歐康維視生物-B(01477.HK)公佈年度業績:商業化產品營收大增183.1%,臨牀研發項目斬獲多項重要里程碑
格隆匯3月30日丨歐康維視生物-B(01477.HK)公佈,截至2022年12月31日止年度,集團收益由2021年度的人民幣5610萬元增至人民幣1.59億元;經調整虧損淨額人民幣1.81億元,較2021年度減少人民幣630萬元。研發開支為人民幣1.84億元,截至2022年12月31日,擁有銀行結餘及現金約人民幣13.14億元。
收益增加乃主要歸因於(i)核心產品優施瑩®商業化後,其銷售收入大幅增加;(ii)銷售其他眼科產品(包括歐沁®、埃美丁®及酒石酸溴莫尼定滴眼液)所得的收益增加,這主要是由於醫院營銷及推廣該等產品的進展順利;(iii)醫藥產品推廣服務所得的收益增加,尤其是集團向暉致提供的有關適利達®(拉坦前列素滴眼液)及適利加®(拉坦噻嗎滴眼液)的推廣服務所產生的收入增加;及(iv)有關埃美丁®及貝特舒®的以銷售為基礎的特許權使用費收入增加。
於報吿期內,公司產品管線已擴充至24個藥物資產,其中六種候選藥物已處於臨牀III期試驗階段,涵蓋所有主要的眼前及眼後段疾病。我們的候選藥物覆蓋葡萄膜炎、小兒近視、結膜炎、青光眼、wAMD及DME等諸多眼科用藥急需領域。我們在III期臨牀試驗的重大進展使我們在中國眼科創新藥領域佔據領先地位,是目前在CDE登記進行III期臨牀試驗的創新眼科藥物數量最多的企業之一。
於報吿期內,公司臨牀研發項目斬獲多項重要里程碑。在報吿期內及直至公吿日期,公司的核心產品OT-401(氟輕鬆玻璃體內植入劑,商品名稱:優施瑩®)的NDA已正式獲得NMPA批准,以真實世界研究數據及海外臨牀數據在中國獲批上市;公司首個自研產品康文涓®(OT-601,鹽酸莫西沙星滴眼液)在中國獲得了產品註冊證書;OT-1001(ZERVIATE®,0.24%西替利嗪滴眼液)的III期臨牀試驗,已達到其主要臨牀終點指標並取得了積極的結果;OT-101(0.01%硫酸阿托品滴眼液)已完成全球III期隨機、雙盲、安慰劑對照、平行組、多中心臨牀試驗在中國的患者入組;OT-502(地塞米松植入劑)的真實世界研究正穩步進行;及我們研發的治療乾眼症1類新藥OT-202(酪氨酸激酶抑制劑)成功完成I期臨牀試驗。
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