Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms DuoBody, TALQUETAMAB-TGVS, 替吉妥单抗 + [7] |
Target |
Action stimulants, inhibitors |
Mechanism CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (09 Aug 2023), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union) |




| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Refractory Multiple Myeloma | Japan | 24 Jun 2025 | |
| Relapse multiple myeloma | Japan | 24 Jun 2025 | |
| Multiple Myeloma | United States | 09 Aug 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Extramedullary Disease in Multiple Myeloma | Phase 2 | United States | 01 Jul 2026 | |
| Residual Neoplasm | Phase 2 | United States | 21 Aug 2025 | |
| Peripheral Stem Cell Transplantation | Phase 2 | United States | 05 Jun 2025 | |
| Smoldering Multiple Myeloma | Phase 2 | United States | 04 Dec 2023 | |
| Hematologic Neoplasms | Phase 1 | United States | 16 Dec 2017 | |
| Hematologic Neoplasms | Phase 1 | Belgium | 16 Dec 2017 | |
| Hematologic Neoplasms | Phase 1 | Netherlands | 16 Dec 2017 | |
| Hematologic Neoplasms | Phase 1 | Spain | 16 Dec 2017 |
Not Applicable | 43 | ygdfmihrpi(fofzvegkuk) = tjtblemqxs gfzvkbubez (xbnbuhgpqs ) | Positive | 04 Feb 2026 | |||
ygdfmihrpi(fofzvegkuk) = evgoctgybm gfzvkbubez (xbnbuhgpqs ) | |||||||
Not Applicable | 465 | pjytnoises(ohkubsjtrj) = svbjqjjwsg bjdtyhuzhm (vgyhnxnhqo ) View more | Negative | 04 Feb 2026 | |||
pjytnoises(ohkubsjtrj) = wafoiuodom bjdtyhuzhm (vgyhnxnhqo ) View more | |||||||
Not Applicable | 36 | (Renal Impairment) | ajzffqnuwg(ncvtmedvpo) = Comparable safety profile in RI vs No RI: 66.7% any-grade cytokine release syndrome (CRS) with 8.3% grade ≥3 CRS in each, but more grade 1 CRS in RI 58.3% vs 45.8% (=0.73). Any-grade Immune effector cell-associated neurotoxicity syndrome (ICANS) was 16.7% vs 20.8%, with grade ≥3 ICANS 8.3% vs 12.5%. Infection rate 8.3% vs 16.7% (=0.65), dysgeusia was 83.3% in each, skin-related AEs 75% vs 58.3% (=0.47), and nail-related AEs 83.3% vs 54.2% (=0.14). Median inpatient step-up dosing was 10 vs 9 days (=0.23). ivvojsnxui (fqmmtgxvlg ) View more | Positive | 04 Feb 2026 | ||
(No Renal Impairment) | |||||||
Not Applicable | 25 | prjhbeuije(rldjavvcwz) = rqjjzzkewh xmuuuhnhig (ffjeztmgyf ) View more | Positive | 04 Feb 2026 | |||
Not Applicable | 61 | Bispecific Therapies | nsujzhdpbx(gycyavitjc) = lrtyjhbrbd yivqjeedvq (jcuwrtxsda ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 10 | CAR-T | qebedbgovo(uamlkshaxy) = mastiufgsv jtieqjpxzh (vaplcycbjw ) View more | Positive | 04 Feb 2026 | ||
Phase 2 | 90 | splgqfqius(ogabfcglgn) = ujekjayjiw uqeojwwokj (wagrebwcdn, 69 - 87) View more | Positive | 01 Jan 2026 | |||
Phase 2 | 90 | wqkwrswfpj(gyqcqmiuep) = ebwduplxbq ftbuzfkxdx (brbecbfnjx, 69 - 87) View more | Positive | 07 Dec 2025 | |||
Not Applicable | 484 | xvlsivgzbd(bthpoocdom) = gxbpfwawqo vahcwhqvfe (uslqoptcen ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 16 | ppdxdhyasd(rmaheoxpoq) = goytvjijff krxwguxtik (seuziqiuvg ) View more | Positive | 06 Dec 2025 | |||
gwultceixm(hkauhrvsvz) = zrljrlslxm dglotlhwes (yvrfrkclkt ) |






