The board of directors of Luye Pharma Group Ltd. announced that the Group has submitted a New Drug Application for Lurbinectedin for injection, a product of the Group licensed in from PharmaMar, S.A. in Macao, China, for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after receiving platinum-based chemotherapy. Lurbinectedin is a selective inhibitor of oncogenic transcription. Its unique dual-action mechanism allows it to regulate the microenvironment for tumors, while inhibiting oncogenic transcription and leading to the apoptosis of cancer cells.

In 2020, Lurbinectedin received the Accelerated Approval from the United States Food and Drug Administration for the above indication. The NDA filed in Macao is based on data from two clinical studies of Lurbinectedin conducted in China and overseas. The study conducted overseas is an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC (including platinum-sensitive and platinum-resistant ones) whose disease progressed after receiving platinum-based chemotherapy).

In this study, patients treated with Lurbinectedin demonstrated an overall response rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months. The study conducted in China is a single-arm, dose-escalation, and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced solid tumors including relapsed SCLC. The results of the study showed promising efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients.

An independent review committee confirmed the ORR was 45.5% in subjects with relapsed SCLC. Lung cancer is a malignant tumor with high morbidity and mortality rates worldwide, and SCLC is estimated to account for 13%-17% of all lung cancer cases. SCLC is highly likely to metastasize to distant sites within the body in early stages, and patients are often already in an advanced stage upon diagnosis, resulting in poor prognosis.

Meanwhile, advancements in the treatment of SCLC have been limited. For over 20 years prior to the accelerated approval of Lurbinectedin by the U.S. FDA, the agency approved only one new chemical entity for the treatment of metastatic SCLC in 1996. Currently, Lurbinectedin is also being reviewed for its NDA in the mainland China and Hong Kong SAR of China.

Moreover, the drug is available to Chinese patients for urgent clinical use at designated medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone and through the Named Patient Program in Hong Kong. The Group will continue to promote the registration and commercialization of Lurbinectedin In the market of China, so that the product can serve patients with urgent needs as soon as possible.