Helixmith (084990.KQ) will participate in the BIO International Convention (BIO USA) 2026 for the first time in five years to find a global partner for its gene therapy Engensis. Engensis received approval from China's National Medical Products Administration (NMPA) as a treatment for critical limb ischemia on the 28th of last month.
Helixmith said on the 4th that it will attend BIO USA, to be held in San Diego, the United States, from the 22nd to the 25th of this month (local time). It marks the company's first participation in BIO USA since 2021. "Following the Chinese marketing approval of 'NL003 (Engensis)' by our Chinese partner Northland Biotech, we have received a series of meeting requests from global biotech companies, leading us to decide to attend BIO USA," a Helixmith official said. "We will fully begin discussions on global business development (BD) for Engensis this time."
Earlier, the NMPA decided to grant marketing approval for NL003, a gene therapy using Engensis. NL003 confirmed superior ulcer-healing effects compared with the control group in a Phase 3 clinical trial targeting critical limb ischemia. Helixmith will receive a certain percentage of Northland's NL003 sales as royalties for seven years. According to Helixmith, the global market for critical limb ischemia treatments amounts to several trillion won.
Helixmith decided to fully begin business development discussions, including local joint clinical development, investment attraction, and technology transfer, targeting major global markets such as the United States, Europe, and the Middle East. "In the past, we successfully completed up to Phase 2 clinical trials of Engensis targeting critical limb ischemia in the United States," a Helixmith official said. "Last year, through a 'Type D' meeting with the U.S. Food and Drug Administration (FDA), we also received a positive response regarding the establishment of primary endpoints for conducting a Phase 3 clinical trial."
