CHO PHARMA announced yesterday (20th) that it has submitted an Investigational New Drug (IND) reassessment application for its preventive bacterial vaccine (CHO-V08) to Taiwan's Ministry of Health and Welfare's Food and Drug Administration (TFDA). The submission includes supplementary materials addressing deficiencies in the chemical manufacturing controls and non-clinical pharmacology and toxicology sections identified by the TFDA.

According to the announcement, CHO PHARMA received a letter from the TFDA on September 23 last year stating that due to deficiencies in the chemical manufacturing controls and non-clinical toxicology data, approval to proceed was not granted. In response, the company compiled the necessary documentation and submitted the reassessment application within four months.

CHO-V08 is primarily designed as a bivalent preventive vaccine against hypervirulent Klebsiella pneumoniae. The completion timeline for the vaccine's development will depend on the TFDA's review progress.

CHO PHARMA highlighted a July 2024 global alert issued by the World Health Organization (WHO), warning about the spread of hypervirulent Klebsiella pneumoniae. Among its various strains, serotype K1 (K1-ST23) and serotype K2 (K2-ST65) are the most threatening, and no vaccine targeting this superbug has been developed to date.

Currently, five pharmaceutical companies worldwide are engaged in the development of vaccines against Klebsiella pneumoniae. These include Swiss firms LimmaTech and Idorsia, Spanish company Vaxdyn, U.S.-based Omniose, and CHO PHARMA.

CHO PHARMA noted that it possesses advanced, patented bacterial glycan extraction technology, including K-antigen-based antigens and carbohydrate-protein conjugation (Conjugate Vaccine) techniques. Utilizing these technologies, the company has developed CHO-V08, a bivalent preventive vaccine targeting the high-risk K1 and K2 serotypes. Preclinical studies have demonstrated that CHO-V08 exhibits strong immunogenicity and protective efficacy in various pharmacological tests and mouse challenge models.

According to a BCC Research report, the global pneumonia vaccine market is projected to reach USD 7.5 billion by 2030. If CHO-V08 succeeds in development, it will not only help curb the spread of superbugs but also reduce the risk of infections in elderly individuals, patients with chronic illnesses, and those exposed to hospital-acquired infections.

Resource: 醣基預防性細菌性疫苗 向TFDA提出IND申復審查申請