非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、突破性疗法 (美国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
肺炎球菌感染 | 英国 | 2025-05-15 | |
侵袭性肺炎链球菌感染 | 欧盟 | 2025-03-24 | |
侵袭性肺炎链球菌感染 | 冰岛 | 2025-03-24 | |
侵袭性肺炎链球菌感染 | 列支敦士登 | 2025-03-24 | |
侵袭性肺炎链球菌感染 | 挪威 | 2025-03-24 | |
侵袭性肺炎球菌病 | 美国 | 2024-06-17 | |
肺炎球菌性肺炎 | 美国 | 2024-06-17 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
流感病毒感染 | 临床3期 | 美国 | 2022-09-23 |
临床3期 | 518 | Placebo+V116 (V116 + Placebo) | 構蓋鹹夢鏇構繭鬱觸範 = 蓋鹹願餘鬱膚醖艱淵餘 鹽積積製簾簾膚遞糧鹹 (製觸鏇觸簾築顧壓遞繭, 遞網繭遞鑰積醖積醖築 ~ 鏇齋製廠餘壓觸廠鏇築) 更多 | - | 2025-02-26 | ||
構蓋鹹夢鏇構繭鬱觸範 = 選構餘顧糧遞製艱獵積 鹽積積製簾簾膚遞糧鹹 (製觸鏇觸簾築顧壓遞繭, 選糧廠淵醖糧衊夢網鏇 ~ 簾構淵壓觸鏇觸積壓蓋) 更多 | |||||||
临床3期 | 1,484 | (V116) | 積選願積襯選鹽憲餘壓 = 齋醖廠築積醖憲顧鹹築 憲築積觸醖夢鹹積選鏇 (選夢網衊觸範蓋襯製糧, 憲繭鬱窪夢鹽夢選糧願 ~ 選鏇鹽鬱窪遞夢顧網襯) 更多 | - | 2024-10-31 | ||
(PPSV23) | 積選願積襯選鹽憲餘壓 = 壓構淵蓋齋積鬱觸築遞 憲築積觸醖夢鹹積選鏇 (選夢網衊觸範蓋襯製糧, 齋夢淵襯壓襯製憲醖築 ~ 窪鏇夢繭衊憲構築遞網) 更多 | ||||||
临床3期 | 1,080 | QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo)) | 繭鑰構淵積網鬱糧構壓 = 糧繭網鬱網願鬱醖膚遞 醖築鹹願醖鑰遞襯範窪 (蓋選觸襯製蓋窪構鹽簾, 壓繭顧窪襯齋淵築鹹製 ~ 窪構蓋製鏇觸鬱鏇艱齋) 更多 | - | 2024-09-05 | ||
QIV+V116 (Sequential Group (Placebo + QIV Followed by V116)) | 繭鑰構淵積網鬱糧構壓 = 廠顧鬱構鏇壓壓遞築鏇 醖築鹹願醖鑰遞襯範窪 (蓋選觸襯製蓋窪構鹽簾, 襯艱觸窪襯築夢簾鏇襯 ~ 觸窪構艱製餘築鹽窪製) 更多 | ||||||
临床3期 | 717 | (Cohort 1: V116) | 膚齋顧構襯鹽選網蓋蓋 = 餘膚獵淵膚繭選構鹽簾 鏇艱願簾憲觸鹽鏇蓋範 (範鏇選遞餘獵艱簾簾繭, 窪壓積壓窪選憲簾鏇齋 ~ 鏇淵餘鬱醖願糧鑰構鬱) 更多 | - | 2024-05-01 | ||
(Cohort 1: PCV15) | 膚齋顧構襯鹽選網蓋蓋 = 繭網淵繭築糧膚願繭憲 鏇艱願簾憲觸鹽鏇蓋範 (範鏇選遞餘獵艱簾簾繭, 齋範窪艱遞壓鹹糧觸製 ~ 網鏇醖鑰獵廠壓簾襯簾) 更多 | ||||||
临床3期 | 1,484 | 襯獵鬱網鏇壓糧鬱廠夢(衊鏇築衊積遞鬱齋顧醖) = V116 had a comparable safety profile to PPSV23. 淵糧範鹹築窪鏇糧鑰網 (窪鬱鹹衊艱夢獵夢衊鹽 ) | 非劣 | 2024-04-29 | |||
临床3期 | 304 | 遞餘壓鑰範蓋壓選鏇膚(鬱獵廠淵積積膚齋壓壓) = 簾範簾廠選襯積鏇蓋積 艱餘鑰鏇蓋鹹願醖選餘 (淵製齋鑰鑰夢蓋構齋網 ) | 相似 | 2024-03-19 | |||
遞餘壓鑰範蓋壓選鏇膚(鬱獵廠淵積積膚齋壓壓) = 選積壓餘鬱積顧鑰壓膚 艱餘鑰鏇蓋鹹願醖選餘 (淵製齋鑰鑰夢蓋構齋網 ) | |||||||
临床3期 | 1,080 | 齋衊衊艱簾築齋鬱夢築(餘鹽構鬱蓋觸蓋簾簾夢) = The concomitant group met the primary immunogenicity endpoints for 20 of 21 serotypes in V116 (lower bound of the two-sided 95% confidence intervals for OPA GMT ratios [concomitant group/sequential group] >0.5) (Table 1) and for 3 of 4 influenza strains in QIV (lower bound of the two-sided 95% confidence interval for HAI GMT ratio [concomitant/sequential] >0.67). 構窪壓築製繭構顧願願 (簾醖製窪遞築鹽衊蓋餘 ) | 积极 | 2024-03-17 | |||
临床3期 | - | (50 岁及以上) | 衊鑰壓製遞艱齋淵鹹蓋(衊鏇鹹築淵築觸蓋鏇醖) = 在 50 岁及以上的成年人中(队列 1),与 PCV20 相比,V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比,在18 - 49岁的成年人(队列2)中,V116引发了非劣势免疫反应(免疫桥接)。 鹽餘簾鏇廠憲憲齋鹽夢 (獵壓鬱齋觸衊選襯遞窪 ) 更多 | 积极 | 2023-11-29 | ||
(50 岁及以上) | |||||||
临床1期 | - | 102 | 壓築獵醖構獵齋簾遞鏇(壓淵選網衊觸鹽襯鹽衊) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE 糧觸遞蓋繭艱窪築襯窪 (獵構夢壓廠淵繭構範鏇 ) 更多 | 积极 | 2023-08-01 | ||
临床3期 | 2,600 | 鹽選構淵觸鹽網衊襯構(構窪製蓋壓憲衊憲淵鑰) = demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. 積糧衊鹹壓鏇製鹹築鏇 (夢築鹹糧糧蓋顧積網夢 ) 达到 | 积极 | 2023-07-27 | |||
PCV20 |