Hanmi Pharm Begins Phase 2 Trial for New Melanoma Drug with No Existing Treatments in Korea or Abroad

Hanmi Pharm has become the first company in Korea to initiate a Phase 2 clinical trial for "Belvarafenib," a novel targeted anticancer drug for the treatment of malignant melanoma. There is growing anticipation that this innovative new drug could offer hope to patients suffering from NRAS gene mutation cancers, for which there are currently no adequate treatment options.

Hanmi Pharm, a core business subsidiary of Hanmi Science, announced on January 8 that it had received approval from the Ministry of Food and Drug Safety on January 5 for the domestic Phase 2 clinical trial protocol (IND) for the targeted anticancer drug Belvarafenib.

Seoul Special City Songpa-gu Hanmi Group Headquarters exterior view. Hanmi Pharm

Efficacy Confirmed in Patients with NRAS Mutations

This Phase 2 clinical 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 harboring NRAS mutations. 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. Through the development of Belvarafenib, Hanmi Pharm aims to improve the domestic cancer treatment landscape and strengthen its competitiveness in the anticancer field, which is highly dependent on imports.

Belvarafenib, developed for the first time by Hanmi Pharm, is an oral targeted anticancer agent that inhibits 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 targets tumors with BRAF Class II/III mutations and RAS mutations by selectively inhibiting RAF dimers, a differentiated mechanism. Unlike existing BRAF inhibitors that mainly suppress monomers, Belvarafenib is designed to inhibit both BRAF and CRAF dimers, thereby overcoming resistance issues caused by RAF dimer formation.

Accordingly, the combination therapy of Belvarafenib and Cobimetinib is considered a treatment strategy that can overcome the mechanistic limitations of existing BRAF monomer and MEK inhibitor combination therapies, offering clinical benefits to a broader group of patients with various gene mutations.

In the previously conducted Phase 1 clinical trial, the safety and preliminary efficacy of the combination therapy with Belvarafenib and Cobimetinib were confirmed in patients with solid tumors. Notably, significant antitumor effects were observed in patient groups with NRAS and BRAF mutations, providing a basis for further clinical development.

Kim Nayoung, Executive Vice President and Head of New Product Development at Hanmi Pharm, stated, "We expect Belvarafenib to establish itself as a next-generation innovative therapy in the field of rare and refractory cancers with limited treatment options, including melanoma," adding, "We will work in close collaboration with domestic healthcare professionals, patients, and regulatory agencies to ensure the successful development and commercialization of Belvarafenib without delay."

Selected for the Ministry of Food and Drug Safety's 'Guide' Product Commercialization Support Program... Full-Cycle Support for Development and Approval

Belvarafenib was selected for "Guide," an innovative product commercialization support program newly introduced last year by the Ministry of Food and Drug Safety to accelerate the commercialization of innovative drug candidates with high social urgency and productization potential.

This program provides full-cycle support from the early development stage through the approval process for selected innovative products such as pharmaceuticals, biopharmaceuticals, and medical devices. Belvarafenib was selected through an objective review by a selection committee of external experts, taking into account factors such as social necessity for the treatment of severe, rare, or refractory diseases, unmet medical needs, new technologies and concepts, and the stage of development.

For selected items, the Ministry assigns dedicated staff for pre-consultation, offering customized advice on clinical trial design, compilation of non-clinical and clinical data, and the appropriateness of statistical analyses throughout the development process. The Guide program systematically supports rapid productization by assisting with the preparation of approval documents in conjunction with the rapid review (GIFT) program and, when necessary, pre-reviewing data preparation standards.

Currently, in clinical practice, Belvarafenib is being administered on a limited basis to some patients through treatment-use approval. There is a pressing need for a new domestic treatment option for NRAS-mutant melanoma patients for whom no domestic or international therapies are available.

Hanmi Pharm plans to pursue clinical development and early commercialization of Belvarafenib through close collaboration with domestic healthcare professionals, patients, researchers, and regulatory agencies, while also exploring the potential to expand its indications to various rare and refractory cancer areas in the future.

Park Jaehyun, CEO of Hanmi Pharm, stated, "Addressing unmet medical needs in disease areas with insufficient treatment alternatives is the fundamental mission of a pharmaceutical company," adding, "We will make every effort to ensure that Belvarafenib becomes an important treatment option for a wide range of cancer patients."