K-Bio Ramps Up China Push With Drug Approvals, Tech Deals

International|
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By Han Min-Gu, Lee Jeong-Min
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Korean biotech companies are ramping up efforts to tap the Chinese market, which had slowed somewhat amid U.S.-China tensions. China, one of the world's largest pharmaceutical markets alongside the United States and Europe, is considered a must-enter market for Korean biotech firms. Companies are pursuing local approvals and sales of new drugs and medical devices while also incorporating promising drug candidates developed in China into their pipelines. Industry observers expect exchanges between Korean and Chinese pharmaceutical and biotech industries to intensify as China's sector continues its rapid growth.

SK Biopharmaceuticals (326030.KS) announced Wednesday that its epilepsy drug cenobamate, Korea's 41st domestically developed new drug, received new drug application (NDA) approval from China's National Medical Products Administration (NMPA). The sleep disorder treatment solriamfetol, submitted simultaneously, also obtained approval. Ignis Therapeutics, a joint venture between SK Biopharmaceuticals and Chinese investment firm 6 Dimensions Capital, filed for approval a year ago and is expected to begin full-scale local sales next year.

China has more than 11 million epilepsy patients, with a market size of $1.1 billion as of last year, making it the world's largest. Patients with obstructive sleep apnea (OSA) are estimated to exceed 170 million. "This approval is the fruit of long-term collaboration between SK Biopharmaceuticals and Ignis Therapeutics," said Lee Dong-hoon, CEO of SK Biopharmaceuticals. "It will be an important milestone for our global expansion."

L&C Bio also announced Wednesday that it has begun selling MegaDerm Plus, a human tissue-based medical device, through its Chinese subsidiary L&C China in partnership with local firm Shanghai Jieya Life. Shanghai Jieya Life once held more than 70% of the local skin graft market, and the two companies have completed preliminary procedures for official sales. "Jieya Life's solid sales channels will greatly help MegaDerm Plus gain early market traction," said Lee Hwan-chul, CEO of L&C Bio.

Pharmaceutical and biotech trade between Korea and China, which peaked during the COVID-19 pandemic, is showing signs of increase again. This is because China's pharmaceutical market has grown rapidly and its technological competitiveness has improved, spurring active technology cooperation between companies in both countries. According to global pharmaceutical market research firm Evaluate, China's share of global technology exports is projected to surge from less than 5% in 2020 to approximately 40% this year.

Samsung Bioepis signed a co-development deal with China's Frontline for antibody-drug conjugates (ADC) this year. GC Cell signed an agreement with China's EasorBio to introduce CAR-T therapy for multiple myeloma. HK inno.N also initiated Phase 3 clinical trials in Korea this year for a diabetes drug licensed from China's Sciwind. SK Biopharmaceuticals, which holds a 41% stake in cenobamate partner Ignis, is reportedly considering licensing new drug candidates from China after recovering its investment returns.

"China's pharmaceutical market, the world's second largest, has grown more than 30% over the past five years, significantly increasing its attractiveness," an industry official said. "China's technological capabilities have also improved rapidly, and we're now seeing a trend of licensing Chinese technology rather than just exporting to them, which is expanding exchanges between the two countries."

Original reporting by Han Min-Gu, Lee Jeong-Min for Seoul Economic Daily.

AI-translated from Korean. Quotes from foreign sources are based on Korean-language reports and may not reflect exact original wording.

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