GC Pharma, SK Bioscience Also Sign CMO Deals
Samsung Biologics announced on Nov. 17 that it has started production and delivery of COVID-19 antibody treatments for Eli Lilly.
The two companies entered into a manufacturing partnership agreement in May 2020 to address the increasingly urgent demand for COVID-19 treatments worldwide.
Samsung Biologics announced that it was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API), which meet Good Manufacturing Practices (GMP) and regulatory expectations, within 5 months of contract signing by leveraging the full force of both companies’ collaborative efforts. It added that the timeline for tech transfer was reduced dramatically to less than 3 months, due in large part to close communications and coordination between technical, quality, supply chain, and regulatory experts from both companies.
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) received on Nov. 10 FDA emergency use authorization for the treatment of recently diagnosed COVID-19. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. The U.S. government has decided to purchase 300,000 doses of antibody treatments worth US$375 million on Oct. 28.
Discussions on the introduction of treatments developed by global pharmaceutical giants to Korea are underway, but actual prescriptions are expected to take a considerable period of time. This is because most global pharmaceutical companies prioritize home countries and pre-orders in supplying their treatments. The Korean government reportedly did not sign a letter of intent for domestic supply cooperation when Samsung Biologics signed a manufacturing contract with Eli Lilly.
Samsung Biologics’ partnership with Lilly is the second contract the company signed to produce COVID-19 treatments. In August, it signed a 439.3 billion won contract with British pharmaceutical company GlaxoSmithKline to produce antibody treatments for COVID-19.
To date, Remdesivir has been the only COVID-19 treatment being used.
Korean companies such as Celltrion and GC Pharma are also developing treatments. In September, Celltrion was allowed to carry out Phase 2 clinical trial of antibody treatment CT-P59 for mild cases. After completing clinical trials at the end of 2020, Celltrion started producing process verification batches with an application for emergency use approval in mind. The company intends to ensure a mass supply immediately after approval.
GC Pharma inked a contract to produce COVID-19 vaccines with the Coalition for Epidemic Preparedness Innovations (CEPI), a global private organization, in October. CEPI recognized GC Pharma’s high-level production infrastructure. GC Pharma will operate a production facility for CEPI for at least 500 million doses from March 2021 to May 2022. In addition, GC Pharma was allowed to carry out Phase 2 clinical trial of the plasma treatment GC5131A in August. It administered the drug to patients for the first time in September. Clinical results are expected to come out as early as the end of 2020.
In August, SK Bioscience also struck a deal with Novavax, a U.S. pharmaceutical company which is supported by CEPI to produce a COVID-19 vaccine. Once COVID-19 vaccines are developed, GC Pharma and SK Bioscience will be in charge of producing them.