PharmaMar and Luye Pharma's NDA for lurbinectedin accepted in China

12 June 2023

Spanish drugmaker PharmaMar (MC: PHM) and China-based Luye Pharma (SEHK: 2186) have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

The drug is intended for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy.

In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in SCLC, and potentially in other indications in mainland China, Hong Kong and Macao.

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