The group's wholly-owned subsidiary, Livzon Pharmaceutical Science and Technology (Shanghai) Co., Ltd., has seen its self-developed innovative drug, Vitecetumab "CLDN18.2 ADC" (R&D code: LM-302), accepted for review by China's Center for Drug Evaluation (CDE) following a new drug marketing application submission.
The application is for the treatment of CLDN18.2-positive, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior lines of systemic therapy.
On May 22, this specific indication was included in the CDE's priority review and approval process.
LM-302 is an antibody-drug conjugate targeting CLDN18.2, composed of a recombinant humanized monoclonal antibody conjugated with the small molecule toxin MMAE.
LM-302 not only precisely identifies CLDN18.2-positive tumor cells, but the MMAE it carries also exhibits a "bystander effect," capable of further eliminating surrounding tumor cells with low or heterogeneous expression.
Additionally, LM-302 can induce immunogenic cell death, and when combined with PD-1 monoclonal antibodies, it demonstrates a synergistic anti-tumor effect, providing an important mechanistic foundation for "ADC + immunotherapy" combination treatment.
The acceptance of this LM-302 marketing application is based on positive results from a pivotal Phase III clinical study.
This study evaluated the efficacy and safety of LM-302 monotherapy for third-line or later treatment of CLDN18.2-positive locally advanced or metastatic GC/GEJ.
The study has completed an interim analysis and met its two primary endpoints, with the relevant research data scheduled for formal presentation at an international academic conference in early 2027.
Beyond the third-line or later GC/GEJ indication currently under application, LM-302 is also undergoing a pivotal Phase III clinical study evaluating its combination with a PD-1 monoclonal antibody for the first-line treatment of CLDN18.2-positive locally advanced or metastatic GC/GEJ.
Both of these indications have been designated as Breakthrough Therapy by the CDE.
Concurrently, LM-302 has received three Orphan Drug Designations from the U.S. Food and Drug Administration, covering three cancer types with high unmet clinical needs: gastric cancer, pancreatic cancer, and biliary tract cancer.
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