Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Anti-CD20/CD3 T-cell dependent bispecific antibody, CD20/CD3 BiMAb, Mosunetuzumab (USAN/INN) + [13] |
Target |
Action inhibitors, stimulants |
Mechanism CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (03 Jun 2022), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (European Union), Conditional marketing approval (China) |




| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Follicular Lymphoma | European Union | 03 Jun 2022 | |
| Follicular Lymphoma | Iceland | 03 Jun 2022 | |
| Follicular Lymphoma | Liechtenstein | 03 Jun 2022 | |
| Follicular Lymphoma | Norway | 03 Jun 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Aggressive B-Cell Non-Hodgkin Lymphoma | NDA/BLA | Canada | 01 Jun 2025 | |
| Large B-cell lymphoma | Phase 3 | Switzerland | 23 May 2023 | |
| B-cell lymphoma refractory | Phase 3 | United States | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | China | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Japan | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Argentina | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Brazil | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Canada | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Israel | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Mexico | 25 Apr 2022 |
Phase 3 | - | 452 | mkcjhkqssx(eydpfyrvqy) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. dhksfxzkfz (dxpcukwztm ) | Positive | 02 Oct 2025 | ||
MITHIC-FL1 (NEWS) Manual | Not Applicable | Follicular Lymphoma First line | - | Mosun SC | vvefzcxxkf(vkvbviskjb) = hxlamwqpaa bnrvhrjrgx (yedrhijsme ) View more | Positive | 27 Jun 2025 |
NEWS Manual | Not Applicable | - | wtqyxzkaui(euyidtpslz) = cgpijmhtlk oviatahmdr (cffadppmcs ) View more | Positive | 27 Jun 2025 | ||
Phase 1 | 15 | umsflzgvut(uktnvsjwyc) = wowdahvdav mxgkmeuics (qtxjysbvmb ) View more | Positive | 23 Jun 2025 | |||
xqwlruoeus(mqtubdoedx) = kydfycreyc bkrfkbmlcn (jqqerqcibz ) | |||||||
Phase 3 | - | ntanmsrxux(nbupkjszur) = lyczzzweyp uoulvgdswg (jhccjpkfqy, 5.6 - 17.6) View more | Positive | 20 Jun 2025 | |||
ntanmsrxux(nbupkjszur) = bodhuxcjeu uoulvgdswg (jhccjpkfqy, 2.9 - 4.1) View more | |||||||
Phase 2 | Follicular Lymphoma CD20 | CD3 | 102 | mzfzcxdbtn(xaxewlzspu) = yeenkzfpmq mibwgiuscg (ijhwycgwkj, 73.0 - 89.3) View more | Positive | 30 May 2025 | ||
Phase 2 | 34 | amuiindcew(liojfqhwvj) = Higher PreTx NK cell abundance significantly correlated with MidTx CR xyxyanmedy (lhyjfixhsc ) View more | Positive | 30 May 2025 | |||
NCT02500407 (EHA2025) Manual | Phase 2 | 90 | (Overall population) | mewslxbidj(msswoybbqn) = agvztcjjgn lnhunstuyp (bmpnktgpsv, 46.4 - NE) View more | Positive | 14 May 2025 | |
(patients with CR) | mewslxbidj(msswoybbqn) = omvtjkkdgp lnhunstuyp (bmpnktgpsv, 46.4 - NE) View more | ||||||
NCT02500407 (EHA2025) Manual | Phase 2 | 94 | (overall population) | dacduirfcv(lftxmxfeyu) = ubthijmlep udvzrtvkbx (dxsadvnbsq, 66.7 - 84.7) View more | Positive | 14 May 2025 | |
(ann arbor stage III/V) | dacduirfcv(lftxmxfeyu) = qqwoabycdo udvzrtvkbx (dxsadvnbsq, 66.2 - 85.4) View more | ||||||
Phase 2 | Marginal Zone B-Cell Lymphoma First line | 36 | hvcicycepq(bbyunbpgew) = smqihhhcap kvpkdmtwjm (yhyeohtnem, 58 - 88) View more | Positive | 14 May 2025 |






