国国家药监局药品审评中心（CDE）官网公示，徐诺药业申报的甲苯磺酸艾贝司他片拟纳入优 先审评，拟用于既往接受过至少两种系统性治疗的复发或难治滤泡性淋巴瘤成年患者。公开资料显示， 艾贝司他是一种新型有效的口服泛HDAC抑制剂。 鲁抗医药吉非替尼片获药品注册证书 政策动向 国家药监局再次公开征求药品附条件批准上市审批程序修订意见 7月8日，鲁抗医药公告，近日收到国家药品监督管理局颁发的关于吉非替尼片《 ...

中经记者晏国文卢志坤北京报道 2019年11月，国家药监局对甘露特钠胶囊附条件批准上市。 据业内人士介绍，药品附条件批准上市是在未完成完整的临床研究情况下，通过"先批准后验证"的形式 加快具有突出临床价值的临床急需药品上市。 药品附条件批准上市后，药品上市许可持有人（MPA）应按照药品注册证书中所附的特定条件，在规 定期限内完成新的或正在进行的药物临床试验，以补充申请方式报国家药监局药品审评中心（CDE）申 请常规批准上市。对附条件批准的药品，持有人逾期未按照要求完成研究或者不能证明其获益大于风险 的，国家药监局应当依法处理，直至注销药品注册证书。 （ 目前国家药监局数据库已经无法查询到甘露特钠胶囊。官网/图） 近日，网络流传知名国产抗AD（阿尔茨海默症）药物甘露特钠胶囊停产、相关办公区和生产区关闭的 信息。 6月12日，甘露特钠胶囊的生产企业上海绿谷制药有限公司（以下简称"绿谷制药"）方面对《中国经营 报》记者表示，本次临时性调整方案仅限于甘露特钠产品线相关岗位。公司对此深表遗憾。停工员工实 发工资将按当地最低工资标准发放，社保公积金按正常缴纳。待恢复生产经营后，公司将第一时间恢复 原薪酬标准。 附条件批准 ...