InscoV, Subsidiary Apimez Completes MFDS Approval for Resale of 'Apitoxin'

InscoBio, a KOSPI-listed company (CEO Insoo Yoo and Jagap Koo), announced on the 17th that it has obtained approval from the Ministry of Food and Drug Safety (MFDS) for the resale of ‘Apitoxin,’ a treatment for osteoarthritis pain and inflammation, which is the 6th domestic new drug developed by its bio-subsidiary Apimez.

In 2021, Apimez signed a supply contract for Apitoxin with BC World Pharm and applied for a change in approval for resale to the MFDS in October last year. The company has devoted great effort to passing a rigorous review process equivalent to new drug approval, including inspections of the main ingredients and finished product manufacturing processes. Through close cooperation with the licensing partner BC World Pharm and well-known pharmaceutical distributors, a detailed sales strategy has been established, and the company expects sales to begin soon.

Apitoxin is a prescription injectable drug based on Melittin, which has efficacy in improving pain from osteoarthritis (degenerative arthritis), and it is making a full-scale re-entry into the osteoarthritis market. Due to population aging, the number of osteoarthritis patients continues to increase. According to the Health Insurance Review & Assessment Service, as of last year, there were 4.17 million osteoarthritis patients in South Korea. Market research firm Presidence Research forecasts that the global osteoarthritis treatment market will grow at an average annual rate of 8.38%, from $8.2 billion (approximately 10.82 trillion KRW) last year to $18.36 billion (24.2 trillion KRW) by 2032.

With the MFDS approval of Apitoxin, momentum is expected to build for the ongoing Phase 3 FDA clinical trials and investment attraction for ‘Apitox’ (Apitoxin with the same ingredient), a treatment for multiple sclerosis (MS) being developed in the United States. Since the U.S. investment securities firm, which is handling listing and investment activities locally, has been closely monitoring the approval results for Apitoxin resale in Korea, the company plans to actively utilize the sales and clinical data from Korea for U.S. clinical trials and investment activities.

An InscoBio official stated, “The MFDS approval for Apitoxin resale is the first achievement and starting point in the bio new drug field,” adding, “Furthermore, research is underway to expand indications to include psoriasis, lupus, and other conditions to broaden the pipeline.” They also added, “We expect that this achievement will facilitate smooth progress in listing and investment activities in the U.S.”

Meanwhile, InscoBio recently appointed Erik Emerson, who has extensive experience and know-how in investment attraction in the new drug field, as the new CEO of Apimez’s U.S. subsidiary, alongside capital expansion, accelerating efforts for listing and investment attraction.