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君實生物(688180.SH):上半年實現營收約9.46億元、特瑞普利單抗國內銷售收入約2.98億元

格隆匯8月30日丨君實生物(688180.SH)公佈2022年半年度報吿,報吿期內,公司實現營業收入約9.46億元。雖然生產經營受到上海等地疫情的一定程度影響,但公司積極應對複雜形勢,堅持各項業務有條不紊的推進。報吿期內,公司研發投入約10.62億元,7項創新藥物的臨牀試驗申請獲得NMPA或FDA批准。

報吿期內,公司在產品商業化、臨牀試驗、管線擴張方面取得了諸多重要進展,現金流情況良好,公司核心管理層及研發團隊穩定,吸引了大量優秀人才加入。隨着更多在研產品逐步實現商業化,特瑞普利單抗注射液更多適應症獲批並納入國家醫保目錄,公司的持續經營能力將不斷提升。

隨着產品管線的不斷豐富和對藥物聯合治療的進一步探索,公司的創新領域已持續擴展至包括小分子藥物、多肽類藥物、抗體藥物偶聯物、雙特異性或多特異性抗體藥物、核酸類藥物等更多類型的藥物研發,以及針對癌症、自身免疫性疾病等的下一代創新療法的探索。報吿期內,公司在公司業務運營及在研產品開發方面取得了諸多的重大進展。

截至報吿期末,公司商業化團隊超過1100人,2022年上半年國內市場實現特瑞普利單抗銷售收入約2.98億元。其中,特瑞普利單抗2022年一季度銷售收入較2021年四季度環比提升約212%。雖然在4至5月受到了上海、吉林等地區疫情影響,2022年第二季度銷售收入仍然環比一季度提升約70%。特瑞普利單抗在國內的銷售情況已逐步恢復並開始進入正向循環,公司對特瑞普利單抗未來的商業化工作充滿信心。

截至報吿披露日,公司自主研發的重組人源化抗PCSK9單克隆抗體昂戈瑞西單抗(JS002)正在更廣泛的患者人羣(包括非家族性及雜合子型家族性高膽固醇血癥)中開展III期臨牀研究進一步驗證療效和安全性。此外,公司還在純合子型家族性高膽固醇血癥(罕見病)患者中開展了一項II期臨牀研究,該研究將為PCSK9單抗在中國純合子型家族性高膽固醇血癥患者人羣中的臨牀應用提供寶貴的臨牀研究數據。公司與英派藥業合作開發的PARP抑制劑senaparib(JS109)作為一線維持治療鉑類藥物敏感性晚期卵巢癌患者的III期臨牀研究已完成患者入組,正在等待臨牀數據評估;VEGF抑制劑貝伐珠單抗(JS501)的III期臨牀研究正在進行中。

在產能擴充方面,公司上海臨港生產基地於2022年5月獲得NMPA批准,可與蘇州吳江生產基地同時負責生產商業化批次的拓益®。上海臨港生產基地按照CGMP標準建設,其中一期項目產能30,000升。由於規模效應,上海臨港生產基地帶來的產能擴充將使公司獲得更具競爭力的生產成本,並支持更多臨牀試驗加速推出新藥物。配合目前在研產品管線的研發進度,公司計劃進一步提升生產設施,以提供可與公司日益增長及漸趨成熟的在研藥物相匹配的充足產能,支持公司的業務在未來的持續擴張。

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