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榮昌生物-B(09995.HK)公佈中期業績 研發開支大增73.5% 希望年底完成產能擴充
格隆匯 08-23 21:23

格隆匯8月23日丨榮昌生物-B(09995.HK)發佈公吿,截至2021年6月30日止六個月,公司收益增加至人民幣2920萬元,毛利為人民幣2460萬元,研發開支增加約73.5%至約人民幣3.27億元。截至2021年6月30日止,銀行結餘及現金為約人民幣16.36億元。

收益增加乃主要由於於中國進行注射用泰它西普的商業化期間產品銷售收入錄得的人民幣2920萬元。公司預計未來幾年的收益將主要來自銷售注射用泰它西普、注射用維迪西妥單抗。

於本公吿日期,公司於推進我們的產品管線及業務運營方面取得重大進展:泰它西普(商品名稱:泰愛)用於治療SLE於2021年3月在中國獲得NMPA頒發的有條件上市許可,並進入商業化上市銷售。Disitamabvedotin(商品名稱:愛地希)用於治療HER2表達局部晚期或轉移性胃癌(GC)於2021年6月在中國獲得NMPA頒發的有條件上市許可,並於同年7月進入商業化上市銷售。截至2021年6月30日,公司成功組建完成基於上述產品的兩隻獨立銷售團隊。其中自身免疫領域銷售人員130人,腫瘤領域到崗銷售人員160人。

此外,NMPA於2021年6月授予disitamab vedotin突破性藥物認證,用於治療既往接受過曲妥珠單抗和紫杉類藥物治療的HER2陽性存在肝轉移的晚期乳腺癌患者,目前公司正在中國開展相關III期臨牀試驗。

於2021年上半年,隨着公司兩款產品在中國的成功上市,公司已成功轉型為全面整合的生物製藥公司。公司將繼續在中國擴大公司的銷售團隊並增加銷售力度,已推廣泰它西普及維迪西妥單抗。憑藉公司對中國環境的認知以及銷售團隊人員的豐富經驗,公司將制定穩定的市場準入策略,以滿足市場需求。

此外,公司將加快這兩種產品在中國及美國的臨牀試驗進度以擴大適應症範圍。針對國際市場,公司將採取措施,加大拓展力度。公司希望今年下半年在美國開展泰它西普治療SLE的三期臨牀試驗以及治療IgA腎病的二期臨牀試驗。同時,公司計劃與公司的合作伙伴Seagen共同在美國開展維迪西妥單抗二線治療HER2過表達尿路上皮癌的二期臨牀試驗。此外,公司希望今年年底完成產能擴充,屆時生產能力將從現有的12,000升容量的一次性袋裝生物反應器提升至36,000升。

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