華領醫藥-B(02552.HK)公佈年度業績,研發開支達1.868億元
格隆匯3月16日丨華領醫藥-B(02552.HK)發佈截至2021年12月31日止年度的年度業績公吿,截至2021年12月31日,銀行結餘及現金為約人民幣6.752億元。公司於截至2021年12月31日止年度產生開支總額約人民幣3.272億元,其中約人民幣1.868億元為研發開支。
根據披露,華領醫藥是一家收益前階段的中國藥物開發公司,目前專注於開發dorzagliatin(用於治療T2D的首創新藥口服藥物。華領醫藥於2012年就dorzagliatin向NMPA提交1.1類創新藥的新藥臨牀試驗(“IND”)申請及於2013年9月啟動新型葡萄糖激酶激活劑 dorzagliatin的第Ia期臨牀研究。華領醫藥亦於2015年3月就dorzagliatin向美國食品藥品監督管理局(“FDA”)提交IND申請。
華領醫藥在中國完成了八項I期試驗、在美國完成了四項I期試驗、在中國完成了一項II期試驗及在中國完成了兩項III期試驗。華領醫藥的兩項III期試驗於中國110個研究中心招募1,230名患者。兩項III期試驗(亦稱為SEED及DAWN試驗)均達到其主要療效終點,在試驗期間,dorzagliatin的安全性及耐受性表現良好。兩項III期試驗的最終52周結果已於2020年宣佈及刊發。於2021年3月,華領醫藥就治療T2D的dorzagliatin向NMPA遞交NDA,並於2021年4月從NMPA收到通知,華領醫藥提交的NDA已獲受理。NDA現時正獲NMPA積極審查。
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