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May 16, 2013

RuiYi Licenses mAb Development to China's Genor

  • RuiYi said today that it will co-develop its monoclonal antibody RYI-008 in China with a Chinese-owned partner, Genor Biopharma, under an exclusive license and collaborative development whose value was not disclosed.

    “The team at Genor has deep global development experience and strong commercial, regulatory, and government relationships in China, making them the ideal development partner,” Paul Grayson, RuiYi’s president and CEO, said in a statement. “We look forward to working with them to deliver novel, breakthrough therapeutics for the Chinese healthcare system.”

    The agreement comes just two days after RuiYi announced it would accelerate development of a cell line for RYI-008 by using the CHEF1® high-productivity expression plasmid of CMC Biologics, in a separate collaboration whose value was also not disclosed. RuiYi is eager to launch RYI-008 in the world’s most populous nation as a treatment for cancer and autoimmune diseases—especially rheumatoid arthritis, which affects some 4.1 million Chinese patients naïve to biologic treatment, as Grayson noted in the statement.

    RuiYi envisions treating these and other patients with a once-monthly, low-milligram, subcutaneous dose of RYI-008, which is highly selective to IL-6, a cytokine widely implicated in inflammation and cancer.

    "The clinical data on IL-6 modulation continues to be extremely favorable in multiple diseases,” Joe Zhou, Genor’s CEO, said in the statement.

    Genor has drawn about $30 million in total investment since it was founded in December 2007. The company focuses on development and commercialization of therapeutic mAbs and Fc-fusion proteins, and has more than 10 products in its pipeline—three of them at IND and clinical stages. Those include lead product GB221, a biosimilar being developed in-house to fight cancer, which has finished Phase I testing.

    Genor has a team of approximately 110 employees, and maintains a 6,000 square-meter (about a 64,580-square-foot) R&D center, which includes R&D and process development labs, an analytical and quality center, and a cGMP clinical production facility. A commercial-scale cGMP production facility is in planning stages.

    RuiYi company is developing RX under an exclusive global commercialization license from Belgian-owned arGEN-X, which discovered RUI-008 and previously named it ARGX-109. In October, RuiYi agreed to take over development of the molecule in return for an undisclosed up-front payment to arGEN-X consisting of cash and equity.

    In addition to RYI-008, RuiYi’s pipeline includes two monoclonal antibodies that target G protein-coupled receptors (GPCRs). Both were developed internally, using the company's intramembranous Conformation Antigen Presenting (iCAP) system and other technologies.

    Headquartered in La Jolla, CA, RuiYi—which changed its name in October from Anaphore—carries out drug discovery in China, at the Zhangjiang Hi-Tech Park in Pudong, Shanghai. 


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