Chinese Biotech YS Biopharma's Next-Gen Rabies Vaccine Non-Inferior To Approved Competitor
Chinese Biotech YS Biopharma's Next-Gen Rabies Vaccine Non-Inferior To Approved Competitor
Tuesday, YS Biopharma Co Ltd (NASDAQ:YS) revealed interim results from the ongoing Phase 3 clinical trial of its next-generation PIKA Rabies Vaccine.
週二，YS Biopharma Co Ltd（納斯達克股票代碼：YS）公佈了其下一代PIKA狂犬病疫苗正在進行的3期臨床試驗的中期結果。
The interim results indicate that the PIKA Rabies Vaccine has successfully met the primary endpoints and can potentially meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.
中期結果表明，PIKA狂犬病疫苗已成功達到主要終點，有可能實現世衛組織爲期一週的狂犬病疫苗方案以取代傳統的三到四周方案的目標。
The PIKA Rabies Vaccine, which utilizes YS Biopharma's proprietary PIKA adjuvant technology, is designed to produce a more robust immune response in an accelerated timespan than existing rabies vaccines.
PIKA狂犬病疫苗採用了YS Biopharma的專有PIKA輔助技術，旨在在更短的時間內產生比現有狂犬病疫苗更強大的免疫反應。
The FDA granted it orphan drug designation for prevention of rabies virus infection, including post-exposure prophylaxis for rabies.
美國食品藥品管理局授予其預防狂犬病病毒感染的孤兒藥稱號，包括狂犬病暴露後預防。
The Phase 3 trial, which includes 4,500 participants, is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule versus a globally marketed comparator following the standard 28-day regimen.
該3期試驗包括4500名參與者，旨在使用7天疫苗計劃對照全球上市的比較方案，評估健康成年人中三批PIKA狂犬病疫苗的免疫原性、安全性和批次間一致性。
The study's primary immunogenicity endpoints were the geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and the RVNA seroconversion rate at Day 14 in the first 900 participants.
該研究的主要免疫原性終點是狂犬病病毒中和抗體（RVNA）的幾何平均滴度（GMT）以及前900名參與者在第14天的RVNA血清轉化率。
The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants and RVNA seroconversion rate at Day 7 and Day 365 in all participants.
次要免疫原性終點是前900名參與者在第28天、第42天、第90天和第180天的RVNA血清轉化率和RVNA的GMT，以及所有參與者在第7天和第365天的RVNA血清轉化率。
Based on the interim data analysis, the PIKA Rabies Vaccine demonstrates non-inferior immunogenicity to a globally marketed comparator while helping patients achieve immunity in a shorter timeframe of 7 days.
根據中期數據分析，PIKA狂犬病疫苗的免疫原性不遜於全球上市的對照品，同時幫助患者在較短的7天時間內獲得免疫力。
The data, which comes from the first 900 participants enrolled in the trial, revealed that the RVNA seroconversion rate of the PIKA Rabies Vaccine was twice that of the comparator by Day 7, showing the superiority of the PIKA rabies vaccine in offering a quick onset of protection against virus infection.
這些數據來自該試驗的前900名參與者，顯示到第7天，PIKA狂犬病疫苗的RVNA血清轉化率是比較者的兩倍，這表明了PIKA狂犬病疫苗在提供快速啓動的病毒感染保護方面的優勢。
"At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA rabies vaccine might have a positive impact on patients," Zenaida Mojares, Chief Medical Officer said. "We are proud of our team for the hard work and dedication which got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies."
首席醫學官澤奈達·莫哈雷斯說：“目前，現有狂犬病疫苗的療程漫長而不便是完成治療的主要障礙，我們渴望看到PIKA狂犬病疫苗速度的提高將如何對患者產生積極影響。”“我們爲我們的團隊的辛勤工作和奉獻精神感到自豪，我們很高興看到我們的進步將如何爲正在進行的全球抗擊狂犬病做出貢獻。”
Price Action: YS shares are down 2.27% at $0.86 on the last check Tuesday.
價格走勢：週二的最後一次支票中，美國股價下跌2.27％，至0.86美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。