COVID-19 Vaccine(Janssen)

药品注册受理审评审批一周情况 （2026年8月24日—8月28日） 统计周期：2026年8月24日—8月28日 查询时间：2026年8月29日  |  数据可能动态更新，请以官方最新公示为准 一、受理总况 本周CDE受理427个受理号，化药占比51.5%，1类创新药（化药）首次IND 10个品种；NMPA批准上市87个（1类创新药5个）。 本周 CDE 共承办 427 个受理号，三类药品分布如下： 药品类型 受理号数 占比 环比变化 化药 220 51.5% +0.9% 生物制品 85 19.9% -9.6% 中药 122 28.6% -17.6% 合计 427 100% -7.2% 环比对比上周（8/17–8/23，460个）。本周总量小幅回落，主要受中药受理减少拖累；化药基本持平。 数据来源：戊戌数据-CD E受理库（cbrq 20260824:20260829）二、化药受理（220个） 2.1 按申请类型分布 2.2 按注册分类分布（仅统计新药+进口+仿制，共103个） 2.3 化药1类新药首次IND（10个品种） 药品名称 企业名称 承办日期 GST101片 枕石生物 08-24 ST-1703片 赛特明强 08-25 注射用QHL-1031 亲合力 08-26 HW281171片 湖北生研院 08-27 AHB-137注射液 浩博医药 08-27 PRT-064040鼻喷剂 普锐特 08-27 KQB198胶囊 今桔生物 08-27 WD-910片 文达医药 08-28 HRS-9308片 成都盛迪(恒瑞) 08-28 ZX-8177片 征祥医药 08-28 其中 HW281171、KQB198、HRS-9308、ZX-8177 按不同规格/适应症各申报 2 个受理号。 数据来源：戊戌数据-CDE受理库（化药，新药+进口+仿制） 2.4 重点品种 ① HRS-9308片（恒瑞医药·成都盛迪） HRS-9308 片为恒瑞医药旗下成都盛迪医药申报的 1 类化药小分子创新药，本次系首次提交临床试验申请（IND）（靶点/机制以企业官方披露为准）。本次承办日期 2026-08-28，申请类型为新药（IND），同一品种申报 2 个受理号。 ② AHB-137注射液（浩博医药） AHB-137 为杭州浩博医药研发的反义寡核苷酸类 1 类创新药，全球层面已进入 III 期临床（Bravenew 新药库，NME，中国化药一类），本次为国内首次提交 IND。承办日期 2026-08-27，申请类型为新药（IND）。 数据来源：戊戌数据-CDE受理库（化药，新药+进口+仿制）；Bravenew新药库（AHB-137）三、生物制品受理（85个） 本周生物制品受理85个，治疗用76个，预防用9个，一次性进口0个。 1 类生物制品（新药/进口，部分重点）： 药品名称 类别 注册分类 企业名称 承办日期 AZD8205 治疗用 1类 阿斯利康 08-24 Telisotuzumab Adizutecan 治疗用 1类 艾伯维 08-24 RC148注射液 治疗用 1类 荣昌生物 08-24 DS-3939a 治疗用 1类 第一三共 08-24 依赛弗酶α注射液 治疗用 1类 Alexion/阿斯利康 08-24 注射用ZL-1310 治疗用 1类 再鼎医药 08-24 注射用SKB500 治疗用 1类 科伦博泰 08-25 注射用AN4035 治疗用 1类 阿诺医药 08-25 MK-2010注射液 治疗用 1类 默沙东 08-26 ARGX-121注射液 治疗用 1类 argenx 08-26 重组3型副流感病毒疫苗 预防用 1.1类 迈科康 08-26 注射用GB268 治疗用 1类 亿腾医药 08-26 BA2201注射液 治疗用 1类 博安生物 08-26 重点品种（AZD8205）： AZD8205 注射液为阿斯利康进口申报的 1 类生物制品（ADC 类新药），本次为临床试验申请（IND）。承办日期 2026-08-24，申请类型为进口（临床）。本周阿斯利康、艾伯维、第一三共等跨国企业 ADC/创新生物药临床申报密集。 数据来源：戊戌数据-CDE受理库（治疗用/预防用生物制品）四、中药受理（122个） 中药受理122个，补充申请119个，新药IND 2个，NDA 0个，仿制药1个。 药品名称 申请类型 注册分类 企业名称 承办日期 芪珀生脉颗粒 新药 1.1类 春风药业 08-24 麻痛颗粒 新药 1.1类 泰州乐耶 08-27 西帕依固龈液 仿制 4类 江西和盈 08-26 本周1款中药仿制药：江西和盈药业申报西帕依固龈液。 其余119个为补充申请（以原9/老文号规整为主，企业如吉林高邈、洛阳伊龙、神威药业等批量申报）。 数据来源：戊戌数据-CDE受理库（中药）五、药品上市（NMPA批准） NMPA批准上市药品87个（按批准生产/批准进口计），化药85个（新药3个、进口2个、仿制药80个），生物制品2个，中药0个。其中1类创新药上市5个。 注：本次批量获批集中于 2026-08-25；以下以受理号标识。 药品名称 注册分类 企业名称 受理号 批准日期 GR1803注射液 1类 智翔金泰 CXSS2600003 08-25 凡瑞格拉替尼片 1类 和记黄埔 CXHS2500162 08-25 甲磺酸艾多替尼片 1类 同源康 CXHS2600026 08-25 盐酸伊可白滞素片 1类 强生(Janssen) JXHS2500133 08-25 莱康奇塔单抗注射液 1类 丽珠单抗 CXSS2500144 08-25 重点获批品种： ① GR1803注射液（维可妥）——智翔金泰研发、复星医药合作商业化 GR1803 由重庆智翔金泰研发，复星医药控股子公司重庆药友合作推进商业化；获国家药监局附条件批准，用于既往至少接受过三线治疗的复发/难治性多发性骨髓瘤（适应症来源：复星医药公告）。时间线：2026-01-09 CDE承办 → 2026-08-25 批准生产。合作信息：复星医药与智翔金泰合作开发（重庆药友）。 ② 酒石酸凡瑞格拉替尼片——和记黄埔医药 和记黄埔医药（上海）申报的 1 类化药小分子创新药，本次获批上市。时间线：2025-12-24 NDA 受理 → 2026-08-25 批准生产（靶点/适应症以官方说明书为准）。 ③ 甲磺酸艾多替尼片——同源康医药 浙江同源康医药 1 类化药新药获批上市。时间线：2026-02-06 CDE 承办 → 2026-08-25 批准生产。 ④ 盐酸伊可白滞素片——强生（Janssen） 强生旗下 Janssen 进口申报的 1 类新药，本次获批进口。时间线：2025-11-19 承办 → 2026-08-25 批准进口。 ⑤ 莱康奇塔单抗注射液——丽珠单抗 珠海丽珠单抗 1 类生物制品获批上市。时间线：2025-12-24 承办 → 2026-08-25 批准生产。 仿制药批量获批（82个化药）：本周 8/25 集中批准大批仿制药，覆盖磷酸芦可替尼片（哈三联、常州制药厂等多家）、富马酸伏诺拉生片（迪沙）、艾司奥美拉唑镁肠溶干混悬剂（石药欧意）、丙戊酸钠缓释片（安必生、联亚）、注射用醋酸西曲瑞克（苏州天马）等。 数据来源：戊戌数据-注册审批库（pz_date 20260824:20260829，批准生产/批准进口）；复星医药公告（GR1803适应症）六、CDE文件/公告/新闻（本周8/24–8/28热点） 1. CDE公开征求《药物浓度-QTc临床研究技术指导原则（征求意见稿）》意见（2026-08-25）https://m.cnpharm.com/c/2026-08-25/1105236.shtml 2. 国家药监局发布仿制药参比制剂目录（第一百零八批）通告（2026年第29号）（2026-08-24）https://www.dayi.org.cn/information/157.html 3. 复星医药GR1803注射液（维可妥）获国家药监局附条件批准上市（2026-08-27）https://stock.stockstar.com/RB2026082700041854.shtml 数据来源：中国食品药品网（CDE）、国家药监局/医药信息平台、复星医药公告（via 证券之星） 说明：第五部分上市数量以 CDE/NMPA 审评结论（批准生产/批准进口）口径统计；1类新药靶点/适应症信息部分以官方说明书或企业公告为准，未核验处已注明。 想查更多？药达·isearch 免费体验 文末「阅读原文」直达 戊戌数据 · 可视化看板 数据来源：药达isearch（https://isearch.wuxuwang.com） 戊戌数据（www.wuxuwang.com） 内容仅供参考，不构成投资或用药建议 END ★ 点击下方卡片，发现更多精彩

Both vaccine candidates leverage the same technology used to develop the COVID-19 vaccine. Credit: Unsplash Amid a growing outbreak, Oxford University researchers and Moderna announced that clinical trials for a Bundibugyo virus strain vaccine have begun In close succession, two separate candidates for an Ebola vaccine to tackle the deadly Bundibugyo strain have entered Phase 1 clinical trials. It provides a ray of hope amid an Ebola outbreak in the DR Congo (DRC) which, according to DRC public health estimates, has seen a recorded 3,973 cases and 1,801 deaths recorded as of 4 August 2026. Oxford University researchers are behind one of the trials, while Moderna is advancing the other in Canada, with both leveraging technology used to develop the COVID-19 vaccine. In addition, a clinical trial of a potential post-exposure prophylaxis medicine is underway, led by the DRC’s National Institute for Biomedical Research, supported by an international consortium of research and outbreak-response partners. Key statistics behind the current Ebola outbreak 3,973 cases and 1,801 deaths have been recorded as of 4 August 2026. Cases are rising faster than the 2014–2016 West Africa epidemic, which remains the largest Ebola outbreak on record. Treatment infrastructure is improving, with a 100-bed treatment centre opening in Bunia, capital of Ituri province - the epicentre of the outbreak. Moderna leads the pharma industry’s efforts Moderna announced clinical trials began on 4 August 2026. The vaccine candidate draws on Moderna's mRNA platform — the same technology that proved capable of rapid development, scalability and worldwide rollout during the COVID-19 pandemic. It also builds on work Moderna has already put into filoviruses, the family of viruses that includes Ebola. Stéphane Bancel, CEO of Moderna. Credit: LinkedIn "Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists," says Stéphane Bancel, Chief Executive Officer of Moderna. The programme sits within Moderna's partnership with the Coalition for Epidemic Preparedness (CEPI), which has pledged up to US$50m toward preclinical work and the Phase 1 trial. "We are grateful to CEPI, Health Canada, the investigators and study participants for their contributions to advance this work," continues Stéphane. That funding also covers scaling up manufacturing of trial doses alongside early-stage clinical work, a move designed to enable larger Phase 2 and Phase 3 trials to launch quickly should the Phase 1 data hold up. "Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," says Dr. Richard Hatchett, CEO of CEPI. Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness. Using the COVID vaccine template On 13 July 2026, Oxford University announced that researchers were initiating the first clinical trials for the Bundibugyo strain. The trial will test the safety of the ChAdOx1 BDBV vaccine and the immune response it triggers in 50 healthy adults between 18 and 55. Volunteer recruitment has begun, and the first recruits have received doses of the vaccine candidate. To get the study up and running quickly and push the vaccine candidate into clinical testing, the Serum Institute of India (SII) has manufactured and stockpiled roughly 620,000 doses. Scientists at the University of Oxford's Oxford Vaccine Group and Pandemic Sciences Institute developed the vaccine candidate using the same viral vector platform behind the Oxford/AstraZeneca COVID-19 vaccine – a vaccine credited with saving over six million lives in its first year alone. Professor Katrina Pollock, MRC Clinician Scientist in Vaccinology and Chief Investigator at the Oxford Vaccine Group. Credit: University of Oxford Professor Katrina Pollock, MRC Clinician Scientist in Vaccinology and Chief Investigator at the Oxford Vaccine Group, says: 'Launching this first-in-human study of a Bundibugyo ebolavirus vaccine is an important milestone for the programme and the culmination of a significant effort by teams across vaccine development, manufacturing and clinical testing. “We are focused on delivering a rigorous Phase 1 trial, to the highest standard of care, to evaluate the safety, tolerability and immune responses generated by the vaccine.” A race against time As both vaccine candidates move through the clinical trial process, the search for a safe, effective vaccine candidate is a pressing race against time. The current outbreak is the second-largest in history, only behind the 2014-2016 West African epidemic, which claimed 11,325 lives and infected over 28,600 people. With concerns among health officials that the virus could be mutating, the vital work by Moderna and Oxford University researchers is of paramount importance in protecting global health. Dr. Richard Hatchett, CEO of CEPI. Credit: World Bank "This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 - 2016 West Africa epidemic, which remains the largest on record. "Every day matters, and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible," says Richard. Company portals Moderna Executives Stéphane Bancel Founding CEO