K-bio firms gears up for renewed foray into China after coronavirus pause

2020.10.20 15:55:56 | 2020.10.20 15:56:24

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Hugel"s Botulex

Korean drug makers are gearing up for renewed foray into China normalizing fast from pandemic crisis.

Hugel, the No. 1 botulinum toxin producer in Korea, is prepping to launch marketing of its botox label Letybo (branded as Botulex in Korea) in the world¡¯s most populated country as the product is expected to be cleared by China¡¯s health authorities early next month.

The company said it had to delay its market entry into China by months due the pandemic, but marketing authorization will come within the next 20 business days as the Chinese government declared normalization in regulatory work with the virus under control.

If approved, Letybo would be the first Korean botox product available in China, where U.S.-based Allergan and two local companies are in competition.

GC Pharma, a Korean pharmaceutical company, is preparing to launch its Hunter syndrome treatment Hunterase, which was approved last month, an achievement made in 14 months after its first application in July last year. It is the first Korean-made therapy for the rare disease that affects the spine and the nervous system.

Medytox¡¯s flagship cosmeceutical brand Neuradum was approved by China¡¯s health regulators on Sept. 2 and is anticipating marketing authorization for its botox product Neuronox, whose approval application was first filed in April 2018.

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Boryung Pharm is another Korean pharmaceutical company to restart local marketing activities. It is now looking for a Chinese partner to help launch its hypertension drug Kanarb, Korea¡¯s 15th independently developed novel therapy. In 2014, Boryung Pharm teamed up with Gloria over marketing exclusivity of Kanarb in Chia, but their partnership ended up unfruitful in June.

Samsung Bioepis which suspended marketing activities in China due to the pandemic in the first half of this year is now waiting for regulatory clearance for a Phase 3 clinical trial of its cancer drug SB8 (bevacizumab) in China. SB8 is a biosimilar referenced to Avastin used to treat patients with breast cancer. If approved, the Korean biosimilar developer would conduct planned clinical trials for all three candidates including another breast cancer drug SB3, and rare disease treatment SB12.

SK Biopharm is on standby for a Phase 1 and 3 trial of its epilepsy drug Xcopri (cenobamate) in China. The company is planning to conduct Phase 3 global clinical trials of 500 patients in Korea, Japan and China.

HK inno. N is in process to receive marketing authorization for its gastroesophageal reflux drug Kcab after completing a Phase 3 study in China.

Celltrion recently resumed studying the timing of building a 120,000-liter biopharma plant in Wuhan after the plan was on halt due to the pandemic.

By Kim Si-gyun and Minu Kim

[¨Ï Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]