Corona 19 response strategy revealed at JPMorgan conference
Rolontis and Axol are expected to get marketing approval from the US FDA within this year
Tri-acting NASH treatment indication to be expanded
In the News Reporter Nam Gung-gyeongㅣHanmi Pharm (CEO Woo Jong-soo and Kwon Se-chang) announced the business direction this year at the 39th JP Morgan Healthcare Conference held online. The company has unveiled a global strategy and roadmap for responding to COVID-19 for the first time along with a specific vision of the innovative new drug pipeline.
Hanmi Pharm announced on the 12th that it will contribute to the end of the corona pandemic through’DNA/mRNA vaccine production’ and’diagnosis kit/treatment development’ centered on the Pyeongtaek bio plant.
According to Hanmi Pharmaceutical, Pyeongtaek Bioplant currently has a GMP facility that can produce corona plasmid DNA vaccine, mRNA vaccine, and enzymes required for mRNA synthesis through E. coli fermentation and purification drug production facilities. In addition, Hanmi Fine Chemical, a subsidiary, has the capability to produce various raw materials, including nucleotides, synthetic raw drugs, intermediates, peptides, and lipids (raw materials for mRNA vaccine formulations).
Hanmi Pharm also said that it is developing a full-cycle lineup from coronavirus prevention to diagnosis and treatment. Following the recent release of’Hanmi Cold Mask Nasal Spray’, which contains lambda carrageenine, which can enhance the effect of blocking respiratory virus infection, we are preparing to release a kit that can diagnose both corona and flu at the same time.
In addition, we also derived preclinical candidates for corona treatment using a new drug synthetic chemical that is a PIKfyve inhibitor and thymosin hormone.
Kwon Se-chang, president of Hanmi Pharm, said, “Hanmi Pharm has a variety of capabilities based on facilities capable of consignment production of mRNA and DNA vaccines (CMO/CDMO),” and said, “The possibility of cooperation with various companies to contribute to overcoming the global pandemic crisis I keep it wide open.”
Hanmi Pharm has comprehensively disclosed major R&D updates and expected research results.
Hanmi Pharmaceutical is currently developing a total of 28 new drug pipelines, including 8 metabolic diseases, 12 anticancer diseases, 5 rare diseases, and 3 other diseases, with more than 580 professional R&D personnel.
◇ Hanmi Pharmaceutical’s new drug R&D development strategy in 2021
Hanmi Pharm plans to create global R&D results based on innovations in the areas of inflammation-fibrotic treatment, metabolic diseases, anticancer and rare disease treatments, such as innovative new drugs for non-alcoholic steatohepatitis (NASH) treatment.
The two new drugs developed by Hanmi Pharmaceutical are expected to receive marketing approval from the US FDA this year. ‘Rolontis’, a neutropenic treatment drug exported to Spectrum in the US, and’Oraxol,’ a metastatic breast cancer treatment exported to Artenex, are about to announce the results of the FDA’s marketing approval (BLA) and priority review, respectively.
President Kwon said, “The R&D capabilities of Hanmi Pharmaceutical and the trust with various partners are solid.” “In the near future, two new drugs will be approved for marketing by the FDA. I emphasized.
◇ Labs Triple Argonist indication expansion notice
‘Labs Triple Argonist’, a NASH treatment, is on a cruise with proven effectiveness in reducing fatty liver by more than 50% through a recent clinical trial. Fatty liver reduction effect within 12 weeks was up to 80% compared to placebo control, and liver enzyme reduction effect was also significant. Based on this, Labs Triple Argonist is currently undergoing global phase 2 clinical trials, and has been designated as FastTrack, which is supported by the FDA for rapid development of NASH treatment.
Labs Triple Argonist was also designated by the FDA last year as an orphan drug for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), and has indications for idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD). It will be expanded.
Epeglenatide, which is being developed as a diabetes treatment, recently completed phase 3 clinical trials, and succeeded in ’30 weeks of glycated hemoglobin (HbA1c) reduction compared to placebo’ in all dose cohorts, satisfying the primary endpoint, and the secondary endpoint. The company reported that it also confirmed the weight loss effect. Hanmi Pharm plans to maximize the synergy of the therapeutic effect by combining it with new drugs such as’Labs Glucagon Analog’.
‘Epinopegdeutide’, which was exported to MSD last year, entered phase 2 clinical trials this year, and its development as a NASH treatment is expected to accelerate further.
◇ Leading anticancer field through open innovation
Through open innovation, Hanmi Pharm also emphasized plans for intensive development in the areas of immune cancer, inflammation and fibrosis, new platforms, and rare diseases.
Pogiotinib, which successfully conducted clinical trials for HER2 mutant non-small cell carcinoma (NSCLC) patients in the second half of last year, is expected to apply for a marketing license from the FDA this year. Velbarafenib (HM95573, solid cancer), which has been technically exported to Genentech, is currently undergoing global clinical trials, and’HM43239′, which has shown complete remission in patients with FLT3 mutant acute myelogenous leukemia (AML), who have failed the existing treatment, seeks to increase and expand the dose I’m doing it.
Hanmi Pharm is discovering standard and AI-based preclinical substances to derive T cell-targeted anticancer drug candidates, and is confirming the possibility of gastric cancer treatment with the combination therapy of US Rapto’s oral immunotherapy candidate (FLX475) and Kitruda. .
In addition, we are conducting active research by introducing dual antibodies from Paines of the United States, and the plan is to increase the anticancer effect in the tumor microenvironment (TME) through synergy with Pentambody, a dual antibody platform technology developed by Beijing Hanmi Pharmaceutical. .
In addition, the PD-1/HER2 dual antibody drug developed with Innovent is currently undergoing clinical trials in China to find an appropriate dose for solid cancer patients.
◇ Also strives to develop treatments for rare diseases
Hanmi Pharm plans to devote itself to its role as a pharmaceutical company for a small number of rare patients with high unmet needs.
LAPSGLP-2 Analog (code name: HM15912), which is being developed as a treatment for short bowel syndrome, which occurs in 3 out of 1 million people, has increased its half-life so that it can be administered once a month for the first time in the world, confirming safety in phase 1 clinical trial, and entering phase 2 clinical trial this year. I will do it.
In addition, the development of a treatment for congenital hyperinsulinemia (CHI) and a treatment for LSD syndrome, a lysosomal accumulation disease, is also on the go. In particular, the treatment for congenital hyperinsulinemia was approved by the FDA on the 9th for phase 2 clinical trials.
President Sei-Chang Kwon said, “Hanmi Pharm will fulfill its mission of respecting human life by rapidly progressing the task of overcoming the Corona 19 global pandemic. We will meet our high expectations for Hanmi Pharmaceutical’s R&D through such activities.”