DSK "Protox, Joint Clinical Trial in China... Exclusive Supply After Approval"

[Asia Economy Reporter Hyunseok Yoo] DSK announced on the 15th that its subsidiary, Protox, a botulinum toxin bio-specialized company, has signed an exclusive supply and joint clinical trial agreement with a Chinese pharmaceutical and bio-specialized company for the botulinum toxin type A formulation ‘Protoxinju,’ which is being developed based on its own strain.

Through this agreement, the two companies plan to jointly conduct the Phase 3 clinical trial in China for ‘Protoxinju,’ which has completed Phase 1/2 clinical trials domestically, and work together to obtain local product approval in the future. The costs for the Phase 3 clinical trial in China will be fully borne by the local partner company.

According to the contract, after successfully completing the Phase 3 clinical trial in China and obtaining local approval, the expected sales amount over 10 years is at least 400 billion KRW, and ‘Protoxinju’ will be exclusively supplied to the local partner company. This contract marks Protox’s first export achievement since receiving overseas export approval for ‘Protoxinju’ from the Ministry of Food and Drug Safety (MFDS) in Korea last year.

A Protox official stated, “This contract means that ‘Protoxinju,’ which is being developed independently, has been recognized for its safety and efficacy overseas following domestic approval, externally proving the high potential for the product’s success. Through this agreement, we can smoothly advance into the Chinese market and secure large-scale data by conducting the local Phase 3 clinical trial, which is a significant advantage.”

He added, “Due to a confidentiality agreement, we cannot disclose the contracting party, but both companies will closely cooperate and do their best to ensure ‘Protoxinju’ successfully enters the Chinese market.”

Protox is pursuing strategic partnerships with major local companies to facilitate market entry in accordance with regulatory agency guidelines of key countries worldwide. Through this, it plans to enter core global botulinum toxin markets such as the Americas, Europe, Brazil, and Russia.

Protoxinju is a botulinum toxin independently developed by Protox, and the strain has been confirmed to match 99.99% with the ATCC3502 species registered in the GenBank, a gene bank operated by the U.S. National Center for Biotechnology Information (NCBI).