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Home Qilu Pharmaceutical's Trispecific Antibody QLS4131 Expands from Oncology to Autoimmunity with New Clinical Approval for Systemic Lupus Erythematosus

Qilu Pharmaceutical's Trispecific Antibody QLS4131 Expands from Oncology to Autoimmunity with New Clinical Approval for Systemic Lupus Erythematosus

May 06, 2025 10:17 CST Updated 10:17
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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On May 6, the CDE website showed that Qilu Pharmaceutical Co., Ltd.QLS4131 for Injection Approved for Clinical Use,Used forSystemic Lupus Erythematosus。
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ScreenshotSource: CDE Official Website
According to publicly available data,QLS4131 is a BCMA/GPRC5D/CD3 trispecific antibody. The drug was first applied for clinical trials in China in May 2024, and it was initially approved for clinical trials in July 2024, intended for use inMultiple Myeloma。
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ScreenshotSource: 2025 AACR Poster
At the 2025 AACR Annual Meeting, Qilu Pharmaceutical disclosed the early development data of this drug. Compared with Johnson & Johnson's JNJ-79635322(BCMA/GPRC5D/CD3 Tri-specific Antibody)In comparison, QLS4131 exhibits higher affinity for multiple myeloma tumor cell lines and effectively clears dual targets.(BCMA and GPRC5D)And Single-Target(BCMA or GPRC5D)Expressing cells,Its cytotoxicity is significantly higher than that of JNJ-79635322.。
Currently, the Phase I dose-escalation study of QLS4131 for the treatment of multiple myeloma is underway.(NCT06500507). This clinical approval meansQLS4131 From the Oncology Field to the Autoimmune Field。
Insight database shows that currently, there are a total of 12BCMA/GPRC5D/CD3 Tri-specific Antibody Pipeline Under Research(Only active status is counted), five of which have initiated clinical trials, respectively from Tian Guangshi/Kangyuan Bochuang (MBS314), Innovent (IBI3003), Qilu (QLS4131), Simcere (SIM0500) and Johnson & Johnson (JNJ-79635322）。
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ScreenshotSource: Insight Database
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Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.

Editor：ccai
PR Article Coordination: WeChat insightxb
SubmissionWeChat: insightxb; Email: insight@dxy.cn
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