November 29, 2024

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Hyundai Pharmaceutical's corporate logo (Hyundai Pharm)

The Ministry of Food and Drug Safety said on Friday Hyundai Pharmaceutical voluntarily withdrew its application for the approval of its abortive drug Mifegyne, consequently dimming South Korea's prospect for medication abortions.

"The company was unable to send in the data required by the Ministry of Food and Drug Safety in time, and decided to withdraw the application for the time being," said an official from Hyundai Pharm.

As Mifegyne contains a new substance to be used for the first time in the country, the regulatory agency requested supplementary data on safety, efficacy and quality in accordance with the review standards for new drug. But it failed to do so although the regulator extended the submission deadline twice.

The Seoul-based pharma company has been putting in effort to get the green light from the drug regulatory agency since 2021.

Mifegyne, sold under the brand name Mifegymiso, consists of one tablet of Mifepristone and four tablets of Misoprostol -- chemicals whose combination induces miscarriage with 97 percent probability.

Mifegyne was developed in 1980 by French pharmaceutical firm Exelgyn and is sold in 76 countries, including the United States and China.

Following the Constitutional Court's ruling in 2019 that the domestic law banning all abortion was unconstitutional and the consequent revision of laws to allow medication abortions, Hyundai Pharm, in March last year, signed an exclusive agreement with Linepharma International to sell Mifegyne in the Korean market.

The prospects for commercialization of medication abortions currently look unclear.

"It is difficult to state our exact plan at the moment. As soon as the data is available, the company plans to re-apply for the approval by actively discussing and preparing the matter with the developer of the medicine," said the official from Hyundai Pharm, when asked when the company will reapply for the approval of Mifegyne.

By Lee Yoon-seo (yoonseo.3348@heraldcorp.com)