A Chinese ankylosing spondylitis (AS) patient in China represents the first dosed patient in a Phase III clinical trial testing SCB-808, a potential biosimilar of Enbrel (etanercept) being developed for the treatment of rheumatic diseases in that country. The Study is being led by Feng Huang, MD, of Beijing 301 Hospital. Ankylosing spondylitis and other rheumatic diseases continue to represent a high unmet need in China. Consequently, a majority of patients are severely undertreated. Moreover, the lack of an affordable, high-quality and convenient biologic treatment presents major hurdles to a wide patient adoption, compliance and care.
Clover Biopharmaceuticals’ SCB-808, similar to Amgen’s Enbrel, blocks tumor necrosis factor (TNF), a pro-inflammatory molecule with a key role in AS and other disorders as reported in a press release.
TNF Inhibitor Market in the U.S.
The following TNF inhibitors in the American market include: Humira, Infliximab (Remicase, Remsima and Inflectra),Cimzia (Certolizumab), and Simponi (golimumab).
The Phase III, multi-center trial in China is designed to assess the efficacy, safety and pharmacokinetics of SCB-808 and originator drug Enbrel® in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) viasubcutaneous administration
SCB-808 a biosimilar for Enbrel, is being developed in a prefilled syringe formulation, which is ready for skin injections and can be self-administered by patients at their homes.
Lead Research/Investigator Comment
“The treatment of ankylosing spondylitis and other rheumatic diseases remains a high unmet medical need in China, as the majority of patients remain severely undertreated. Currently, the lack of affordable, convenient and high-quality biologics therapies presents a major hurdle to wide patient adoption and compliance,” said Dr. Feng Huang of Beijing 301 Hospital and leading principal investigator of this trial. “My team and I look forward to evaluating SCB-808 as a potential new and convenient therapeutic option for the treatment of patients with rheumatic diseases in China.”
Current Treatments in China
Currently available etanercept biosimilars in China were all developed and approved prior to the implementation of the CFDA’s Technical Guideline for Development and Evaluation of Biosimilars and were not compared to the originator drug Enbrel® in clinical trials to demonstrate their bioequivalence. Furthermore, they are currently only approved in the lyophilized powder formulation, which must be reconstituted typically by trained medical personnel before being subcutaneously injected into patients. SCB-808 is being developed in the prefilled syringe formulation, which is ready-for-injection and can potentially be self-administered by patients in the convenience of their own homes. Thus, in the Western world, ready-for-injection formulations constitute the overwhelming majority of Enbrel® prescriptions. As such, Clover’s SCB-808 has the potential to address the unmet needs of Chinese patients for this class of drugs.
“Having compared SCB-808 to both Enbrel® and other Chinese etanercept biosimilars in preclinical studies, we believe that the advantages of our robust biomanufacturing process, head-to-head comparisons to Enbrel® in clinical trials and the convenient ready-for-injection prefilled syringe formulation will allow us to potentially have meaningful commercial advantages once SCB-808 is brought to the market,” said Dr. Peng Liang, co-founder, Chairman and President of Clover. “With a new state-of-the-art 35,000m cGMP biomanufacturing facility, with initial 2 x 2,000L bioreactor capacity and further expandable, Clover certainly has the vision and capacity to make a positive impact on the millions of suffering autoimmune patients in China.”
About Beijing 301 Hospital
Also known as the People’s Liberation Army General Hospital, which constitutes simultaneously the PLA Postgraduate Medical School located in Beijing, China, is a military hospital directly subsidiary to Logistic Support Department of the Central Military Commission and the largest general hospital under the auspices of the People’s Liberation Army. Its mission includes assuring the health of PLA and China’s leaders.
The hospital was founded in 1953, and is situated on the western part of the 4th Beijing Ring Road.
The China PLA General Hospital was formerly the second clinical institute affiliated to Peking Union Medical College, which was changed in October, 1953 into “Hospital directly affiliated to the military commission of the Central Committee of the Communist Party of China. In July 1954, it was renamed as the 301 Hospital of the PLA. In June 1957, the Department of Defense mandated to cancel the appellation of “301 Hospital”, while appointing the name of “the China PLA General Hospital”. PLA Postgraduate Medical School was constructed with support from the China PLA General Hospital. It was founded in November 1958 and closed down in 1962, and in June 1979, it was restored with approval from the military commission. In September 1986, it was formally listed among the universities and colleges of the whole army, with an authorization number. In 2004, the 304 Hospital and 309 Hospital of the PLA were renamed respectively as the 304 and 309 Clinical Branches, and publicly referred to as the First and the Second Hospitals affiliated to the China PLA General Hospital, meanwhile listed into the compilation sequence of the China PLA General Hospital.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases. Having raised more than US$ 100 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit our website here.
Feng Huang, MD of Beijing 301 Hospital