On January 12, it was learned from 3DMed Pharmaceuticals that its New Drug Application (NDA) for Envida (Envorimab Injection), a commercial product, in combination with gemcitabine and oxaliplatin for first-line treatment of unresectable or metastatic biliary tract cancer, has recently been accepted by the National Medical Products Administration (NMPA). This acceptance is based on the results of a Phase III clinical trial. If the NDA is successfully approved, it will become another indication for Envida.

Envita is reportedly the world's first and only approved subcutaneous PD-L1 inhibitor. As 3DMed Pharmaceuticals' first commercialized product, Envita has achieved total sales of over 1.7 billion yuan since its launch, covering more than 3,000 hospitals and 763 pharmacies in 30 provinces across China, and has been included in the "Huiminbao" (a type of health insurance) catalog in 36 cities.

Meanwhile, the company is actively expanding the commercialization of Envita in overseas markets. In 2024, the company reached an agreement with Glenmark, granting Glenmark exclusive licensing rights for the development and commercialization of oncology indications in emerging markets, with milestone payments exceeding $700 million. Currently, 3DMed Pharmaceuticals retains commercialization rights in Europe, the US, and Japan, and is actively pursuing business development (BD) negotiations.

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