華領醫藥-B(02552.HK)公佈年度業績 研發開支達3.22億元 虧損大幅減少88.2%
格隆匯3月16日丨華領醫藥-B(02552.HK)公佈截至2019年12月31日止年度業績，公司其他收入2957.4萬元人民幣，同比增長185.6%；公司擁有人應占虧損4.25億元，虧損同比減少88.2%；每股虧損0.45元。
虧損大幅減少主要由於上年同期以公允價值計量且其變動計入當期損益的金融負債公允價值變動虧損32.66億元。截至2019年12月31日，銀行結餘及現金為約人民幣11.056億元。研發開支增加約約19.6%至約人民幣3.22億元。
HMM0301是在中國進行的一項針對未用藥2型糖尿病患者的dorzagliatin單藥療法III期臨牀試驗。截至2019年2月28日，公司已完成逾450名患者的招募，並於2019年11月12日發佈首個24周正面結果。該試驗已達到主要療效終點，與安慰劑相比，其於統計學上顯示糖化血紅蛋白(HbA1c)水平顯著減少。
此外，HMM0302是在中國進行的針對具有二甲雙胍耐藥性的2型糖尿病患者的dorzagliatin與二甲雙胍聯合用藥的III期臨牀試驗。截至2019年8月30日，公司已完成逾750名患者的患者招募，並於2020年2月完成24周的雙盲、安慰劑對照，並預期於2020年下半年完成整個52周（另加一週跟進）臨牀試驗。
公司計劃於2020年第三季度前發佈單藥療法試驗(HMM0301)的首個52周III期臨牀試驗結果，於2020年第三季度前發佈與二甲雙胍聯合用藥試驗(HMM0302)
的首個24周III期結果，以及於2020年年底前發佈首個52周結果。公司計劃於完成該兩項52周臨牀試驗後向NMPA提交NDA批准。公司計劃與中國或國際醫藥公司合作，讓dorzagliatin可供位於中國或中國境外的患者使用。為持續擴大2型糖尿病治療的適應症範圍，公司計劃開展與其他幾種現有藥物的試驗，以擴大dorzagliatin的產品組合。作為將dorzagliatin成為全球2型糖尿病治療基礎療法的策略的一部分，公司期望與全球2型糖尿病專家合作，進一步瞭解dorzagliatin的潛力。
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