Eubiologics said it has begun developing a botulinum toxin product.
The Ministry of Food and Drug Safety on Tuesday approved the company to conduct a phase-1/2 trial on its BTX candidate “ATGC-100 Injection,” it said.
Eubiologics’ study will evaluate ATGC-100’s safety and effect in adult patients with moderate or severe frown lines. In the phase-1 trial, the treatment will be tested in 10 patients, and the phase-2, 25 patients in the trial group and the control group, respectively.
ATGC-100 is botulinum toxin A just like Allergan’s Botox. Eubiologics and ATGC are jointly developing ATGC-100.
Locally developed and authorized BTX products, including those for exports, are Daewoong Pharmaceutical’s Nabota, Pharma Research Bio’s Rientox, Medytox’ Meditoxin, Innotox, Coretox, Hugel’s Botulax, HuonsGlobal’s Hutox, and Hanall Biopharma’s BITI XA.
Daewoong, Medytox, and Hugel are intensely competing in the local BTX market.
Daewoong has recently obtained the U.S. Food and Drug Administration’s nod for Nabota, expanding its target market to overseas.
Medytox is to release Coretox, almost free of drug resistance, as the third BTX after Medytox and Innotox. Medytox is to chase not only Allergan’s Botox but Merz’ Xeomin as well.
The domestic BTX market is estimated to be about 110 billion won ($97.3 million) and the global market, 4.5 trillion won, including the 2 trillion-won U.S. market.