The latest healthcare and pharma news from South Korea, including SK Bioscience’s COVID-19 vaccine, Daewoong’s partnership with AstraZeneca Korea and UCI Therapeutics, Vivozon production halt and GC’s acquistion of US-based CDMO, BioCentriq.
SK Bioscience’s COVID-19 vaccine to be tested against Omicron (Korea Biomedical Review)
SK Bioscience’s has submitted a biologics license application for SKYCovione (GBP510), a synthetic antigen-based COVID-19 vaccine, jointly developed by SK Bioscience and the Institute for Protein Design (IPD) at the University of Washington School of Medicine.
According to the company, SKYCovione proved its efficacy and safety in the global phase 3 trials, demonstrating superior neutralizing antibody titers and antibody conversion rate to the control vaccine, AstraZeneca’s Vaxzevria.An official at SK Bioscience said the company was planning “… to conduct an expansion trial to confirm SKYCovione’s preventive effect against Covid-19 variants, including Omicron.”
The company has already agreed with the Korea Disease Control and Prevention Agency (KDCA) to supply 10 million doses of SKYCovione in Korea.
After obtaining the local license, SK Bioscience plans to provide SKYCovione globally through COVAX. Additionally, the company aims to apply for emergency use listing (EUL) and marketing authorizations at regulatory agencies around the world.
Daewoong to cooperate with AstraZeneca on Asian launch of hyperlipidemia (Korea Biomedical Review) and partner with UCI Therapeutics on immune cell therapy (BioSpectrum Asia Edition)
Daewoong Pharmaceutical has signed a license-out and cooperation agreement with AstraZeneca Korea for Crezet, its hyperlipidemia treatment, for Indonesia, Thailand, Malaysia, and the Philippines.
The two companies are set to apply for local licenses for Crezet in Indonesia this year and for Thailand, the Philippines, and Malaysia next year. Daewoong will obtain and maintain licenses, manufacture and export products to these countries while AstraZeneca Korea will distribute and sell them. The hyperlipidemia market in the four countries is estimated at USD622 million.
“This agreement will be a new milestone in our partnership with Daewoong, which has continued to grow in the Korean and Asian markets,” AstraZeneca Korea’s CEO Kim Sang-pyo said.
In addition, Daewoong Pharmaceutical has signed a joint research and development agreement with UCI Therapeutics to cooperate on the development of immune cell therapy.
UCI Therapeutics, a bioventure set up in 2020, is developing CAR-NK immune cell therapy based on NK cell engineering technology through gene introduction. CAR-NK is a next-generation immune anticancer cell therapy combining CAR (Chimeric Antigen Receptor) that specifically responds to cancer cells and NK (Natural Killer) cells.
The ‘CellTaCT’ platform, UCI Therapeutics’ core technology, is a cell-based fusion therapy development platform to overcome the limitations of the existing combination therapy that administers both cell therapy and anticancer drugs.
Production halt for Vivozon due to unauthorised additives (Endpoints)
Last year, Vivozon was forced to recall and discard 13 drugs because of the use of unauthorized additives. Now, the Ministry of Food and Drug Safety has ordered production suspensions for a number of these drugs, including Decorafen, Rebadmi, Rebaratin, and Mucopid.
All drugs found to have the unauthorized additives have been suspended for four months while tablet production has been suspended for a month and 29 days, capsule production suspended for six weeks, and syrup production for five.
Both Samsung Pharma and Binex have received punishments from Korean regulators for similar offences.
GC buys US-based CDMO BioCentriq to build global capabilities (BioSpectrum Asia edition)
GC corporation has acquired the US-based contract development and manufacturing organization (CDMO), BioCentriq, Inc., a company that develops scalable cell and gene technologies.
With this acquisition of the New Jersey-based company that manufactures autologous and allogeneic cell therapies and gene therapies and specialises in viral vector production, cell and viral banking, and upstream and downstream processing GC companies will broaden their capabilities in scaling CDMO platforms
“BioCentriq’s unique expertise in the rapidly growing cell and gene therapy CDMO will be a transformative addition to our business that we believe will accelerate our growth, with additional expansion projects underway adjacent to current BioCentriq facilities.” said Yong-Jun Huh, president of GC.
