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Chong Kun Dang (CKD) Bio has jumped into the botulinum toxin (BTX) race with an independently developed product.
After years of marketing other companies’ BTX injections, the CKD subsidiary secured approval Monday for TYEMVERS, a homegrown Clostridium BTX type A targeting moderate to severe glabellar lines.
The move marks a sharp pivot from contract sales to original innovation and puts CKD Bio toe-to-toe with Korea’s toxin giants—Hugel, Daewoong, and Medytox—in a high-stakes, IP-heavy slugfest already spilling into China, Europe and the U.S., the company said Tuesday.
Chong Kun Dang Bio steps into the global toxin market with its first independently developed botulinum toxin product, TYEMVERS. (KBR photo)
Chong Kun Dang Bio steps into the global toxin market with its first independently developed botulinum toxin product, TYEMVERS. (KBR photo)
TYEMVERS uses a licensed European strain registered in the NIH’s GenBank and is formulated without animal components, an increasingly strategic choice as patients demand safer, vegan-compatible injectables. A CKD Bio spokesperson said the toxin’s animal-free profile broadens access for patients with allergies or infection risks. Production is set at the company’s GMP-certified Osong plant, North Chungcheong Province, which can turn out up to 6 million vials annually.
The approval caps a six-year R&D push that started with a strain licensing deal in 2019 and accelerated through trials under the project code CKDB-501A. Phase 1 wrapped in mid-2022, and phase 3 was completed by late 2023.
CKD Bio filed for marketing approval last May. In September, it hit a minor speed bump over branding, changing the name from TIMEVERS to TYEMVERS, but it closed the gap with a formal trademark last week. Approval came 10 months after filing.
CKD Bio said it is angling beyond wrinkles. U.S.-based Healis Therapeutics, which struck a supply deal with CKD Bio last year, is gearing up for phase 2 trials testing the same active ingredient as a treatment for depression and PTSD. Early data from phase 3 trials in aesthetic use showed non-inferiority to AbbVie’s Botox, enough to give Healis confidence to push forward in the U.S. and Europe.
“This agreement could one day impact over 42 million Americans,” Healis co-founder Sebastian De Beurs said last year, calling the neuropsychiatric potential of BoNT/A the largest therapeutic opportunity in the toxin’s history.
In China, CKD Bio’s partner Cutia Therapeutics kicked off a phase 3 trial last April under the name CU-20101, which is targeted for approval by 2026.
The move gives CKD Bio a second toxin track alongside its parent company, which has marketed biosimilars like Huons’ Wondertox for years. But TYEMVERS, an original, in-house molecule, ups the stakes in a global BTX market projected to more than double to 31 trillion won ($21 billion) by 2030.
Hugel—whose toxin is approved in the U.S., Europe, and China—pulled in 203.2 billion won in toxin sales last year, a 20 percent jump. Daewoong’s Nuceiva, branded as Nabota in Korea, grabbed 186.4 billion won with 84 percent from exports and now ranks No. 2 in the U.S. aesthetic toxin market in sales. Medytox is betting on its next-gen toxin, Newlux, with Chinese approval in sight by 2028.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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