Hanmi presents solution package for coping with COVID-19, including the mass production of nucleic acid vaccines (DNA/mRNA vaccine)

SEOUL,South Korea,Jan. 13,2021 -- Hanmi Pharmaceutical Co.,Ltd.,announced "endless challenges and new commitments for the pharmaceutical industry" as their management slogan for the new year,presenting the business direction for the year 2021 at the 39th JP Morgan Healthcare Conference,which was held online.

Hanmi Pharmaceutical Co.,Ltd Bio Plant manufacturing and Development facilities.

During the day's presentation,Hanmi Pharmaceutical Co.,Ltd. drew attention by going public with their global strategy and a solution package for coping with COVID-19 for the first time,along with their presentation on specific vision for the existing pipeline that will lead to innovative new drugs.

This strategy included the company's vision of using Pyeongtaek Bio Plant to contribute to COVID-19 pandemic situation as a CDMO through the vision for the production of DNA vaccines and mRNA vaccines,as well as release of COVID-19 & Influenza dual diagnostic kit and development of potential COVID-19 medicines.

A view of the Pyeongtaek Bio Plant of Hanmi Pharmaceutical Co.,Ltd.

Pyeongtaek Bio Plant possesses a GMP facility where bulk drug substances of mRNA and pDNA vaccines can be produced. This facility is also capable of manufacturing enzymes for RNA synthesis and processing (the raw materials used in the mRNA manufacturing) via process involving E. coli fermentation and purification. In addition,Hanmi Fine Chemical. Co.,a subsidiary company has the capabilities to produce various synthetic raw materials including nucleotides,synthetic drug substances (APIs),intermediates,and peptides,as well as lipids (raw materials used in mRNA vaccine formulation).

Hanmi Pharmaceutical Co.,Ltd. is developing a full package to handle the prevention,diagnosis,and treatment of COVID-19. Hanmi recently released 'Hanmi Cold-Mask™ nasal spray',whose main ingredient is λ-carrageenan (lambda-carrageenan) extract that can prevent respiratory viral infection. The company is also preparing to release a diagnostic kit that can simultaneously diagnose COVID-19 and Influenza.

In addition,the identification of preclinical candidate substances for the treatment of COVID-19 using new chemical entities (NCEs) and the thymosin (thymosin α1) hormones of PIKfyveinhibitors is still underway.

Se Chang Kwon,CEO of Hanmi Pharmaceutical Co.,explained,"Hanmi Pharmaceutical Co.,Ltd. has various capabilities based on the facilities where we can produce nucleic acid vaccines as a contract manufacturing/development organization (CMO/CDMO)," adding "We are open to potential collaboration with various companies to contribute to ending the global pandemic."

In addition to this,Dr. Kwon comprehensively disclosed key R&D updates and expected research results,and highlighted the sustainable growth of Hanmi Pharmaceutical Co.,which has seen increased sales of the main products even during the COVID-19 pandemic.

Currently,Ltd. is focusing on the development of pipeline of 28 new drugs,including 8 drugs for metabolic diseases,12 anti-cancer drugs,5 drugs for rare diseases,and 3 drugs for other diseases,with more than 580 personnel who are specialized in R&D.

Hanmi Pharma's nucleic acid vaccines and biologics CDMO program is focused at the Hanmi Bio Plant based in Pyeongtaek,Gyeonggi-do,about 80 miles south of Seoul. Hanmi Bio Plant uses E. coli to produce a protein substance called "LAPS Carrier" as an intermediate in new biological drugs of the Hanmi platform technology "LAPSCOVERY". The process to manufacture LAPS Carrier is similar to the process of producing plasmid DNA,the precursor to mRNA synthesis,which is the key substance of the nucleic acid vaccines.

Hanmi Bio Plant is able to obtain approximately 10,000 liters of culture media per batch through a 3-day E. coli culture process. This amount can produce millions of doses of nucleic acid vaccines. The Bio Plant can supply over 100 batches of nucleic acid vaccine drug substances per year to vaccinate hundreds of millions of people.

Hanmi Bio Plant has two production buildings (Production Buildings 1 and 2) at the site with an area of 51,498 m2. With over 500 employees including teams of Manufacturing,QC,QA,Engineering,Process/Analytical Development,and CMC RA,they can perform the development,manufacturing,regulatory documentation,and commercial production of biological drugs. Clinical and commercial supplies for various biological drugs co-developed by Hanmi Pharmaceutical Co.,Ltd. are currently being produced.

In particular,newly constructed Production Building 2,which was completed in 2019 as a 6-story building with a total floor area of 28,211 m2,is a state-of-the-art facility that can produce up to 100 batches per year of 20,000 liters of microorganism culture and purification. The plant also has a syringe filling facility to produce finished injectable products,possessing optimal conditions as a global manufacturing base for biological drugs.