NMPA accepts new drug application for IBI303, a biosimilar candidate to Humira (adalimumab)


Innovent Biologics, a biopharmaceutical company, has announced that the National Medical Products Administration (NMPA, successor to the 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).

The prevalence rate of AS varies across different countries. A survey in China showed that the prevalence rate is about 0.3%, so the number of patients suffering from this disease is more than 4 million. The disease is more common in adolescent males with an age of onset of 20 to 30. After 40 years of age, the incidence of this disease decreases. The ratio of male to female is about 2-3:1. In 15%-20% of patients, AS seriously diminishes the health and quality of life of the patients and is one of the major causes of disability.

Branded adalimumab (Humira) has been globally recognised 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 this 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 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.


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