康方生物2024 年报

2024Annual Report年 報 23791112374496113119121123125127202 ACECMCGMPTetrabodyCMC1.2.3. 50711NMPA12III12I/II15first-in-classbest-in-classADC IGCS IND LI LLCKampfire LLC201964100% 20226282024630 97927 20246302024630 2024630 Cooley HK 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 202432552425III 20242022025PCSK9IL-12/IL-23 IO240 PD-L1sNDA8III320II 2024EGFR-TKInsq-NSCLCPD-L1NSCLCIIIHARMONi-2IIIsq-NSCLCIIIHARMONi-6PFS3III2PD-1NSCLC 2024SOCSUMMIT12III6PD-(L)120II IIICD47ADCAK138D1Trop-2/Nectin4ADCAK146D1IL-4R/ST2AK139mRNA 2025 1. 202412312,123.9202312314,526.353.08%20242,002.420231,603.524.88%20241231121.6SUMMITSUMMIT202463 2. 202412311,834.9202312314,393.058.23%2023SUMMITSUMMIT202412311,713.3202312311,470.216.53% 3. 20241231501.1202312311,942.4 2,123.92,002.41,603.524.88%®PD-1/CTLA-4®PD-1/VEGF20245 121.6SUMMIT ®PD-1/CTLA-4 2028 202411202511 G/GEJsNDA20249NMPA •III2024 AACR(Nature Medicine) •2024CSCO2024CSCOPD-L1 PD-L1sNDANMPA •III2024 IGCS(Lancet)(Nature Reviews Clinical Oncology) PD-(L)1PD-L1PD-L1 III IIIIII •PD-L1(NSCLC)III•NSCLCIII •AK109VEGFR-2PD-(L)1G/GEJIIIII2024 ASCO •III •(TACE)(uHCC)IIIII2024 ASCO GI PD-(L)1 ®PD-1/VEGF 182712III7 EGFR-TKINSCLC 20245NMPA®EGFR-TKIEGFRNSCLC202411202511®EGFR-TKINSCLC 20246IIIAK112-301/HARMONi-A2024 ASCO(JAMA)2024CSCOIV(2024) AK112-303/HARMONi-2(WCLC)sNDA PD-L1NSCLCIIIAK112-303/HARMONi-2202452024 WCLCIII20253(Lancet) 20254NMPA 67III III •NSCLCIIIAK112-306PFS •PD-(L)1NSCLCIII •IIIII2024 ASCO •AK117CD47PD-L1IIIII2024 ESMO •PD-L1IIIII2024 ESMO •IIIII2024 ESMO •III (IO) IIIIO+ADC 2.0 SUMMIT3III •EGFR-TKIEGFRNSCLCIII(HARMONi)•NSCLCIIIHARMONi-3•PD-L1TPS≥ 50%NSCLCIIIHARMONi-7 •20246SUMMITSUMMIT •20247SUMMITM.D. Anderson5 •20252SUMMITPFE(ADCs)IO+ADC2025 AK117CD47 CD47III •AK117PD-L1IIICD47IIIII2024ESMO •AK117II2024 ASCO •AK117II2024 ESMO II •AK117(MDS)II •AK117(AML)II •AK117AK129PD-1/LAG-3PD-(L)1(cHL)I/II AK109VEGFR-2 IOIII •PD-(L)1G/GEJIIIII2024 ASCO ®PD-1 •20244NMPA®(NPC)•20253NPMA®NPC•20254FDA2 sNDA •202411®sNDANMPA® ®PD-L1 •202412®NPC•20251®NPCsNDANMPA ®PCSK9 20249NMPA®PCSK9(HeFH) ®IL-12/IL-23 20254NMPA®IL-12/IL-23III2024 EADV AK111IL-17 NDA NDA20251NMPAIII III III •AK135IL-1RAP(CIPN)ICIPN•AK137CD73/LAG-3IAK137•AK138D1(HER3 ADC)ADCIAK138D1IO+ADC 2.0•AK146D1Trop2/Nectin4ADCADCIND20253CDE •AK139IL-4R/ST2IND20252CDEAK139 502415first-in-classbest-in-classADC ®PD-1/CTLA-4®PD-1/VEGF®PD-1AK117CD47AK119CD73AK109VEGFR-2AK115(NGF)AK127(TIGIT)AK129 PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132CLDN18.2/CD47AK135IL-1RAPAK137 CD73/LAG-3AK138D1(HER3 ADC)AK146D1Trop2/Nectin4ADC ®PCSK920249®IL-12/IL-2320254AK111IL-17NDAAK120IL-4RAK139IL-4R/ST2 18A.08(3)®PD-1/CTLA-4®PD-1/VEGF®PD-1®PCSK9®IL-12/IL-23AK117CD47AK109VEGFR-2AK119CD73AK115(NGF)AK127 (TIGIT)AK129 PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132CLDN18.2/CD47AK135 IL-1RAPAK137CD73/LAG-3AK138D1(HER3 ADC)AK146D1 Trop2/Nectin4ADCAK111IL-17AK120IL-4RAK139IL-4R/ST2 202412 313,035 94,000GMPFDAEMANMPAGMP 100,0002025355,00040,00015,000 36,000 3,000 2025®PD-1/CTLA-4®PD-1/VEGF 2.0 2025 (IO)ADC •2028 •1827SUMMIT •AK117CD47IIIIIII•AK109VEGFR2IOIIIII ADC AK129PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132 CLDN18.2/CD47AK135IL-1RAPAK137CD73/LAG-3III ADCAK138D1(HER3 ADC)IAK146D1Trop2/Nectin4ADCINDADC AK101IL-12/IL-23AK111IL-17NDAAK120IL-4RIIIAK139IL-4R/ST2IND 1. 202412312,002.4202312311,603.524.88%20245®PD–1/VEGF 2. 20241231121.6202312312,922.82023SUMMITivonescimabAK112PD–1/VEGF2024SUMMIT 3. 20241231289.020231231133.2116.92%®PD–1/CTLA–4®PD–1/VEGF 4. 202412311,834.9202312314,393.058.23%202412 311,713.3202312311,470.216.53% 5. 20241231366.020231231454.219.42% 6. 202412311,187.7202312311,254.05.29% NDAPD–1/VEGF20245PD–1/CTLA–4AK10420249PCSK9AK10220249INDAK135IL–1RAPAK137CD73/LAG–3AK138D1(HER3 ADC) (i)(ii)(iii)(iv) 7. 202412311,001.820231231890.412.51% 8. 20241231203.620231231200.11.77% 9. 2024123168.32023123187.021.53% 10. 20241231501.1202312311,942.4 11. 2024 202412318,691.67,343.91,347.7 202312314,894.42,449.4202412317,343.9 202412311,686.6425.2715.1535.5 20241231535.53,406.1LPR1.2%4.35% 12. 202412311,455.2 13. (1)(2)100% 14. 20241231 15. 202428267.435%202429202434 20241231 16. 20241231 17. 20241231734.020231231770.0 18. 20241231 20241231 19. 202412313,035202312312,778 20241231950.120231231847.1 2019829D.— 1.2024630202465202466 20211262021202112720212024630202465202466 20226282022612024630202465202466 (a)2022 202271524,000,000202278202224.27202220222.85% 24.27(i)202226.107.0%(ii)2022202225.675.5% 24.032022576.65 202412312022 20222022782022715202412312022202278202412312022 (b)20243 20243 2824824,800,00020243 212024347.6520243202432.86% 47.65(i)2024350.706.02%(ii)202432