Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that National Medical Products Administration (NMPA, successor to CFDA) has accepted its new drug application (NDA) for adalimumab biosimilar candidate (IBI303). IBI303 is a recombinant human anti-TNF-α monoclonal antibody independently developed by Innovent for the treatment of ankylosing spondylitis (AS), rheumatoid arthritis (RA) and psoriasis. This is Innovent’s second NDA accepted by the NMPA.
Branded adalimumab (Humira) has been globally recognized for its high efficacy and acceptable safety profile. Its adoption rate in China is relatively low despite the clinical demand for TNF-α antagonists is huge with high unmet medical needs in China. Innovent’s adalimumab biosimilar candidate (IBI303) offers a high-quality and affordable alternative to Chinese patients.
The NDA is based on analytical, clinical and pharmacokinetics data generated from three clinical studies. Phase 3 comparative efficacy and safety studies were conducted in patients with ankylosing spondylitis. PK parameters and immunogenicity of IBI303 were also compared directly against adalimumab in studies.
“Innovent successfully developed IBI303, which will provide as an alternative to the branded original product. Because of the high price of the branded drug, many patients in China have difficulty getting treatment for these chronic diseases which require long-term medication. We believe IBI303 will become a high quality biosimilar drug for Chinese patients, helping the advancement of China’s biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients’ life,” said Dr. Qinwei Zhou, Chief Operating Officer of Innovent.
“IBI303 is the second product NDA filing Innovent submitted to NMPA. At present, we have ten products in clinical development stage, four products in phase III clinical trials. We are excited about reaching this important milestone much quicker than we originally planned. Our team will continue to deliver high quality biopharmaceutical drug from our rich pipeline to benefit more ordinary people with needs,” said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.