[THE INVESTOR] A growing number of Korea’s biotech and pharmaceutical companies are pushing the boundaries of conventional product portfolios that depend heavily on imported therapies and generic drugs.

Encouraged by a series of out-licensing deals and development of biosimilars, more than four companies take aim to go beyond the Korean market with drug candidates in crucial phase 3 clinical trials.

“Various products from the Korean biopharmaceutical industry are undergoing global development programs with improved technology levels since the launch of biosimilars in Europe and the US,” NH Investment & Securities analyst Ku Wan-sung said.

Here’s a list of Korean companies that have potential drugs in phase 3 clinical trials. 

Hanmi Pharmaceutical

Hanmi Pharmaceutical is just ahead of completing phase 3 clinical research on its long-lasting neutropenia drug candidate Rolontis.

“The studies are in the final stage and US partner Spectrum Pharmaceuticals plans to conduct a pre-Biologic License Application meeting in the third quarter to ensure alignment with the US Food and Drug Administration in preparation for a planned BLA filing between October and December,” company official Kim Ji-yoon said.

The three-week long-acting Granulocyte-Colony Stimulating Factor had met its primary endpoint of non-inferiority in duration of severe eutropenia in comparison to Amgen’s Neulasta, a potent rival drug, in earlier trials.

If approved by the US, Rolontis is expected to be the first to reach commercialization stage among out-licensed treatments by Hanmi Pharmaceutical.



Celltrion

To expand its biosimilar portfolio, Celltrion is actively speeding up clinical trials of its versions of AbbVie’s rheumatoid arthritis treatment Humira and Roche’s oncology therapy Avastin.

This month, the company announced updates on the studies of the two drug candidates to kickstart phase 3 clinical programs.

Celltrion plans to initiate the final-stage studies of CT-P16, its biosimilar referencing Avastin at 150 sites in the EU and Latin American countries.

Humira’s copy version CT-P17 will undergo phase 3 studies at 75 sites in eight countries from this month, aiming to complete it by 2020.



SillaJen

SillaJen’s lead clinical candidate Pexa-Vec, an oncolytic virus vaccine designed to kill cancer cells, is undergoing phase 3 clinical trials in China to treat patients with liver cancer. China is an important market for research and commercialization of Pexa-Vec as approximately 50 percent of liver cancer occurs in the country. China Oncology Focus, SillaJen’s partner which owns rights to Pexa-Vec in China, is in charge of the studies.



ViroMed

ViroMed’s lead drug candidate VM-202 has been undergoing phase 3 clinical studies as a treatment for ulcers since the first patient was dosed in August last year. In a bid to accelerate the clinical program, ViroMed CEO Kim Sun-young held a meeting with over 70 researchers in Chicago, Aug. 9.

“Since there is no precedent in gene therapy for diabetic foot ulcers, I would like to share opinions and help medical staff through this meeting. We have laid the groundwork,” Kim said. So far, a total of 22 patients have enrolled for the program.


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