On September 29, 2025, Henan Genuine Biotech Co., Ltd. announced that its self-developed anti-tumor drug GEN-725 in combination with doxitinib mesylate has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations.
GEN-725 is an anti-tumor drug developed by Henan Genuine Biotech Co., Ltd. with independent intellectual property rights. Systematic studies have revealed that GEN-725 exerts its anti-tumor effects through a dual mechanism: (1) as a nucleoside analog, it competes with metabolites or directly binds to enzymes, preventing cancer cell proliferation; (2) as an immunomodulator, it inhibits the infiltration of myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment and promotes the infiltration and proliferation of CD8⁺ T cells and NK cells, thereby exerting tumor-suppressive effects.
Doxitinib mesylate tablets are a deuterated derivative of osimertinib. Theoretically, they offer better stability compared to osimertinib, prolong the drug metabolism cycle, and reduce the generation of toxic metabolites and drug-drug interactions. In the ongoing Phase I/II clinical study of doxitinib monotherapy in patients with EGFR mutation-positive locally advanced or metastatic NSCLC, doxitinib has demonstrated favorable safety and efficacy.
Non-clinical pharmacological study results of the GEN-725/doxitinib mesylate combination indicate that, in mouse xenograft tumor models, the combination produced additive or synergistic inhibition of tumor growth without significant increases in toxicity. Additionally, in vitro pharmacodynamic results show that GEN-725 is effective against the major osimertinib resistance mutation C797S. Therefore, the combination of GEN-725 and doxitinib not only has the potential to enhance efficacy but also offers the possibility of continued benefit for patients with locally advanced or metastatic NSCLC who have progressed after third-generation EGFR‑TKI therapy. In the future, this combination could potentially be advanced to first-line treatment, more effectively managing EGFR mutation-positive NSCLC and prolonging progression‑free survival.
The receipt of this clinical trial approval not only demonstrates Genuine Biotech's strong R&D capabilities and forward-looking strategic layout but also reflects the determination of Chinese innovative pharmaceutical companies to continuously explore and break through in the field of complex disease treatment. As the clinical study progresses, its outcomes are expected to bring new and better treatment options for patients with advanced lung cancer.