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.
About Ankylosing Spondylitis, Rheumatoid Arthritis & Psoriasis
A large body of basic and clinical research shows that TNF-α plays an important role in the pathogenesis of AS, RA and psoriasis. Substantial clinical trial data have demonstrated both the clinical efficacy and acceptable safety profile for Humira in the treatment of AS, RA and psoriasis.
AS is a chronic inflammatory disease that primarily affects the articular system including the ankles, spine, paraspinal soft tissue and peripheral joints, as well as extra-articular organs such as the eye, skin, and cardiovascular system. The main clinical symptoms are low back pain, ankle arthritis, spinal rigidity, anterior chest wall inflammatory pain, morning stiffness and hip pain. Without timely and effective treatment severe bone destruction, stiffness, osteoporosis and joint fusion ensue. Eventually patients lose mobility and become disabled, which not only causes great pain to the patients, but also places a heavy burden on families and society.
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.
RA is a systemic autoimmune disease characterized by chronic erosive arthritis. If left untreated about 75% of patients will be disabled within 3 years, and the average life expectancy will be reduced by 3 to 18 years. The morbidity and mortality of RA bring great pain to patients and create a heavy burden for families and society. The disease is more common in women with a male to female ratio of about 1:3. RA can occur at any age, but...
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