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1 / 23 | 2021 5 12 陈梦洁 S0300520100001 010-64814022 12 2021-04-19 2021-04-20 2021-04-27 50 AK104 KN046 2 AK104 PD-1 CTLA4 AK112 PD-1 VEGF AK104 Tetrabody PD-1 CTLA-4 TIL AK115 PD-1/VEGF PD-1 VEGF VEGF PD-1 AK112 PD-1 VEGF 2 KN046 PD-1 CTLA-4 KN026 HER2 HER2 KN046 BsAb sdAb Fc sdAb PD-L1 CTLA-4 KN026 HER2 HER2 D2 D4 -3% 9% 22% 34% 47% 20-05 20-08 20-10 21-01 21-04 沪深300 医药生物 2 / 23 . 5 AK104 . 6 AK112. 9 . 10 KN046 . 12 KN026 . 17 . 21 1 . 4 2 . 5 3 AK104 . 6 4 PD-1 CTLA-4 FDA . 6 5 AK104 . 7 6 AK104 . 7 7 AK104 . 8 8 AK104 G/GEJ . 9 9 AK112 . 9 10 AK112 + . 10 11 . 10 12 CRIB .11 13 KN046 . 12 14 KN046 . 13 15 KN046-201 . 14 16 KN046-201 . 14 17 KN046-201 PFS . 14 18 KN046-201 OS . 14 19 KN046 PD-1 . 14 20 KN046-201 . 15 21 KN046-203 . 15 22 KN046 . 16 23 KN046 AK104 . 17 1 KN026 . 17 2 KN026 . 18 3 KN026 . 18 4 KN026-201 . 19 5 KN026-201 . 19 3 / 23 6 KN026-201 . 20 7 KN026-201 . 20 8 KN026+KN046 . 20 9 KN046-IST-02 . 20 10 KN046-IST-02 . 20 4 / 23 50 1 5 Blincyto CD3 CD19 ZW25 HER2 HER2 AMG701 CD3 BCMA AMG160 CD3 PSMA AMG199 CD3 MUC17 6 IBI-302 C3 VEGF IBI-318 PD-1 PD-L1 IBI-315 PD-1 HER2 IBI-319 PD-1 4-1BB IBI-322 PD-L1 CD47 IBI-323 PD-L1 LAG-3 2 AK104 PD-1 CTLA4 AK112 PD-1 VEGF 2 KN046 PD-L1 CTLA4 KN026 HER2 HER2 3 SI-B001 EGFR HER3 GNC-039 PD-L1 4-1BB CD3 EGFR SI-B003 PD-(L)1 CTLA-4 2 EMB-01 EGFR cMET EMB-02 PD-1 LAG-3 2 A-337 CD3 EPCAM A-319 CD3 CD19 2 M802 CD3 HER2 M701 CD3 EPCAM 2 ES101 PD-L1 4-1BB ES104 VEGF DLL4 2 IMM0306 CD47 CD20 IMM2510 PD-L1 VEGF 2 PM8001 PD-1 PD-L1 5 / 23 PM8002 PD-L1 TGF 2 REGN1979 CD3 CD20 MGD013 PD-1 LAG-3 1 SHR-1701 PD-L1 TGF- 1 CD3-MUC1 CD3 MUC1 1 GB261 CD3 CD20 1 K193 CD3 CD19 1 CD3 EPCAM 1 HB0025 PD-L1 VEGF 1 MBS301 HER2 HER2 1 QL1706 PD-1 CTLA-4 1 TQB2858 PD-L1 TGF 1 JS201 PD-1 TGF 1 Q-1802 PD-L1 Claudin 18.2 1 MCLA-129 EGFR cMET 1 HX009 PD-1 CD47 1 SG12473 PD-L1 CD47 2 AK104 PD-1 CTLA4 AK112 PD-1 VEGF 2 6 / 23 Tetrabody Tetrabody CMC PD-1/CTLA-4 AK104 PD-1/VEGF AK112 Tetrabody ACE AK104 AK104 Tetrabody PD-1 CTLA-4 TIL 3 AK104 PD-1 CTLA-4 T T PD-1 CTLA-4 PD-1 CTLA-4 PD-1 CTLA-4 PD-1 CTLA-4 PD-1 CTLA-4 PD-1 CTLA-4 CTLA-4 PD-1 ORR FDA RCC 2018 4 MSI-H dMMR CRC 2018 7 4 PD-1 CTLA-4 FDA 2015 10 O +Y 2018 4 O +Y RCC 2018 7 O +Y 12 MSI-H dMMR CRC 2020 3 O +Y HCC 2020 5 O +Y PD-L1 EGFR ALK 7 / 23 PD-1 CTLA-4 TRAE CheckMate 067 PD-1 3-4 22% CTLA-4 3-4 28% 3-4 59% AK104 PD-1 CTLA-4 TIL Tumor Infiltrating Lymphocyte AK104 PD-1 CTLA-4 TIL TIL PD-1 CTLA-4 CTLA-4 PD-1 TIL PD-1 CTLA-4 PD-1/CTLA-4 5 AK104 AK104 10 AK104 2021 4 28 AK104 CDE 3 AK104 / 3 6 AK104 8 / 23 1 2020 11 AK104 2020 31 2020 AK104 NDA AK104 ORR DCR 47.6% 66.7% PD-1 PD-1 CTLA-4 AK104 (TRAE) 12.9% PD-1 PD-L1 7 AK104 N ORR DCR AK104 31 47.6% 66.7% Agenus Balstilimab+Zalifrelimab PD-1+CTLA-4 143 21.6% - 160 14.0% - MSD 77 14.3% 31.2% 15 - 20% BMS O +Y (1mg/kg) 26 23.1% 53.8% O +Y (3mg/kg) 22 36.4% 72.7% 2020 Annual Results Presentation 2 AACR 2020 PD-1/CTLA-4 AK104 G/GEJ Ib/ G/GEJ 36 AK104 4 6 10mg/kg mXELOX 85mg/m 2 1000mg/m 2 2020 1 17 20 AK104 mXELOX AK104 4mg/kg 6mg/kg 17 3 15 ORR 60% 9/15 DCR 93.3% 7 9 / 23 1+ 168+ 1 40% PD-L1 AK104 AK104 TRAE 45% 3 TRAE 20% 4/20 4 TRAE TRAE TRAEs 15% 15% 15% 8 AK104 G/GEJ ORR DCR PFS 6 PFS AK104+mXELOX 4.9 66.2% 94.4% - 67.1% AK104+mXELOX 4mg/kg 11.4 68.8% 93.8% 9.6 76.5% 15.4 46.7% 80% 6.1 - MSD + 22.6 48.6% - 6.9 53% KEYNOTE-062 - 37.2% - 6.4 2020 Annual Results Presentation AK112 AK115 PD-1/VEGF Tetrabody PD-1 VEGF VEGF PD-1 AK112 PD-1 VEGF PD-(L)1 VEGF FDA Tecentriq PD-L1 Tecentriq PD-1 VEGF PD-1/PD-L1 VEGF AK112 PD-1 VEGF AK112 PD-1 VEGF PD-1/PD-L1 VEGF-A , T T 2019 AK112 2019 6 AK112 FDA 2020 8 AK112 NMPA b 9 AK112 /EGFR-TKI 2021 - 10 / 23 b 2021 - 2021 - 2021 - a/ b 2019 10 - / a AK117 - 2020 1 AK112 PK PD a AK112 MTD RP2D b AK112 MTD RP2D AE DLT Ia 2020 AK112 a PD-1 PD-1 11 4 ORR 36% 7 DCR 64% 2021 3 19 41 6 0.3mg/kg n=1 1mg/kg n=3 3mg/kg n=3 10mg/kg n=13 20mg/kg Q2W n=18 30mg/kg Q2W n=3 41 TRAE 63.4% 3 TRAE 19.5% + AK112 10 AK112 + AK112 N=29 Immotion151 1200mg+ 15mg/kg Q3W TRAE 16(55.2%) 91% Grade 3 TRAE 3(10.3%) 40% Drug-related SAE 1(3.4%) Not reported TRAEs leading to discontinuation 2(6.9%) 5% 2020 / 16 15 1 2021 2-3 IND KN035 11 11 / 23 2020 1 sdAb KN046 PD-L1 CTLA-4 sdAb 2 CRIB CRIB Fc CMC Fc BsAb CRIB CRIB 12 CRIB 12 / 23 KN046 KN046 BsAb sdAb Fc sdAb PD-L1 CTLA-4 KN046 10 20 PD-1 KN046 2022 13 KN046 1 KN046 CTLA-4 PD-L1 PD-L1 Treg Nanobody 2 Fc Fc Fc KN046 Fc T KN046 3 CTLA-4 CTLA-4 B7 CTLA-4 KN046 CTLA-4 sdAb CDR CTLA-4/B7 13 / 23 14 KN046 KN046 KN046 / KN046 1 EGFR ALK KN046-201 TKI NSCLC EGFR ALK 23 22 KN046 3.0mg/kg Q2W 7 PR PR SD DCR 85.7% ORR 28.6% KN046-201 22 20 3.0mg/kg Q2W 22 16 72.7% TEAE 9.1% 3 TEAE 18.2 14 / 23 SAE 31.8% irAE 15 KN046-201 16 KN046-201 2021WCLC KN046 NSCLC KN046-201 64 NSCLC 13 PFS 3.68 (95 CI3.35 7.29) (sqNSCLC) (non-sqNSCLC) PFS 7.29 (3.68,9.23) 3.58 (2.46,5.52) OS 6 OS 85.6% 12 OS 69.7% PD-1/PD-L1 64 24 (37.5 ) 3 TRAEs (10.9%) (4.7%) (3.1%) (3.1%) (3.1%) irAEs (3.1%) 3.1% 17 KN046-201 PFS 18 KN046-201 OS 19 KN046 PD-1 N PFS OS KN046 NSCLC 2L 64 7.3 3.6( ) 13.6 MSD NSCLC 2L 394 3 9.3 15 / 23 BMS NSCLC 292 2.3 12.2 BMS NSCLC 135 3.5 9.2 2020 Annual Results Presentation 2 KN046-203 Ib/ TNBC 18 KN046 KN046-203 1 3mg/kg Q2W 5mg/kg Q2W 14 3mg/kg Q2W 5mg/kg Q2W 2 KN046 3mg/kg Q2W 5mg/kg Q2W 3mg/kg Q2W SD DCR 40% ORR 66.7% 18 50% TEAE 16.7% 3 TEAE 11.1% SAE 1 5.6% irAE 20 KN046-201 21 KN046-203 2021 4 AACR KN046 b/ KN046-203 27 2021 3 8 25 (ORR) 40.0% (DCR) 96.0% 13.7 (PFS) 7.3 (95%CI 3.7NE) (mOS) 15 OS 73.4% (95% CI 46.188.4%) PD-L1 (IC PD-L1 1%) PFS 13.8 (95% CI 1.6NE) 15 OS 77.1% (95% CI 16 / 23 34.593.9%) 2021 3 8 KN046 13 (48.1%) 34 KN046 (AE) 4 (14.8%) KN046 (SAE) 11 (40.7%) (irAEs) irAEs 12 3 3 irAEs 2 3 1 3 3 2021 WCLC KN046 KN046 PK 3+3 DL 0.3 1 3 5 10mg/kg 5 4 1 1 3mg/kg KN046 4 5mg/kg Q2W 4 ORR 75% CR 20% 3 PR 60% 1 SD=20% DCR 100% 5 2 40% (1 3 2 ) DLT 22.7 TRAEs 1 2 1 2 3 TRAEs 3 14 irAE TRAEs 22 KN046 4 2021 1 KN046 ASCO GI KN046 KN046 KN046 1mg/kg 3 mg/kg 5mg/kg Q3W 17 / 23 KN046 (ORR) (DCR) 44.4% 94.4% 15 3mg/kg 9 2 (CR) 5 (PR) (ORR) 55.6% 9 (DCR) 100% 2020 6 30 18 KN046 23 KN046 AK104 ORR PFS OS KN046 1L / 64 - 7.3 3.6( ) 13.6 - KN046 NSCLC PD-1 / 24 8.3% 2.8 - KN046+ 1L 27 40% 7.3 - KN046+ 1L 15 55.6% - - KN046 1L / 4 75% - - AK104+ 1L 71 66.2% - - AK104+ 1L 16 56.3% - - AK104 3L 17 37.3% - - AK104 2L 31 47.6% - - KN026 KN026 HER2 HER2 D2 D4 KN026 2018 NMPA FDA / 1 KN026 HER2 BsAb HER2 18 / 23 HER2 HER2 2 KN026 KN026 HER2 HER2 Fc BsAb 1 HER2 KN026 HER2 HER2 HER2 2 HER2 HER2 HER2 HER2 HER2 HER2 HER2 3 Fc BsAb ADCC KN026 Fc HER2 KN026 3 KN026 19 / 23 KN026 CRIB CMC KN026 1 HER2 KN026-CHN-201 KN026 a b 2018 9 HER2 HER2 GC/GEJ 2019 9 20 32 KN026-CHN-001 KN026 MTD RP2D 32 2019 9 20 21 PR PR SD 2019 9 20 32 26 81.3% TEAE 9.4% 3 TEAE 9.4% SAE 3.1% TEAE 3 TEAE 4 KN026-201 5 KN026-201 2020 5 ASCO KN026 PK 62 KN026-CHN-001 KN026 MTD RP2D 2020 1 22 (ORR) (DCR) 29% 74.2% 32.1% DCR 76.8% 20mg/kg Q2W 30mg/kg Q3W KN026 KN026 DLT AE 1 2 4 6.45% 3 TEAE 3 TEAE 20 / 23 6 KN026-201 7 KN026-201 2 KN026 KN046 HER2 2020 11 SITC KN046+KN026 HER2 KN046-IST-02 2020 KN026 KN046 HER2 Ib KN046+KN026 HER2 2020 9 8 26 KN026+KN046 b 18 HER2 14 HER2 ORR 64.3% DCR 92.9% PFS OS DLT AE 1-2 3 TRAE 23%-24% 3 8 KN026+KN046 9 KN046-IST-02 10 KN046-IST-02 21 / 23 22 / 23 2016 S0300520100001 10485001 12 300 10% 5%10% -5%5% -5% 12 300 5% -5% 5% 5 23 / 23 60 21-23 6 2 1088 20
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