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

• Clinical Phase II, III, NDA
• Clinical Phase I

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