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I-123 MIBG of NARI Has Been Issued the TFDA Drug Permit License


Published:2024-10-30  09:03

【Technical introduction】
The active ingredient of "INER MIBG Injection" is meta-iodobenzylguanidine (MIBG). MIBG has a similar chemical structure to the neuro-transmitter norepinephrine in the sympathetic nervous system (SNS) and has been confirmed to have a high uptake rate in tissues with SNS (e.g., the heart, salivary glands, and tumors), particularly those that originate from neural crest or neuroendocrine cells. I-123 MIBG is already used for diagnosis and treatment outcome assessments of cancers such as phenochromocytoma and neuroblastoma. The use of I-123 MIBG for diagnosing cardiac sympathetic nerve function has drawn increased attention in recent years. Applications include prediction of potential arrhythmia and assessment of patients at high risk of cardiac failure to provide important information for clinical treatment and decision-making. Many studies have also concluded that I-123 MIBG can provide information for clinical diagnosis of neurodegenerative diseases such as Lewy body dementia or Parkinson’s disease. NARI is the only research institution in Taiwan that can supply I-123 MIBG and has obtained multi-national patents for the synthesis system. "INER MIBG Injection" is intricately formulated through a stringent sterile filtration procedure subsequent to the exchange of non-radioactive iodine within the MIBG structure with Iodine-123, accomplished using a solid-phase method.


▲Drug Permit License of INER MIBG Injection (MOHW-PM-R00037).

【Project Planning/Technology Application】
NARI operates the only 30 MeV medium-sized cyclotron in Taiwan that is capable of producing I-123. The cyclotron can produce a variety of medical radioisotopes and the PIC/S GMP-certified Radiopharmaceutical Production Center develops and produces radiopharmaceuticals for clinical diagnosis and treatment use. Radioactive iodine labeling technology was developed by the NARI to create Taiwan’s first I-123 MIBG injection. A computer-controlled synthesis system with automatic or semi-automatic control was also developed to improve the consistency of product quality and produce high-quality radiopharmaceuticals for clinical use. The synthesis system is now patented in the ROC, Japan, and the US. The synthesis system was also used by the NARI to establish chemistry, manufacturing, and control technical (CMC) documentation and apply for pharmaceutical registration. Pharmaceutical registration for the "INER MIBG Injection" was approved in 2019 (MOHW-PM-R00037). To increase the shelf-life of drug to meet the needs of hospitals in central and southern Taiwan, restocking inspection, process testing, and personnel training were carried out before three consecutive batches of "INER MIBG Injection" were produced and tested for efficacy/stability. All quality assurance requirements were met so the MOHW approved an extension of the shelf-life to 10 hours in 2022 and the injection is now routinely supplied to hospitals for clinical trials on request.
 
【Future layout】
A stable supply of "INER MIBG Injection" is now being provided to hospitals for academic and clinical trials in nuclear medicine for studying cardiac and central nerve function. With the completion of the PIC/S GMP-compliant pilot sterile production line and pharmaceutical facilities, along with the integration of the automated synthesis system for "INER MIBG Injection", NARI will be positioned to supply high-quality radiopharmaceuticals for various applications while also supporting expanded R&D efforts.
 
 
【Contact information】
Name: Ming-Cheng Chang, Deputy Director
Tel: 886-3-4711400 Ext.7002
E-mail:mcchang@nari.org.tw

Name: Cheng-Liang Peng, Associate Researcher
Tel: 886-3-4711400 Ext.7298
E-mail:clpeng@nari.org.tw