The board of directors of Luye Pharma Group Ltd. announced that ZEPZELCA (Lurbinectedin or LY01017), a product of the Group licensed from PharmaMar, S.A. has been approved by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy. The product will also benefit patients in mainland China through the Hong Kong-Macao Medicines and Medical Devices Connect policy of the Guangdong- Hong Kong-Macao Greater Bay Area, which allows patients in mainland China to access this globally innovative treatment solution at designated medical institutions in Guangdong Province without leaving the country. 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 (FDA). It was the only new chemical entity approved by the FDA for the treatment of metastatic SCLC in more than 20 years.

The approval of Lurbinectedin in Hong Kong is based on a study conducted overseas. It was an open- label, multicenter, and single-arm Phase II clinical trial in 105 adult patients with SCLC whose condition progressed after receiving the platinum-based chemotherapy. This study also provided evidence for the accelerated approval of Lurbinectedin in the U.S. In this study, patients treated with Lurbinectedin demonstrated an overall response rate (ORR) of 35.2%, with a median duration of response (DoR) of 5.3 months.

In addition to its approval in Hong Kong and Macao, Lurbinectedin is also under review for its New Drug Application in Chinese mainland. Moreover, the drug has been granted a priority review status by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Lurbinectedin is recommended by multiple authoritative guidelines in China and abroad, including the NCCN Guidelines for SCLC (V2.

2024), which recommends this drug as a preferred treatment for SCLC patients with a chemotherapy-free interval (CTFI) 6 months, and the 2023 CSCO Guidelines for SCLC, which recommends it as a second-line treatment for SCLC relapsed within or after 6 months. The Group will continue to promote the registration and commercialization of Lurbinectedin in the Chinese market, so that the product can serve patients with urgent needs as soon as possible.