Daewoong Pharmaceutical to Launch Painless ​Growth‌ Hormone Injection

Daewoong Pharmaceutical has received IND ‌(clinical trial plan) approval for a phase 1 clinical trial of a‍ human growth‍ hormone-soluble microneedle patch, marking the first domestic clinical trial of a biopharmaceutical soluble microneedle.

• Growth hormones requiring long-term administration, significantly improving patient compliance and convenience with microneedle patches
• Prevents ⁢concerns about microneedle shape and function deterioration by applying patented ‘Clopham’ technology
• This approval gives a green light to the development of microneedle patches ​for obesity treatment using GLP-1 analogues

Human growth hormone is an essential drug for treating diseases such as dwarfism that‍ are caused by growth hormone deficiency, and since it​ is a chronic disease, long-term ⁤administration is⁤ required. However, substances such as growth hormone have large molecular sizes, so they could ‌only be developed‍ as subcutaneous ⁢injections.

Daewoong Pharmaceutical⁣ expects that by loading growth hormones into soluble microneedle patches, patient compliance will be greatly improved. The soluble microneedle patch⁢ is a patch consisting of about 100 fine needles within​ an area of 1cm in length⁣ and width, and can be easily administered by attaching it to the skin, ‍greatly improving patient ‍convenience.

This Phase 1 IND approval‌ is very significant in that it provides the foundation for Daewoong Pharmaceutical​ to commercialize a biopharmaceutical-based dissolvable microneedle patch for the first time ‍in Korea. Based on this approval, Daewoong Pharmaceutical plans ‌to expand clinical development ​to various product⁤ groups, ⁣including a dissolvable ⁣microneedle patch for obesity‍ treatment containing GLP-1 analogues.

Daewoong Pharmaceutical’s dissolvable microneedle patch,⁢ which was⁢ selected as a bio-industry technology development project of the 1st Industrial Core Technology Development Project of the Ministry of Trade, Industry and⁤ Energy ​in 2020 and is being developed, shows‍ high efficacy as ⁢it applies the ‘CLOPAM’ patented technology developed by Daewoong’s subsidiary Daewoong Therapeutics.

The purpose of the phase 1 clinical trial of somatropin microneedle approved by‌ the Ministry of ‌Food and Drug Safety‍ this time is to evaluate the safety and pharmacokinetic and pharmacodynamic⁣ characteristics by comparing ⁣the human growth ‍hormone‌ soluble microneedle patch with ​the subcutaneous ‌injection preparation, Caretropin Cartridge Injection.

Park Sung-soo, CEO of Daewoong Pharmaceutical, said, “Daewoong Pharmaceutical is pursuing sustainable growth in the global healthcare market through various innovation pipelines. ‍Beyond drug development, we will⁣ lead⁢ the future pharmaceutical market by developing an⁤ innovative administration route platform that significantly improves patient compliance and convenience, and take the lead in providing the best medicine for the health of the people.”