Hanmi Pharm seeks FDA approvals of two novel drugs

By Nam Hyun-woo

Hanmi Pharmaceutical said it is expecting the U.S. Food and Drug Administration (FDA) to approve two novel drugs this year, raising expectations over the company's pipeline. The announcement was made during the J.P. Morgan Health Care Conference, Tuesday.

The drug maker also claimed it possesses the facilities to manufacture COVID-19 vaccines and develop products covering prevention, testing and treatment of the disease.

“Expectations over Hanmi's pipeline are the highest ever, with two novel drugs anticipated to win approvals from the FDA in the near future,” Hanmi Pharmaceutical CEO Kwon Se-Chang said during the conference.

The two novel drugs are Rolontis, a biologic used to treat neutropenia or an abnormally low concentration of a type of white blood cell called neutrophil; and Oraxol, an oral anticancer treatment for metastatic breast cancer. Rolontis, licensed out to the U.S. pharmaceutical firm Spectrum, needs an FDA biologics license, while Oraxol, licensed out to Athenex, is waiting for the results of a priority review.

Along with the two drugs, Hanmi said it is making strides in developing treatments for non-alcoholic steatohepatitis (NASH), including LAPS Triple Agonist. Presently undergoing global phase 2 studies, LAPS Triple Agonist reduced fatty liver disease in patients by more than 50 percent in a recent trial, the company said. The FDA designated the drug for fast-track approval in July last year.

Another NASH treatment candidate, efinopegdutide, which was licensed out to MSD in 2020, is scheduled to enter phase 2 trials this year, according to Hanmi. Kwon added the company will cover all cycles of COVID-19 with products for prevention, testing and treatment.

Hanmi said its new bio plant in Pyeongtaek, Gyeonggi Province, will play a central role in this plan. The plant is capable of producing COVID-19 vaccines, including plasmid DNA and mRNA types. The plant can also produce enzymes needed to synthesize mRNA, which is a molecule that carries DNA information to parts of a cell that make proteins.

Kwon also said Hanmi's affiliate, Hanmi Fine Chemical, can handle volume manufacturing for nucleotides, active pharmaceutical ingredients, intermediates and a slew of other ingredients required for drugs.

For testing, the company said it is preparing for the launch of a kit which can diagnose the coronavirus and flu at the same time. Hanmi added that it has come up with a COVID-19 treatment candidate which utilizes Thymosin alpha-1 hormone and PIKfyve inhibitors. PIKfyve is an enzyme that controls the process of signaling in cells.

“Hanmi Pharmaceutical is capable of contract manufacturing and development of mRNA vaccines and DNA vaccines,” Kwon said.