On April 30, 2024, Sapalizumab's new commercial production facility has officially obtained approval from the National Medical Products Administration (NMPA) of China. This marks the initiation of the commercialization process supported by Chime Biologics to assist clients in obtaining approval for their drugs to enter the market. Currently, Chime Biologics has 12 late-stage projects in progress.
The NMPA, after conducting a rigorous review and assessment, confirmed that Intellectivebio's pharmaceutical production complies with Good Manufacturing Practice (GMP) standards and that the product quality meets the required comparability and quality standards.
The IP180 project, which included comprehensive research work on technology transfer and the addition of a new production site, faced numerous challenges, including the constraints imposed by the pandemic. Despite these obstacles, both companies worked diligently to advance the project, successfully submitting the application for the new production site addition. The project subsequently cleared the registration site inspection and GMP compliance check, culminating in official approval in April 2024.
The comparability study work is of utmost importance for the IP180 project, which falls under the category of post-marketing changes. Intellectivebio, relying on a comprehensive quality analysis system and a strong team of scientific and production experts, has meticulously studied the regulations published domestically and internationally. They have formulated reasonable and effective research methods and tools. Considering aspects such as product release testing, extended characterization studies, and the consistency of degradation trends and pathways in stability studies, Intellectivebio has effectively evaluated the consistency of quality before and after the site change. The approval of IP180 is also an affirmation of Intellectivebio's platform for developing comparability research strategies.
