Hanmi quickens developing belvarafenib as new targeted chemotherapy

Hanmi Pharm has unveiled a plan to develop belvarafenib as its new targeted chemotherapy with the pipeline name HM95573 Tab.

In a briefing to Minister of Food and Drug Safety Oh Yu-kyoung at the company’s research center, Hanmi Vice President Suh Gwi-hyun said the company had selected belvarafenib, an oral targeted cancer therapy, as its next new drug pipeline following Rolontis (eflapegrastim), a neutropenia treatment.

“Belvarafenib, a pan-RAF (rapidly accelerating fibrosarcoma) inhibitor, can apply for approval based on phase 2 clinical trial results, will likely win the nod in 2026 or 2027,” Suh said.

Belvarafenib is a selective mutant inhibitor that exhibits anti-tumor effects in solid cancers caused by RAF and RAS (rat sarcoma) mutations. Hanmi expects it to become a new targeted chemotherapy that can be prescribed for NRAS-mutated melanoma patients aside from existing BRAF mutation.

U.S.-based Genentech has the global right to develop belvarafenib.

Hanmi transferred the technology at $910 million to the U.S. company in 2016. Genentech has since been developing belvarafenib through a global phase 1b clinical trial.

Genentech recruits NRAS-mutated melanoma patients in six countries – the U.S., Canada, Australia, Germany, Korea, and Norway. According to clinicaltrials.gov, a website for clinical trial information of the U.S. National Institutes of Health (NIH), Genentech has expanded its clinical site since it began recruiting patients in April 2021.

In addition, Roche, the parent company of Genentech, included belvarafenib in its TAPISTRY project, a clinical trial project targeting the company’s core pipelines. Roche also conducts a clinical trial in which it administers only belvarafenib in BRAF class 2/3 mutation solid tumor patients.

The Korean medical community also has high expectations of commercializing belvaratinib. For the past two years, medical workers have won approval for 16 treatment purposes and use them in medical fields. The target diseases were also varied, including malignant myeloid, colorectal cancer, renal pelvis cancer, thyroid cancer, and non-small cell lung cancer.

"We developed belvarafenid as a BRAF inhibitor like Norvatis’ treatments (Rafinlar and Meqsel). However, clinical studies have shown that it is effective for BRAF and NRAS mutation myeloma. So that has quite a significance,” said a professor at a university hospital.

Noting that belvarafenib showed excellent effects in BRAF-fusion mutation patients, the professor said, “These patients have had no treatments. Now that the new drug can target NRAS mutations, what’s left is to prove its treatment effects through large-scale clinical trials. I hope it will win approval.”

The expert said that although the mechanism of belvarafenib has changed since its initial development, it has sufficient potential to expand, making it possible to combine it with other drugs and apply it to targets we don't know yet.

For example, when used in combination with MET inhibitors, resistance appeared late, he added, expressing expectations.

“As belvaratinib was licensed out, Hanmi is playing the role of the bridge between the medical field and Genentech in making major decisions,” the expert said. “Hanmi and Genentech are rather slow in developing the drug. I hope they speed up for the benefit of patients.”