[비즈한국] First-generation domestic biotech firm Helixmith071970 plans to restart the development clock for its "painful finger," Engensis. The company intends to shift its focus from diabetic peripheral neuropathy (DPN)—which it had long pursued—to critical limb ischemia (CLI), the indication for which its Chinese partner recently saw success, to resume global clinical trials. Attention is now focused on whether the company can produce meaningful results at a time when the key figures behind Engensis's development have left and its research and development (R&D) staff has been significantly reduced.
Helixmith held an investor relations (IR) event on the 24th. This was the first IR session for institutional investors in four years since June 2021, and the first since BioSolution086860 became the largest shareholder in December 2023.
At this IR event, Helixmith revealed plans to resume global clinical trials and pursue technology exports for the gene therapy Engensis. The decision follows a strategic adjustment as the commercialization of Engensis in China by its partner, Northland, nears. Last July, Northland filed a New Drug Application (NDA) for Engensis as a CLI treatment with China's National Medical Products Administration (NMPA). Once Engensis is launched in China, Helixmith will receive royalties from Northland amounting to the higher of 4% of total sales or 7% of net sales for seven years.
Engensis is the new drug candidate Helixmith has prioritized most heavily. The company had previously focused on the potential of Engensis as a DPN treatment and conducted global clinical trials. However, it failed to meet its primary endpoints in two consecutive global clinical trials. During this period, the largest shareholder changed twice, leading BioSolution, which owns the knee cartilage regeneration treatment "CartiLife," to become Helixmith’s largest shareholder.
Since then, Helixmith has shifted focus toward new businesses—such as cell and gene therapy CDMO (contract development and manufacturing organization), non-clinical CRO (contract research organization), and health supplements derived from natural products—rather than drug development, which requires massive capital. Recently, the company has also been working on cost reduction and profit improvement, including pushing for the sale of its Magok office building worth 110 billion won.
Some in the industry remain skeptical about whether Helixmith's stated intent to restart Engensis development will lead to meaningful results, pointing to questions regarding its R&D capabilities. Key founding members who had researched and developed Engensis since its days as ViroMed—former CEO Kim Sun-young, former CEO Yoo Seung-shin, and former Chief Technology Officer (CTO) Jung Jae-kyun—have all left the company. Former CEO Kim has joined JW Holdings009670 as an R&BD advisor, while former CEO Yoo joined Daewoong003090 as an outside director. Former CTO Jung left the company in 2021, returned in March 2024 after BioSolution became the largest shareholder, but departed again at the end of last month.
R&D staff numbers have also dropped significantly. The R&D department decreased from 31 members at the end of 2023 (5 with doctoral degrees, 20 with master's degrees) to 15 at the end of the second quarter of this year (4 with doctoral degrees, 8 with master's degrees), a reduction of more than half.
A Helixmith representative commented on this, stating, "The overall headcount has decreased due to internal restructuring of personnel and the pipeline. However, the company's management philosophy is to thoroughly review business performance and company resources to selectively pursue R&D and clinical trials." They added, "There is currently no issue in pursuing core development, and we will conduct additional hiring in the future if necessary."