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

• 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

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