20230529_德邦证券_医药行业：MNC大药企2023年重要研发看点预告系列三_22页.pdf
0MNC 2023 2023 5 29|S0120521080001 1 01020304 VertexGSKBiogen CONTENTSYWCXwPrMpMmNoQtQsPoRmN9PcM8OsQmMpNpMfQnNnQlOnPvM7NmNrMNZpOwOuOtPwP2 01 Regeneron3 Eylea 8mg Eylea Dupixent DUPIXENT dupilumab IL-4R 2023 FDA 12 EoE 2022/5/20 FDA EoE off-label PPI IL-5 mepolizumab reslizumab benralizumab EoE IL-5 IL-4 IL-13 TSLP Tezepelumab 2021/10/8 FDA EoE 1/2000 17.5 CSU PDUFA 2023/10/27 CSU BTK remibrutinib 3 NCT05795153 2023H2 2024 Gastroenterology&Hepatology Update on Emerging Pharmacologic Therapies for Patients With Eosinophilic Esophagitis Erin Phillips Syverson EoE4 PRALUENT alirocumab PCSK9 2023 FDA HeFH Odronextamab CD20 xCD3 2023H2 FDA B-Cell NHL CD20 BLOOD Bispecific antibodies for the treatment of B-cell lymphoma:promises,unknowns,and opportunities Lorenzo Falchi CD20 Eylea 8mg5 BLOOD Bispecific antibodies for the treatment of B-cell lymphoma:promises,unknowns,and opportunities Lorenzo Falchi CD20 Eylea 8mg6 Linvoseltamab BCMAxCD3 2023H2 FDA R/R MM EYLEA aflibercept PGF/VEGF-A 8mg PDUFA 2023/6/27 Vabysmo Eylea 2023Q1 6%Eylea 8mg 2023Q3 PHOTON(DME)and PULSAR(wAMD)2 Eylea 8mg BLOOD Bispecific antibodies for the treatment of B-cell lymphoma:promises,unknowns,and opportunities Lorenzo Falchi BCMA7 Pozelimab Anti-C5 CHAPLE PDUFA 2023 8 20 CHAPLE(CD55 CD55)CD55 pozelimab CHAPLE Fianlimab+Libtayo LAG3+PD-1 2023H2 perioperative melanoma 3 2023H2 perioperative NSCLC 2 PSMAxCD28+Libtayo 2023H2 Eylea 8mg8 02 Vertex9 Vertex Vanzacaftor/tezacaftor/deutivacaftor CFTR 3 2023 12 CF 3 2 Trikafta ivacaftor PK royalty Trikafta VX-522 CFTR mRNA 2023 CF SAD single ascending dose MAD multiple ascending dose 5000 mRNA Moderna LNP Moderna VX-522 mRNA CF 202310 Exa-cel SCD beta TDT 2023Q1 FDA FDA 8 Bluebird Zynteglo beti-cel 280/exa-cel 300/2023Q1 Immunogen ADC exa-cel Vertex VX-548 Nav1.8 2023 2024 3 Nav1.8 CNS Vertex exa-cel11 Vertex VX-880 2023 1 Part C-1 Alpha-1 Antitrypsin Deficiency AATD COPD DMT VX-864 2023 2 48 AAT AAT biomarker 2022/10/11 28 Z-polymer 90%VX-634 2023 FIH AAT corrector VX-864 Drug-like-property POC VX-634 VX-864 Vertex AATD12 03 GSK13 GSK Jemperli dostarlimab-gxly PD-1 2023H2 1L RUBY RUBY dMMR MSI-H dostarlimab vs.dostarlimab+SOC 24m PFS%HR=0.28 OS HR=0.3 PFS HR=0.64 24m OS%HR=0.64 SOC mOS 3 3 dostarlimab OS%60%dMMR MSI-H HR=0.64 Keytruda K 1 pMMR 2 s MSI-H or/dMMR NEJM Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer M.R.Mirza RUBY 3RNAi14 Bepirovirsen B-Together 2b 2023H2 Ionis ASO 2022/11/24 B-clear 2022 3 B-Well 1 B-Well 2 2025 RNAi Bepirovirsen 2 GSK NEJM Bepirovirsen in Chronic Hepatitis B Infection HBV B-clear B-clear 15 AREXVY RSV 2023/5/4 FDA 60 RSV LRTD Blenrep belantamab mafodotin-blmf BCMA ADC 2023H2 2L+multiple myeloma DREAMM-7 3 2023H2 2L+multiple myeloma DREAMM-8 3 Momelotininb ACVR1/ALK2,JAK1,JAK2 2023/6/16 PDUFA date Zejula Niraparib PARP1/2 1L FIRST 3 2023H2 gepotidacin Top II 2023H2 EAGLE-1 3 2023H2 EAGLE-2/3 GSK 16 04 Biogen17 Biogen Leqembi 5 18 LEQEMBI lecanemab APP beta Amyloid FDA 6/9 Adcom Leqembi BLA FDA 7/6 PDUFA 2023/1/6 AA 2 3 topline AA A-beta Aducanumab CMS 1 2 full approval A-beta aducanumab lecanemab 2.5/7/6 CMS Nature FDA new drug approvals in Q1 2023 2028 18.7 zuranolone GABAA FDA 8/5 MDD PPD Leqembi 7/6 CMS Zuranolone Nature FDA new drug approvals in Q1 2023 Lisa Urquhart 2023Q1 FDA18 19 2019 2018 2017 2016 2015 1.6 6 20%5%20%-5%+5%5%2.A 500 10%-10%10%10%20 2017 7 1/21 600 N1 9+86 21 68761616+86 21 68767880400-8888-128
