Hanmi Pharmaceutical Presents Phase 2 Clinical Trial Status of "Belvarafenib" at Korean Cancer Association Meeting

Hanmi R&D Filling the Gap in Melanoma Treatment

Hanmi Pharmaceutical is smoothly conducting the first domestic phase 2 clinical trial of the oral targeted anticancer drug "belvarafenib," developed for the treatment of malignant skin cancer melanoma.

Patient enrollment is currently underway for individuals who meet the clinical trial criteria. If belvarafenib is commercialized, it is expected to offer a new treatment option for melanoma patients with NRAS gene mutations who currently suffer from a lack of appropriate therapies.

On July 10, Hanmi Pharmaceutical, a core business subsidiary of Hanmi Science, announced that it presented a poster detailing the phase 2 clinical trial design and research status of "belvarafenib" at the 52nd Korean Cancer Association Scientific Meeting (KCA 2026), held over two days from June 25 to 26 at the Grand InterContinental Seoul Parnas in Gangnam-gu, Seoul.

At the 52nd Korean Cancer Association Annual Meeting (KCA 2026), a representative from Hanmi Pharmaceutical is presenting on belvarafenib. Hanmi Pharmaceutical

Belvarafenib, developed for the first time by Hanmi Pharmaceutical, is an oral targeted anticancer agent that inhibits RAS dimers within the mitogen-activated protein kinases (MAPK) pathway, which is involved in tumor cell growth and proliferation.

Melanoma is a refractory cancer with limited treatment options and a high risk of recurrence, and most current therapies are supplied by overseas pharmaceutical companies. In particular, NRAS-mutant melanoma is reported to have higher tumor invasiveness and metastatic potential than typical melanoma, as well as a shorter overall survival period.

Belvarafenib demonstrated significant antitumor activity in NRAS- and BRAF-mutant patient groups during a global phase 1 clinical trial in patients with solid tumors. Based on these results, subsequent clinical development is currently underway in Korea for patients with NRAS-mutant melanoma.

Melanoma is a therapeutic area with high unmet medical needs, where no approved standard therapy exists either domestically or internationally. Currently, belvarafenib is being administered to some patients on a limited basis through treatment-use approval in clinical settings.

The ongoing domestic phase 2 clinical trial is a multicenter, single-arm study evaluating the efficacy and safety of combination therapy with belvarafenib and the MEK inhibitor cobimetinib in patients with locally advanced or metastatic melanoma harboring NRAS mutations.

The combination of belvarafenib and cobimetinib is considered a treatment strategy that could overcome the mechanistic limitations of existing combination therapies using BRAF and MEK inhibitors, and provide long-term clinical benefits to a broader group of patients with various gene mutations.

The domestic phase 2 trial has been progressing smoothly at 10 research institutions nationwide since the first patient was enrolled in February, with ongoing registration of patients who meet the trial criteria. Hanmi Pharmaceutical plans to complete enrollment of a total of 45 patients by the end of this year and apply for conditional domestic approval in 2028 based on the results of the phase 2 trial.

Belvarafenib was selected for the "Giljabi" program, a newly introduced innovative product commercialization support program by the Ministry of Food and Drug Safety last year, designed to expedite the commercialization of innovative new drug candidates with urgent social needs and high potential for productization. The Giljabi program systematically supports rapid commercialization by assisting with preparation of approval documents in connection with the expedited review (GIFT) program and conducting pre-reviews of documentation standards when necessary.

Moonhee Lee, Head of Clinical at Hanmi Pharmaceutical (Executive Director), stated, "Through the phase 2 trial of belvarafenib, we are systematically verifying its efficacy and safety in patients with NRAS-mutant melanoma, focusing on providing a therapeutic option that can address high unmet medical needs. As patient enrollment is ongoing, we hope this clinical trial will offer a new treatment opportunity for patients with limited options."

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