Gensci's VEGFR2 mAb NDA Accepted by NMPA
Time
2026-07-30
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Recently, the marketing application for GS043-01 injection has been accepted by the National Medical Products Administration (NMPA), marking the first locally developed monoclonal antibody targeting vascular endothelial growth factor receptor 2 (VEGFR2) to enter the NDA review process in China. It is proposed for use in combination with paclitaxel in the treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma after failure of first-line therapy.
Gastric cancer remains one of the most prevalent malignancies, ranking fifth worldwide in both incidence and mortality[1]. In China, more than 80% of patients with gastric cancer are diagnosed at an advanced stage, resulting in poor prognosis[2]. Over the past decade, progress in second-line treatment options for advanced gastric cancer has remained limited, and current treatments include single-agent chemotherapy or the combination of paclitaxel and ramucirumab, highlighting a significant unmet medical need for additional effective therapeutic options.
GS043-01 is a recombinant human-mouse chimeric monoclonal antibody which specifically targets VEGFR2 to block the VEGF-VEGFR2 signaling pathway, thereby inhibiting tumor angiogenesis and growth. In the phase 3 clinical trial, a randomized, double-blind and parallel-controlled study was conducted, in which 754 patients were involved, demonstrating the efficacy and safety of GS043-01. The study results showed that the treatment regimen successfully achieved its primary endpoint of overall survival(OS) with statistically significant efficacy.
The NDA acceptance of GS043-01 marks a pivotal milestone in GenSci's rapidly expanding oncology portfolio. GenSci will remain committed to bringing innovative treatment options to cancer patients.
Disclosure Notice：
1. Innovative drug development entails high risks, and the outcome of regulatory review remains uncertain.
2. This press release is provided as a medical information source for healthcare experts only and is not used for commercial purposes.
3. GenSci does not recommend the use of any unapproved drugs or indications.
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