The application for clinical trial of the MCLA-129 injectable drug from Beda Pharmaceuticals was accepted

On January 11, Beda Pharmaceuticals announced that it had received the "Notice of Acceptance" issued by the State Drug Administration (acceptance number: CXSL2100011), and that the company's application for a clinical trial of MCLAU-129 injections (hereinafter referred to as "the Clinical Trial") had been accepted by the State Drug Administration.
MCLA-129 is a dual-specific antibody for both EGFR and c-Met targets intended for use in the treatment of patients with advanced solid tumors with EGFR or MET abnormalities.
January 2019, the Company announced a strategic partnership with MeluS N.V. (NDAQ:MRUS, "Merus Company"), which obtained exclusive implementation licenses for the development and commercialization of MCRA-129 in China and is responsible for CMC-related work, and Merus retains all global interests outside China.
generally speaking, patients develop access resistance after receiving EGFR inhibitors for a certain period of time, and c-Met amplification or over-expression is a common molecular biological mechanism for access resistance.
MCLA-129 preclinical data show that MCLA-129 can be combined with NSCLC cell line with different EGFR/c-Met expression levels and different EGFR mutation types, showing good anti-tumor effect in animal solid tumor transplantation models, and good physical and pharmacological properties and safety.
MCLA-129 is expected to effectively address EGFR inhibitor resistance caused by a variety of mechanisms, especially c-Met amplification or over-expression, with the potential to provide benefits to patients with drug-resistant NSCLC.
As of the date of disclosure of this announcement, Amivantamab, the EGFR/c-Met dual-specific antibody of Johnson and Johnson Group Jansen, filed a Biological Product Licensing Application (BLA) and Marketing Authorization Application (MAA) with the FDA and EMA of the United States in December 2020, respectively, for the treatment of metastasis non-small cell lung cancer patients with EGFR exon 20 insertion mutations.
other similar drugs at home and abroad are in the pre-clinical or clinical trial stage, there is no drug on the market.
MCLA-129 belongs to therapeutic biological products which are not listed at the domestic or foreign level, and their registration is classified as a class 1 biological products for therapeutic use.