First Subjects Dosed in Australian Phase I Clinical Study of a Denosumab Biosimilar
HSINCHU, Taiwan, May 18, 2020 /PRNewswire/ -- JHL Biotech, Inc. today announced that the first group of subjects has been randomized and dosed last week in the company's Australian Phase I Clinical Trial of JHL1266 in healthy subjects.
The Three-Arm Study is randomized, double-blinded, parallel-grouped, and single-dosed and will compare the pharmacokinetic similarity of JHL1266 versus Prolia® sourced from the EU and the US in healthy human subjects. It is one of the pivotal studies for registration with the ultimate objective to evaluate the similarity in Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity.
JHL1266, a proposed biosimilar to denosumab, is a monoclonal antibody targeting RANKL and works by inhibiting the development of osteoclasts and then preventing break down of bones in the human body. The targeted indications include the treatment of osteoporosis, bone metastases, giant cell tumors of bone, and other treatment-induced bone loss.
"Denosumab is an important biologic for the treatment of post-menopausal osteoporosis and other common bone related diseases. Because it's unfortunately very expensive for patients and healthcare payers, JHL1266 would provide an affordable treatment for these patients," said James Huang, CEO of JHL Biotech. "I am very proud of this achievement especially considering the COVID-19 pandemic. This is a significant milestone for JHL and a tremendous step forward in our mission to increasing public access to safe, effective, and high-quality biologics."
Media Contact:
Urania Lee
[email protected]
About JHL Biotech, Inc.
JHL is a biopharmaceutical company established in 2012 and after a transformation under new executive leadership led by James Huang, Chairman and CEO (also Managing Director of KPCB China), JHL continues to focus on three biotech sectors: 1) Accelerating the development programs for clients through the provision of Contract Development and Manufacturing Services (from cell line development to commercial manufacturing with regulatory filing support; 2) Developing a Proprietary Biosimilar Pipeline; and 3) Collaborating & Licensing of New and Innovative Biologics.
For more information, please contact JHL at [email protected]
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.
SOURCE JHL Biotech, Inc.
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