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IR

Huonslab Receives IND Approval from MFDS to Start Pivotal Clinical Trial for ‘Recombinant Human

Writer : Huonslab
Date : 07 Aug 2024
Views : 214

Huonslab Receives IND Approval from MFDS to Start Pivotal Clinical Trial for ‘Recombinant Human Hyaluronidase’

IND for Pivotal Phase 1 Study approved -


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SEONGNAM, South Korea, August 07, 2024 -- Huonslab has taken a significant step towards commercialization with MFDS IND approval for recombinant human hyaluronidase. 

Huonslab announced on the 7th that Ministry of Food and Drug Safety (MFDS), S. Korea approved the Investigational New Drug (IND) application for HLB3-002, a recombinant human hyaluronidase.  

This study will evaluate the safety and tolerability of a single subcutaneous administration of HLB3-002 in 243 healthy volunteers. The study will be conducted at four medical institutions in South Korea, including Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. 

Huonslab has confirmed that HLB3-002 exhibits comparable efficacy to the original drug through several animal efficacy studies. The safety of HLB3-002 has also been established through non-clinical toxicity studies.

The study will be pivotal for the Biological License Application (BLA), and Huonslab plans to apply for product approval with the MFDS by June next year, upon confirming the safety and tolerability of HLB3-002. 

HLB3-002 is a stand-alone product developed as an alternative to Hylenex. Unlike existing animal-derived hyaluronidase products, which derived from animal tissues, HLB3-002 is manufactured using recombinant CHO cell line and Huonslab process patented manufacturing technology for HyDIFFUZETM.   

This manufacturing technology allows for the expression of natural human hyaluronidase during animal cell culture and offers the advantage of high-purity purification without fragmented byproducts. Huonslab completed patent registration for this manufacturing method in July in S. Korea, and an international patent application is currently in progress.   

Huonslab anticipates that HLB3-002, manufactured using this technology, will have fewer side effects, such allergies, compared to existing animal-derived hyaluronidase products.

Im Chae Young, the chief technology officer of Huonslab Bio Institute stated "HLB3-002 can be used for the treatment of cosmetic, dermatological, pain, and edema conditions. It will also be effectively utilized as a platform technology to convert intravenous (IV) medications into self-administered subcutaneous (SC) injections.”