康方生物-B(09926.HK)：研發順利推進，產品落地在即
機構：興業證券
投資要點
現金充裕，支持研發持續投入：2020 年上半年研發支出同比上升 95.4%至 2.4 億元。截至 2020 年 6 月 30 日，公司的現金及現金等價物由去年年末的 11.86 億元增加 23.01 億元至 34.87 億元，新增資金主要來源於 IPO所得款項，為公司後續研發項目的推進提供了保障。
領跑雙抗新藥賽道，打造下一代 IO 治療基石藥物：公司核心產品 AK104（PD-1/CTLA-4 雙抗）研發進度全球領先，若進展順利，有望於 2021年下半年申報上市。臨牀試驗數據已顯示出其與 PD-1 及 CTLA-4 單抗聯合療法可比的臨牀療效，以及更優的安全性（非頭對頭）。基於腫瘤免疫治療的廣譜抗癌效果，針對 AK104，公司目前已經開展了多個適應症的臨牀研究，包括宮頸癌、鼻咽癌、胃癌、肝癌等，市場潛力巨大。在生產方面，公司利用專有的 Tetrabody 技術有效解決了雙抗開發和生產中的多項 CMC 難題，提升產品的產量和質量。
PD-1 差異化開發，聯合正大天晴助力商業化：AK105 已於 2020 年 5 月 向 NMPA 遞交三線治療複發性或難治性經典型霍奇金淋巴瘤的上市申請。儘管 AK105 在上市速度上沒有明顯優勢，但其較常規 PD-1 單抗完全去除了抗體的 Fc 區段，有效避免了因 PD-1 單抗與 Fc 受體結合而導致的 T 細胞抗腫瘤活性降低，上市後有望憑藉產品的差異化取得一定的市場份額。此外，公司與中國生物製藥附屬公司正大天晴合作，共同對AK105 進行開發及商業化。AK105 上市後亦有望藉助中國生物製藥強大的銷售能力充分挖掘商業潛力，為公司帶來收益。
積極尋求戰略合作、儲備人才與擴大產能，為多元化管線保駕護航：公 司多元化的創新藥物管線覆蓋腫瘤、自身免疫性疾病等重要疾病領域。通過戰略合作、人才儲備、擴大產能，可以適應和滿足公司處於不同發展階段的需求，為多元化的管線保駕護航。
我們的觀點：我們預計未來 1-3 年公司將有產品陸續上市。憑藉公司技術平台的優勢、戰略合作方面的強強聯合、自身人才及產能的儲備，疊加產品差異化的開發策略，產品上市後有望較快打開市場，帶動業績增長，建議積極關注。
風險提示：研發進度不及預期，市場競爭加劇，政策風險，疫情影響超預期。
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