April 20, 2024

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[THE INVESTOR] Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, said on Aug. 14 that it will begin clinical trials of its drug candidate to treat acute pancreatitis, marking the first study on a new drug after years of biosimilar-focused development.

The potential drug -- SB26, an ulinastatin-FC fusion protein, is a first project that the company is working with Japan’s Takeda Pharmaceutical under a “risk-sharing partnership” the two drug makers had forged in August last year. 

With approval from the US Food and Drug Administration, Samsung Bioepis will initiate randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study which is designed to assess the safety, tolerability and pharmacokinetics of intravenous SB26 in healthy volunteers.

According to the US National Institute of Diabetes and Digestive and Kidney Diseases, there are 275,000 hospitalized patients for acute pancreatitis every year in the US. The global acute pancreatitis therapy market was valued at approximately 5 trillion won (US$4.42 billion) last year.

The move is a part of Samsung Bioepis’ push to have an extensive drug pipeline, which is currently filled with biosimilars -- copy versions of key blockbuster therapies, including Remicade, Enbrel, Humira, Lantus, Herceptin and Avastin.

By Park Han-na (hnpark@heraldcorp.com)