Market Overview

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


Clover Biopharmaceuticals, a biotechnology company focused on developing
novel and transformative biologic therapies, today announced that the
first patient was dosed in a Phase I trial of SCB-808, a proposed
biosimilar of Enbrel® (etanercept) being developed in the
prefilled syringe formulation for the treatment of rheumatoid arthritis
and other autoimmune diseases.

"This milestone marks Clover's second biologic product to initiate human
clinical trials in as many months. Now with clinical trials actively
enrolling patients in multiple countries, Clover has demonstrated its
ability to execute on its goals across multiple functional areas," said
Joshua Liang, Chief Strategy Officer and Board Director at Clover. "We
look forward to further advancing our deep pipeline of promising
biological candidates in the months ahead."

The Phase I trial in China is designed to assess the pharmacokinetics,
safety and immunogenicity of subcutaneously administered SCB-808 and
originator drug Enbrel® in healthy volunteers.

"Having compared SCB-808 to both Enbrel® and other Chinese
etanercept biosimilars in preclinical studies, we believe that our
superior biomanufacturing process, biosimilarity to Enbrel®
and convenient ready-for-injection prefilled syringe formulation will
allow us to have significant commercial advantages once SCB-808 is
brought to the market," said Dr. Peng Liang, co-founder, Chairman and
President of Clover. "Importantly, we hope that SCB-808 will
meaningfully impact the lives of many patients, and the initiation of
this Phase I 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 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.

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. 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:

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