Gelonghui October 30 | 3D MEDICINES (01244.HK) issued an announcement. On October 28, 2023, the US Food and Drug Administration (FDA) approved the company to launch its first commercial product, EnvedaPhase III multi-country, multicenter, randomized, open-label clinical study with lenvatinib versus carboplatin-paclitaxel chemotherapy for first-line treatment of patients with advanced or recurrent endometrial cancer with mismatch repair (pMMR). This approval marks EnvidaGreat progress has been made in global development.
EnvidaIn February 2017, it was approved by the FDA to complete the world's first patient medication, then clinical studies were carried out in China and Japan. The first indication was approved for marketing in China in 2021. As of June 30, 2023, EnvidaThe cumulative sales since commercialization was 980.2 million yuan. A number of clinical trials for registration of indications are currently underway. The board believes that EnvidaAs the only new drug for subcutaneous PD-1/PD-L1 antibody approved for marketing in the world, it has obvious differentiation advantages and an opportunity to provide more treatment options for cancer patients around the world.