The Ministry of Food and Drug Safety starts operating a microbiome treatment product support team on the 22nd
[팍스넷뉴스 김새미 기자] It is expected that Genome & Company will benefit from the government’s recent policy to support microbiome treatments.
According to the bio industry on the 24th, the Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) started to form and operate a microbiome treatment product support team on the 22nd.
The support team consisted of three departments: the pre-counseling department of the Korea Food and Drug Administration, the related review department, and the research department. The Ministry of Food and Drug Safety plans to establish guidelines for quality, non-clinical, and clinical data requirements that take into account the characteristics of microbiome through discussions on research projects and expert councils, as well as standards for approval.
In related industries, the government’s support team is contributing to the benefits of Genome & Company.
Established in 2015, Genome & Company, a developer of microbiome treatments, passed the technology evaluation for a special listing in July and completed listing before the KOSDAQ on the 23rd. In particular, the fact that it is the only company in Korea that has been approved by the Ministry of Food and Drug Safety as a clinical trial plan (IND) for microbiome treatment is leading to expectations for policy benefits.
Last month, Genome & Company received approval from the Ministry of Food and Drug Safety for the clinical phase 1/1b clinical trial of’GEN-001′. With this approval, Genome & Company has been approved for both a researcher-led clinical trial, GEN-001 alone, and a company-led clinical trial, GEN-001 combination therapy. Earlier, Genome & Company was approved by the U.S. Food and Drug Administration (FDA) in April for a company-led clinical trial for GEN-001, and completed its first patient medication in October.
GEN-001 is meaningful in that it will be developed as the world’s first microbiome anticancer drug. The treatments being developed by Go Bio Lab are developing the autoimmune disease treatment’KBLP-001′ and the allergic immune disease treatment’KBLP-002′. ChunLab has also discovered’CLCC1′, a microbiome solid cancer treatment candidate, but has not yet entered clinical trials. ChunLab aims to promote Phase 1 clinical trials in Australia next year.
Domestic and foreign pharmaceutical companies are also paying attention to GEN-001. LG Chem secured the domestic, Chinese and Japanese copyrights of Genome & Company’s GEN-001 in April. In addition, Merck and Pfizer signed a cooperation and supply contract for the GEN-001 clinical trial last December. Based on this, Genome & Company is conducting phase 1/1b clinical trials in combination with Merck and Pfizer’s immune anticancer drug’Avelumab (product name: Babyncio)’.
An official of Genome & Company said, “Since Genome & Company is the only Korean microbiome company that is undergoing clinical trials in Korea, it is expected to benefit from government policy in the long term.”
On the other hand, microbiome refers to the entire genetic information of microbes or microbes themselves that exist in a specific environment. It is known that there is a correlation between psoriasis, reflux esophagitis, obesity, colitis, and cardiovascular disease, and related treatments are being developed. Currently, there are 204 microbiome treatments under development worldwide, of which five are undergoing phase 3 clinical trials in the US and UK.
The global market size of microbiome was 56.3 million dollars in 2018. By 2024, it is expected to increase 167 times to $9.387 billion.
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