Hong Kong, China, March 4, 2022 — Luye Pharma Group today announced that it has filed a New Drug Application (NDA) in Hong Kong, China for Lurꦐbinectedin, for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy. Lurbinectedin is an innovative oncology drug licensed to Luye Pharma by PharmaMar.

The NDA is based on the accelerated approval of Lurbinectedin by the U.S. Food and Drug Administration (FDA) and the provisional marketing approval granted by the Australian Therapeutic Goods Administration (TGA). Those approvals were based on clinical data from an open-label, multi-center, and single-arm study of the drug in 105 adult patients with SCLC (including those who are platinum-sensitive and platinum-resistant) whose disease progressed after receiving platinum-based chemotherapy. In this study, the patients receiving treatment with Lurbinectedin demonstrated an overall response rate (ORR) of 35%, a median duration of response (DoR) of 5.3 months, and a median overall survival (OS) of 9.3 months. Lung cancer is a malignant tumor with high morbidity and mortality rates worldwide, and SCLC accounts 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 prognosis1 . Meanwhile, advancements in the treatment of SCLC have been limited. For over 20 years prior to the accelerated approval of Lurbinectedin by the FDA, the agency approved only one new chemical entity for the treatment of metastatic SCLC, in 1996. In 2019, Luye Pharma was exclusively licensed by PharmaMar to develop and commercialize Lurbinectedin in China, covering all indications including SCLC. In addition, Luye Pharma holds the right to request the transfer of the manufacturing technology for Lurbinectedin from PharmaMar within the valid licensing period, so that Luye Pharma can produce the drug locally in China. “Lung cancer is the most malignant cancer in China in terms of morbidity and mortality2 , and SCLC, in particular, is known for being highly malignant and aggressive, with huge unmet needs from patients,” said Yang Rongbing, President of Luye Pharma Group. “We are pleased to see the filing of the NDA for Lurbinectedin in Hong Kong, China. This is a major milestone in bringing this therapy to Chinese patients. Meanwhile, the clinical trials of Lurbinectedin are underway in Chinese mainland, and we hope that more patients will be able to benefit from this innovative therapy soon.”

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About Lurbinectedin

Lurbinectedin is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia 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 the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. To date, Lurbinectedin has received the accelerated approval in the U.S., and provisional marketing approval in Australia, the United Arab Emirates, Canada, and Singapore, for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after receiving platinum-based chemotherapy.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (Lurbinectedin), in the US and China; and Aplidin® (Plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: Lurbinectedin and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
 

References：
1.  The 2021 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Small Cell Lung Cancer. People’s Medical Publishing House. 2021
2. International Agency for Research on Cancer. Globocan 2020. //gco.iarc.fr/today/data/facts🌜heets/populations/160-china-fact-sheets.pdf.