康方生物-B(09926.HK):單抗及雙抗共舞,腫瘤與免疫齊飛,給予“買入”評級,目標價36港元
機構:國金證券
評級:買入
目標價:36港元
基本結論
國際領先的創新型生物醫藥公司。2012年在中國中山成立,主要從事生物製藥產品研發、技術轉讓及諮詢服務。已組建了具有國際先進水平的高端生物藥開發、產業化人才團隊,包括多位海歸專家;通過自身先進的ACE平台持續快速地創新生產高質量候選藥物,研發管線覆蓋抗腫瘤、自身免疫疾病等多個領域,擁有在研項目20多項,其中處於臨牀研究階段產品11項。
在研管線涵蓋腫瘤、免疫領域多款未來重磅品種。抗腫瘤領域,PD-1/CTLA-4 雙抗 AK104 同時針對 PD-1 與CTLA-4 雙靶點,目前處於臨牀2期試驗階段。全球範圍內尚無同靶點產品上市,AK104 已展示出其安全性和有效性優勢,已被納入突破性治療藥物品種。PD-1 產品派安普利單抗cHL適應症已遞交NDA,預計2021年獲批上市,上市後銷售由正大天晴負責,未來有望與天晴抗腫瘤管線更多產品聯用。CTLA-4 單抗為公司獨立研發產品,目前已授權給默克,海外處於臨牀2期,公司成為中國首家向全球領先製藥公司授權完全自主研發的單克隆抗體的公司。自身免疫疾病領域,公司研發管線全面佈局二代靶點IL-12/IL-23,IL-17。同靶點現有上市產品均為進口產品,治療費用高,公司產品有望一梯隊上市,為自身免疫疾病患者提供更多的選擇方案。
先進的雙抗平台,迅速推動未來雙抗領域發展。單抗看靶點,雙抗看平台。與單抗相比,雙抗在研發、生產、臨牀等各方面技術壁壘更高。公司擁有依靠Tetrabody技術的ACE一體化平台,基於該平台研發的AK104雙抗、AK112雙抗已處於臨牀試驗階段,未來有望研發更多雙抗品種。
盈利預測與估值:
根據公司在研管線核心品種的拆分與估值,我們預計公司合理估值為238億元。派安普利單抗預計2021年獲批上市,預計2020-2022年公司收入額約0.1/4.1/9.8億元,首次覆蓋,給予“買入”評級,目標價為36.0港元。
風險提示:
研發項目進展不確定性;核心品種上市後生產、銷售不確定性;初創型創新藥公司管理層、研發和銷售核心人員可能存在變動;醫保談判不確定性。
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