South Korea’s biopharmaceutical companies have had a mixed licensing record this year, with some striking major license-out deals and others losing their contracts over reporting issues related to clinical trials.

Last week, HanAll BioPharma — an affiliate of Seoul-based Daewoong Pharmaceutical — and Genexine both sealed licensing deals for their drug candidates with foreign pharma firms, raising market expectations for the two Korean drugmakers.

HanAll Biopharma has licensed out the development of its new drug candidate for autoimmune diseases -- caused when the body’s immune system mistakenly attacks its own healthy cells -- to Roivant Sciences in a deal valued at $502.5 million.

The drug candidate -- HL161BKN -- fights autoimmune diseases by inhibiting the neonatal Fc receptor, or FcRn, that allows autoantibodies to be retained in the body.

HanAll Biopharma said Tuesday that it has received an upfront payment of $30 million from Roivant Sciences, and is due to receive $20 million in research and development expenditure and $452.5 million as development milestones.

Under the deal, Roivant Sciences holds the exclusive rights to develop and commercialize HanAll BioPharma’s drug candidate in North America, Latin America, Europe, the Middle East and North Africa.

HL161BKN, currently undergoing phase 1 clinical trials in Australia, is expected to treat autoimmune disorders such as myasthenia gravis, pemphigus, chronic thrombocytopenia and neuromyelitis optica.

Likewise, Seoul-based Genexine signed an exclusive licensing agreement worth $548 million with China’s I-Mab Biopharma to develop and commercialize its immuno-oncology drug candidate HyLeukin. News of the deal last week led the firm’s shares to soar by around 30 percent.

According to the agreement, Shanghai-based I-Mab Biopharma will pay an upfront payment of $12 million as well as 548 million in development milestone payments to Genexine. The Korean drugmaker is subject to receive additional sales royalties once the drug is commercialized.

HyLeukin is an immuno-oncology drug candidate that comprises of a genetically modified Interleukin-7 molecule based on Genexine’s proprietary long-acting platform technology, hyFc. The proposed drug is designed to target cancer, lymphocytopenia and infectious diseases, according to the firm.

At the same time, Kolon Life Science -- the biopharma unit of Korea’s Kolon Group -- took a major hit last week as its Japanese partner decided to terminate a licensing deal signed last year over negligent reporting on clinical trials of its drug candidate.

Mitsubishi Tanabe Pharma is seeking to cut ties with Kolon, which holds the Asia license for the novel osteoarthritis drug Invossa, originally developed by Kolon’s US subsidiary TissueGene.

The Japanese drugmaker has asked Kolon to return the upfront payment of $24 million and cancel the licensing deal altogether, citing that the Korean firm failed to report that its phase 3 clinical trials had been put on hold by the US Food and Drug Administration.

Mitsubishi Tanabe Pharma also claimed that Kolon did not provide proper information on a change in the manufacturer of the drugs being used for the clinical trials to be initiated in the US.

However, Kolon argues that it has sufficiently informed its Japanese partner of the manufacturing changes. It also asserts that the USFDA’s decision was simply a procedural step needed in obtaining US FDA approval and not related to the drug’s effectiveness or safety.

“The termination of the licensing deal between Mitsubishi Tanabe Pharma and Kolon Life Science will not impact Invossa’s phase 3 clinical trials in the US. We are smoothly preparing the trials in line with our agenda,” a TissueGene representative said.

While a slew of early-stage drugs are being licensed out, the biopharma unit of Korea’s SK Group is drawing closer to launching a new sleep disorder drug it has developed to the US market.

Last Friday, SK Biopharmaceuticals said it has filed a new drug application for SKL-N05 (solriamfetol), a novel sleep disorder drug, to the US FDA.

SKL-N05, which was licensed out to Jazz Pharmaceutical in 2011, has shown statistically-significant improvement in alertness among patients with narcolepsy or obstructive sleep apnea, via last-stage clinical trials in the US, according to SK.

The company is expecting the drug to become available in the US market by as early as the beginning of 2019, after which it can begin collecting sales royalties. It further expects SKL-N05 to become a superior alternative to Jazz Pharmaceutical’s Xyrem -- the dominant drug currently used to reduce daytime sleepiness.

By Sohn Ji-young (jys@heraldcorp.com)