FDA Names RDA As … From "Pancreatic Cancer" to "Malaria"

Recently, new drugs developed by Korean pharmaceutical companies have been designated as rare drugs by the US Food and Drug Administration (FDA). It is a beachhead for Korean drugs to accelerate the entry into the world market of rare drugs.

According to the pharmaceutical industry, on March 3, new drugs developed by Korean companies such as GC Green Cross Cell and Shinpoong Pharma, including Hanmi Pharm, have been designated as rare drugs by the FDA. In particular, Hanmi Pharm has constantly expanded its lifeline, with three items being designated.

In April, Hanmi Pharmaceuticals received the new FDA-approved drug "Oral Sole", an oral anti-cancer drug that was marketed as an injectable drug in April.

Amarasol is an anticancer drug that converts injectable anticancer drugs into oral medications. In 2011, Hanmi Pharm granted a license to use these products and technologies to Atenex, a US biopharmaceutical company. The fun sole was applied to Hanmi Pharmaceutical's "ORASCOVERY" platform technology, which altered the oral injection.

Last November, Entertainment Solsol was designated as an innovative promising drug by the British Health Authority.

Hanmi Pharmaceutical Co., Ltd. has been designated as a drug containing the badog of glucagon (development name HM15136), a drug for conbad hyperinsulinemia, in front of the entertainment bars.

Glucagon badogues are glucagon preparations that promote the synthesis of glucose in the body (glucose in the blood) and were developed once a week.

The glucagon badogue has been applied to the new technology of the pharmaceutical platform of L & # 39; Hanmi Pharmaceutical, "LAPS COVER". This technology increases the short half-life, which is a disadvantage of biopharmaceutical products, in order to reduce the number of doses and the doses, thus reducing the side effects of the drugs and improving the efficiency.

GC Green Cross Cell's Eisse Cell-EL was approved in June by the FDA as a rare drug in liver cancer, and as a rare drug in brain tumors and pancreatic cancer in August and October.

Immune Cancer Drug Cell – EL is a personalized anti-cancer drug that makes the patient's blood its raw material.

It has recently been recognized as a new concept of anti-cancer drug that is transformed into a strong immune cell maximizing anti-cancer function through a special culture process lasting about 2 weeks and administered to a patient.

In September, Shin Pung Pharmaceutical's antimalarial drug, Piramax Jung, was approved by the Food and Drug Administration (FDA) as a rare drug.

The antimalarial drug Pyramax has proven its clinical efficacy and efficacy in Pyramax medicines, including essential medicines from the World Health Organization (WHO) last year.

At the international MIM conference in Dakar, Senegal, Africa, in April, the results of Piramas Phase 4 clinical trials involving 4,000 patients in three African countries were announced.

In addition, Udenafil, a medication for erectile dysfunction at Medion, has already been designated as a rare drug and phase 3 clinical trials are to be finalized.

ISU-304, currently being developed by Isu Abxis, was also approved last year as a rare drug by the FDA and the European Medicines Agency (EMA).

The FDA's orphan drug designation (ODD), the first in the world in 1983, is designed to help facilitate the development and approval of therapeutic drugs for rare or life-threatening diseases.

In accordance with the Rare Medicines Act, it provides incentives for direct financial support and authorization procedures for the research and development of drugs for rare diseases and gives them a longer period of market monopoly than new drugs.

According to the FDA's designation for rare drugs, treatments for rare diseases will receive the fee corresponding to development costs and will benefit from economic benefits such as the exemption of processing fees of about 2, KRW 5 billion. In addition, if the program is selected for the rapid screening program, it can be approved and continued quickly.