Hanmi Pharmaceutical has become the first in Korea to initiate a Phase 2 clinical trial of a targeted anti-cancer drug for the treatment of melanoma, a malignant skin cancer. Expectations are high for an innovative new drug that can alleviate patient suffering in a setting where there are no appropriate treatment options for cancers with NRAS gene mutations that cause melanoma through genetic alterations.

Hanmi Pharmaceutical announced on the 8th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for an Investigational New Drug (IND) application to conduct a domestic Phase 2 clinical trial of the targeted anticancer drug “Belvarafenib.”

This Phase 2 trial is a multicenter, single-arm study designed to evaluate the efficacy and safety of combination therapy with Belvarafenib and the MEK inhibitor Cobimetinib in patients with locally advanced or metastatic melanoma who have NRAS mutations. NRAS is a gene that produces a protein that regulates cell growth and division. However, when it is mutated, it is known to cause cancers such as melanoma and colorectal cancer.

Melanoma is a hard-to-treat cancer with limited treatment options and a high risk of recurrence. Most current treatments are supplied by overseas pharmaceutical companies. Through the development of Belvarafenib, Hanmi Pharmaceutical aims to help improve the domestic cancer treatment environment and strengthen competitiveness in the oncology sector, which is highly dependent on imports.

Belvarafenib, originally developed by Hanmi Pharmaceutical, is an oral targeted anticancer agent designed to inhibit RAF and RAS gene mutations within the mitogen-activated protein kinases (MAPK) pathway, which is involved in tumor cell growth and proliferation. In particular, Belvarafenib is characterized by targeting tumors harboring BRAF Class II/III mutations and RAS mutations, based on a differentiated mechanism that selectively inhibits RAF dimers. Unlike conventional BRAF inhibitors, which mainly inhibit monomers, Belvarafenib is designed to inhibit BRAF and CRAF dimers as well, and has been developed to overcome resistance issues arising from RAF dimer formation.

Accordingly, combination therapy with Belvarafenib and Cobimetinib is evaluated as a treatment strategy that can overcome the mechanistic limitations of existing combination therapies using BRAF monomer inhibitors and MEK inhibitors, and provide clinical benefits in a broader range of patients with genetic mutations.

In a preceding Phase 1 clinical trial, the safety and initial efficacy of the combination of Belvarafenib and Cobimetinib were confirmed in patients with solid tumors. In particular, the treatment demonstrated meaningful antitumor effects in patient groups with NRAS and BRAF mutations, providing the basis for subsequent clinical development.

Kim Na-young, Executive Vice President and Head of New Product Development at Hanmi Pharmaceutical, said, “We expect it to establish itself as a next-generation innovative therapy in rare and hard-to-treat cancers, including melanoma, where treatment options are limited,” and added, “We will work in close collaboration with domestic healthcare professionals, patients, and regulatory authorities to ensure the successful development and commercialization of Belvarafenib without setbacks.”

Hanmi Pharmaceutical emphasized that Belvarafenib was selected for the “Guide” program, an innovative product commercialization support initiative introduced last year by the MFDS. This program was established to support the rapid commercialization of innovative new drug candidates and similar products that are urgently needed by society and have high commercialization potential. Its core feature is to provide full life cycle support from early-stage development through the marketing authorization stage for selected products. As products are chosen through a strict and objective screening process, this selection is seen as recognition of Belvarafenib’s anticancer efficacy.

In practice, it was reported that Belvarafenib is already being administered on a limited basis to some patients through treatment-use approval in clinical settings. As a result, expectations are high for a new treatment option for patients with NRAS-mutant melanoma, for whom no domestic or overseas therapies are available. Hanmi Pharmaceutical plans to seek early commercialization of Belvarafenib in close cooperation with domestic healthcare professionals, patients, researchers, and regulatory authorities, while also exploring the potential for future expansion of its indications.

Park Jae-hyun, CEO of Hanmi Pharmaceutical, said, “Addressing unmet medical needs in disease areas where treatment alternatives are insufficient is the fundamental mission of a pharmaceutical company,” and added, “We will make company-wide efforts to ensure that Belvarafenib can become an important treatment option for a wide range of cancer patient groups.”

Popular News