Hugel's 'Botulax' Delayed US Approval... Second Supplementary Request

The approval of Hugel's botulinum toxin (BTX) 'Letibo' (domestic name Botulex), which was aiming to enter the U.S. market, by the U.S. Food and Drug Administration (FDA) has been delayed. Having received a second Complete Response Letter (CRL), the company plans to quickly address the required corrections but will proceed cautiously with the reapproval application.

Hugel's botulinum preparation 'Botulax Injection' [Photo by Hugel]

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According to industry sources on the 18th, after the FDA conducted an on-site inspection of Hugel's factory in Godeu, Chuncheon-si, Gangwon Province last month, it recently sent a CRL to Hugel America, Hugel's U.S. subsidiary. A Hugel representative explained, "This CRL is related to factory management and is not connected to the approval itself," adding, "The requests for corrections and updates mainly concern matters that were not included in the first CRL."

Previously, Hugel submitted its first Biologics License Application (BLA) in March 2021 and received a CRL from the FDA once in March last year. At that time, the FDA requested additional documentation and data regarding equipment and approvals added to the factory after the initial BLA. Hugel supplemented these and reapplied for the BLA in October last year but was rejected again. Although the product has received approvals in over 20 countries including China, Europe, and domestically, it has yet to clear the FDA approval hurdle.

The company emphasized, "While the first inspection was somewhat simplified, the second inspection was a more in-depth and thorough review, which seems to have led to the CRL. However, it is not related to the approval itself."

Typically, when a BLA receives a CRL, the applicant prepares the necessary materials and reapplies within one year. The FDA then decides on approval within six months from the BLA submission date. Considering this timeline, if Hugel quickly reapplies, approval within this year is possible.

Chairman Cha Seok-yong, CEO and Chairman of the Board at Hugel
[Photo by Hugel]

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However, with Chairman and Board Chair Cha Seok-yong recently appointed, there is speculation that the company will coordinate the timing of the reapplication more cautiously. A Hugel representative stated, "We will make every effort to ensure perfection in supplementing data and related documents," adding, "We will review the overall strategy together with newly appointed Chairman Cha and the management team."

Additionally, the company noted, "The U.S. sales forecast is not included in this year's internal guidance," and added, "There will be no significant impact on the company's sales growth." According to the consensus from financial information provider FnGuide, securities firms predict Hugel's annual sales this year to reach 339.3 billion KRW, a 20.47% increase compared to the previous year.

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