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開拓藥業-B(09939.HK):巴西ANVISA有條件批准普克魯胺治療住院新冠患者的III期臨牀試驗
格隆匯 09-26 22:11

格隆匯9月26日丨開拓藥業-B(09939.HK)公佈,開拓藥業已於2021年9月22日獲得巴西國家衞生監督局(“ANVISA”)有條件批准,於巴西進行普克魯胺用於治療住院新型冠狀病毒肺炎(“新冠”)患者的III期臨牀試驗。

作為開拓藥業在全球超過十個國家和地區開展關鍵性普克魯胺治療住院新冠患者的全球多中心III期臨牀試驗(“美國、中國及國際III期臨牀試驗(住院患者)”或“該MRCT”)的一部分,隨着上述的批准,巴西為繼美國、中國及菲律賓後,第四個批准該MRCT的國家。美國、中國及國際III期臨牀試驗(住院患者)(NCT05009732)為隨機、雙盲、安慰劑對照的III期MRCT,預計招募1030名患者,主要終點為30天內評估的持續康復時間。有關進一步資料,請參閲公司日期分別為2021年5月18日和2021年9月1日的公吿。

香港聯合交易所有限公司證券上市規則第18A.08(3)條規定的警示聲明:公司無法確保公司最終將能成功開發及營銷普克魯胺。公司股東及潛在投資者在買賣公司股份時務請審慎行事。

董事會已注意到公司股份價格及成交量於2021年9月24日在聯交所出現不尋常的波動。董事會謹此澄清,董事會並不知悉任何導致股份價格及成交量出現波動的任何原因,或根據聯交所證券上市規則第13.09條必須公吿以避免公司證券出現虛假市場的任何資料,或根據香港法例第571章證券及期貨條例第XIVA部的內幕消息條文(定義見上市規則)須予披露的任何內幕消息。截至公吿日期,董事會並不知悉任何可能對公司商業前景產生重大不利影響的發展或進展。

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