JHL Biotech's Clinical Trial Application Accepted By China For Bevacizumab Biosimilar To Treat Colorectal, Lung, And Ovarian Cancers

Hsinchu, Taiwan and Wuhan, China /PRNewswire/ -- JHL Biotech announced today that the China Food and Drug Administration (CFDA) has accepted for review JHL's Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat cancer.

JHL1149 is a biosimilar to bevacizumab and would provide an affordable alternative to treat several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma.

JHL is planning to conduct a Phase I pharmacokinetic study in healthy volunteers in China followed by a multinational Phase III efficacy study in non-small cell lung cancer patients. Currently, a Phase I clinical trial for JHL1149 is ongoing in Europe. The data from these trials will support the global registration and commercialization of JHL1149. Once approved, JHL1149 will be manufactured at JHL's facility in Wuhan, China, the world's largest biopharmaceutical manufacturing plant based on single-use technologies, which will provide a high-quality supply of products worldwide.

JHL1149 is an anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody. The reference biologic, bevacizumab, is marketed by Roche under the trade name, Avastin®. In 2017, bevacizumab generated worldwide revenues of approximately US$7 billion.

"JHL 1149 has been demonstrating a high level of similarity to the innovator product in physicochemcial and biological characteristics and in comparative preclinical studies," said Dr. Rong Chen, Chief Medical Officer, JHL Biotech. "Clinical trial for JHL1149 in China is a milestone in delivering quality and accessible products to patients worldwide who suffer from high unmet medical needs."

"Bevacizumab is an important biologic that is unfortunately very expensive for patients suffering from certain cancers, and JHL1149 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "JHL's clinical trial in China is a step forward in our mission to become a global leader in developing, manufacturing, and commercializing biologics."

In addition to JHL1149, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:

• Rituximab biosimilar, JHL1101, to treat rheumatoid arthritis and non-Hodgkin lymphoma. Currently in Phase I trial in Europe.
• Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Currently in Phase I trial in Europe.
• Trastuzumab biosimilar, JHL1188, to treat breast cancer.
• JHL1211, to treat asthma and chronic idiopathic urticaria.
• JHL1199, to treat breast cancer.
• JHL1266, to treat osteoporosis.

About JHL Biotech
JHL Biotech, Inc. is a biopharmaceutical startup founded by a group of industry veterans with deep experience in pharmaceutical development and operations. JHL is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity, and the China Development Industrial Bank. JHL Biotech's mission is to provide the world with low-cost medicines of exceptional quality. JHL is focused on research and development of new protein-based therapies and biosimilars. JHL has two world-class facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards. For more information, please visit www.jhlbiotech.com.

Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.