GDB's lead pipeline candidate, SHX-021, is a once-weekly oral semaglutide tablet for treating type 2 diabetes and body weight management. The original product, Rybelsus (a daily oral tablet developed by Novo Nordisk), was approved by the U.S. FDA in 2019 and by the China NMPA in 2024 for type 2 diabetes treatment. However, Rybelsus has very low oral bioavailability (~0.7%) and high pharmacokinetic (PK) variability (over 150% coefficient of variance after a single dose) (FDA Clinical Pharmacology Review). SHX-021 aims to improve oral bioavailability, reduce absorption variability, lower drug costs, and enable the development of a weekly oral formulation, thereby enhancing patient access and adherence. SHX-021 has demonstrated significantly higher bioavailability (several times greater than the original product) and substantially reduced variability, supporting its development as a weekly formulation. GDB has completed two Pre-IND (PIND) meetings with the FDA, securing agreements on a concise IND pathway. The company is currently advancing IND-enabling studies with its partner.
The high performance of oral absorption of SHX-021 was achieved with the innovative oral delivery platform (MO-PION) that GDB has developed with global proprietary right. The MO-PION technology has demonstrated broad applications for a variety of large molecules, including 9 incretin peptides, large sugar molecule (like heparin, SHX-020), cyclic peptides (like micafungin), and combinations of small and large molecules in one pill. GDB also extends the MO-PION technology to the collaborations with partners with their own molecules.
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