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DAEWOONG THERAPEUTICS

About us

Delivery science, built for partnership.

We design delivery platforms that are built to be partnered. GMP-ready, sterile, and at commercial scale — so your science becomes a product patients want to use.

01 — What we do

Two platforms and our own pipeline

02 — Daewoong Group

Backed by Daewoong Group

We are the group's formulation and drug delivery company, drawing on its R&D, regulatory and manufacturing strength.

  • Daewoong Group

    Daewoong Pharmaceutical

    Over-the-counter and prescription drugs

  • You are here

    Daewoong Therapeutics

    Formulation and drug delivery systems

  • Daewoong Group

    16 other affiliates

    Veterinary, API, biologics and more

  • Research & development

    • A proven record in innovative drug development, including Fexuclue® and Envlo®
    • Multiple proprietary drug candidates advanced into clinical development

  • Regulatory success

    • Nabota®: U.S. FDA approval and global regulatory success
    • Expertise in global regulatory strategy and submissions (U.S. FDA, ANVISA, EMA and more)

  • GMP manufacturing

    • Hyangnam plant: global-standard manufacturing for botulinum toxin (Nabota®)
    • Hyangnam plant: fully aseptic, automated GMP manufacturing for CLOPAM®
    • Seongnam plant: dedicated aseptic GMP line for Thermicra™, from 2H 2027

03 — Our team

Every discipline a drug product needs, under one roof.

Formulation, CMC, regulatory and nonclinical experts work as one team on every program — no hand-offs between vendors.

  • ~40

    Specialists

  • 4

    Core disciplines

  • 1

    Team from feasibility to IND

  • 01

    Formulation development

    Designs the CLOPAM patch or the Thermicra formulation around each molecule.

  • 02

    CMC

    Process development, scale-up and transfer into our own GMP lines, with specifications and stability.

  • 03

    Regulatory affairs

    IND strategy and submissions — behind two Phase 1 IND approvals, with FDA filings planned for 2028.

  • 04

    Nonclinical evaluation

    PK, tolerability and safety studies that support each IND.

GMP backed by Daewoong Group

Our plants run with Daewoong Group's manufacturing and quality expertise — the group that manufactures biologics such as Nabota® under U.S. FDA cGMP for the U.S. market. Scale-up, quality systems, inspections and commercial supply are well-trodden ground.

  • U.S. FDA cGMP manufacturing of biologics, proven commercially
  • Group quality, validation and inspection experience
  • From clinical supply to commercial scale

For partners, that means one point of contact and faster decisions.

04 — Locations

Where to find us

Headquarters

27 Dongtancheomdansaneop 1-ro, Geumgang Penterium IX Tower #A-401, Hwaseong-si, Gyeonggi-do, South Korea

  • R&D center · Hwaseong · at headquarters

    27 Dongtancheomdansaneop 1-ro, Geumgang Penterium IX Tower #A-401, Hwaseong-si, Gyeonggi-do, South Korea

  • R&D center · Seoul · Daewoong Innovation Center

    Daewoong Innovation Center, 192 Magokjungang-ro, Gangseo-gu, Seoul, South Korea

05 — Group companies

Visit the Daewoong family