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The leading biopharmaceutical company dedicated to R&D and commercialization of innovative tumor therapies-Deqi Pharmaceutical Co.
, Ltd.
announced today that the company's new PD-L1/4-1BB bispecific antibody ATG-101 has completed Quantitative System Pharmacology (Quantitative).
and Systems Pharmacology, QSP), this model will guide the design and development of the first human trial of ATG-101
.
Deck Pharmaceuticals plans to submit the first human (FIH) clinical trial application of ATG-101 in Australia in mid-2021, and will subsequently submit clinical trial applications in the United States and China
Quantitative system pharmacology is an emerging and highly innovative new drug research and development method
.
It uses modeling and simulation methods to study pharmacological effects, and combines pharmacokinetics (PK), pharmacodynamics (PD) and statistical models to quantitatively evaluate the potential pharmacological effects of drugs and their influencing factors, thereby designing and researching experiments Provide basis for decision-making and rational drug use [1]
Dr.
Dirk Hoenemann, vice president of Deqi Pharmaceuticals, head of early clinical research and development and Asia-Pacific medical affairs, said: "The cooperation with Applied BioMath has laid the best ground for us to accurately predict the dosage of drugs and conduct the first human trial
.
Through Applied With the model provided by BioMath, Deqi has a thorough understanding of the anti-tumor mechanism of ATG-101, and we are able to better design the first human trial and other clinical trials
Dr.
John Burke, Co-founder, President and CEO of Applied BioMath, said: "Systematic pharmacology models are an effective tool to transform antibody therapy from in vivo trials to first human trials
.
As is common in the current antibody therapy design, complex The mechanism of drug action requires a more sophisticated transformation model than traditional methods
Since the establishment of the project, ATG-101 has made a number of research and development progress, and has actively carried out relevant preparations for clinical trials in China, the United States, Australia and other places
.
In China, Deqi Pharmaceuticals has reached a cooperation with WuXi Biologics on the CMC production of ATG-101 to further optimize and accelerate the development of ATG-101
