Luye Pharma : Announces the Approval of Lurbinectedin for the Treatment of Relapsed Small Cell Lung Cancer in Hong Kong

• Lurbinectedin is a new chemical compound with a novel mechanism of action. It's been the only new chemical entity approved by the U.S. FDA for the treatment of relapsed SCLC over the past 26 years.
• Lurbinectedin has been approved in Hong Kong and Macao. Its NDA is also under review in Chinese mainland, where patients will be able to get access to this innovative therapy soon at designated healthcare institutions in Guangdong via the Greater Bay Area Initiative.

Shanghai, China, December 12, 2023 - Luye Pharma Group today announced that ZEPZELCA^®(Lurbinectedin) 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.

Lurbinectedin is a new chemical compound with a novel mechanism of action. In 2020, it received the accelerated approval from the U.S. Food and Drug Administration (FDA) for the above indication. It was the only new chemical entity approved by the FDA for the treatment of relapsed SCLC during the 26-year period after 1997.

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%, and a median duration of response (DoR) of 5.3 months.

Dr. Leung Kwong Chuen, Clinical Oncologist and Clinical Associate Professor (Honorary) at the Department of Medicine and Therapeutics of the Chinese University of Hong Kong said:" In Hong Kong, lung cancer has the highest mortality rate among all cancers, especially SCLC, which is notoriously difficult to treat because it's highly malignant and invasive. Most patients would develop drug resistance and experience a relapse after receiving the initial treatment. Meanwhile, there has been very limited progress in the treatment of this disease, with almost no substantial breakthrough in more than two decades. The approval of Lurbinectedin will provide a new treatment option for physicians. I believe that this drug will become a new second-line treatment for SCLC, to help improve patient outcomes."

In addition to its approval in Hong Kong and Macao, Lurbinectedin is also under review for its New Drug Application (NDA) 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 (V1. 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.

Yang Rongbing, President of Luye Pharma Group, said: "Lung cancer is the No.1 malignant cancer in China in terms of morbidity and mortality rates, and SCLC is a subtype of lung cancer that is relatively difficult to treat. It is pressing to address the unmet treatment needs of patients. We're excited to see the approval of Lurbinectedin in Hong Kong shortly after its approval in Macao. We'll take multiple measures simultaneously to make Lurbinectedin available to more patients by, for example, taking advantage of the Greater Bay Area Initiative, which is designed to make pharmaceuticals and medical devices registered in Hong Kong and Macao available to patients throughout the Guangdong-Hong Kong-Macao Greater Bay Area."

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About Lurbinectedin

Lurbinectedin is an analog of the marine compound ET-736 isolated from sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of tumors.

In 2020, Lurbinectedin received the accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy. After that, the drug was also approved in several other countries. Luye Pharma owns the relevant rights to Lurbinectedin in China.

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.