Efficacy and Safety Demonstrated in Phase 3 Clinical Trial with Domestic Patients
Securing Competitiveness in Islamic Markets with the World's First Halal Certification
Chongkundang Bio announced on July 22 that it has launched the next-generation botulinum toxin preparation, 'Tyemvers' (TYEMVERS).
Tyemvers is indicated for the treatment of moderate to severe glabellar lines and was developed based on a strain exclusively sourced from a European research institute. Notably, it uses a non-animal stabilizer instead of human serum albumin (HSA), fundamentally eliminating the risk of infection from blood-derived pathogens.
Chongkundang Bio explained that Tyemvers demonstrated both efficacy and safety in a Phase 3 clinical trial involving 300 domestic patients with moderate to severe glabellar lines. Through randomized, double-blind, active-controlled, and multicenter clinical trials, Tyemvers was proven to be non-inferior to Botox (onabotulinumtoxinA). There was no difference in the incidence of adverse reactions between the treatment groups, and no drug-related serious adverse events were observed. The results of this study were recently published in the SCIE-indexed international journal, Journal of Cosmetic Dermatology.
In particular, by thoroughly excluding animal-derived ingredients and adopting a non-animal (vegan) manufacturing process, Tyemvers became the world's first botulinum toxin preparation to receive halal certification from Indonesia's Halal Product Assurance Organizing Agency (BPJPH). The product was developed using a strain officially registered in GenBank, the genome information database of the U.S. National Center for Biotechnology Information (NCBI), thereby eliminating legal risks related to strain sourcing.
A Chongkundang Bio representative stated, "Tyemvers is a next-generation botulinum toxin preparation that has proven its safety and efficacy through systematic clinical trials based on a strain with transparent origins. Leveraging the world's first halal certification, we plan to expand into global markets, including Indonesia, the Middle East, Malaysia, and other Islamic countries."
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