Pipeline Updates | 바이오정보모아

AntibodyCurated CoreFDAJohnson & JohnsonApproved

nipocalimab (Imaavy, M281, nipocalimab-aahu)

Generalized myasthenia gravis (AChR or MuSK antibody-positive, age ≥12); warm autoimmune hemolytic anemia · FcRn

#FcRn#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 27상태 APPROVED임상 갱신 2026년 9월 8일

AntibodyCurated CoreFDABeOne MedicinesApproved

tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr)

Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and c… · PD-1

#PD-1#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 213상태 APPROVED임상 갱신 2026년 9월 8일

AntibodyCurated CoreFDARegeneronApproved

linvoseltamab (Lynozyfic, REGN5458, linvoseltamab-gcpt)

Relapsed or refractory multiple myeloma after ≥4 prior lines including a PI, an IMiD, and an anti-CD38 antibody · BCMA × CD3

#BCMACD3#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 24상태 APPROVED임상 갱신 2026년 9월 8일

ADCCurated CoreFDAAbbVieMMAE (microtubule inhibitor)Approved

telisotuzumab vedotin (Emrelis, ABBV-399, Teliso-V, telisotuzumab-vedotin-tllv)

Previously treated locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression · c-Met

#c-Met#ADC#Approved#FDA승인#바이오정보모아추천+5

임상시험 12상태 APPROVED임상 갱신 2026년 9월 8일

AntibodyCurated CoreFDAJohnson & JohnsonApproved

guselkumab (Tremfya, CNTO 1959)

Plaque psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease · IL-23 p19

#IL-23p19#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 87상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAargenxApproved

efgartigimod (Vyvgart, ARGX-113, Vyvgart Hytrulo, efgartigimod alfa-fcab)

Generalized myasthenia gravis (AChR antibody positive), chronic inflammatory demyelinating polyneuropathy · FcRn (neonatal Fc receptor)

#FcRnneonatalFcreceptor#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 48상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAAstraZenecaApproved

tezepelumab (Tezspire, AMG 157, MEDI9929, tezepelumab-ekko)

Severe asthma add-on maintenance, chronic rhinosinusitis with nasal polyps · TSLP (thymic stromal lymphopoietin)

#TSLPthymicstromallymphopoietin#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 47상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAUCBApproved

bimekizumab (Bimzelx, UCB4940, bimekizumab-bkzx)

Plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa · IL-17A / IL-17F

#IL-17AIL-17F#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 58상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAEli LillyApproved

donanemab (Kisunla, LY3002813, donanemab-azbt)

Early symptomatic Alzheimer's disease with confirmed amyloid pathology · N3pG amyloid-beta plaque

#N3pGamyloid-betaplaque#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 21상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAEisaiApproved

lecanemab (Leqembi, BAN2401, lecanemab-irmb)

Early symptomatic Alzheimer's disease (MCI or mild dementia) with confirmed amyloid pathology · Amyloid-beta protofibrils

#Amyloid-betaprotofibrils#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 37상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDARocheApproved

faricimab (Vabysmo, RG7716, faricimab-svoa)

Wet AMD, diabetic macular edema, macular edema following retinal vein occlusion · Ang-2 / VEGF-A

#Ang-2VEGF-A#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 53상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAAstellasApproved

zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab)

CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma · CLDN18.2 (claudin-18.2)

#CLDN182claudin-182#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 26상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAJazz PharmaceuticalsApproved

zanidatamab (Ziihera, ZW25, zanidatamab-hrii)

First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract can… · HER2 (biparatopic)

#HER2biparatopic#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 35상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAGenmabApproved

epcoritamab (Epkinly, GEN3013, Tepkinly, epcoritamab-bysp)

Relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma · CD20 × CD3

#CD20CD3#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 57상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDARocheApproved

glofitamab (Columvi, RO7082859, glofitamab-gxbm)

Relapsed or refractory diffuse large B-cell lymphoma · CD20 × CD3

#CD20CD3#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 90상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAAmgenApproved

tarlatamab (Imdelltra, AMG 757, tarlatamab-dlle)

Extensive-stage small cell lung cancer after platinum-based chemotherapy · DLL3 × CD3

#DLL3CD3#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 39상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

AntibodyCurated CoreFDAJohnson & JohnsonApproved

teclistamab (Tecvayli, JNJ-64007957, teclistamab-cqyv)

Relapsed or refractory multiple myeloma · BCMA × CD3

#BCMACD3#Antibody#Approved#FDA승인#바이오정보모아추천+5

임상시험 132상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

CGTCurated CoreFDAOrchard Therapeutics (Kyowa Kir…Approved

atidarsagene autotemcel (Lenmeldy, OTL-200, Libmeldy, arsa-cel)

Pre-symptomatic and early-symptomatic metachromatic leukodystrophy · ARSA (arylsulfatase A) gene

#ARSAarylsulfataseAgene#CGT#Approved#FDA승인#바이오정보모아추천+5

임상시험 3상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

CGTCurated CoreFDAIovance BiotherapeuticsApproved

lifileucel (Amtagvi, LN-144, tumor infiltrating lymphocyte)

Unresectable or metastatic melanoma after PD-1 blockade · Polyclonal tumor neoantigens (TIL)

#PolyclonaltumorneoantigensTIL#CGT#Approved#FDA승인#바이오정보모아추천+5

임상시험 47상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일

CGTCurated CoreFDAJohnson & JohnsonApproved

ciltacabtagene autoleucel (Carvykti, cilta-cel, LCAR-B38M, JNJ-68284528)

Relapsed or refractory multiple myeloma · BCMA

#BCMA#CGT#Approved#FDA승인#바이오정보모아추천+5

임상시험 29상태 APPROVED임상 갱신 2026년 9월 2일제약 갱신 2026년 9월 2일