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綠葉製藥(02186.HK):利斯的明透皮貼國內獲批,神經用藥管線持續壯大,維持“審慎增持”評級,目標價5.00 港元
格隆匯 06-15 14:22

機構:興業證券

評級:審慎增持

目標價:5.00 港元

投資要點

事件:近日,公司利斯的明透皮貼(金斯明)獲NMPA批准上市。

阿爾茨海默症患者眾多且數量快速增長,用藥市場龐大:利斯的明(卡巴拉汀)主要用於輕、中度阿爾茨海默症的治療。2019年全球痴呆患者人數高達5000萬,預計2050年將增長至1.52億。我國老齡化程度的提升也直接導致了阿爾茨海默症患者人數的快速增加,治療需求強烈。截至目前,美國FDA僅批准了5款藥物:他克林(後因肝毒性過大退市)、多奈哌齊、利斯的明、加蘭他敏以及美金剛,2003年以後一直沒有批准新藥(不含老藥組合療法)面世。目前國內阿爾茨海默症治療藥物以多奈哌齊和美金剛為主,二者合計市場份額在95%左右,利斯的明的市場份額約5%。

透皮貼依從性更好,金斯明和LY30410有望取得部分市場:利斯的明藥物主要有口服劑和透皮貼劑兩種。此前由21個國家100個研究中心參與的IDEAL臨牀研究顯示,10cm2的利斯的明透皮貼與12mg的膠囊基本等效,但與口服劑相比,透皮貼劑避免了口服劑帶來的腸胃不適以及部分患者吞嚥困難的問題,同時提供平穩持續的藥物釋放,降低了血藥濃度波動帶來的副作用,患者使用依從性更好。公司開發的利斯的明透皮貼(金斯明)已於美國、歐洲17國等多個國家上市,本次獲NMPA批准後亦成為國內首個以一致性評價審評要求上市的透皮貼劑產品,有望在龐大的阿爾茨海默症用藥市場上取得一定的份額。此外,公司的創新藥物利斯的明多日透皮貼(LY30410)在歐洲的上市申請也已獲歐盟主管部門受理,該產品每週給藥兩次,有望進一步提高患者的依從性,上市後將增強公司在神經系統治療藥物領域的市場競爭力。

盈利預測與估值:公司產品研發進度符合預期,我們維持之前的盈利預測,預計2020-2022年實現收入70.48、81.49、95.68億元,同比增長10.9%、15.6%和17.4%;股東淨利潤16.24、18.36、20.71億元,同比增長10.6%、13.0%和12.8%。維持目標價5.0港元,對應2020-2022年分別為9.47、8.38和7.43倍市盈率,20PEG為0.80,維持“審慎增持”評級。

風險提示:全球疫情影響超預期,新產品研發和銷售不及預期,市場競爭加劇。

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