First Domestic Company to Obtain Sales Approval in China... Sales to Begin March-April Next Year
[Asia Economy Reporter Seo So-jung] "We aim to capture the number one position with a 30% market share in the Chinese botulinum toxin market by 2023."
On the 27th, Hugel held an online press conference to commemorate the acquisition of sales approval in China for botulinum toxin for the indication of glabellar lines, announcing their plan to become the market leader in China within the next three years.
On this day, CEO Son Ji-hoon stated, "Hugel's botulinum toxin product (Letibo) obtained sales approval in China on the 21st," adding, "Production started today, shipments will begin in early December, and we plan to start actual sales around March to April next year."
The Chinese botulinum toxin market is currently estimated to be worth approximately 500 to 600 billion KRW and is expected to grow at an average annual rate of about 30%, reaching around 1.75 trillion KRW by 2025.
To establish a foothold in the local market, Hugel has formed a partnership with Sahuan Pharmaceutical, the third-largest pharmaceutical company in the Chinese drug market, and began clinical trials in May 2017. Phase 3 clinical trials involving a total of 492 patients were completed in January 2018.
Subsequently, in April last year, Hugel submitted a product approval application to the China National Medical Products Administration, and after about a year and a half, on the 21st, became the first domestic company to cross the threshold of the Chinese market. Only three companies have obtained local sales approval in China so far.
Currently, the products sold in China are Allergan's "Botox" and Lanzhou Institute's "BTXA." Ipsen's "Dysport," which obtained Chinese approval before Hugel, differs in dosage from Hugel's approved product. CEO Son said, "Given the high favorability and trust in Korean products in the local market, Hugel's entry into China and expansion of market share are positive."
Hugel plans to gradually expand its product portfolio in China. As part of this, the approval review for the 50-unit botulinum toxin product is currently underway in China, and they expect to obtain approval within this year.
Additionally, the hyaluronic acid (HA) filler product recently completed the approval application process, targeting approval in the first half of 2021. Earlier this year, Hugel signed a license-in contract for a next-generation fat-dissolving agent under development, securing priority sales rights for this product in China.
Leveraging this entry into the Chinese market, Hugel plans to complete its entry into the global big three markets by entering Europe in 2021 and North America in 2022. To this end, they completed the European sales approval application for "Letibo" in June. Aiming for successful establishment in the European market, Hugel formed a partnership with Austria-based pharmaceutical company Croma, which will handle distribution in Europe after approval is obtained next year.
Furthermore, to enter the U.S. botulinum toxin market and establish a direct sales system, Hugel established a local subsidiary, "Hugel America," together with Croma in 2018, appointing James Hartman as CEO in May. The goal is to submit a Biologics License Application (BLA) in the U.S. by the end of this year or early next year and obtain sales approval by the end of next year, about one year later.
CEO Son said, "Hugel plans to target the Chinese market with reasonable prices and excellent product quality," adding, "Through sequential entry into China, Europe, and the U.S., we aim to achieve sales of 1 trillion KRW by 2025."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
