GluBio’s WIZ Molecular Glue Degrader GLB-005 Included in CDE Patient-Centered Action for Rare Diseases Encouragement Plan
August 31, 2026Shanghai, China, and San Diego, U.S. – August 31, 2026 – GluBio Therapeutics Inc., a biotech company dedicated to the discovery and development of innovative molecular glue degraders (MGDs), today announced that its proprietary WIZ (Widely Interspaced Zinc Finger) molecular glue degrader GLB-005 for the treatment of transfusion-dependent β-thalassemia has been officially included in the Center for Drug Evaluation (CDE)’s Patient-Centered Action for Rare Diseases Encouragement Plan.
As the first WIZ-targeting degrader developed in China, GLB-005 secured a strategic equity backing from Sanofi, a global leader in rare hematology, earlier this year – underscoring strong market confidence in its R&D prospects and commercial potential. Currently in IND-enabling studies, GLB-005 is approaching its first-in-human clinical trial application. This inclusion in the “CARE Plan” Pilot Program marks regulatory recognition of its innovation and therapeutic promise for transfusion-dependent β-thalassemia. GluBio will accelerate clinical translation, maintain close communication with the CDE, and drive the development and regulatory pathway of this drug with full commitment.
About GLB-005
GLB-005 is a potent and highly selective WIZ molecular glue protein degrader. It mediates ubiquitination and proteasomal degradation of WIZ – a fetal hemoglobin (HbF) suppressor – via CRBN E3 ubiquitin ligase, thereby potently upregulating HbF expression. It is intended for the treatment of β-hemoglobinopathies, including but not limited to transfusion-dependent β-thalassemia and sickle cell disease.
About the “CARE Plan”
The Patient-Centered Action for Rare Diseases Encouragement – "CARE Plan" is a pilot work in the field of rare disease drug development. It has been launched to promote patient-centered drug development and to implement the work deployment of the NMPA in accelerating the development and availability of drugs for rare diseases. It aims to enhance the scientific rigor, standardization, and rationality of integrating patient experience, particularly that related to the clinical benefit-risk evaluation, into the clinical development of drugs for rare diseases. It also seeks to strengthen communication and collaboration among regulatory authorities, drug development entities, and patients involved in drug development for rare diseases, ultimately facilitating the marketing authorization of these drugs to address clinical needs.