57 articles
MajesTEC-1 trial (NCT03145181)
MajesTEC-1 (NCT03145181/NCT04557098), a phase 1/2 single-arm trial of teclistamab (Tecvayli), a BCMA×CD3 bispecific antibody, in relapsed/refractory multiple myeloma; 165 patients at 1.5 mg/kg weekly subcutaneous dosing achieved 63% ORR, supporting the 2022 FDA accelerated approval.
Mifamurtide acid
Mifamurtide (L-MTP-PE, Mepact) is a synthetic NOD2-activating liposomal immunostimulant approved in the EU in 2009 for high-grade resectable non-metastatic osteosarcoma in patients aged 2 to 30.
Motavizumab
Motavizumab (MEDI-524, Numax) is an unlicensed humanized IgG1 monoclonal antibody derived from palivizumab for RSV prophylaxis; 13 amino-acid changes gave higher F-protein affinity, but the FDA declined approval and AstraZeneca withdrew it in 2010.
Navicixizumab
Navicixizumab (OMP-305B83) is a bispecific anti-DLL4/anti-VEGF monoclonal antibody developed by OncoMed, licensed to Feng Biosciences, tested in ovarian cancer phase 1-3 trials.
Naxitamab
Naxitamab (Danyelza, naxitamab-gqgk, hu3F8) is a humanized anti-GD2 monoclonal antibody FDA-approved in 2020 with GM-CSF for relapsed/refractory high-risk neuroblastoma in bone or bone marrow; Trial 201 showed 50% ORR.
Nimotuzumab
Nimotuzumab is a humanized monoclonal antibody against EGFR, developed in Cuba in the 1990s and sold as Theracim, used to treat head and neck tumors, nasopharyngeal carcinoma, and glioma.
Otelixizumab
Otelixizumab (ChAglyCD3, TRX4) is an aglycosylated humanized anti-CD3E monoclonal antibody tested in new-onset type 1 diabetes; high doses preserved C-peptide but caused EBV reactivation, and phase III trials missed endpoints.
Penpulimab
Penpulimab (AK105, penpulimab-kcqx, 安尼可) is Akeso Biopharma's Fc-engineered IgG1 anti-PD-1 antibody, FDA-approved April 23, 2025 for non-keratinizing nasopharyngeal carcinoma, with phase 3 PFS benefit and low immune-related toxicity.
Polatuzumab vedotin
Polatuzumab vedotin (Polivy, polatuzumab vedotin-piiq) is a Genentech anti-CD79b antibody-drug conjugate carrying MMAE; FDA-approved in 2019 with bendamustine-rituximab for relapsed/refractory DLBCL and in 2023 with R-CHP for first-line DLBCL.
Prademagene zamikeracel
Prademagene zamikeracel (Zevaskyn, formerly EB-101) is an autologous COL7A1 gene-modified keratinocyte sheet gene therapy for recessive dystrophic epidermolysis bullosa wounds, FDA-approved April 28, 2025 after the VIITAL phase 3 trial.
Qyuns TSLP/IL-33 bispecific antibody (licensed to Roche)
QX031N (RG6981) is Qyuns Therapeutics' long-acting bispecific antibody targeting TSLP and IL-33 for COPD and asthma, licensed globally to Roche in October 2025 for $75 million upfront plus up to $995 million in milestones; Phase I began in New Zealand in 2026.
RC148
RC148 (ABBV-1480) is a humanized IgG1 PD-1/VEGF bispecific antibody from RemeGen, in phase 3 for NSCLC and solid tumors in China and licensed ex-Greater China to AbbVie in 2026 for $650 million upfront plus up to $4.95 billion in milestones.
Retlirafusp alfa (SHR-1701)
Retlirafusp alfa (SHR-1701, 瑞拉芙普-α), Hengrui's bifunctional anti-PD-L1/TGF-βRII fusion protein, approved in China January 2026 with chemotherapy for first-line PD-L1-positive advanced gastric or gastroesophageal junction adenocarcinoma.
SAL003 (PCSK9 antibody)
SAL003, taikeximab (泰卡西单抗注射液), is Shenzhen Salubris's recombinant fully human anti-PCSK9 monoclonal antibody injection for hypercholesterolemia and mixed dyslipidemia; NMPA accepted its Class 1 NDA in September 2025, dosed one subcutaneous injection every 4 weeks.
Satralizumab
Satralizumab (Enspryng) is a humanized IgG2 anti-IL-6 receptor antibody approved from 2020 for AQP4-IgG-positive NMOSD in patients 12 and older, dosed 120 mg subcutaneously every 4 weeks after a three-dose loading phase.
SHR-4849 (IDE849)
SHR-4849 (IDE849) is Hengrui Pharma's DLL3-targeting topoisomerase-I-payload antibody-drug conjugate, licensed ex-Greater China to IDEAYA Biosciences for up to $1.045 billion, showing ~73% ORR in relapsed SCLC Phase 1.
SIM0500, GPRC5D/BCMA/CD3 trispecific antibody
SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific T-cell engager antibody by Simcere Zaiming for relapsed/refractory multiple myeloma, in Phase 1 trials (NCT06375044) in China and the U.S., with an AbbVie option-to-license deal worth up to $1.055 billion.
SIM0660
SIM0660 is a preclinical CD79a/CD19/CD3 tri-specific T-cell engager from Simcere Zaiming (2096.HK), licensed globally to Roche on 1 September 2026 for $75 million upfront and up to $1.53 billion total, targeting B-cell-mediated diseases.
SSGJ-707 (PF-08634404), PD-1/VEGF bispecific antibody
SSGJ-707, renamed PF-08634404, is 3SBio's tetravalent IgG4 PD-1/VEGF bispecific antibody built on the CLF2 platform; licensed to Pfizer ex-China in 2025 for $1.25 billion upfront, with phase 2 NSCLC ORR 67.6% and phase 3 trials ongoing.
SYSA1801 (EO-3021)
SYSA1801 (EO-3021, CPO102), an anti-Claudin 18.2 MMAE antibody-drug conjugate (DAR 2) developed by CSPC and licensed to Elevation Oncology in 2022; Phase 1 trials in gastric and other CLDN18.2-positive solid tumors; development discontinued March 2025.
Tasonermin
Tasonermin (Beromun) is recombinant human TNF alfa-1a from E. coli, EU-approved 1999, given with melphalan by isolated limb perfusion to treat limb soft-tissue sarcoma and avoid amputation.
Tebentafusp
Tebentafusp (Kimmtrak), a gp100 x CD3 bispecific T-cell receptor fusion protein, approved 2022 for HLA-A*02:01-positive unresectable or metastatic uveal melanoma; first TCR bispecific and first mUM drug, with phase 3 overall survival benefit.
TL-003
TL-003 (BYN-003) is an extended-half-life TL1A × IL-23p19 bispecific antibody from TrueLab Biopharmaceutical, licensed to Bionyra Pharma for up to $985 million, in Phase 1 testing in Australia for ulcerative colitis.
Trafermin
Trafermin (Fiblast, Regroth) is recombinant human basic FGF (FGF2) approved in Japan in 2001 as a topical spray for skin ulcers and pressure ulcers, and in 2016 for periodontal bone defects.
Trastuzumab brengitecan
Trastuzumab brengitecan (T-Bren, BL-M07D1) is a Sichuan Baili HER2-directed antibody-drug conjugate using the Ed-04 topoisomerase I inhibitor payload, GGFG cathepsin B-cleavable linker, and DAR 8, in phase 3 breast cancer trials.
Tulisokibart
Tulisokibart (PRA023, MK-7240) is Merck's investigational humanized IgG1 anti-TL1A monoclonal antibody for ulcerative colitis and Crohn's disease; phase 2 ARTEMIS-UC showed 26% vs 1% remission, and phase 3 ATLAS-UC met its endpoint.
Zopapogene imadenovec drba
Zopapogene imadenovec-drba (PRGN-2012, PAPZIMEOS), Precigen's non-replicating adenoviral vector immunotherapy expressing HPV 6/11 fusion antigen; first FDA-approved therapy for adult recurrent respiratory papillomatosis, approved August 14, 2025.