Hanmi Science announced on Friday that its key subsidiary, Hanmi Pharmaceutical, presented a poster detailing the clinical phase 2 design and research progress of Belvarafenib at the 52nd Annual Meeting of the Korean Cancer Association (KCA 2026). The conference took place on June 25-26 at the Grand InterContinental Seoul Parnas in Gangnam, Seoul.
Belvarafenib, pioneered by Hanmi Pharmaceutical, is an oral targeted cancer therapy. It works by inhibiting the RAS dimer in the mitogen-activated protein kinase (MAPK) pathway, which plays a crucial role in tumor cell growth and proliferation.
Melanoma remains a formidable challenge in oncology, with limited treatment options and a high recurrence rate. Currently, most treatments are supplied by international pharmaceutical companies. NRAS mutant melanoma, in particular, is known for its increased tumor invasiveness, higher metastatic potential, and shorter overall survival compared to other forms of melanoma.
NRAS is a gene that regulates cell growth and proliferation. Mutations in this gene can lead to uncontrolled cancer cell growth. Research indicates that NRAS mutations are present in approximately 15-25% of all melanoma patients.
In a global phase 1 clinical trial involving solid tumor patients, Belvarafenib showed promising anti-tumor activity, particularly in those with NRAS and BRAF mutations. Building on these results, Hanmi Pharmaceutical is now conducting follow-up clinical development for NRAS mutant melanoma patients in South Korea.
Melanoma represents an area of high unmet medical need, lacking approved standard treatments both domestically and internationally. At present, Belvarafenib is being administered to a limited number of patients under a compassionate use program.
The ongoing phase 2 clinical trial in South Korea is designed as a multicenter, single-arm study. It aims to evaluate the efficacy and safety of combining Belvarafenib with the MEK inhibitor Cobimetinib in patients with locally advanced or metastatic melanoma harboring NRAS mutations.
The Belvarafenib and Cobimetinib combination therapy is viewed as a promising strategy to overcome the limitations of existing BRAF and MEK inhibitor combinations. It’s expected to offer clinical advantages by maintaining long-term effectiveness across a wider range of genetic mutations.
The domestic phase 2 trial has been progressing smoothly since the first patient enrollment in February. Currently, ten research institutions across the country are actively recruiting eligible patients. Hanmi Pharmaceutical aims to complete the enrollment of 45 patients by 2027 and plans to apply for conditional product approval in South Korea in 2028, based on the phase 2 trial results.
In a notable development last year, Belvarafenib was selected for the GIL-Jabi program. This innovative initiative, launched by the Ministry of Food and Drug Safety, aims to accelerate the commercialization of promising new drug candidates that address urgent societal needs and demonstrate high product viability.