榮昌生物-B(09995.HK)2020年其他收入及收益達7540萬元 研發開支升32%至4.66億元
格隆匯3月26日丨榮昌生物-B(09995.HK)公佈2020年度業績,期內集團產生開支總額約7.08億元(單位下同),其中約4.66億元為研發開支(研發開支增加約1.14億元或約32%至約4.66億元)。截至2020年12月31日,銀行結餘及現金為約28.09億元。
期內集團的其他收入及收益由2019年的3850萬元增加至2020年的7540萬元,主要由於實現的政府補助較去年同期增加3680萬元。
展望2021年,集團會致力將泰它西普和disitamab vedotin在中國獲批上市併成功商業化。同時,集團會加速推進這兩款產品適應症拓展的申報和臨牀試驗工作。其中,集團預計會在第三季度在中國向NMPA申報disitamab vedotin就治療UC適應症的NDA。另外,集團儘快推進泰它西普的其他幾個自身免疫疾病適應症的臨牀試驗工作。
國際方面,集團會加大在國際市場,尤其是美國和歐洲的拓展力度,快速推進並啟動集團兩個核心產品在國際市場的臨牀研究。集團預計2021年下半年在美國啟動泰它西普治療SLE適應症的III期臨牀試驗以及治療IgA腎病的II期臨牀試驗,同時集團也計劃在美國啟動disitamab vedotin就二線治療HER2過表達UC適應症的II期臨牀試驗。
集團預計2021年將完成產能擴建,產能將由目前的1.2萬升一次性生物反應器的生產設施增加至3.6萬升。
值得一提的是,於2021年3月11日,泰它西普(品牌名稱:泰愛®)用於治療SLE在中國獲得NMPA頒發的有條件上市許可,集團已於同月開始在中國就該產品進行銷售。
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