SK bioscience seeks Korean regulatory approval to initiate phase 1/2 trial of NBP607B

SK bioscience seeks Korean regulatory approval to initiate phase 1/2 trial of NBP607B

By, Admin 21 July 2025

Overview

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a phase 1/2 clinical trials of a new influenza vaccine candidate, ‘NBP607B’. The candidate incorporates an adjuvant into its existing cell-based influenza vaccine, ‘SKYCellflu’ to enhance protective efficacy.

Seeking approval expansion

SK bioscience previously utilized adjuvants in its Covid-19 vaccine, ‘SKYCovione’, and now seeks to expand this technology to influenza vaccines as part of its broader platform strategy.

NBP607B Uses VFI Adjuvant to Boost Elderly Immunity

  • NBP607B contains an adjuvant developed by the Vaccine Formulation Institute (VFI), a Swiss-based non-profit vaccine research organization. Comprising multiple immune-boosting components, the adjuvant is expected to induce strong immune responses and antibody production in elderly individuals. 
  • SK bioscience has proactively conducted non-clinical studies since 2023 and reported promising results.

The upcoming phase

The phase 1/2 clinical trial is scheduled to begin during the upcoming Northern Hemisphere flu season, enrolling approximately 320 older adults in Korea and abroad. The study will evaluate the vaccine’s immunogenicity and safety compared to an approved high-immunogenicity flu vaccine, with interim results expected by 2027.

1st attempt from Korea for IND

  • This marks the first attempt by a Korean company to submit an IND to develop a high-immunogenicity influenza vaccine using an adjuvant. If successful, the company plans to leverage the platform for other vaccines and establish a competitive edge in the global high-value vaccine market.
  • The development aligns with global health authorities’ increasing recommendations for enhanced flu vaccines in high-risk groups.

CDC’s on adjuvanted influenza vaccines

  • The US Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) recommends high-dose or adjuvanted influenza vaccines for adults aged 65 and older. 
  • The World Health Organization (WHO) also supports the use of adjuvanted vaccines for vulnerable populations. 
  • In Korea, the Korea Disease Control and Prevention Agency (KDCA) has indicated that domestically developed high-immunogenicity vaccines may be considered for inclusion in the National Immunization Programme (NIP) if they meet appropriate criteria.

Global vaccine market growth

  • According to market research firm Mordor Intelligence, the global vaccine market is projected to grow from USD 83.9 billion in 2025 to USD 114.8 billion in 2030, with an average annual growth rate of 6.5%. 
  • Demand for high-immunogenicity vaccines is expected to rise continuously due to global aging and the increasing number of immunocompromised individuals and those with chronic illnesses.

About SKYCellflu

  • SKYCellflu, SK bioscience’s existing cell-based influenza vaccine, has already been recognized for its innovation. 
  •  It became the world’s first cell-based flu vaccine to receive prequalification (PQ) from the WHO and is currently approved in 11 countries, with supply through international procurement programs by United Nations Children´s Fund (UNICEF) and Pan American Health Organization (PAHO).

Words from Jaeyong Ahn: CEO of SK bioscience

Jaeyong Ahn, CEO of SK bioscience, said, “We believe the combination of our proven SKYCellflu platform and our experience in adjuvanted vaccine development positions us well for success. We aim to establish a differentiated presence in the high-immunogenicity vaccine market while building a flexible platform for future infectious disease preparedness.

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