Zhifei Bio’s 15-valent pneumococcal conjugate vaccine Phase III clinical trial fully achieved the preset goals

March 21, 2025  Source: drugdu 51

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On the evening of March 19, the "15-valent pneumococcal conjugate vaccine" developed by Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd. obtained the Phase III clinical trial summary report. The report shows that the vaccine "has good immunogenicity and safety, fully achieved the preset goals of the clinical trial, is non-inferior to the control vaccine in terms of immunogenicity, and meets the design requirements of the "Technical Guidelines for Clinical Comparability Studies of Preventive Vaccines" for immunogenicity and safety evaluation."

It is understood that the "15-valent pneumococcal conjugate vaccine" developed by Zhifei Bio has no similar products approved for marketing in China. The vaccine is used to prevent infectious diseases caused by 15 serotypes of pneumococci, covering the 15 serotypes with the highest detection rates in Asia, and is also in line with the distribution of dominant serotypes in China.

The company pointed out that according to the relevant national drug registration management regulations, this product can submit a drug production registration application to the National Medical Products Administration after obtaining the Phase III clinical trial summary report. After that, it must go through technical review, clinical trial site verification, production site inspection and other procedures. It can only be marketed after obtaining the drug registration approval and the product is approved.

Zhifei Bio also stated that if the vaccine is approved for marketing in the future, it will form a synergistic effect with the company's 23-valent pneumococcal polysaccharide vaccine that has been launched and the 26-valent pneumococcal conjugate vaccine that is currently in Phase I/II clinical trials, further enriching the company's pneumonia vaccine matrix product structure, strengthening the company's market position, and enhancing industry competitiveness.

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