Clover Biopharmaceuticals Initiates Phase III Study of Etanercept Biosimilar Candidate SCB-808 in China

BEIJING–(BUSINESS WIRE)–Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, today announced that the first patient was dosed in a Phase III trial of SCB-808, a proposed biosimilar to Enbrel^® (etanercept) being developed in the prefilled syringe formulation for the treatment of rheumatic diseases, including ankylosing spondylitis and rheumatoid arthritis.

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) via subcutaneous administration.

“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.”

“We are excited to work with Dr. Huang and these world-class investigators and sites participating in this study,” said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover. “More importantly, we hope that SCB-808 will meaningfully impact the lives of many patients in China who suffer from autoimmune diseases, and the initiation of this Phase III trial brings us one step closer to this goal.”

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 35,000m² 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 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: www.cloverbiopharma.com.

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