November 26, 2015, Shandong Luoxin Pharmaceutical Group Stock Co., Ltd ( "Luoxin") entered into a collaboration agreement with Shanghai Institute of Materia Medica, Chinese Academy of Sciences (SIMM) and Fudan University (the "Partners") in the area of developing a cancer therapeutic product (the "Product").
Under this Agreement, Luoxin agrees to make payments to the Partners, including immediate cash payments and subsequent progress billings of clinical, regulatory and performance-based payments for an exclusive right to research and development ("R&D"), manufacturing and commercialization of the Product in the People's Republic of China (the "PRC"), Hong Kong and Macau. The rights to the Product in markets beyond the PRC, Hong Kong and Macau will be jointly owned by Luoxin and the Partners. The team will work together to expedite the R&D efforts in all stages of the product development. In addition, the Partners will receive commercial royalty based on certain percentage of the Product sales upon its launch to the market. Upon entering into the Agreement, Luoxin and the Partners are expected to submit an application for Investigational New Drug (IND) to the China Food and Drug Administration (CFDA) and related foreign drug administrative authorities soon.
"R&D focus has always been the top priority of Luoxin, on top of the Group's existing generic drugs, we have strengthened the efforts in R&D of innovative drugs, through collaboration with different partners and in-licensing assets, to further expand the innovative drug product line step by step. The R&D of innovative drugs focuses on oncological, gastrointestinal, respiratory and cardiovascular treatments." said Baoqi Liu, Chairman of the Board of Luoxin. "This collaboration with SIMM and Fudan University on the Drug Development is a major step in the R&D strategy of innovative high-end therapeutics. The organic combination of generic drugs with innovative drugs forms a quality product portfolio with enriched resources, enabling the Group to lay a solid foundation for future development."
The collaborative project will focus on a new and ATP competitive mTOR kinase inhibitor that acts as potent and highly selective dual inhibitor of mTORC1 and mTORC2. The PI3K-AKT-mTOR is an essential signal transduction pathway in the cancer cells and plays a crucial role in controlling the process of tumor formation, growth and resistance to current treatments. Given that about 50% of human tumors occur by abnormal activation of mTOR and the central position of mTOR in the tumor signal network, mTOR-targeted therapy may offer a new treatment strategy for multiple hard-to-treat solid tumors driven by numerous distinct ¡°driver mutations¡± and drug resistance mechanisms . Compared with simple mTORC1 inhibitor, mTOR kinase inhibitor, with its prospect in broadening cancer spectrum and enhancing effectiveness of cancer treatment, may offer enormous clinical application going forward, especially in the fields of treating breast cancer, lung cancer and gastric cancer.
Cancer remains a leading threat to human health nowadays. According to statistics in the World Cancer Report 2014 by the World Health Organization (WHO), there were approximately 14 million new cancer cases in 2012, with 8.2 million mortality cases. China saw approximately 3.12 million new cancer cases, with around 2.2 million mortality cases. New cancer cases in China is estimated to reach 5 million per year by 2025. The five illnesses with the highest incidence and mortality rates are, in order, lung cancer, liver cancer, gastric cancer, colorectal cancer and breast cancer amongst females. Developing countries like the PRC still have a long way to go in catching up the developed countries¡¯ general standard of cancer treatment, and the cancer patients¡¯ need is well short of being sufficiently addressed.
Luoxin is a well-established domestic pharmaceutical company in China, which has the full chain capability of R&D, manufacture, supply, and commercialization. In 2014, sales revenue reached 1B USD. In 2014, Luoxin Shanghai R&D center was set up, with the commitment to enrich current pipelines (generics) with innovative medicines, through in-licensing and strategic partnerships. With the comprehensive capabilities in China market, Luoxin is committed and dedicated to provide good medicines to Chinese patients. For further information, please visit us at www.luoxinbio.com.
Shanghai Institute of Materia Medica (hereafter referred as SIMM), Chinese Academy of Sciences, has the longest history as a comprehensive research institution for drug discovery in China, now located in Zhang Jiang Hi-Tech Park in Shanghai. SIMM was evolved from Peking Institute of Materia Medica, Academia Sinica founded in 1932. In line with frontiers in life sciences and aiming at solving key scientific problems in drug discovery, SIMM carries out both basic and applied studies and develops new theories, methods and technologies. Through several generations¡¯efforts, SIMM has become one of the leading interdisciplinary centers of excellence in China. It is recognized worldwide by its outstanding achievements and distinguished research team.
About Fudan university
Fudan University, founded in 1905, is one of China's most prestigious learning institutions. Fudan is a comprehensive multi-disciplinary Research University with many highly-ranked subject programs. Fudan School of Pharmacy (formerly School of Pharmacy, Shanghai Medical University), located in Zhangjiang High-Tech Park in Shanghai, is one of the internationally well-known colleges for Pharmacy Sciences, with comprehensive research disciplines and specialties, excellent faculty and research facility. The School is charged with producing highly qualified graduates who devote themselves to global biomedical and pharmaceutical research and development and make contribution to world health.