FugenBio, a South Korean bio firm using original materials to develop health care and medical products, announced Tuesday it has found novel materials to treat diabetes after its decade-long research.

The firm’s CEO Kim Yoon-soo said at a press conference that it has received approval for its breakthrough fungus ceriporia lacerate from the local Drug Ministry as a viable health supplement ingredient.

“If it succeeds, we would be the world’s first to develop and commercialize ceriporia lacerata as a diabetes treatment. But being the first in the world created higher obstacles when gaining approvals from authorities, as there was more of a burden to prove this unprecedented substance’s safety and efficacy,” Kim said.

Ceriporia lacerata is a rare form of white fungus that was discovered in Japan in 2002. In a world now largely barren of new species, the discovery of ceriporia lacerata posed hope of new, untested possibilities.

According to FugenBio, ceriporia lacerata has proven through two sets of animal tests and human clinical trial that it helps improve blood sugar levels on an empty stomach, as well as meaningfully lower insulin resistance in diabetic patients.

FugenBio came in to possession of ceriporia lacerata 10 years ago by chance while studying Ganoderma Applanatum, or artist’s bracket mushroom.

The firm's first clinical trials completed in 2015 showed ceriporia lacerata to have a significant therapeutic effect on diabetic patients, but it took FugenBio five more years to finally get the go-ahead to make it into health supplement pills.

FugenBio said it will launch the ceriporia lacerata health supplement pills “Cepona” within the month and target insulin resistant patients. The pills will go global starting in China, Japan, Europe and the US, in that order, Kim said.

Cepona pills are the company’s second line of commercial business, after the launch of skin care essence product CepoLAB in 2018.

FugenBio envisions creating the ceriporia lacerata compound as a novel drug candidate for diabetes and out-license the pipeline in 2022.

FugenBio said its novel fungus will become an alternative to the diabetes drug metformin, which were found to contain varying amounts of carcinogenic substances.

Metformin, a standard treatment for type 2 diabetes in adults, has its origins in natural compounds found in french lilac. Metformin drugs are considered an “irreplaceable” treatment for diabetes, and their recalls have alarmed health professionals. Drug Ministries across the world advised against a sudden halt of taking the drug.

Despite the significant development, FugenBio is currently involved in a lawsuit with CLBio, which it alleges misappropriated the fungus.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)