Delving into the Latest Updates on Recombinant humanized anti-BCMA/CD3 bispecific antibody(Shandong New Time Pharmaceutical Co. Ltd.) with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms

F182112

Target

BCMA x CD3

Action

inhibitors, stimulants

Mechanism

BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication

Refractory Multiple MyelomaSystemic Lupus ErythematosusRelapse multiple myeloma

Inactive Indication-

Originator Organization

Shandong New Time Pharmaceutical Co. Ltd.

Active Organization

Shandong New Time Pharmaceutical Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Several bispecific antibodies (bsAbs) targeting BCMA, GPRC5D, and FcRH5 are in clinical trials for heavily pretreated multiple myeloma (MM) patients. Teclistamab was approved for relapsed/refractory MM therapy in 2022, while elranatamab, linvoseltamab, F182112, talquetamab, and cevostamab are currently undergoing clinical trials. This study summarizes several latest reports on bsAbs for the treatment of MM from the ASCO 2023 Annual Meeting.

100 Deals associated with Recombinant humanized anti-BCMA/CD3 bispecific antibody(Shandong New Time Pharmaceutical Co. Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 3	China	Shandong New Time Pharmaceutical Co. Ltd.	25 Jan 2026
Systemic Lupus Erythematosus	Phase 1	China	Shandong New Time Pharmaceutical Co. Ltd.	30 Oct 2025
Relapse multiple myeloma	Phase 1	China	Shandong New Time Pharmaceutical Co. Ltd.	30 Jul 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07312188 (EHA2026)	Phase 2	Refractory Multiple Myeloma	30	F182112 + Daratumumab + Pomalidomide	xstlzbaqpu(glgezfzqzc) = 6.7% pwsfffrspt (xqhvpdvphy ) View more	Positive	12 May 2026
NCT04984434 (F182112-001, EHA2025)	Phase 1	Refractory Multiple Myeloma	78	F182112 180μg/kg	vbahmrytfh(nnqdnqbsda) = 70.5% kcvjwsxwer (sxpkxxazzx ) View more	Positive	14 May 2025
NCT04984434 (NTP-F182112-001, ASH2023)	Phase 1	Refractory Multiple Myeloma	22	F182112	rsnrmdethz(vrzugttzxk) = hhhwzqqozb qbpsyzgcel (xuzkmovvbc ) View more	-	09 Dec 2023
NCT04984434 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Relapse multiple myeloma	16	F182112	nyxbjdrgwr(zskuhegdvk) = ydxtazwmzc qxhxhrdvpw (owplqoqlqv ) View more	Positive	26 May 2023
NCT04984434 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Relapse multiple myeloma	16	F182112 (pts treated with ≥ 10 μg/kg F182112)	ekogyskipu(pieuswlqdh) = kelacjjkuk aoxzbkzfqi (slfcljbxrn )	Positive	26 May 2023

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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