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Next Steps for Yttrium-90 Microspheres Registration in South Korea and China for Liver Cancer Treatment

Rafarma Pharmaceuticals is pleased to announce that it has begun a new stage in the preparation of documentation to prepare data for registration procedures for microspheres with yttrium-90. The company's goal is to prepare new DMF files following the regulatory framework of South Korea and China. These documents are necessary for the registration of microspheres on the markets of South Korea and China as an independent drug for the radioembolization procedure as part of the treatment of liver cancer.

The following stages of work take place:

  1. The development of the protocol is nearing completion: Technical control protocol No. Msh 01/24;

  2. At the same time, product packaging is being modified to use smart packaging technology for drug delivery.

Radioembolization of the liver is the most promising method for treating inoperable liver cancer. The method is based on the introduction of glass microspheres containing yttrium-90 into the patient’s artery.

This microsphere treatment takes place in four stages: diagnosis, examination, diagnostic administration of microspheres with technetium and then administration of microspheres with yttrium-90 under the control of an angiograph and SPECT/CT. Advantages of the method: convenience for doctors, ease of assembly of the box and system for introducing microspheres, as well as radiation safety for doctors and patients. The patient is discharged within 24 hours after the administration of the yttrium-90 microsphere.

RAFA Rafarma Pharmaceutical

ISIN (CUSIP) Number 75062C100

ID 012-000631222

203 South Main Street, Suite 3000

Sheridan, Wyoming, 82801, USA

+1 (307) 429-2029

Rafarma Pharmaceuticals is positioned as a major driver of the modern healthcare industry. It provides nuclear, technological and pharmaceutical solutions for hundreds of thousands of patients worldwide. We put all the effort in the fields we know best: nuclear medicine, novel pharmaceuticals, medical devices and cancer treatment technologies. Our products are trusted by medical professionals and institutions across the globe. With a diversified product portfolio and a wide array of R&D projects, Rafarma Pharmaceuticals is committed to spreading its work and its core values.


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