Efficacy confirmed in NRAS-mutant melanoma patients with no available treatment options
Advancing new drug development through close collaboration with physicians, patients, and regulators
(Seoul, January 8, 2026) Hanmi Pharmaceutical has entered domestic Phase 2 clinical trials of Belvarafenib, a targeted anticancer drug for malignant melanoma, marking Korea’s first domestically developed therapy for the disease. The drug is expected to offer a novel option for patients with NRAS-mutant cancers, for whom no adequate therapies currently exist.
Hanmi announced on January 8 that the Ministry of Food and Drug Safety (MFDS) has cleared the Phase 2 Investigational New Drug (IND) application for Belvarafenib, a targeted anticancer therapy.
The Phase 2 trial is designed as a multicenter, single-arm study to evaluate the efficacy and safety of a combination therapy of Belvarafenib and the MEK inhibitor cobimetinib in patients with locally advanced or metastatic melanoma harboring NRAS mutations.
Melanoma is a challenging cancer with few treatment options and a high risk of recurrence, and the majority of existing therapies are supplied by foreign pharmaceutical companies. By developing Belvarafenib, Hanmi seeks to strengthen Korea’s domestic oncology capabilities and reduce dependence on imported drugs.
Belvarafenib, originally developed by Hanmi Pharmaceutical, is an oral targeted anticancer agent that inhibits RAF and RAS mutations within the mitogen-activated protein kinas signaling (MAPK) pathway, which plays a key role in tumor cell growth and proliferation.
In particular, Belvarafenib targets NRASmut melanoma and BRAF class II or class III alteration-positive tumors based on its differentiated mechanism as a selective RAF dimer inhibitor. Unlike conventional BRAF inhibitors that primarily suppress RAF monomers, Belvarafenib is designed to inhibit both BRAF and CRAF dimers, enabling it to overcome associated resistance to the RAF dimer formation.
Accordingly, the combination therapy of Belvarafenib and cobimetinib is regarded as a treatment strategy capable of overcoming the mechanistic limitations of existing BRAF monomer？MEK inhibitor combination therapies, while offering potential clinical benefits across a broader range of genetically defined patient populations.
In a previously completed Phase 1 clinical trial involving patients with solid tumors, the combination therapy of Belvarafenib and cobimetinib demonstrated a favorable safety profile and preliminary efficacy. Notably, meaningful antitumor activity was observed in patients with NRAS and BRAF mutations, providing a strong rationale for further clinical development.
Na-young Kim, Executive Vice President and Head of New Product Development Division at Hanmi Pharmaceutical, said, “We expect Belvarafenib to establish itself as a next-generation innovative therapy in rare and unrescatable cancers with limited treatment options, including melanoma,” adding, “We will work closely with domestic physicians, patients, and regulatory authorities to successfully complete its development and commercialization.”
◆ Selected for MFDS Guidance Program for Innovative Products…End-to-End Support for Development and Approval
Belvarafenib has been selected for the MFDS Guidance Program for Innovative Products, newly introduced last year, and is recognized as an innovative drug candidate with both strong commercialization potential and the ability to address a critical unmet medical need.
The program selects a total of 20 innovative products―including new drugs, advanced biopharmaceuticals, and innovative medical devices―and provides comprehensive, end-to-end support from early development through regulatory approval. Belvarafenib was chosen through an objective review by an independent selection committee composed of external experts, based on its development status and technological competitiveness.
Under the program, MFDS assigns dedicated review personnel and provides pre-consultation services, offering tailored guidance across all stages of development, including clinical trial design, nonclinical and clinical data preparation, and statistical analysis.
In addition, the program supports preparation of regulatory submission materials in coordination with the fast-track review (Global Innovative products on Fast Track, GIFT) program, and systematically facilitates accelerated product development by reviewing documentation standards in advance when necessary.
Currently, Belvarafenib is being administered on a limited basis to certain patients under compassionate use approval, highlighting the ongoing need for a new domestically developed treatment option for NRAS-mutant melanoma patients for whom no approved therapies exist either in Korea or globally.
Hanmi plans to advance the clinical development and early commercialization of Belvarafenib through close collaboration with domestic clinicians, researchers, and regulatory authorities, while also exploring opportunities to expand its indications into other rare and intractable cancer areas.
Jae-hyun Park, CEO of Hanmi Pharmaceutical, stated, “Addressing unmet medical needs in disease areas with insufficient treatment options is a fundamental mission of pharmaceutical companies,” adding, “We will spare no effort to ensure that Belvarafenib becomes an important treatment option for a wide range of cancer patients.”