News
2021.12.06
“Hanmi Pharmaceutical has secured a proprietary mRNA vaccine platform technology. Even if a new variant emerges, as long as the genes of the variant are obtained, it will be possible to develop an mRNA vaccine within a month. We’ve secured a vaccine candidate for the Delta variant, and we plan on introducing the related technology by collaborating with a lipid nanoparticle (LNP) company by the end of this year,” said Kwon Se-chang, CEO of Hanmi Pharmaceutical at the 2021 Korea Bio Investment Conference (KBIC) held at the Dragon City in Yongsan, Seoul by the Korea Economic Daily on December 6. Hanmi Pharm CEO Kwon emphasized that the company would strive to deliver tangible results in the key areas, anticancer and rare disease treatment and mRNA vaccines.
With regard to the development and production of an mRNA vaccine for COVID-19, he said, “We’ve secured a proprietary platform technology that is unrelated to Moderna and Pfizer’s patents. [...] We’ve secured a vaccine candidate for the Delta variant, and we plan on introducing the related technology by collaborating with a lipid nanoparticle (LNP) company by the end of this year.”
He added, “Even if a new variant emerges, as long as the genes of the variant are obtained, it will be possible to develop an mRNA vaccine within a month.”
He expressed confidence stating, “We’ve successfully synthesized various types of ingredients, including the 5’-capping ingredient, which is key to mRNA vaccine production and gained the capacity for mass production. [...] We will secure most of the mRNA-related patented technologies to secure an advantageous position against our competition.”
“We’ll speed up the development of a one-stop system for production, development of core platform technologies, and mass production, based on the R&D capacities of Pyeongtaek Bio Plant, Hanmi Fine Chemical, and Hanmi Pharm R&D Center. [...] We will develop mRNA to not only apply it to vaccines but also anticancer therapy,” he said.
In the field of anticancer therapy, poziotinib, a new drug for non-small-cell lung cancer, became the fastest investigational drug to enter the approval process. Spectrum, a partner of Hanmi, plans to submit a new drug application (NDA) to the FDA by the end of this year. The goal is to obtain conditional approval in 2022 based on the results of the Phase II clinical trial.
CEO Kwon explained, “In the case of belvarafenib, a new drug for targeted therapy, Genentech, a subsidiary of Roche, began a global Phase I clinical trial to evaluate its safety and effectiveness in concomitant therapy. [...] Roche has included belvarafenib in a large-scale clinical research project (Tapistry) for which it has mobilized all of its promising new drug pipelines.”
As for GLP-glucagon (epinopegdutide) licensed to MSD last year, a multinational Phase II clinical trial has recently kicked off to develop the drug for non-alcoholic steatohepatitis (NASH). CEO Kwon said, “This is meaningful in that the new drug returned by Janssen has turned into an opportunity to make new innovations with a new partner.”
Hanmi Pharm is dedicated to developing dual-acting and triple-acting therapeutic agents for NASH. The Triple Agonist, which is a GLP-1 receptor agonist, glucagon receptor agonist, and GIP receptor agonist at the same time, is being examined through Phase II clinical trials in the United States and Europe. It is expected to be designated as an orphan drug for idiopathic pulmonary fibrosis (IPF) in Europe this month.
CEO Kwon said, “In the field of anticancer therapy, we will be able to obtain FDA approval and present the results of the global clinical trials through presentations at conferences next yar.”
Hanmi Pharm is also expected to produce excellent results in the area of rare diseases. “Six new drugs being developed by Hanmi Pharm have been given the orphan drug designation (ODD) for ten indications by the US FDA and European Medicines Agency (EMA) and seventeen designations by the Ministry of Food and Drug Safety of Korea,” said CEO Kwon.
Source: The Korea Economic Daily