August 31, 2026 —Gluetacs Therapeutics announced that GT818 capsules, its self-developed first-in-class innovative drug, has been approved by the U.S. Food and Drug Administration (FDA) to enter clinical trials for the treatment of advanced malignant tumors. The candidate previously received an implied clinical trial approval from China’s National Medical Products Administration (NMPA) on July 1, 2026, and a Phase I study is currently underway in China.
GT818 is the world’s first bifunctional degrader targeting RSK, and the third Gluetacs pipeline to obtain clinical trial approval in both China and the United States. It also marks the third targeted protein degradation (TPD) drug approval enabled by Medicilon’s one-stop preclinical R&D service platform, which covers chemical synthesis, formulation development, pharmacology, pharmacokinetics, and safety evaluation. The two companies’ partnership in the TPD field has once again delivered results.
Advancing the frontiers of TPD: one-stop enablement of PROTAC and molecular glue preclinical R&D
Medicilon has built a comprehensive service platform for the preclinical R&D of PROTAC and molecular glue drugs, spanning drug discovery, pharmaceutical research, and preclinical studies:- Drug discovery: comprehensive services for PROTAC and molecular glue development. Our AI-driven platform facilitates the intelligent design, bioactivity prediction, and synthesis of of target proteins, E3 ligands, and linkers. We also support the synthesis, optimization, and application of key intermediates, advancing TPD drug R&D across various targets and indications.
- Pharmaceutical research: a dedicated technical platform tackling process development, quality research, and solubility-enhancing formulation challenges specific to PROTAC molecules.
- Preclinical studies: leveraging nearly 1,100 pharmacology models (including 800 tumor models), an AI-ADMET prediction platform, and international GLP accreditations to systematically complete efficacy, pharmacokinetic, and safety evaluations that fully support CN-US dual filing requirements.
As of the end of June 2026, Medicilon has supported 8 PROTAC drugs to obtain clinical approval, with over 20 additional PROTAC programs in active development.
A global compliance framework as a moat: rapid growth of CN-US dual filing services
As one of the earliest CROs in China to provide a full suite of services compliant with both Chinese and U.S. GLP standards, Medicilon holds NMPA and OECD GLP accreditations and AAALAC International certification, and meets U.S. FDA GLP requirements. In 2026, the company further upgraded its international capabilities, passing the NMPA GLP re-inspection and completing AAALAC certification at its Boston overseas center, bringing its domestic and global quality control and operations systems in line with international best practices. Leveraging 29,000 m² of standardized GLP laboratories, together with frontier technologies such as AI and organoids, the company continues to enhance its global drug R&D evaluation services.
This mature international footprint and compliance system underpins the rapid growth of the company’s multi-country filing services. Medicilon has supported a cumulative total of 691 INDs to obtain clinical approval, including 90 multi-country filing projects, 77 of which achieved CN-US dual approval. In the first half of 2026 alone, revenue from CN-US dual filing projects reached RMB 167 million, up 93.46% year over year, underscoring strong market recognition of Medicilon’s core competitiveness in this area.
Looking ahead, Medicilon will continue to deepen its focus on TPD, concentrating on frontier technologies such as PROTAC and molecular glues while iteratively optimizing its one-stop preclinical service platform to overcome fundamental R&D challenges. The company will further strengthen collaborations with innovative drug developers worldwide, delivering professional, efficient, and globally integrated end-to-end R&D services to accelerate more innovative drugs from Target to IND.
