Hyundai is preparing for domestic approval of Mifegyne

Consultation on approval from the MFDS, such as inquiries in advance on data submission requirements

Could the title of the first induced abortion drug in Korea be granted?

Hyundai Pharm, which maintains the No.

 

1 market share in the emergency (post) contraceptives market, is preparing for the domestic market approval of the artificial abortion drug Mifegyne.

 

Mifegyne was ruled by the Constitutional Court for an abortion inconsistency in April last year, and the need to legalize domestic use and interest in domestic pharmaceutical companies also increased significantly.

 

On the 1st, it was confirmed that Hyundai Pharm had inquired in advance with the MFDS about the requirements for submitting data on safety and efficacy in order to apply for Mifgene for artificial saving during pregnancy.

 

So far, no pharmaceutical company has applied for approval or consulted in advance for spontaneous abortion-inducing drugs.

 

Hyundai Pharm’s Mifegyne is the only drug that has inquired in advance on the data submission requirements.

 

The MFDS believes that it is possible to apply for Mifegyne's product permission in the future based on the fact that the revision of the Criminal Law, the Maternal and Child Health Law, and the Pharmaceutical Affairs Law were announced.

 

Under the current law, artificial abortion is possible only by surgery.

 

After the constitutional abortion crime was determined to be inconsistent with the constitution, amendments to the related law are announced, and artificial abortion through medicines is expected to be allowed.

 

Mifegyne is a prescription drug approved in 1998 by the French pharmaceutical company Exelgyn.

 

Mifegyne (Mifepristone) induces abortion by blocking the progesterone receptor.

 

Approved in France in 1998, the prescription drug was developed by Russel Uclaf SA, one of Sanofi's predecessors.

 

Currently, All rights reserved outside the United States by Exelgyn.

 

If Hyundai Pharm acquires the copyright of Mifegyne and succeeds in licensing, it becomes the first pharmaceutical company to market artificial abortion drugs in Korea.

 

In addition, Hyundai Pharm is expected to enjoy the effect of further strengthening its obstetrics and gynecology pipeline.

 

Hyundai Pharm currently holds the No.

 

1 market share in the domestic emergency contraceptives market with Ellaone and Norebwon.

 

A company official briefly replied that it is difficult to respond to the related details as there is currently no specific knowledge of the plan to introduce Mifegyne in Korea.