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花旗:君實生物-B(01877.HK)核心產品特瑞普利單抗步入正軌,維持“買入”評級,目標價HK$ 40
格隆匯 04-06 11:18

格隆匯財經APP獲悉,花旗發佈報告稱,君實生物科技公佈其2019財政年度的收入達人民幣7.75億元,淨虧損人民幣7.41億元,均好於市場預期。核心產品特瑞普利單抗發展勢頭迅猛,生產和銷售能力不斷升級。預計特瑞普利單抗2020年/2021年的銷售額分別為人民幣13億元/22億元。同時,公司打造具有成本效益的研發平台,迎接挑戰,不斷創新。最近,君實還宣佈了另一個令人振奮的消息,公司與微生物研究所建立合作,共同開發COVID19(新冠肺炎)中和抗體。花旗調整了2021年,2022年和2023年的收入和研發成本預測模型,以反映特瑞普利單抗和管線藥物的最新狀態。維持“買入”評級。新目標價HK$ 40。

據瞭解,2019財政年度的公司核心產品特瑞普利單抗的商業化銷售費用為人民幣3.2億元(佔收入的41.3%)。研發費用為人民幣9.46億元,用於關鍵臨牀試驗,聯合研發,以及獲得許可的小分子藥物和抗體藥物偶聯物(ADC)項目的不斷拓展。其中,特瑞普利單抗(PD-1)實現10個月收入人民幣7.75億元,毛利率88.3%(19年上半年為86.9%)。正在進行中的14項特瑞普利單抗關鍵註冊臨牀試驗,包括:尿路上皮癌(UC),鼻咽癌(NPC),一線黑色素瘤(1L melanoma)和非小細胞肺癌(NSCLC)。特瑞普利單抗也在美國進行1b期臨牀試驗。

2020年3月,特瑞普利單抗聯合阿昔替尼用於粘膜黑色素瘤被美國FDA授予孤兒藥稱號。特瑞普利單抗是《孤兒藥法案》頒佈以來,第一個在黏膜黑色素瘤領域被授予“孤兒藥”認定的品種。上海臨港基地(產能30,000升)於2021年上半年投入PD-1商業化使用後,君實的PD-1總產能將提升至33,000升。管理層預測,由於生產效率的提升,利潤空間也將進一步擴大。銷售團隊從2019年底的380人擴大到500人。

與此同時,君實在管線開發計劃、臨牀試驗計劃、以及藥物許可方面,也取得了多項突破。2019年11月,NMPA接收了NDA提交的阿達木單抗注射液(修美樂生物類似藥)。JS002(PCSK9)處於二期臨牀試驗。人類首創的TAB004/JS004(BTLA),目前正在美國和中國進行第一階段試驗。其他的臨牀試驗階段產品包括JS501(安維汀生物類似藥),JS003(PD-L1)和JS101(泛CDK抑制劑)。JS005(IL-17A)一期臨牀試驗則有望在2020年上半年完成第一例患者入組。同時,君實積極探索與全球合作伙伴進行前沿研發的合作/許可機會,以實現最佳成本效益。公司將進一步將管線領域擴展到CDK抑制劑,PI3K抑制劑,Trop 2 ADC和IL-21融合蛋白。

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