Frequently asked questions

DAEWOONG THERAPEUTICS (대웅테라퓨틱스) is a drug delivery system (DDS) company and a subsidiary of Daewoong Group in Korea. We develop two delivery platforms, CLOPAM dissolving microneedle patches and Thermicra ultra-high concentration formulations for subcutaneous injection, and use them in our own programs and with pharmaceutical and biotech partners worldwide.

Our headquarters and one R&D center are in Hwaseong, Gyeonggi-do, South Korea; a second R&D center is at the Daewoong Innovation Center in Magok, Seoul.

We are part of Daewoong Group. The group's R&D, regulatory and GMP manufacturing experience, including U.S. FDA cGMP manufacturing of biologics, stands behind our platforms and partnerships.

CLOPAM (Closed-Packed Aero-Pressurized Microneedle) is a dissolving microneedle patch. Patented aero-pressure drying concentrates the drug in the needle tips, each patch is sealed aseptically in its own mold, and an applicator places it on the skin with consistent force, so patients can apply it themselves without a needle and syringe.

CLOPAM suits potent molecules dosed in micrograms to milligrams: peptides, hormones, vaccines, hard-to-deliver small molecules and mRNA. It is used for systemic delivery, for example once-weekly peptides, and to carry large molecules into the skin for topical use.

Yes. Human pilot pharmacokinetic studies showed about 80% relative bioavailability compared with a subcutaneous injection. Two of our CLOPAM peptide programs have Phase 1 INDs approved by Korea's MFDS, and two patches for rare skin diseases are heading for FDA Phase 1 IND submissions in 2028.

Yes. Our early commercial-scale site in Yongin passed MFDS GMP inspection and has made Phase 1 clinical samples since 2024. Since 3Q 2026 our Hyangnam plant has made CLOPAM patches on fully automated, aseptic commercial GMP lines, to our knowledge the first such plant in the world. A large-scale commercial site in Osong is planned for 2030.

Thermicra is an ultra-high concentration formulation for subcutaneous (SC) injection. It packs biologics to 300–600 mg/mL for antibodies and 300–400 mg/mL for ADCs in a ready-to-use prefilled syringe that is injected by hand, with an autoinjector where needed, while keeping the molecule intact.

Monoclonal antibodies, antibody–drug conjugates (ADCs), antibody–oligonucleotide conjugates (AOCs), bispecific antibodies and other therapeutic proteins.

No. Thermicra reaches subcutaneous doses through concentration rather than an enzyme, so an SC version can be developed outside the hyaluronidase patent families. This lets biosimilar developers turn an IV drug substance into an SC biobetter.

Yes. A Thermicra formulation of a marketed ADC matched the reference product in every in vitro binding and cytotoxicity assay (98–110% of the reference) and reached about 74% absolute bioavailability subcutaneously in rabbits. Our own subcutaneous ADC program, DWRX 6001, is heading for IND filing in 2028.

A dedicated aseptic GMP line for ultra-high concentration biologics in Seongnam, Korea, is planned to start in 2H 2027, followed by a large-scale commercial site in Osong.

Send an inquiry through our contact form. We then hold a short call on non-confidential information, sign a confidentiality agreement (CDA), run a feasibility study on your molecule under a material transfer agreement (MTA), and agree the collaboration model. Partnerships can grow from feasibility to research collaboration, licensing and commercialization.

Your drug substance and its analytical methods. We take on the formulation study and process optimization, lab-scale sample manufacturing, stability and in vivo PK studies, and, optionally, reproducibility and pilot-scale manufacturing.

Our business development team replies within 5 business days. Please do not include confidential information in the first message; we sign a CDA before details are shared.

Yes, we hire year-round across formulation development, CMC, regulatory affairs and nonclinical evaluation. Send your CV and a short introduction through the contact form.