QL Biopharm Presented Results from Phase 1c Clinical Study on its Novel Once-Monthly GLP-1RA ZT002 at EASD 2024

The presentation titled 'ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomized, placebo-controlled, multiple ascending dose phase 1c study' highlighted recent findings on QL Biopharm's lead drug candidate ZT002 - a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration. The presentation titled'ZT002, a novel ultra long-acting GLP-1 receptor agonist in...

The presentation titled 'ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomized, placebo-controlled, multiple ascending dose phase 1c study' highlighted recent findings on QL Biopharm's lead drug candidate ZT002 - a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration.

The study enrolled 28 overweight/obese patients in Part A in two cohorts. Eligible participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (dose escalated to 40 or 80 mg; n=10+10) or matched placebo (n=4+4) for a 12- or 14- week treatment period, in the 40 mg and 80 mg dose arms, respectively. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Following a 6-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). In this extension patients from the ZT002 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a once-monthly (Q4W) administration of ZT002 120 mg (n=8). The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met.

Key conclusions from today's presentation are outlined below:

Dr. Zhang Xujia, Ph.D., Founder, Chairman and Chief Executive Officer of QL Biopharm said: "We are pleased to present data highlighting the potential of ZT002 and its promising clinical profile in obesity care. The additional advantage of monthly dosing simplifies life for patients living with obesity. We look forward to advancing the Phase 2 program for ZT002 in overweight and obesity and providing further updates in due course."

Abstracts are available on the EASD website here, and on the QL Biopharm website here.

NOTES TO EDITORS

About QL Biopharm

QL Biopharm is a clinical-stage biopharmaceutical company focused on developing novel best-in-class peptide therapeutics for metabolic diseases. The Company leverages its proprietary E. coli manufacturing process enabling rapid and cost-effective scaling of manufacturing for high volume markets. The lead drug candidate, ZT002, is an ultra long-acting subcutaneously administered GLP-1 receptor agonist, currently in a Phase 2 study for obesity and in Phase 1 for type 2 diabetes. In Phase 1 studies, ZT002 demonstrated potential for once-monthly dosing with compelling weight loss and tolerability consistent with the GLP-1RA class. The Company is also advancing a broader portfolio of novel preclinical assets for the treatment of metabolic diseases, in addition to its biosimilar semaglutide program, currently in Phase 3. QL Biopharm is led by a team of pharma industry veterans with expertise in E. coli–based peptide manufacturing and the development of drugs for metabolic diseases. The Company is backed by leading professional life science investors.

For additional information, please visit https://qlbiopharm.com/

About EASD

The European Association for the Study of Diabetes e.V. (EASD) is a membership-based academic non-profit organization. It was founded in 1965 and its headquarters is based in Duesseldorf, Germany. The aims of the Association are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge and to facilitate its application.

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