K-Bio Renews China Push with Drug Approvals, Tech Deals

Korea's bio industry is stepping up efforts to penetrate the Chinese market after a period of hesitation amid U.S.-China tensions. China, one of the world's largest pharmaceutical markets alongside the U.S. and Europe, remains a must-enter market for Korean bio companies. Companies are seeking local approvals and launching sales of new drugs and medical devices, while also incorporating promising drug candidates developed in China into their pipelines. Industry observers expect exchanges between Korea and China to intensify as China's pharmaceutical and bio industry continues its rapid growth.

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

China has more than 11 million epilepsy patients, with the market valued at $1.1 billion last year, making it one of the world's largest. The number of obstructive sleep apnea patients is estimated at more than 170 million. "This approval is the fruit of long-term collaboration between SK Biopharmaceuticals and Ignis Therapeutics," said Lee Dong-hoon, president of SK Biopharmaceuticals. "It will be an important milestone for our global expansion."

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

Pharmaceutical and bio trade between Korea and China, which peaked during the COVID-19 pandemic, is showing renewed growth. This comes as China's pharmaceutical market has expanded 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 worldwide technology exports is projected to surge from less than 5% in 2020 to approximately 40% this year.

This year, Samsung Bioepis (207940.KS) signed an antibody-drug conjugate (ADC) co-development agreement with China's Frontline BioPharm, while GC Cell signed a deal with China's IASO Biotherapeutics to license a CAR-T therapy for multiple myeloma. HK inno.N also began Phase 3 clinical trials in Korea this year for a diabetes drug licensed from China's Sciwind Biosciences. SK Biopharmaceuticals, which holds a 41% stake in Cenobamate partner Ignis, is reportedly considering using investment returns to license new drug candidates from China.

"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 importing Chinese technology beyond simple exports, with exchanges between the two countries expanding considerably."