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

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
F-DOPA
- Diagnosis of brain tumors that are undetectable using FDG
- World’s first stable neutralization manufacturing technology
Rights & Permissions / Sales NDA in Korea and international licensing & commercialization Drug classification Diagnosis of brain tumor
Dates (Approval/Agreement) Acquired NDA approval on Oct. 2019 Remarks
  • Manufacturing technology joint development with Asan Medical Center
  • Best-in-class with exclusive rights
Rights & Permissions / Sales NDA in Korea and international licensing & commercialization
Drug classification Diagnosis of brain tumor
Dates (Approval/Agreement) Acquired NDA approval on Oct. 2019
Remarks
  • Manufacturing technology joint development with Asan Medical Center
  • Best-in-class with exclusive rights
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) 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
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
Solucin(177Lu-DOTATOC)
- Developed and launched therapeutic Radiopharmaceutical for the first time in the country
- Korea’s first Radiopharmaceutical therapy for Neuroendocrine tumor in the market
Rights & Permissions / Sales For approval in Korea Drug classification Gastroenteropancreatic Neuroendocrine Tumor Treatment
Dates (Approval/Agreement) August 30, 2019 – Exclusive licensing agreement signed Remarks
  • Phase II clinical trial in South Korea in 2020
  • Commercialization in January 2020
  • Compassionate Use Program for non-clinical trial subjects
Rights & Permissions / Sales For approval in Korea
Drug classification Gastroenteropancreatic Neuroendocrine Tumor Treatment
Dates (Approval/Agreement) August 30, 2019 – Exclusive licensing agreement signed
Remarks
  • Phase II clinical trial in South Korea in 2020
  • Commercialization in January 2020
  • Compassionate Use Program for non-clinical trial subjects

그누보드5
Address 4F, 47, Kyonggidae-ro, Seodaemun-gu, Seoul, Republic of Korea [03752]
Tel 02 332 4868 Fax 02 323 3437

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