中國生物製藥(01177.HK)：派安普利上市獲藥監局受理，業績可期，維持“增持”評級
機構：國泰君安
評級：增持
本報告導讀：
公司公告抗 PD-1 單抗派安普利上市申請獲藥監局受理，申報適應症為復發或難治性經典型霍奇金淋巴瘤，公司產品線不斷創新升級，維持增持評級。
摘要：
維持“增持”評級。公司2020 年5月26日發佈公告，其與康方生物共同開發及商業化的抗PD-1單抗藥物安尼可(通用名：派安普利，研發代號： AK105)的新藥上市申請，已獲中國國家藥品監督管理局受理，用於治療復發或難治性經典型霍奇金淋巴瘤患者。我們維持公司2020-2022年EPS預測值0.27/0.33/0.38元，考慮到公司大品種研發成果不斷落地，產品線不斷創新升級，上調目標價至13.80 港元（原為 12.13港元），維持增持評級。
派安普利可能是第5個上市的國產 PD-1抑制劑，有望藉助公司強大銷售網絡快速放量。截止2020年5月，我國PD-(L)1產品已體現出進口和國產4+4的局面，從上市申報適應症來看，派安普利延續了國產 PD-1用小適應症快速獲批上市的策略。國產和進口PD-1由於定價不同，搶佔的是不同消費層級的患者，派安普利未來的上市，更多對現有的國產PD-1產品有衝擊。我們預計卡瑞利珠單抗在 2019年上市5個月銷量突破10億，（對比信達和君實的 PD-1產品已在 2018年底獲批，而2019年全年銷售額分別為 10.2億、 7.8億），可以看出， PD-1的推廣與企業醫院終端覆蓋面、銷售體系等商業化綜合能力休慼相關。未來派安普利上市，有望憑藉公司 3000多人的腫瘤銷售網絡快速放量。
商業化策略逐漸清晰：以小適應症快速上市，大適應症的臨牀加快跟進。截止 2020 年 5 月 16 日，派安普利共有 13 項臨牀正在進行，其中 9項試驗同時在中美進行了申報。目前已經進入三期階段的有肺癌一線、胃癌二線和晚期肝細胞癌 3項患者基數較大的適應症，其中胃癌和肝癌的用藥方式皆為派安普利與安羅替尼聯用，“強強組合銷售+大適應症策略”的發展態勢已初見端倪。
催化劑：新產品及新適應症的研發進展，光腳品種的放量。
風險提示：帶量採購的風險；新藥研發的不確定性風險。
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