双抗深度报告(六):国内双抗企业及管线梳理(百济神州).pdf

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1 / 14 | 2021 05 28 S0300520100001 010-64814022 ( 12 ) 2021-05-17 2021-05-20 ASCO 2021-05-24 60 1 5 6 Blincyto CD3 CD19 AMG701 CD3 BCMA AMG160 CD3 PSMA AMG199 CD3 MUC17 ZW25 HER2 HER2 ZW49 HER2 HER2 ADC T BiTE ZW25 ZW49 Zymeworks AMG701 BCMA T CD3 BCMA AMG701 BCMA CD3 7 BCMA CD3 AMG420 AMG160 HLE-BiTE PSMA T CD3 T 2020 6 11 AMG160 mCRPC ZW25 Zanidatamab Azymetric HER2 HER2 HER2 ECD4 ECD2 ECD4 ScFv ECD2 IgG HER2 HER2 ZW49 Zymeworks Azymetric ZymeLink HER2 ADC ZW49 ZW25 Linker 0% 13% 26% 38% 51% 20-05 20-08 20-11 21-02 21-05 沪深300 医药生物 2 / 14 . 3 AMG701 CD3 BCMA. 3 AMG160 CD3 PSMA . 6 AMG199 CD3 MUC17 . 8 ZW25 HER2 HER2 . 8 ZW49 HER2 HER2 ADC . 11 . 12 1 . 3 2 BCMA . 4 3 BiTE HLE BiTE . 4 4 BCMA CD3 . 5 5 2015 . 6 6 . 7 7 AMG160 . 7 8 ZW25 . 8 9 ZW25 . 8 10 Azymetric . 9 11 ZW25 . 9 12 ZW25 . 10 13 ZW49 . 11 14 ZymeLink . 12 3 / 14 Zymeworks SpringWorks 6 Blincyto CD3 CD19 AMG701 CD3 BCMA AMG160 CD3 PSMA AMG199 CD3 MUC17 ZW25 HER2 HER2 ZW49 HER2 HER2 ADC T BiTE ZW25 ZW49 Zymeworks 1 NDA ALL Blincyto CD3 CD19 AMG701 CD3 BCMA AMG160 CD3 PSMA AMG199 CD3 MUC17 ZW25 HER2 HER2 HER2 ZW49 HER2 HER2 AMG701 CD3 BCMA BCMA B-cell Maturation Antigen 17 TNFRSF17 B BCMA B B CD34 B BCMA BCMA APRIL BAFF BCMA APRIL BAFF BCMA BAFF BAFF-R TACI APRIL TACI BCMA APRIL BCMA APRIL NF- B BAFF BCMA TACI BAFF-R NF- B JNK 4 / 14 2 BCMA BCMA in multiple myeloma: current therapeutic approaches AMG701 BCMA T CD3 BCMA AMG701 BCMA CD3 7 BCMA CD3 AMG420 AMG420 Half-Life Extended HLE BiTE BiTE BiTE HLE BiTE Fc BiTE Fc IgG Fc FcRn 3 BiTE HLE BiTE Amgen 2020 8 17 AMG701 / 2021 AMG701 2021 CRS 5 / 14 1 MM 2020 12 ASH Amgen AMG701 a a AMG701 a 85 6 3-12mg AMG701 36% 16/45 ; 1.6mg BCMA 0.8mg 1/27 9mg 83% 5/6 3PR 2VGPR 3 CRS 43 23 20 CRS 61 31 25 25 29 39 13 CRS 7 2 1 6 4 CRS 4 BCMA CD3 RENGN5458 TNB-383B JNJ-64007957 Teclistamab PF-06863135 Elranatamab AMG701 AMG420 Regeneron Abbive Pfizer Amgen Amgen / / 45 58 84 44 18 85 42 5 6 6 8 6 4 ORR 35.6% 60% VGPR 81.3% 2020ASH 5.4mg ORR 52% 12/23 2020ASH ORR=63.9% VGPR=51% CR=7% n=9 1500ug/kg RP2D 2020ASH ORR 33% 215ug/kg 360ug/kg ORR 75% 2020ASH 3-12mgORR 36% 16/45 1.6mg 1/27 9mg ORR 83% 2020ASH 400 g/d ORR 70% CR 50% VGPR 10% PR 10% 2 DLT 4 3 ALT/AST 3 54% 3 CRS NT 3 18% 2 DLT 3 4 3 TEAE 57% SAE 33% 3 CRS 3 AE 38% 36% 24% 3 CRS 3 AE 53.3% 26.7% 16.7% 16.7% CRS 3 PN 3%,3/100 4 AE 3 CRS 9% SAE 39% n=13 CRS n=7 n=2 2 AE 21 SAE 50% SAE n=12 PN n=2 CRS n=3 ASH ASCO 6 / 14 AMG160 CD3 PSMA 2020 6.47/10 5 2015 Cancer incidence and mortality in China PSMA PSMA Prostate-Specific Membrane Antigen 750 707 24 19 100KDa PSMA PSMA PSA PSA 2014 50 45 PSA Prostate Specific Antigen Gleason PSMA PSA 7 / 14 6 Gleason PSA 2-6 T1 T2a 10 7 T1 T2a b 10-20 8-10 T1 T2a b c 20 AMG160 HLE-BiTE PSMA T CD3 T 2020 6 11 AMG160 mCRPC 1 mCRPC 2020 9 ESMO AMG160 mCRPC AMG160 0.003-0.8mg AMG160 2020 5 11 32 1 AMG160 65.5 20 63% 3 18 PR 5 SD 5 PD 63% 15/24 PSA DL5 DL6 60% PSA 50% 6/10 CRS 84.4% 27/32 3 CRS 31.3% 10/32 3 12.5% 4/32 9.4% 3/32 3.1% 1/32 6.3% 2/32 3.1% 1/32 2 DLT MTD 7 AMG160 ESMO 8 / 14 AMG199 CD3 MUC17 Mucin MUC MUC MUC17 AMG199 HLE BiTE MUC-17/CD3 T CD3 MUC17 T 2020 9 15 AMG199 MUC17 GEJ 1 / GC/GEJ 2020 6 ASCO AMG199 GC/GEJ (NCT04117958) AMG199 DLT TRAE/TEAE AMG199 PK ORR DoS PFS OS 2020 1 ZW25 HER2 HER2 Zymeworks 2003 ZW25 Zanidatamab Azymetric HER2 HER2 HER2 ECD4 ECD2 ECD4 ScFv ECD2 IgG HER2 HER2 ZW25 HER2 8 ZW25 9 ZW25 Zymeworks Zymeworks 9 / 14 Azymetric TM Fab Azymetric Fc Azymetric IgG Fabs scFvs VHHs 10 Azymetric Zymeworks 2018 Zymeworks ZW25 ZW49 ZW25 ZW49 Zymeworks 4000 3.9 2020 11 16 ZW25 HER2 BTC 11 ZW25 ZW25 HER2 / ZW25 / II 2021-02-24 HER2 ZW25 II 2021-01-12 1 2020 ASCO ZW25 ZW25 10 / 14 ZW25 ZW25 36 5 QW 31 Q2W ZW25 26 11 ZW25 Q2W 6 ZW25 Q2W 9 ZW25 Q3W ZW25 HER2 ORR 38% 13/36 ,DCR 62% 21/36 mDOR 6 ZW25 ORR 60% 12/26 DCR 85% 17/26 mDOR 8.9 ZW25 1/2 AE 61% 22/36 3 AE 11% 4/36 ZW25 1/2 AE 65% 17/36 3 AE 15% 4/26 12 ZW25 2020ASCO 2 2020 ASCO ZW25 NCT02892123 ZW25 ZW25 ZW25 20mg/kg Q2W 2020 7 28 20 HER2 ZW25 17 ORR 47% 8/17 DCR 65% 11/17 mDoR 6.6 70% 14/20 1/2 AE 3 AE AE 45% 9/20 30% 6/20 3 2020 ASCO ZW25 1B/2 Zymeworks HER2 ZW25 HER2 11 / 14 ZW25 PD-1 HER2 GEA 50 ZW25 30mg/kg / ZW25(30mg/kg) 200mg CAPOX ZW49 HER2 HER2 ADC ZW49 Zymeworks Azymetric ZymeLink HER2 ADC ZW49 zanidatamab ZW25 Auristatin ZW49 1I HER2 HER2 HER2 HER2 13 ZW49 Zymeworks ZymeLink TM Zymeworks ADC ZymeLink Azymetric ADC ZymeLink ADC 1 2 Fc 3 FcRn 12 / 14 14 ZymeLink Zymeworks 1 HER2 2021 1 Zymeworks ZW49 1 ZW49 3+3 Q2W Q3W Q3W 2.0mg/kg 4 Q3W 2.5 3.0mg/kg 6 HER2+ 6 2 PR 2 SD 3 ZW49 35 DLT 90% 1 2 13 / 14 2016 S0300520100001 10485001 12 300 10% 5%10% -5%5% -5% 12 300 5% -5% 5% 5 14 / 14 60 21-23 6 2 1088 20
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