康方生物2025 中期报告

Akeso, Inc. (Incorporated in the Cayman Islands with limited liability)Stock Code: 9926 2025INTERIM REPORT 目 錄 頁次 2 3 6 8 9 27 66 67 69 71 73 75 ACECMCGMPTetrabodyCMC1.2.3. 507®PD-1/CTLA-4®PD-1/VEGF®PD-1®PCSK9®IL-12/IL-232157.HK™PD-1®PD-L11NMPA12III12I/II15first-in-classbest-in-classADC 5710.0000120226282024630sNDASUMMITSummit Therapeutics Inc.NASDAQ: SMMTTetrabody(tetravalent antibody)WANG LLCBlazing Rosewood LLC201964100%Mahogany Living Trust2019619XIA LLCGolden Oaks LLC201964100%Gemstone Living Trust2019611% 執行董事 97927 非執行董事 Cooley HK 獨立非執行董事 TAN Bo Campbells TAN Bo Floor 4, Willow HouseCricket SquareGrand Cayman KY1–9010Cayman Islands 6528437 33191901 Campbells Corporate Services LimitedFloor 4, Willow HouseCricket SquareGrand Cayman KY1-9010Cayman Islands 183171712–1716 9926 www.akesobio.com 2020424 1.收入 20256301,411.520246301,024.737.75%20256301,401.62024630939.449.20%20256309.9 2.毛利 20256301,120.72024630943.218.82%20256301,110.82024630857.9 3.盈利╱虧損 2025630588.32024630249.3 1)Summit TherapeuticsNASDAQ: SMMTSummit TherapeuticsNASDAQ:SMMT2025630191.7202463032.6159.1 2)2025630731.22024630594.4136.8 3)202563027.220246305.321.9 1,411.51,401.6939.449.20%®PD-1/CTLA-4®PD-1/VEGF2®PCSK9®IL-12/IL-23 1,200 9.9 開坦尼®（卡度尼利，PD-1/CTLA-4） 202810III20 3國家醫保藥品目錄 一線宮頸癌獲批，全面重塑宮頸癌治療格局 PD-L120255NMPA32025IIII(COMPASSION-16)2025 ASCO 一線、IO耐藥、圍手術期胃癌全布局，納入多項權威指南推薦 (G/GEJ)2PD-(L)1PD-L12025CSCOPD-L1IIAIII(COMPASSION-15)(Nature Medicine) (AK109, VEGFR2)IOG/GEJIII(COMPLUS-5)2025 CSCO G/GEJIII(COMPASSION-33) 肺癌2項III期臨床進展積極，IO耐藥鱗狀NSCLC的II期數據即將發表 PD-1PD-L1NSCLCIII(COMPASSION-28)PD-L1NSCLCIII(COMPASSION-30)III AK109 (VEGFR-2)PD-(L)1NSCLCII 肝癌國際多中心註冊性II期臨床已啓動，全球價值持續彰顯 PD-(L)1II(COMPASSION-36) III(COMPASSION-22)(TACE)(uHCC)III(COMPASSION-29) 依達方®（依沃西，PD-1/VEGF） 303013III6PD-(L)14III2EGFR-TKIEGFRNSCLC8 實現肺癌核心適應症全覆蓋，完成多線治療布局 EGFR-TKIEGFRNSCLC20245202520258OSOSOS2025CSCOI4 20254PD-L1NSCLCsNDANMPA2025CSCO 20254sq-NSCLCIII(AK112-306/HARMONi-6)PFS20257NMPAsNDA3+ PD-(L)NSCLCIII(AK112-305/HARMONi-8A)IONSCLCIONSCLCIII (SCLC)III(AK112-311)SCLCIII 拓展「冷腫瘤」市場，5個一線腫瘤適應症III期進行中 •III(AK112-312)•AK117(CD47)III(AK112-310)•III(AK112-309)•(AK117, CD47)PD-L1III(AK117-302)•PD-L1III(AK112-308) 首個國際多中心III期臨床頂線數據讀出，全球一致數據再次驗證依沃西優異的產品力 SUMMIT20255EGFR-TKIEGFRNSCLCIII(HARMONi)PFSOSIII(HARMONi)(HARMONi-A) III •NSCLCIII(HARMONi-3/AK112-3003)•PD-L1(TPS ≥ 50%) NSCLCIII(HARMONi-7/AK112-3007) 強強聯合，依沃西全球合作持續拓展 20255SUMMITRevolution MedicinesRAS(ON) 萊法利(AK117, CD47) 實體瘤兩項III期註冊性臨床入組中 •AK117PD-L1(HNSCC)III(AK117-302) •AK117(PDAC)III(AK112-310) 血液瘤兩項II期臨床完成入組 •AK117(MDS)II •AK117(AML)II •AK117AK129 (PD-1/LAG-3)PD-(L)1(cHL)I/II 安尼可®（派安普利，PD-1） 國內第4項適應症獲批上市 20253NPMA®(NPC) 獲FDA批准上市，本公司全流程體系獲最高標準權威認證 20254FDA®NPC2FDAFDA ®PCSK9®IL-12/IL-232 愛達羅®（依若奇單抗，IL-12/IL-23） 20254NMPA® 古莫奇單抗(AK111, IL-17) NDA已獲NMPA受理 20251NMPA III 曼多奇單抗(AK120，IL-4Rα) 20258(AD)III 腫瘤線新晉臨床階段藥物，IO 2.0+ADC戰略升級 •AK135 (IL-1RAP)(CIPN)ICIPN•AK137 (CD73/LAG-3)IAK137•AK138D1 (HER3 ADC)ADCIAK138D1IO 2.0+ADC•AK146D1 (Trop2/Nectin4 ADC)ADC20257AK146D1FDATGANMPA 自免等領域新晉臨床階段藥物 •AK139 (IL-4R/ST2)I20254AK139 產品管線臨床開發總覽 2025630502415first-in-classbest-in-classADC ®PD-1/CTLA-4®PD-1/VEGF®PD-1(AK117, CD47)(AK119,CD73)(AK109, VEGFR-2)AK115(NGF)AK127(TIGIT)AK129(PD-1/LAG-3)AK130(TIGIT/TGF-)AK131(PD-1/CD73)AK132(CLDN18.2/CD47)AK135 (IL-1RAP)AK137(CD73/LAG-3)AK138D1(HER3ADC)AK146D1 (Trop2/Nectin4 ADC) ®PCSK920249®IL-12/IL-2320254(AK111, IL-17)NDA(AK120, IL-4R)AK139 (IL-4R/ST2) 上市規則第18A.08(3)條規定的警示聲明：®PD-1/CTLA-4®PD-1/VEGF®PD-1®PCSK9®IL-12/IL-23(AK117, CD47)(AK109, VEGFR-2)(AK119, CD73)AK115(NGF)AK127(TIGIT)AK129 (PD-1/LAG-3)AK130 (TIGIT/TGF-)AK131 (PD-1/CD73)AK132 (CLDN18.2/CD47)AK135 (IL-1RAP)AK137 (CD73/LAG-3)AK138D1(HER3 ADC)AK146D1(Trop2/Nectin4 ADC)(AK111, IL-17)(AK120, IL-4R)AK139(IL-4R/ST2)AK150 (ILT2/ILT4/CSF1R) 20256303,529 94,000GMPFDAEMANMPAGMP 100,00055,00040,00015,000 36,000 3,000 2.0(IO 2.0) 商業化體系賦能，多元化產品釋放價值 創新升級迭代，引領全球腫瘤免疫2.0 •II •PD-1— PD-1/VEGF(HARMONi)(HARMONi-A)•II•FDA IO 2.0+ADC 2.0戰略升級 ADCAK146D1 (Trop2/Nectin4 ADC)IAK138D1 (HER3 ADC)IADC2.0ADC 全球首創、早期分子高效推進，創新平台成果轉化初顯 AK129 (PD-1/LAG-3)AK130(TIGIT/TGF-)AK131(PD-1/CD73)AK132 (CLDN18.2/CD47)AK135(IL-1RAP)AK137 (CD73/LAG-3)III (AK111, IL-17)NDA(AK120, IL-4R)IIIAK139(IL-4R/ST2)I ADCADC 2.0AK138D1(HER3 ADC)AK146D1 (Trop2/Nectin4 ADC)IADCIND mRNAsiRNA 1.商業銷售收入 20256301,401.62024630939.449.20%®PD–1/CTLA–4®PD–1/VEGF20251 2.商業授權收入 20256309.9202463085.32024SUMMITivonescimab (AK112PD–1/VEGF) 3.銷售成本 20256 30290.920246 3081.6256.57%®PD–1/CTLA–4®PD–1/VEGF®IL–12/IL–23 4.毛利 20256301,120.72024630943.218.82%20256301,110.82024630857.929.48% 5.其他收入及收益淨額 2025630156.82024630211.825.95% 6.研發開支 2025630731.252.17%11.10%2024630594.463.27% (NDA)(AK112)PD-L1NSCLCNMPA(sq-NSCLC)(HARMONi–6)PFS3III13(AK104)510III(AK117)22II(AK109)III(AK105)FDA4(AK101)(AK111) NDAADCAK146D1IADCAK138D1IIL–4R/ST2AK139I (i)(ii)(iii)(iv) 7.銷售及營銷開支 2025630669.947.80%7.13%