South Korean pharmaceutical companies are in the spotlight for their achievement in new drug development. In particular, not a few companies are gaining momentum in their entry into overseas markets after Hanmi Pharmaceutical Co. set a new milestone in the once-struggling industry by capturing license deals worth more than 8 trillion won last year.

Yuhan Corp. recently teamed up with Sorrento Therapeutics, Inc., a U.S. antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, to form a joint venture called ImmuneOncia, reflecting the Korean company’s willingness to compete in the global market with immunotherapies. Yuhan invested $10 million to own a 51 percent stake in ImmuneOncia, with the remaining stake held by Sorrento.

ImmuneOncia will develop and commercialize a number of immune checkpoint antibodies against undisclosed targets for both hematological malignancies and solid tumors. The joint venture is expected to play a pioneering role in research of immuno-oncology drugs, which emerge as a new paradigm to treat cancer.

Green Cross Corp. also inked a massive contract to export its flu vaccines to the Pan American Health Organization (PAHO) of the World Health Organization. The $32 million order marks the single largest vaccine export deal on record in Korea. As a result, Green Cross took the top spot in terms of market share in Latin America’s flu vaccine bidding market five years after it made first inroads into overseas markets.

Moreover, Korean biopharmaceutical company Celltrion Inc.’s biosimilar product Remsima is much closer to marketing approval in the U.S. The drug received approval recommendation from the FDA’s advisory panel with a 21 to 3 vote. Supporting panel members said the product is proven comparable with the reference drug Remicade of Johnson & Johnson (Janssen) in RA, ankylosing spondylitis, ulcerative colitis, psoriasis and psoriatic arthritis. It would be the first entry of a Korean made biosimilar into the U.S. market when Remsima is finally approved by the FDA in April.

Besides Celltrion, Green Cross and SK Chemical are very likely to win approval from the FDA. Green Cross submitted an NDA to the FDA last November seeking approval for marketing of immunoglobulin IVIG-SN and passed a preliminary review in January. IVIG-SN has been used widely to treat immune- and inflammation-related diseases, such as auto-immune diseases, severe infections and bone-marrow transplants. SK Chemical filed for marketing approval of NBP601, an investigational biologic to treat hemophilia last July. The biologic is a new drug with improved efficacy compared with existing drugs. It has yet to pass a preliminary review.

In January, Samsung Bioepis Co. received final marketing approval of its biosimilar product Benepali from the European Commission. It is the first marketing approval overseas for Samsung Bioepis since its inception in February 2012. The drug can be sold in 28 EU members and the three EEA members.

Benepali is a biosimilar version of Enbrel, which is known to be effective to treat RA, psoriatic arthritis and axial spondyloarthritis.

By Kim Ki-chul

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