日本首批准TEPOXX治療正痘病毒

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生物科技




TEPOXX（tecovirimat）在日本獲批用於治療正痘病毒

2025年1月2日 07:30 ET | 來源：SIGA Technologies Inc.

這項監管決定標誌著日本首次批准用於治療正痘病毒的抗病毒藥物，包括天花、猴痘和牛痘。日本生技藥業有限公司被指定為TEPOXX在日本的獨家分銷商，以供應給日本的國家儲備。

全面的數據包顯示出強大的安全性和良好的前臨床療效。

紐約，2025年1月2日（GLOBE NEWSWIRE）——商業階段的製藥公司SIGA Technologies今天宣布，其抗病毒治療TEPOXX（tecovirimat 200毫克膠囊），在美國市場名為TPOXX，已獲得日本的監管批准，用於治療天花、猴痘、牛痘以及成人和體重至少13公斤的兒童在接種天花疫苗後的併發症。TEPOXX是由日本醫藥品和醫療器械管理局（PMDA）批准的首個抗病毒療法，並與日本厚生勞動省合作，專門用於治療正痘病毒。

SIGA與日本的獨家分銷商日本生技藥業合作，已向日本交付TEPOXX的訂單，以幫助建立日本的戰略國家儲備。

“TEPOXX在日本的批准標誌著我們在全球範圍內擴大這一關鍵抗病毒治療的可及性的重要里程碑，以支持對正痘病毒疫情的有效應對。作為一種具有長期保質期的膠囊，TEPOXX可以在緊急情況下迅速部署，”首席執行官Diem Nguyen表示。“我們感謝日本監管機構的密切合作以及與日本生技藥業的強大夥伴關係，使這一成就成為可能。這一批准突顯了儲備有效抗病毒療法的重要性，作為保護公共健康免受嚴重和潛在破壞性傳染病（如天花）的創新解決方案的基石。”

日本的批准基於15項臨床試驗的數據，涉及超過800名健康志願者，包括在日本進行的一項關鍵性重複劑量第一階段藥物動力學（PK）試驗，涉及20名健康志願者。這些研究顯示沒有與藥物相關的嚴重不良事件，並且在有效劑量範圍內的藥物動力學可量化。在非人靈長類動物（NHPs）中進行的四項關鍵性研究和在兔子中進行的兩項關鍵性研究顯示，TEPOXX顯著降低了死亡率和病毒載量。這些動物療效研究的結果已於2018年7月5日的《新英格蘭醫學雜誌》上發表。TEPOXX還在感染天花病毒的NHPs中進行研究，顯示出改善生存率和減少病變的效果。

“這一里程碑反映了多年的奉獻和科學創新，”首席科學官Dennis Hruby博士表示。“TEPOXX的設計基於對正痘病毒的深刻理解，並有潛力為管理這些潛在破壞性疾病提供有效的治療選擇。我們為自己的工作能夠促進日本的應對準備和公共健康韌性感到自豪。”

TEPOXX是一種高度靶向的小分子抗病毒藥物，能夠抑制所有正痘病毒表面的VP37蛋白。通過阻止病毒從感染的細胞中釋放，TEPOXX減緩了感染的擴散，使免疫系統能夠清除病毒。

TPOXX在美國和加拿大獲得批准用於治療天花。在歐盟和英國，作為Tecovirimat-SIGA銷售，已獲得用於治療天花、猴痘、牛痘及接種天花疫苗後併發症的批准。

關於SIGA

SIGA是一家商業階段的製藥公司，專注於開發創新藥物以治療和預防傳染病。我們主要專注於正痘病毒，致力於保護人類免受世界上最嚴重的傳染病的威脅，包括自然、意外或故意發生的疾病。通過與政府和公共衛生機構的合作，我們致力於建立一個更健康和更安全的世界，提供對這些全球健康威脅的必要應對措施。我們的旗艦產品TPOXX®（tecovirimat）已在美國和加拿大獲得批准用於治療天花，並在歐洲、英國和日本獲得批准用於治療天花、猴痘、牛痘及接種天花疫苗後的併發症。

在這篇報導中，TEPOXX的批准不僅是對抗病毒藥物研發的一個重要進展，也是對公共健康體系的一次重大加強。隨著全球面對的傳染病威脅日益增長，這類藥物的可及性和儲備變得尤為重要。日本的這項舉措可能會成為其他國家效仿的榜樣，促使更多國家重視公共健康的備戰能力，並加強對新興傳染病的應對策略。這不僅是對抗天花等傳染病的必要手段，也為未來可能出現的疫情提供了寶貴的經驗和教訓。

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