Pharma

With a band of biotech collaborators, RuiYi sets sail developing new biologic drugs for China

The La Jolla, California, biotech formerly known as Anaphore is looking a little different these days. Under the leadership of former Fate Therapeutics CEO Paul Grayson, Anaphore changed its name to RuiYi Inc., honed its focus from developing broader classes of proteins to new biologic drugs for the Chinese market,  and set up a four-way […]

The La Jolla, California, biotech formerly known as Anaphore is looking a little different these days. Under the leadership of former Fate Therapeutics CEO Paul Grayson, Anaphore changed its name to RuiYi Inc., honed its focus from developing broader classes of proteins to new biologic drugs for the Chinese market,  and set up a four-way collaboration to bring its first rheumatoid arthritis drug to market.

Biotech is growing fast in China, but most of that effort has been in biosimilars and biobetters, Grayson said. That’s a great place to start because those drug classes are generally less risky to develop, but RuiYi wanted to do something that would make it stand out. “We wanted to be novel without being too novel or we would get back into a different risk bucket,” Grayson said.

So it set its focus on a biologic drug for the Chinese market, and went to work evaluating hundreds of different candidates. Near the end of last year, it licensed its first candidate, RYI-008, from biopharmaceutical company arGEN-X BV. The biologic drug is a monoclonal antibody that’s selective to IL-6, a cytokine associated with inflammation and cancer.

“There’s already an approved antibody that targets the receptor; ours targets the cytokine, so you can actually use a lot less,” Grayson said. “It’s a known biologic mechanism, and there’s a lot of data showing that it’s safe and it has the potential to be a big therapeutic in terms of medical need.”

The antibody also has a long half-life, so patients don’t have to take it very frequently, Grayson said. The company is targeting a once-monthly injection to treat rheumatoid arthritis.

RuiYi’s market strategy starts with commercializing the therapeutic in China, where Grayson said the addressable patient population is nearly four times what it is in the U.S. And, only a small percentage of those patients have ever used a biologic therapeutic for RA, instead being treated with NSAIDs, DMARDs and natural remedies instead. Grayson said these factors not only create a solid market opportunity for RuiYi to establish itself in China, but also set the stage for quick enrollment in clinical trials.

Now that it’s got its strategy in line, the company is working with Shanghai company Genor Biopharma to develop the antibody and with biomanufacturer CMC Biologics to develop a cell line that will be used to manufacture it. Grayson said he’s anticipating filing an IND in China within 18 to 26 months.

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The company has set up a lab in China with about 15 employees, who are also working on some of RuiYi’s own pre-clinical drug candidates. It’s operating with the $38 million it raised a few years back from investors including Merck Serono Ventures, 5AM Ventures and Versant Ventures.