Protox announced on the 27th that it has submitted an application to the Ministry of Food and Drug Safety for approval of phase 1/2 clinical trial plan (IND), GMP certification, and export license of its own botulinum toxin type A type.

The clinical trial will be conducted at Promedis, a CRO specializing in clinical trials, after approval of the clinical trial plan.

Protox analyzed the genetic sequence of its strains through an external analysis agency and found that it matched 99.99% of ATCC3502 species registered with Genbank, operated by the National Center for Biological Information (NCBI).

Protoxin (tentative name) developed with the strain is a finished product that verifies quality control results that meet internationally standardized “standards and test methods,” such as non-clinical safety and efficacy data that meet international standards.

Meanwhile, the bio-production plant that will produce protoxin began construction in May 2017 in the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do, and was completed in about two years.

The plant, which has a total project cost of about 32 billion won, has a total floor area of 6,227㎡ (about 1,886 pyeong) and is designed to be produced and operated on a high quality basis, such as installing a filling line from Germany’s Bausch, which can produce 5.4 million vials of botulinum toxin per year.

Reporter Choo Min-sun cms@newsprime.co.kr