SK Chemicals said it has released for sale in the domestic market a cell-culture influenza vaccine, SKYCellflu, which received a nod South Korea's Ministry of Food and Drug Safety in March to ramp up production after receiving marketing authorization in December last year.
The commercialization coincides with a normal seasonal vaccination cycle expected to start on Aug. 20, the company said in a press release, which cited ministry figures that approximately 20 million doses of influenza vaccines would be supplied this year.
"In a market more competitive than ever following the heightened demand, a new influenza vaccine exhibiting rapid response to mutated influenza strains has been developed entirely with Korean technology," the company said in the release.
The company says the cell-culture process allows the production of a greater amount of influenza vaccine in a shorter amount of time, approximately one-third of that required for the conventional process using fertilized chicken eggs.
Both growth prospects and competition across vaccine markets in Asia were cited by companies like Pfizer ($PFE) and GlaxoSmithKline ($GSK) in second quarter earnings calls as countries like South Korea, Indonesia and Malaysia work to develop vaccine-manufacturing capabilities to meet regional demand and hold down costs by achieving scale.
India is also regional leader in meeting demand from campaigns sponsored in part by the World Health Organization and UNICEF at a size and scale that has attracted attention from firms like Takeda Pharmaceuticals and Sanofi Pasteur. Earlier this year, China's FDA awarded marketing approval of the world's first Sabin strain inactivated polio vaccine, marking a milestone as well for the Institute of Medical Biology of the Academy of Medical Sciences.
In the case of SK Chemicals and the influenza vaccine, the aim is both domestic and international.
"SK Chemicals' goal is to use the launch of SKYCellflu as a springboard to bring about change in the current domestic market that relies on imported vaccines for more than half the supply and eventually penetrate developed overseas markets," the company said in the release.
In March 2014, the company entered a collaboration on an innovative pneumococcal vaccine with Sanofi Pasteur and has also worked with the Bill and Melinda Gates Foundation to develop a new typhoid conjugate vaccine.
In April of this year, SK Chemicals signed a deal to market Sanofi Pasteur's Menactra, a meningococcal conjugate vaccine, and a live-attenuated Japanese encephalitis vaccine upon approval, in South Korea.
Sanofi ($SNY) will provide SK Chemicals with the vaccines, which then will be promoted and distributed for treatment of adult patients through SK Chemicals.
Menactra is a 4-valent protein-conjugate vaccine preventing meningococcal meningitis caused by 4 serogroups (A, C, Y, W-135) of meningococcal bacteria.
It was the first vaccine in its class to obtain U.S. FDA approval in 2005, with more than 70 million doses provided throughout 53 countries to date. It is the most-sold meningococcal protein-conjugate vaccine in the world. It has a proven rate of immunogenicity of over 98% against 4 serogroups in clinical trials carried out in the U.S.
- here's the SK Chemicals release