NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira(R) (adalimumab)

Tuesday, November 13, 2018 Drug News
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SUZHOU, China, Nov. 12, 2018 /PRNewswire/ -- 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-? 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-? 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-? 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 peaks at 30 to 50 years of age. The prevalence of RA in mainland China is about 0.2%-0.4%. RA seriously diminishes human health and the quality of life of patients and is one of the major causes of disability in developed countries.

Psoriasis is a chronic recurring inflammatory skin disease characterized by erythematous scales. An epidemiological survey of China in 2010 showed that the current prevalence of psoriasis is 0.47% which has risen from 0.123 in 1984. Plaque psoriasis is the most common type of psoriasis. The quality of life of patients is severely decreased due to physical, psychological and social issues.

About IBI303

IBI303 is a recombinant human monoclonal antibody of TNF-?, which has the same amino acid sequence as branded adalimumab (Humira) and shows high degrees of similarity in respect to: chemical properties, in vitro biological activity (binding affinity and neutralizing activity against TNF-?), potency, and PK/PD. Pharmacologic and toxicologic studies of IBI303 also showed high similarity to Humira. Clinical studies have demonstrated that IBI303 can significantly alleviate the symptoms and physical signs of AS and decrease the disease activity and enthesitis, while improving both somatic motor ability and mobility of spine in patients with AS. It also improved the quality of life in patients with AS and reduced the disease's impact on their activities of daily life. IBI303 also generated an acceptable safety profile with most of the adverse events graded as mild or moderate. IBI303 may meet Chinese patients' urgent needs with an affordable price at global quality standards.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action", Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and two that have New Drug Applications (NDA) accepted by the NMPA including one with priority review status.

Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, so as to improve drug availability to people and address their aspiration for a healthy, happy life.

For inquiries, please contact:

ir@innoventbio.com+86 512-6956 6088

Cision View original content:http://www.prnewswire.com/news-releases/nmpa-accepts-biosimilar-new-drug-application-for-ibi303-a-biosimilar-candidate-to-humirar-adalimumab-300748236.html

SOURCE Innovent Biologics, Inc.



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