TQ Biopharma Submits IND for Subcutaneous EGFR×c-Met Bispecific Antibody TQB2922 in China

On November 18, the CDE website showed that CHIATAI TIANQING had submittedTQB2922 Injection (Subcutaneous Injection)Received implied permission for clinical trials, with indications forMonotherapy and Combination with 3rd Generation EGFR-TKI Drugs for the Treatment of Advanced Malignant Tumors。

Screenshot source:CDE Official Website

TQB2922 is a humanized bispecific antibody that targets both EGFR and c-Met. This drug not onlyTumor growth and progression can be inhibited by blocking the activation of EGFR and c-Met signaling pathways. Additionally, tumor cells can be targeted through antibody-dependent cellular cytotoxicity (ADCC) mediated by natural killer cells and macrophages, as well as antibody-dependent cellular phagocytosis (ADCP), targeting EGFR and c-Met on the surface of tumor cells to kill them.

Previously, the intravenous formulation of TQB2922 has been approved for clinical trials in China and is currently undergoing two clinical studies:

• One is a single-arm trial（CTR20234256）, the main purpose is to evaluate TQB2922 inAdvanced Malignant TumorSafety and Tolerability in Subjects, Determine Dose-Limiting Toxicity（DLT）、Maximum Tolerated Dose(MTD) (if any)；

• Another is a Phase Ib/II clinical study（CTR20252141）, aimed to evaluate TQB2922 and chemotherapy with or without bevacizumab in patients who failed chemotherapy.RAS/BRAF Wild-Type Advanced Colorectal CancerThe safety, tolerability, and efficacy of the subjects.

Summary

Insight database shows that, in the EGFR×c-Met bispecific antibody track, globally, there are currently onlyJohnson & Johnson's Amivantamab IV and Subcutaneous Formulations Approved。In China, the intravenous formulation of Amivantamab has been approved, and the subcutaneous formulation has been submitted for marketing approval.

Currently, multiple EGFR×c-Met bispecific antibodies have entered the clinical stage in China, from Primus/Hansoh Pharma.(Phase III)、EpimAb Biotherapeutics(Phase II)、Merus/Beida Pharmaceuticals(Phase II)、Hengrui(Phase Ⅰ/Ⅱ), CHIATAI TIANQING(Phase Ⅰ/Ⅱ)Companies such as. Among them, Hengrui and CHIATAI TIANQING have both developed intravenous and subcutaneous injection formulations.

In addition, there areSome companies have laid outEGFR×c-Met Tri-specific Antibody, wherein: Genor Biopharma Co., Ltd.GB263T is currently under development.Phase Ⅰ/Ⅱ Clinical Trials; BeOne MedicinesBG-T187 Intravenous Formulation is Currently in Phase I Clinical Trials, and the Subcutaneous Injection Formulation Has Also Been Approved for Clinical Trials.

[1] CDE Official Website

[2] CHIATAI TIANQING Official WeChat

[3] DXY Insight Database

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