Hanmi Pharmaceutical on Monday has presented its global strategy and roadmap for responding to Covid-19 along with a specific vision of the innovative new drug pipeline during the 2021 J.P. Morgan Healthcare Conference.

To overcome the ongoing Covid-19 pandemic, the company stressed that it would be taking a multi-angle approach. This strategy includes a vision that can contribute to ending the pandemic by producing DNA and mRNA vaccines, centered on its Pyeongtaek bioplant, according to Hanmi.

"Pyeongtaek bioplant has a good manufacturing practice (GMP) facility that can produce Covid-19 plasmid DNA vaccine, mRNA vaccine, and enzymes necessary for mRNA synthesis through E. coli fermentation and purification drug production facilities," Hanmi Pharmaceutical CEO Kwon Se-chang said.

Besides, Hanmi Fine Chemicals can produce various raw materials for manufacturing vaccines, such as nucleotides, active pharmaceutical ingredients (APIs), intermediates, peptides, and lipids, which are raw materials for preparing mRNA vaccines, he added.

Kwon also revealed that the company is developing a full-cycle lineup from prevention to diagnosis and coronavirus treatment at one of the world’s most prestigious yearly healthcare forums.

"Following the recent release of the Hanmi Cold Mask Nasal Spray, which can increase the effect of blocking respiratory viral infections, we are preparing to release a diagnostic kit that can simultaneously diagnose coronavirus and flu," he said. "The company has also discovered preclinical candidates for Covid-19 treatment using the hormone PIKfyve inhibitor and thymosin α1."

Based on such a robust strength in combating the Covid-19 virus, Kwon said, the company is open to the possibility of cooperation with various companies to end the Covid-19 epidemic.

Explaining Hanmi’s R&D roadmap for developing new drugs, Kwon emphasized that the company has more than 580 professional R&D personnel developing 28 new drug pipelines, including treatments for eight metabolic diseases, 12 anti-cancer diseases, five rare diseases, and three other diseases.

"We expect two new drugs developed by the company to receive marketing approval from the U.S. Food and Drug Administration this year," Kwon said.

The two are Rolontis, a neutropenia drug licensed out to Spectrum Pharmaceutical, and Oraxol, a metastatic breast cancer drug licensed out to Athenex.

"Hanmi Pharm's R&D capabilities and trust with various partners are solid, and the company expects to receive the final results for a biologics license application for Rolotins and priority review for Oraxol soon," Kwon said.

During the presentation, the company also introduced its success in non-alcoholic steatohepatitis (NASH) treatment, LAPSTriple Agonist (HM15211).

"HM15211 has recently proved that it reduces fatty liver by more than 50 percent through clinical trials and is one of the most effective NASH treatments under development in the world," Kwon said. "Based on such strong clinical results, the drug is currently undergoing global phase 2 clinical trials, with the FDA granting a fast-track designation."

FDA grants fast track designations to treatments that show excellent therapeutic efficacy in severe or life-threatening diseases.

Kwon noted that the company had continuously expanded indications for HM15211.

"The treatment received orphan drug designation (ODD) from the FDA as a treatment for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in 2020, and the company plans to acquire more indications in the field of idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease."

Besides, the company expects Efinopegdutide, a NASH treatment candidate licensed out to MSD in 2020, to enter phase 2 clinical trials this year, further bolstering its presence in the NASH treatment market.

Commenting on other projects, Kwon said Hanmi would extensively develop immunotherapies through open innovation.

"The company expects to apply for sales approval for Poziotinib, which successfully conducted clinical trials in HER2 (human epidermal growth factor receptor) mutant non-small cell lung cancer (NSCLC) with Spectrum, to the FDA this year," Kwon said. "HM95573, licensed out to Genentech, is also currently undergoing global clinical entry."

It also plans to address the high unmet medical need of rare patients, such as short bowel syndrome, congenital hyperinsulinism (CHI), and LSD (lysosomal storage diseases).

"Hanmi will fulfill its mission of caring for human life by rapidly fulfilling its missions to overcome the Covid-19 global pandemic," Kwon said. "Also, we will meet the high expectations for Hanmi's R&D capabilities by acquiring FDA marketing approvals for new drugs and accelerating clinical progress to increase the value of various pipelines."