SUZHOU, China, Aug. 30, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the clinical trial results of IBI303, an anti-tumor necrosis factor-alpha (anti-TNF-alpha) monoclonal antibody injection developed by Innovent, has been published in The Lancet Rheumatology, a leading international medical journal, with comment by Stanley Cohen, professor of University of Texas Southwestern Medical Center.
Led by Professor Huji Xu of the School of Medicine at Tsinghua University, the Phase III trial was a multi-centre, randomized, double-blind, parallel-controlled trial that compared the efficacy and safety of IBI303 and the originator drug adalimumab (Humira®), on ankylosing spondylitis (AS) patients; it is the first large-scale head-to-head Phase III clinical trial comparing a biosimilar and adalimumab in AS patients. It is also the first time a highly-regarded top-tier medical journal has featured the major phase III clinical trial results of a China-developed biosimilar.
The originator, adalimumab, has been among the world's best-selling drugs for several consecutive years, with sales revenue of USD 19.9 billion in 2018. Adalimumab was approved for treating rheumatoid arthritis, AS and plaque psoriasis in China.
AS is a chronic inflammatory disease that primarily affects spinal joints and peripheral joints and in severe cases can cause spinal deformity and ankylosis. According to the reported studies, China has a prevalence rate of approximately 0.3%, which translates into a potential total patient number of over 4 million AS patients. The occurrence of the disease is dominant in adolescent males, with an onset age of 20 to 30 and a disability rate of 15-20%. The Anti-tumor necrosis factor-alpha inhibitors exhibit satisfactory anti-inflammatory activity and effects in preventing disease progression, which represent the most widely used biologics with the extensive clinical trial data for the treatment of AS worldwide.
Twenty hospitals across China participated in the Phase III trial. All enrolled patients received at least four weeks of NSAIDs treatment and were either treatment ineffective, resistant or intolerable. Patients treated with either IBI303 or Humira® subcutaneous injection of 40 mg/0.8 ml once every two weeks for 22 weeks. The primary endpoint was the ASAS20 response rate (a standard tool to evaluate the clinical improvement of AS) at week 24.
Among 438 patients recruited in total, 220 were treated with IBI303, while those in the control group received Humira®. The initial results concluded ASAS20 response rates of 75% and 72.5% respectively at week 24, indicating clinical equivalency between IBI303 and Humira®. The secondary endpoints were met, including AS assessment points such as ASAS20 response rate at week 12, ASAS40 response rate at week 24, ASAS partial response rates, ASAS5/6 response rate, and BASDAI etc. The overall data indicate the comparable effects to the originator drug in terms of disease activity, improvement of physical functions, spinal mobility, tendonitis, overall patient assessment, and improvement of the quality of life. Moreover, the results showed that IBI303 was well tolerated in patients with safety and immunogenicity comparable to those of Humira®.
"Autoimmune diseases such as AS severely impact on patients' quality of life and pose significant economic burden to the society and the patients. Antibodies targeting TNF-alpha currently play an important role in treating autoimmune diseases such as AS. However, the imported TNF-alpha inhibitor drug is far beyond affordable for most patients in China. IBI303, a biosimilar to adalimumab, was solely developed by Innovent. The Phase III clinical trial proved its equivalence in safety and efficacy to the originator Humira®. The IBI303 trial results were recognized and published in The Lancet Rheumatology, which is exciting news for the China Rheumatic community and indicates that Innovent has reached international standard in process development and clinical research of biosimilars," said Professor Huji Xu, a prominent physician scientist in the area of rheumatic diseases and the leading PI of the trial from the School of Medicine at Tsinghua University.
In 2015, the "Technical Guidance for the Research, Development and Evaluation of Biosimilars (Trial)" issued by the National Medical Products Administration (NMPA), greatly fostered the development of biosimilars in China. Adhering to institutional guidance, Innovent independently developed adalimumab biosimilar IBI303. The NMPA accepted and granted with priority review status the new drug application (NDA) of IBI303 based on the preclinical pharmacokinetics (PK) and pharmacodynamics (PD), toxicology, PK equivalence trial data as well as the results of this Phase III clinical trial.
The launch of IBI303 is expected to reduce medical expenditure of patients in China and enhance the affordability and accessibility of the treatment.
"We are very excited about the publication of IBI303 Phase III clinical trial results in The Lancet Rheumatology, which further validated our clinical results, the drug's efficacy , safety and Innovent's development capability," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "Professor Xu Huji set a great example manifesting the leading standard of Chinese researchers in the clinical science of the related diseases. Although autoimmune diseases such as AS are not fatal, if not treated in time, they can seriously affect patients' quality of life. We sincerely hope this high-quality drug could be approved and launched soon so that it can benefit patients and their families," added Dr. Yu.
To view the article from Lancet in full, please click the link below:
To view professor Stephen Cohen's Comment, please click the link below:
About Ankylosing Spondylitis
Ankylosing Spondylitis (AS) is a chronic inflammatory disease that primarily affects the articular system including the sacroiliac joint, spine, paraspinal soft tissue and peripheral joints, as well as extra-articular organs such as the eyes, skin, and cardiovascular system. The main clinical symptoms are inflammatory low back pain, sacroiliac arthritis, spinal rigidity, anterior chest wall inflammatory pain, morning stiffness and alternating hip pain. Progressive fusion occurs in affected joints. Without timely and effective treatment, it can cause severe bone destruction, stiffness, osteoporosis and joint fusion ensue, and eventually the total loss of mobility and disability, which not only inflict great pain on patients but also heavily burdens families and society.
The prevalence rate of AS varies across different countries. A survey in China showed that the prevalence rate is approx. 0.3%, which translates to over 20 million patients in the country. The occurrence is dominated in adolescent males, with an onset age of 20 to 30 and a disability rate of 15-20%. Presence decreases after the age of 40. The ratio of male to female patients is approx. 2~3:1. With a disability rate of 15%-20%, AS seriously affects the health and quality of life of patients and is a significant cause of disability.
IBI303 is a recombinant human monoclonal antibody of TNF-alpha, 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-alpha), potency, and PK/PD. Pharmacologic and toxicological 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 both disease activity and enthesitis while improving physical motor ability and spine mobility in patients with AS. Results also show improved quality of life in patients with AS. IBI303 also generated an acceptable safety profile with most of the adverse events graded as mild or moderate. IBI303 may meet patients' urgent needs with an affordable price at global quality standards.
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. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmunity and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and three of them have been granted with priority review status, and one,Tyvyt® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
SOURCE Innovent Biologics, Inc.