康方生物2023 年报

ANNUAL REPORT2023 236810113541769399101103105107180 ACECMCGMPTetrabodyCMC501931426first-in-classbest-in-class EADV 2019829 2020414 SITC TACE % 97927 Davis Polk & Wardwell TAN Bo Campbells TAN Bo Floor 4, Willow HouseCricket SquareGrand Cayman KY1–9010Cayman Islands 6528437 202353 6|2023 33191901 Campbells Corporate Services LimitedFloor 4, Willow HouseCricket SquareGrand Cayman KY1–9010Cayman Islands 183171712–1716 9926 www.akesobio.com 2020424 2023 Biopharma202338PD-1/VEGF®PD-1/CTLA-447NDA/sNDA®202313.61819 PD-1/VEGF®12III®®PD-1IL–12/IL–23(PCSK9)IL-17biopharma 2024+®20241III®PD-L12024AACR4FIC/BIC6804PD-1III2 (ADC)mRNA 11 1. 202312314,526.320221231837.7440%202312311631.1®PD-1/CTLA-41,357.820221231546.3149%202312312,922.8Summit Therapeutics IncSMMTSUMMITAK112, PD-1/VEGF2023 2. 202312 314,393.0202212 31743.5491% 3. 202312311,942.4202212311,422.2 4,526.3837.7440%202312311631.1®PD–1/CTLA–41,357.820221231546.3149%202312312,922.8Summit Therapeutics IncSMMTSUMMITAK112,PD-1/VEGF1,942.4202212311,422.2 33(NDA)(NMPA) ®PD-1/CTLA-4 ®PD-1/CTLA-4202312311,357.820221231546.3149%®20® 2III202311G/GEJIII(OS)PD-L120241(sNDA)202311III(PFS)20244(sNDA) 1620 AK112PD-1/VEGF AK112PD-1/VEGFEGFR-TKIEGFRNSCLCIII202320238NMPAPD-L1NSCLCIIINSCLCIII SUMMIT20235SummitEGFR-TKIEGFRNSCLCIIIHARMONi(NCT05184712)202311SUMMITNSCLCIIIHARMONi-3(NCT05899608) ®PD-1 20231NMPA®NSCLCsNDA202312®(NPC)sNDA2023®® Specialised Therapeutics Asia Pte LtdST20234®11 AK102PCSK9AK101IL-12/IL-23 20236AK102PCSK9NDA(i)(ii)(HeFH)20238AK101IL-12/IL-23NDA 202312315019346first-in-classbest-in-class ®PD-1/CTLA-4NDAAK112PD-1/VEGF®PD-1AK117CD47AK119CD73AK109VEGFR-2AK127(TIGIT)AK115(NGF)AK129 PD-1/LAG-3AK130TIGIT/TGF-β2023AK131PD-1/CD73AK132 Claudin18.2/CD47 AK102PCSK9NDA20236AK101IL-12/IL-23NDA20238AK111IL-17AK120IL-4Rα ADCmRNA •®PD-1/CTLA-4 1. —3G/GEJIII—302607.HK601607.SHSPH4336CDK4/6(WDLS)(DDLS)—4AK117G/GEJIINMPA—5IINMPA—7AK127Ia/Ib—7PD-L1NSCLCIIINMPA—909995.HK688331.SH(HER2 ADC)II—11G/GEJIII(AK104-302)(OS)—11III(AK104-303)(PFS) 2. —3mAbs—4®2023—6G/GEJIb/II2023 ASCO—6AK117G/GEJ2023 ASCO—6®2023—8®7(2023)—10Ib/II·—10I—10Ib/II2023(ESMO)—11Ib/II—12®(NCCN)2023.V1—12®2023 3. —20241G/GEJ(sNDA)NMPA—20241(TACE)(uHCC)II2024(ASCO GI)—20241PD-L12023—20242PD-L1NSCLCIII •AK112PD-1/VEGF 1. —3LM-302Claudin18.2 ADC—4AK127INMPA—5SUMMITIIIHARMONiEGFR-TKIEGFRNSCLC—5NSCLCIII—8PD-L1NSCLCIII—8NSCLCIII—11SUMMITIIIHARMONi-3NSCLC 2. —6EGFR/ALKNSCLCII2023 ASCO—8IINatureeclinicalmedicine—10NSCLCIb—11(AACR)(NCI)(EORTC)2023 EORTC-NCI-AACR2023(SITC) 3. —20241AK130TIGIT/TGF-βAK127(TIGIT)Ib/IINMPA •AK117CD47 1. —4AK117G/GEJIICDE—9AK117(MDS)IIFDA 2. —6AK117G/GEJ2023 ASCO—12AK117(MDS)Ib2023(ASH)—12AK117(AML)Ib2023ASH 3.—20241AK117(AML)IINMPA •AK109VEGFR2 1.—3AK109 IESMO Open •AK115 (NGF) 1.—3AK115I •AK127 (TIGIT) 1.—4AK127INMPA2.—7AK127Ia/Ib •AK129PD-1/LAG3 1.—3AK129I •AK130TIGIT/TGF-β 1.—2AK130I •AK131PD-1/CD73 1.—9AK131INMPA2.—20241AK131I •AK132Claudin18.2/CD47 1.—9AK132INMPA2.—20241AK132I •AK102PCSK9 1.—6NDANMPA(HeFH)2.—5AK102III2023(EAS) •AK101IL-12/IL-23 1.—8NDANMPA 2. —2AK101III 3. —6AK101I2023(2023FOCIS)—10AK101III2023(EADV) •AK111IL-17 1. —8AK111III—11AK111III—12AK111III 2. —2AK111Ib •AK120IL-4Rα 1.—3AK120II2.—9AK120I 18A.08(3)AK112PD-1/VEGF(AK117CD47)(AK109VEGFR2)(AK119CD73)AK127 (TIGIT)AK115 (NGF)AK129PD-1/LAG-3AK130 TIGIT/TGF-βAK131 PD-1/CD73AK132Claudin18.2/CD47(AK102PCSK9)AK101IL-12/IL-23AK111IL-17AK120IL-4Rα 202312 312,778 2023123154,000GMPFDAEMANMPAGMP —3,500—36,000—14,5002023100,000 20166IIIAK112PD-1/VEGF16SUMMITIIIAK129PD-1/LAG-3AK130TIGIT/TGF-βAK131 PD-1/CD73AK132Claudin18.2/CD47AK109VEGFR2AK117CD47AK127(TIGIT)AK119(CD73) AK102PCSK9AK101IL-12/IL-23AK111IL-17AK120IL-4RαIII ADCmRNA 2023123120221231 1. 202312311631.1202212311,104.448% (i)2022629®PD–1/CTLA–4202312311,357.8 (ii)20231231273.420218®PD–1SUMMITSUMMITAK112PD–1/VEGF 2. 202312312,922.8202212313.9SUMMITivonescimab (AK112, PD-1/VEGF)2023 3. 20231231133.22022123194.142%®PD–1/CTLA–4 4. 202312 314,393.0202212 31743.5491% 5. 20231231454.220221231158.6186% 6. 202312311,254.0202212311,323.15%PD–1/VEGFAK112PCSK9AK102IL–12/IL–23(AK101) (i)(ii)(iii)(iv) 7. 20231231890.420221231552.761%2022629®PD–1/CTLA–4 8. 20231231200.120221231199.0 9. 2023123187.02022123143.3101% 10. 202312311,942.4202212311,422.2 11. 2023 202312315,676.84,894.4782.3 202212312,288.42,606.0202312314,894.4 202312311,204.6354.8443.6390.5 20231231390.52,577.3LPR1.6%4.45% 12. 202312 31793.3 13. (1)(2) (1) (2)100% 14. 20231231 15. 20231231 16. 20231231 17. 20231231770.020221231981.1 18. 20231231 20231231 19. 202312312,778 20231231847.120221231624.1 201982920211262021D.— 1.2021127 2022628202261 (a) 2,894.12,647.2 2022123120221231 (b)2021 202111430,000,00020211739.60202120213.67% 39.60(i) 20211641.504.58%(ii)40.011.02% 39.0420211,171.3978.12021 202312312021 20212021172021114202312312021202312312021202117 (c)2022 202