Handok Wins Approval for a Two-Phase Clinical Trial of Its New Bio Drug, HL2351

– Handok has developed a new autoinflammatory disease treatment using sustained antibody

convergence technology; the drug can be administered once a week for effective treatment.

– A two-phase clinical trial for those suffering from cryopyrin-associated periodic syndrome (CAPS) is

scheduled to begin at the Seoul National University Hospital in February.

Handok (Chairman and CEO: Kim Young-jin) has recently received approval by the Ministry of Food and Drug Safety for a two-phase clinical trial of HL2351, Handok’s first bio drug for the treatment of autoinflammatory diseases.

The first stage of the clinical trial will test the efficacy and safety of HL2351, while the second phase will test pharmacokinetics and pharmacodynamics. The trial will take place at the Seoul National University Hospital starting in February 2016 and will target CAPS patients.

HL2351 is the first bio drug developed by Handok using the sustainable technology of Genexine, a bio startup company. The drug was developed to find a new cure for autoinflammatory diseases including rare diseases and rheumatoid arthritis, and overcome the shortcomings of Anakinra, an interlukin-1 receptor antagonist currently used to treat autoinflammatory diseases, which must be administered to patients on a daily basis. The main advantage of Handok’s HL2351, which has been developed using sustained antibody convergence technology, is that it only needs to be administered once a week in order to effectively treat autoinflammatory diseases.

A single-phase clinical trial of HL2351 was successfully completed at Seoul National University Hospital in 2014. The trial, which used a group of healthy men as test subjects, found that a single injection of HL2351 was both safe and produced fast-acting results. In trials, the exposure to HL2351 grew in proportion to the dosage. The drug also showed a significantly longer half-life than Anakinra.

Jang Woo-lck, Vice-President of Handok’s R&D Division, explained: “HL2351, our newest drug for the treatment of autoinflammatory diseases, will not only be a groundbreaking bio drug in the market upon its release, but will also provide those suffering from the diseases with the most effective and convenient treatment option available. The drug was designed last October for the treatment of CAPS, but its efficacy will soon be tested on other autoinflammatory diseases in the near future.”

Aside from HL2351, Handok has been working on the development of a sustainable-type growth hormone treatment called GS-H9, made using Genexine’s unique antibody convergence (hybrid Fc) technology. Unlike other growth hormones, GX-H9, will only need to be injected once or twice a month.

In October 2014, Genexine signed a contract with Tasgen, a Chinese company, to export its sustainable-type antibody convergence protein treatment technology, used in the development of GX-H9. The contract is expected to earn Handok USD 25 million (KRW 28.3 billion) in additional revenue.