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兆科眼科以NVK002治療近視加深的第III期臨床試驗完成患者入組

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2022年8月3日 10時18分

兆科眼科以NVK002治療近視加深的第III期臨床試驗完成患者入組

— NVK002的兩項第 III 期臨床試驗均大幅提前完成患者入組
— 使兆科眼科在於中國、韓國和東南亞部分地區滿足對近視加深控制藥物的巨大需求方面,佔據領先位置

香港, 2022年8月3日 – (亞太商訊) – 致力於眼科療法的研發、生產及商業化,以滿足巨大醫療需求缺口的領先眼科製藥企業兆科眼科有限公司(「兆科眼科」或「本公司」;香港聯交所股份代號:6622) 今日欣然宣布,公司核心產品之一NVK002的為期兩年之第 III 期臨床試驗 (「中國CHAMP」)及同步進行的為期一年之第III期橋接臨床試驗(「小型CHAMP」),已分別於2022年7月21日及2022年7月28日完成患者入組,較預期時間大幅提前。

中國 CHAMP和小型CHAMP的主要目標為評估 NVK002 對於治療兒童及青少年近視加深的療效及安全性。

— 中國CHAMP
中國CHAMP試驗由北京同仁醫院王寧利教授出任牽頭研究者,涉及19間中心,於4個月內完成入組777名患者,較原定時間提前2個月。

— 小型CHAMP
小型CHAMP試驗由復旦大學附屬眼耳鼻喉科醫院瞿小妹教授及中山大學中山眼科中心楊曉教授出任聯席牽頭研究者,涉及18間中心,於3個月內完成入組526名患者,較原定時間提前3個月。

上述兩項臨床試驗提前完成患者入組,使本公司在中國開發治療近視加深藥物的市場上佔據領先位置。

本公司的夥伴Vyluma Inc.亦正於歐美進行NVK002的第III期臨床試驗「CHAMP」,療程為期三年,預計將於2022年底前完成,並預期於2023年向美國食品藥品監督管理局(「FDA」)提交新葯申請(「NDA」),而NVK002目前定位為全球首個經臨床驗證可治療近視加深的認可藥物。

兆科眼科董事局主席、執行董事兼行政總裁李小羿博士(Dr. Benjamin Li)表示:「NVK002第 III 期臨床試驗的提前完成患者入組,標誌着兆科眼科又一個重要且激動人心的里程碑。中國CHAMP及小型CHAMP兩項臨床試驗均大幅提前完成患者入組,我由衷感謝我們臨床研究團隊的所有成員,他們在眼科領域不斷地展示出卓越的臨床能力和專業知識。患者入組的提前完成,也清楚地表明中國對安全有效的近視加深治療有着巨大需求。兆科眼科希望透過將NVK002商業化,讓它成為中國首批治療近視加深的低劑量阿托品藥物之一,以滿足中國 、韓國和東南亞部分地區的巨大需求缺口。」

關於NVK002
NVK002乃一種用於治療兒童及青少年近視加深的試驗性新型外用眼部溶液。NVK002乃一項專利配方,成功解決低濃度阿托品的不穩性,此技術在全球均受到知識產權保護。NVK002不含防腐劑,預計保存期超過24個月。根據灼識行業諮詢有限公司(「灼 識」)提供的數據NVK002目前為全球用於控制近視加深的最先進阿托品候選藥物之一,目標患者組別最為廣泛,覆蓋3至17歲的兒童及青少年。

NVK002的臨床開發涉及兩個不同阿托品濃度,讓個別患者可按個人需要靈活地在最少副作用下達致最大療效。

關於控制近視加深
在中國,近視已成為重大社會議題,困擾兒童與青少年的成長。中國政府國務院於《「十四五」國民健康規劃》中清楚指導抓好兒童青少年近視防控,並每年降低兒童青少年的總體近視率0.5%以上。教育部亦發布《綜合防控兒童青少年近視家長倡議書》,呼籲家長關注孩子眼健康。

根據世界衛生組織及灼識的數據,中國目前有約7億名近視患者,當中1.63億為或能受惠於NVK002的兒童及青少年。董事會相信,NVK002的潛在商業生產將讓本公司藉滿足中國龐大的需求缺口,建立領導地位。

關於合作夥伴關係
於2020年10月,公司與Nevakar Inc.(Nevakar Inc.其後將協議轉讓予其全資附屬公司Vyluma Inc.)就一項獨家許可訂立了一份許可協議(即NVK002許可協議),以於大中華,南韓和東南亞若干國家(包括文萊、緬甸、柬埔寨、東帝汶、印度尼西亞、寮國、馬來西亞、菲律賓、新加坡、泰國及越南)開發、製造、登記、進口及商業化生產NVK002。有關NVK002許可協議的詳情,請參閱本公司日期為2021年4月16日招股章程中「業務 – 合作及許可協議 – NVK002 的許可」一節。

如欲了解更多有關兒童及青少年的近視問題,歡迎收聽「與兆科眼科對話」播客系列的第一集。
https://tinyurl.com/wut8fjzm

關於兆科眼科有限公司
兆科眼科(香港聯交所股份代號:6622)成立於2017年,是一家領先的眼科製藥企業,致力於眼科療法的研發、生產及商業化,以滿足巨全球大醫療需求缺口。兆科眼科於2021年4月29日在香港聯交所主板上市。

兆科眼科已建立由創新葯及仿製葯組成的候選藥物,涵蓋影響眼前節及眼後節的6種主要眼科適應症。眾多藥物現時由位於廣州南沙最先進並已全面運作的生產設施所製造。

公司正專註向產品商業化目標推進,務求儘快實現以科研改善中國大眾的視力健康。

憑藉雄心勃勃的增長戰略,包括與國內外製葯公司攜手合作,兆科眼科的目標是成為世界眼科的領導者。

欲查詢更多信息,請瀏覽:www.zkoph.com

關於Vyluma Inc.
Vyluma Inc. 是一家專註於治療屈光不正眼疾的生物醫藥研發公司。Vyluma 擁有以 NVK002 為首的眼科藥物組合,NVK002是一種不含防腐劑、用於治療兒童及青少年近視加深的試驗性低劑量藥用阿托品眼部溶液。 NVK002 目前在美國、歐洲和亞洲均在進行處於後期研發階段的第III期臨床試驗。

Vyluma Inc.的強大藥物管線遍布各個臨床階段,藉此滿足屈光不正或眼痛患者的巨大治療需求缺口。

Vyluma Inc.為 Nevakar Inc. 的全資子公司,Nevakar Inc.是一家控股公司,其子公司專註眼科和注射市場的產品開發。欲查詢更多信息,請瀏覽: www.vyluma.com

媒體聯絡:
安達信顧問 Artemis Associates
傅安緹 Diana Footitt,行政總裁
M: +852 9183 0667
E:diana.footitt@artemisassociates.com

徐寶文,總監
M: +852 9783 0643
E: bowen.chui@artemisassociates.com

裴浩慈,總監
M: +86 15000 465 016
E: iris.pei@artemisassociates.com


News URL: https://www.acnnewswire.com/press-release/simplifiedchinese/76881/

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