On October 27, Gluetacs Therapeutics’ second Class 1 new drug, GT929 capsule, in its molecular glue degrader pipeline, was approved by the U.S. Food and Drug Administration (FDA) to enter clinical trials for the treatment of malignant hematological tumors.
This pipeline has previously been approved by the National Medical Products Administration (NMPA) to conduct clinical trials on July 24, 2023, and is expected to enroll the first patient in China's Phase I clinical study at the end of 2023.
This is the second product pipeline of Gluetacs Therapeutics to be approved for clinical trials in both China and the United States after GT919, which is another milestone in the globalization process of Gluetacs Therapeutics.
As a strategic partner of Gluetacs Therapeutics, Shanghai Medicilon Inc. (Medicilon) provided formulation research and preclinical research (including efficacy, pharmacokinetics, and safety evaluation) for the development of GT929, as well as preparing filing application materials in Chinese and English. This help to provide technical support for GT929 to quickly achieve dual declaration and batch approval in China and the United States!
Another successful case of dual declaration between China and the United States Medicilon’s one-stop shop helps innovative drugs travel
Dual-declaration in China and the United States has enabled the transnational development of innovative drugs such as Gluetacs Therapeutics's GT919 and GT929, and has also become an important opportunity for Chinese pharmaceutical companies to go international. Laboratories with GLP qualifications dual-reported by China and the United States play a key role in non-clinical drug research. As one of the earliest CRO companies in China to provide a complete set of new drug clinical research applications that comply with both Chinese GLP and US GLP standards, Medicilon now has a GLP laboratory of 29,000 square meters. At the same time, Medicilon has established the Provantis GLP Tox data collection system, EMPOWER data collection management system, Chromeleon chromatography data system, and LIMS system in accordance with international standards to strengthen the standardization and traceability of the research process to strengthen the standardization and traceability of the research process, and apply SEND format to process data to ensure that clinical research applications meet FDA requirements.
In the first half of 2023, 45 new drugs and generic drug projects that Medicilon participated in the research and development have been approved by the NMPA to enter clinical trials, and 10 have been approved by the US FDA to enter clinical trials. (Data comes from Medicilon’s 2023 semi-annual report) As Medicilon participates in an increasing number of projects that comply with the requirements of China-US dual reporting standards, research data and practical experience continue to accumulate, which has become one of Medicilon's core competitive advantages.
Gluetacs Therapeutics is a biopharmaceutical company focusing on the development of oral protein-degrading small molecule drugs, which is the first biopharmaceutical company incubated by ShanghaiTech University. It was established in February 2020 and officially in operation in March 2021. It was founded by a number of scientists who have been working in the field of protein degradation for many years. The company has intellectual property rights for the development platforms of molecular glue degraders (GLUE) and dual-mechanism degraders (GLUETACS), which has applied for and authorized nearly 100 patents in this field from different countries, and also has unique and differentiated technical routes and development strategies. Gluetacs Therapeutics has independently established an artificial intelligence virtual screening platform, an in vitro drug efficacy screening platform, a pharmacokinetics platform, a proteomics platform and a tumor animal drug efficacy model platform, which could achieve the construction of a complete full-process drug research and development system. Since its official operation in March 2021, Gluetacs Therapeutics has successfully promoted two drug candidates into clinical trials, fully verifying and demonstrating the ability of the GLUETACS® platform to rapidly discover drug candidates and advance pipelines.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of June 2023, Medicilon has provided new drug R&D services to more than 2,000 clients around the world, and participated in the R&D of 385 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.
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