Good news|Genuine Biotech-Developed Anti-Tumor Drugs GEN-725 in Combination with Dosimertinib Mesylate Obtained IND Approval

On Sep. 29, 2025, Henan Genuine Biotech Co., Ltd. announced that its independently developed anti-tumor drugs GEN-725 in combination with Dosimertinib Mesylate have been approved by the National Medical Products Administration (NMPA) for clinical trials in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer.

GEN-725 is an anti-tumor drug to which Henan Genuine Biotech Co., Ltd. owns the independent intellectual property rights. Systematic studies have found that the anti-tumor effects of GEN-725 are conveyed by dual mechanisms: 1) as a nucleoside drug, it competes with metabolites to bind or directly binds to enzymes to prevent the proliferation of cancer cells; 2) as an immunomodulator, it exerts an anti-tumor effect by inhibiting the infiltration of myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment and promoting the infiltration and proliferation of CD8⁺ T/NK cells.

Dosimertinib Mesylate Tablets are deuterated derivatives of Osimertinib, which are theoretically more stable than Osimertinib, and can prolong the drug metabolism cycle and reduce the production of toxic metabolites and drug-drug interactions. In the ongoing phase I/II clinical study of Dosimertinib, Dosimertinib monotherapy has shown good safety and efficacy in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer.

The results of non-clinical pharmacology studies of GEN-725/Dosimertinib Mesylate showed that in the mouse xenograft model, boosted or synergistic inhibition of tumor growth was achieved without a significant increase in toxicity. In addition, in vitro pharmacodynamic results showed that GEN-725 was effective against the primary resistance gene C797S to Osimertinib. Therefore, the combination of GEN-725 with Dosimertinib not only offers potential synergy, but also has the potential to provide continued benefits to patients with locally advanced or metastatic non-small cell lung cancer who have progressed after third-generation EGFR-TKI therapy. It is anticipated that in the future, this combination will be further advanced to the first-line setting to more effectively treat EGFR-mutated non-small cell lung cancer and prolong the progression-free survival of the patients.

This IND approval not only reflects the strong R&D strength and prospective strategic layout of Genuine Biotech, but also demonstrates the commitment of Chinese innovative pharmaceutical companies to continuous dedication and breakthroughs in the treatment of complex diseases. With the progress of this clinical study, its results are expected to bring a new and better treatment option for advanced lung cancer.