Hanmi Pharmaceutical is making steady progress in the Phase 2 clinical trials of its melanoma treatment, Belvarafenib.
The company announced on July 10 that it presented the design and current status of the Phase 2 trial for Belvarafenib at the 52nd Annual Meeting of the Korean Cancer Association (KCA 2026), held on June 25-26 at the Grand InterContinental Seoul Parnas.
Belvarafenib is an oral targeted cancer therapy developed by Hanmi Pharmaceutical that inhibits the RAS dimer in the mitogen-activated protein kinase (MAPK) pathway, which is involved in tumor cell growth.
Melanoma is a challenging cancer with limited treatment options and a high risk of recurrence. NRAS mutant melanoma, in particular, is known for its aggressive tumor invasiveness and high metastatic potential, with a shorter survival rate, yet there is currently a lack of standard treatments. NRAS mutations are found in approximately 15-25% of all melanoma patients.
In global Phase 1 trials, Belvarafenib demonstrated significant antitumor activity in patients with NRAS and BRAF mutations, confirming its potential. Based on these results, follow-up clinical trials are currently underway in Korea targeting patients with NRAS mutant melanoma.
The ongoing Phase 2 trial in Korea is a multicenter, single-arm study evaluating the efficacy and safety of the combination therapy of Belvarafenib and the MEK inhibitor, Cobimetinib, in patients with locally advanced or metastatic melanoma harboring NRAS mutations.
The company expects this combination therapy to address the limitations of existing BRAF and MEK inhibitor combination treatments and to sustain therapeutic effects across a broader range of genetic mutation patient populations.
The trial has been ongoing since the first patient was registered in February, with patient enrollment continuing across 10 research institutions nationwide. Hanmi Pharmaceutical plans to complete the registration of a total of 45 patients by 2027 and will apply for conditional approval in Korea in 2028 based on the Phase 2 trial results.
Meanwhile, analysts predict that the company will exceed market expectations with its second-quarter performance. Hana Securities estimates that Hanmi Pharmaceutical's consolidated revenue for the second quarter will increase by 36.2% year-on-year to 492 billion won, with operating profit expected to rise by 101.0% to 121.5 billion won. The operating profit margin is projected to be 24.7%.
This increase is attributed to the one-time revenue recognition of approximately 112.9 billion won from the upfront payment received from Eli Lilly for the obesity treatment candidate, Sonapeglutide.
* This article has been translated by AI.
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