BiotoxTech Co., Ltd. (CEO Jong-gu Kang) announced that it will participate in ‘BIO KOREA 5 (Bio Korea 10)’, which will be held at COEX in Seoul for three days from Wednesday, May 12th to Friday, May 3th.
Founded in August 2000, Biotoxtech has the largest number of test items including general toxicity test, carcinogenicity test, reproductive and developmental toxicity test, genotoxicity test, and SEND conversion service for non-clinical GLP tests, as well as MFDS, FDA IND, and NDA. This is a CRO with the largest track record of over 8 data submission approvals. It was listed on KOSDAQ in 150, and as a result of the U.S. FDA GLP inspection in January 2007, it received approval as a domestic private non-clinical testing laboratory. In addition, in 2015, it was selected as a national CRO and successfully performed GLP inspection of OECD MJV (Mutual Joint Visits). It was emphasized that it is the only company in Korea that holds two titles simultaneously.
In terms of animal welfare, it received Full Accreditation, the highest level, from AAALAC International in the United States. In addition, the five alternative animal testing methods developed with the company’s participation are registered and utilized in the international OECD guidelines, and have been certified in the Safety Pharmacology and Alternative Animal Testing Acts, thereby fulfilling its responsibility as a leading non-clinical CRO company in Korea. am. In order to develop the field of toxicokinetics/pharmacokinetics, we established SBB, a joint venture with Japan’s Sumika Analysis Center, to improve the quality of biological sample analysis, and then made a new start as Kypron Bio Co., Ltd. in January 5 to develop synthetic drugs, It has emerged as the only non-clinical CRO in Korea capable of analyzing all biological samples, including antibody drugs and biopharmaceuticals.
In order to provide the total services required and needed by pharmaceutical and bio companies, the parent company, Biotox Tech, performs toxicity evaluation tests under the Good Laboratory Practice (GLP) to ensure reliability and predict and evaluate risks and hazards to humans. Cypron Bio, an affiliate company, provides biodistribution evaluation tests and drug CDMO services, which are required tests for IND approval for cell therapy and gene therapy (CGT), as well as biological sample analysis, efficacy and PK testing, and MRO. .
In addition, in order to solve the bottleneck of overseas requests for primate toxicity tests, which are essential for the development of vaccines, biopharmaceuticals, and biosimilars, and to dominate the overseas market, we established Key Prime Research, a subsidiary that ranks first in Korea and fifth in the world in primate non-clinical testing. Therefore, primate non-clinical services are being provided at the Osong Medical Complex starting in November 1.
BiotoxTech, a specialized organization that conducts non-clinical trials for IND and NDA submissions, conducts more than 2,000 tests per year and over 30,000 cumulative tests for cell therapy, gene therapy, CAR-T & CAR-NK, Microbiome, and nanomedicines (exosomes, nanoparticles). It received permission to register MFDS and the U.S. FDA for specialized drugs, and participated in the development of a total of 36 out of 6 Korean new drugs. Since its establishment, the amount of orders has steadily increased based on stable sales with top companies (top 10 pharmaceutical companies) in various fields, reaching more than 2021 billion won in orders since 400, and the number of contracts is also known to be increasing every year. Not limited to pharmaceuticals, the number of inquiries and contracts for health functional foods, cosmetics, and chemicals is also increasing, and the company has entered not only the domestic market but also the US and Japanese markets, forming trustworthy relationships with overseas companies.
An official from BiotoxTech said, “There is a growing trend of large pharmaceutical companies with their own licensing departments for substance registration, but the number of bio venture companies that are still in the beginning stage of substance development, which are still limited to some pharmaceutical companies, is also increasing. For companies with little experience in material development, we provide free consulting services with our internal experts. However, there are still some shortcomings in understanding the entire process of material development through consulting work in the non-clinical field, so we provide non-clinical and preclinical services. “I felt the need for an all-in-one service that covers all stages,” he said.
“Accordingly, we have joined forces with BiotoxTech Co., Ltd., which has accumulated a large amount of database while developing materials with various companies, C&R Research, a CRO specializing in clinical trials, and Seoul National University Hospital Clinical Trial Center, which is essential for clinical trials, to develop ABC-Bio science. “We are planning to provide consulting services by founding a company,” he said. “The company’s services can be effective in covering all stages from the non-clinical stage, which is the beginning of material development, to the final stage, clinical trials. “Please keep an eye on BiotoxTech Co., Ltd.’s efforts to provide convenient, cost-saving, and specialized services to pharmaceutical and bio companies without their request.”
Meanwhile, ‘BIO KOREA 18’, which celebrated its 2023th this year, is hosted by the Korea Health Industry Development Institute and Chungcheongbuk-do. Since 2006, BIO KOREA, which has been striving to promote the global status and continuous growth of the Korean health industry, has been strengthening its position as Korea’s representative bio-health international convention with world-renowned scholars and business experts participating every year. BIO KOREA 2023, together with domestic and foreign companies related to the health industry such as bio, pharmaceuticals, medical devices, cosmetics, and food, as well as companies and institutions of interest such as consulting, academia, and related organizations, offers various programs such as conferences, business partnering, exhibitions, and invest fairs. It goes on.