Pipeline

The only Radiopharmaceutical company achieving
successful commercialization of all new tracers in Korea

New Drug Development Strategy for Radiopharmaceuticals

  • Expertise in diagnostic Radiopharmaceuticals (cancers and dementia, Parkinson’s Disease, etc.)
  • Expertise in cancer Radiopharmaceuticals for diagnosis & third-line therapy for major cancers

Development & Sales strategies reflecting the characteristics of Radiopharmaceuticals

Pipeline

Expected to finish in 3 years Proof-of-Concept Preclinical Phase Phase I, II Clinical Trial Phase III Clinical Trial Completed Application for Item Approval Health Insurance Review & Assessment Service Commercialize
Oncology Products
18F-FES (Breast Cancer)
18F-FACBC (Prostate Cancer)
68Ga-PSMA-11(Prostate Cancer)
Neurology Products
Cerveau MK-6240 (Alzheimer's Disease)
LMI PI-2620 (Alzheimer's Disease, Progressive Supranuclear Palsy(PSP))
To finish in 5-7 years
confidential
Completed Commercial-ization in 10-12years
FES
- Korea’s first Radiopharmaceutical diagnostic tracer for breast cancer in the market
- Medical imaging agent to detect metastatic breast cancer and differentiate the Estrogen receptor status
Rights & Permissions / Sales Acquire the rights for Korean domestic market and secure the overseas licensing rights Drug classification Diagnosis of breast cancer
Dates (Approval/Agreement) Acquired NDA approval on Nov. 2019 Remarks
  • Manufacturing technology joint development with Asan Medical Center
  • First-In-Class
  • In negotiation with USA, EU, Australia, China and Japan
Rights & Permissions / Sales Acquire the rights for Korean domestic market and secure the overseas licensing rights
Drug classification Diagnosis of breast cancer
Dates (Approval/Agreement) Acquired NDA approval on Nov. 2019
Remarks
  • Manufacturing technology joint development with Asan Medical Center
  • First-In-Class
  • In negotiation with USA, EU, Australia, China and Japan
FACBC
- Korea’s first Radiopharmaceutical diagnostic tracer for prostate cancer in the market
- Open a new era for the diagnosis of metastatic and recurrent prostate
Rights & Permissions / Sales For international market Drug classification Diagnosis of prostate cancer
Dates (Approval/Agreement) Acquired KMFDS approval on Sep. 2021 Remarks
  • First-in-class with exclusive rights
  • Licensed in from Japan NMP
  • Targets the first-mover in the prostate cancer diagnostic market
  • Overlapping effects after new drug approval
Rights & Permissions / Sales For international market
Drug classification Diagnosis of prostate cancer
Dates (Approval/Agreement) June 24, 2019 – Exclusive licensing agreement signed
(Approved by US FDA and EMA)
Remarks
  • First-in-class with exclusive rights
  • Licensed in from Japan NMP
  • Targets the first-mover in the prostate cancer diagnostic market
  • Overlapping effects after new drug approval
68Ga-PSMA-11
- Approved in US for in-house hospital compounding indicated for patients with suspected prostate cancer metastasis and for patients with suspected prostate cancer recurrence based on elevated serum PSA levels.
- listed in the Europeian Pharmacopeia effective April, 2021
- NDA approval from US FDA & EU EMA September, 2021
Rights & Permissions/Sales For approval in Korea Drug Classification Diagnosis of prostate cancer
In early 2022 – Illuccix(cold kit) to be released in Korea December 2, 2020 – Exclusive licensing agreement with Advanced Nuclear Medicine Ingredients S.A. (Telix) Remarks
  • NDA application in H1 2022
  • Commercialization in early 2023
Rights & Permissions/Sales For approval in Korea
Drug Classification Diagnosis of prostate cancer
In early 2022 – Illuccix(cold kit) to be released in Korea December 2, 2020 – Exclusive licensing agreement with Advanced Nuclear Medicine Ingredients S.A. (Telix)
Remarks
  • NDA application in H1 2022
  • Commercialization in early 2023

그누보드5
Address 6,7F, 81, Wausan-ro, Mapo-gu, Seoul, Republic of Korea [04041]
Tel 02 332 4868 Fax 02 323 3437

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