News Center
04-28 2019

Luye Pharma and PharmaMar Sign Licensing Agreement for the Development and Commercialization of Zepsyre® in China

Author:Luye Life Sciences



On April 26, Luye Pharma Group announced an agreement with Pharma Mar S.A (“PharmaMar”) to develop and commercialize a Phase III new innovative anti-cancer drug: Zepsyre® (Lurbinectedin).

According to the terms of the agreement, Luye Pharma will have exclusive rights to develop and commercialize Zepsyre® for Small Cell Lung Cancer and all other indications in China. In addition, Luye Pharma will have the right to request transfer of manufacturing technology for Zepsyre® to the company in China for the duration of the agreement.

Zepsyre® has been granted orphan drug designation by the U.S. FDA

Zepsyre® is a compound currently under clinical investigation. It is an inhibitor of RNA polymerase II, an enzyme essential for the transcription process, and which is over-activated in cancerous cells with transcription addiction. On 3 August 2018, PharmaMar announced that Zepsyre® had been granted orphan drug designation by the U.S. FDA for the treatment of patients with Small Cell Lung Cancer.

Oncological disease is a major cause of death in China. According to the World Health Organization, lung cancer in China was the leading cause of malignant tumors in 2018, with incidence reaching 774,000 and mortality at 690,000 the same year. Meanwhile, it is estimated that lung cancer cases represent approximately 18% of all cancer cases in China. According to the National Comprehensive Cancer Network (NCCN), Small Cell Lung Cancer (SCLC) accounts for 14% of the overall incidence of lung cancer.

Luye Pharma joins forces with innovative companies to serve more cancer patients worldwide

The collaboration with PharmaMar marks another milestone for Luye Pharma in the company’s ongoing commitment to global deployment in oncological therapy. Headquartered in Madrid of Spain, PharmaMar is a world-leading biopharmaceutical company involved with the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program.

Rongbing Yang, President of Luye Pharma Group, said of this new licensing deal: “This agreement with PharmaMar enables us to address the treatment of this type of disease in China, which is much more widespread than in the US and Europe. Oncology is one of the core therapeutic areas for Luye Pharma’s long-term development. We will continue to increase investment to further enrich our oncology pipeline and enhance our competitiveness in this field of treatment, through external partnerships with more innovative companies such as PharmaMar and also through our in-house R&D innovation.”

Luye Pharma has recently made several positive developments with its oncology product pipeline expansion. The company’s independently developed drugs such as Goserelin Acetate Extended-release Microspheres for Injection (LY01005) have entered phase III clinical trials for prostate cancer in China, and phase I trials in the U.S.; LY01013, a IDO/TDO dual-target inhibitor, has been approved for Phase I clinical trials in China; LY01008, a Bevacizumab analog indicated for colorectal cancer and non-small cell lung cancer is progressing smoothly with its Phase III trials, and LY01011, a biosimilar for Xgeva for the treatment of multiple myeloma and bone metastases induced by solid tumors has been approved for clinical trials.

In addition, the company has launched a series of collaborative research and development projects with global leading biotech companies to jointly develop the next generation of therapeutic antibodies for use in immuno-oncology and CAR-T therapy. At present, Luye Pharma has more than ten innovative formulations and drugs in this therapeutic field currently in different stages of clinical development in China and overseas markets.

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