바이오스펙테이터

by Jongwon Jang

InnoTherapy, which listed on KOSDAQ on the first day of february, the expansion of independent biomimetic platform technology. It will expand the existing domain of hemostatic to those of needle injection and drug targeting agents. InnoTherapy will accelerate R&D, and make inroads into the global market with the fund secured publicly.

Lee Mun-soo, the president of InnoTherapy, “… the overseas clinical trials of diverse products that prevent bleeding and perforation will be in progress, as well as the incessant development of platforms…”; “… by exploiting the fund secured publicly, we will be making inroads into the global market approximating 7 trillion KRW…”

InnoTherapy is a venture business jointly founded in 2010 by Lee Mun-soo, who made a career in the Samsung Advanced Institute of Technology and Department of Pharmaceutics in CJ CheilJedang, and his alumni professor, Lee Hae-shin of KAIST (CTO). By applying the mechanism of special functional group adhering to surfaces identified from the adhesive protein of sea mussels, diverse medical materials are attached with special functional group for the development of new materials that express hemostatic function and platform technology.

The hemostatic of InnoTherapy adheres quickly to plasma protein in blood, and simultaneously creates the hemostatic pellicle. It is a mechanism that is independent of the blood coagulation system of the human body; thereby, it can be applicable to patients of disorder in blood coagulation. Thus, it is expected to solve issues of limitations (in the scope of usage, of issues in immunity, and of high cost) of the fibrin system, which currently dominates the global hemostatic market.

InnoTherapy will make inroads into the global market of medical hemostatic, needle injection, and drug targeting through platform technology.

Above all, the InnoSEAL, the in vitro local hemostatic, was approved by the domestic Ministry of Food and Drug Safety (2015), the FDA in the USA (2016), and the Synthetic Association of Medical Drugs and Equipment in Japan (2018). It is currently sold domestically, and in the USA.

The in vivo ‘innoSEAL Plus’, which is used for surgery, and the ‘EndoSEAL’, which is used with endoscope, are waiting for the approval of the product and sales later this year. Both products have completed corroborating clinical trials for Class IV Domestic Medical Instrument Approval, and ‘InnoSEAL’ will be submitted for the approval of the Ministry of Food and Drug Safety in February. President Lee Mun-soo emphasized, “… the non-inferiority of product compared to competitive products was demonstrated through the corroborative clinical trials…” Hopefully, we expect the product to be approved within the first half of the year.

JellySEAL, which is in non-clinical stages, is a gel-type hemostatic injectable without obstruction in pipe, and is a next generation product. In addition, an absorbent gel-type hemostatic that is applicable to all surgery is being developed. Non-clinical trials will be completed within the first half of the year, and large-scaled multi-center corroborative clinical trials will be carried out in 2020.

A product for needle for preventing bleeding will also be developed. It is the mechanism of needle coated with hemostatic of InnoTherapy. Needles to be used for the blood vessel injection of patients of diabetes mellitus or patients administered with aspirin, who commonly experience difficulty in hemostasis, or the needle for direct injection into the eyeball with Eylea or Lucentis, will be developed. The product is at the non-clinical stage.

InnoTherapy expanded its domain to the platform of drug targeting. The ac-TACE therapy, which is in the non-clinical stage, is the platform that improves chemoembolization performance for hepatoma and the delivery function of anticancer agent. It can induce instant coagulation of blood artificially by applying the instant combination of keto acid/catechol based material with albumin in blood, or it can combine with diverse kinds of anticancer agents. TANNylation is a platform technology that selectively delivers protein drugs to myocytes in the heart through intra-venous injection; it is in the stage of R&D.

President Lee Mun-soo expressed clearly that he will challenge the global market. Lee said, “… we will attain certification (CE) of the European medical device through spontaneous clinical trials, and challenge the license agreement and technology transfer…”; “… and we will induce global cooperation more conveniently by securing the initiative of business through global patent and rights of production…”. InnoSEAL is nearing the certification of CE, and expects CE certification of InnoSEAL Plus and EndoSEAL in 2020.

President Lee emphasized, “… 65 % of the fund raised from the public will be exploited for R&D and overseas clinical trials…”; “… and, by listing on KOSDAQ, the efforts will be focused on making inroads into the global market…”.