ABOUT US

Guangzhou Dazhou Biomedicine (GDB) is dedicated to developing oral delivery solutions for macromolecule drugs, following the Category 2 New Drug pathway in China and the 505(b)(2) regulatory pathway in the U.S.


The GDB management team consists of world-leading scientists with decades of experience in pioneering the oral delivery of large molecules. Our formulation technology is built on a deep understanding of physical chemistry, membrane science, and gastrointestinal physiology across animals and humans. We apply this expertise with a strong focus on R&D practicality, ensuring the use of safe excipients and maintaining close interactions with regulatory agencies to seek guidance and establish efficient, well-defined R&D pathways. For these unique oral formulations, the quantitative and accurate translation of formulation and DMPK data between animals and humans is especially critical. In this field, the GDB team brings three decades of academic research at leading universities, over ten years of DMPK and clinical pharmacology R&D experience at major pharmaceutical companies, and four years of dedicated formulation development for the oral delivery of large molecules. This includes conducting hundreds of large-animal PK studies internally at GDB.

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.


Management

Huadong Tang, Ph.D.

Founder, Interim Chief Executive Officer

Huadong founded GDB in 2017 and led the Company as the CEO so far. Huadong is a PK/PD expert, who earned his Ph.D. in Pharmaceutical Sciences from the University of Arizona. Huadong is the Inventor of several important models in predicting human pharmacokinetics, which are widely recognized and used in the pharmaceutical industry and academic field. He has worked over 10 years in big pharma (Wyeth, Schering-Plough/Merck, BMS) as DMPK/clinical lead for multiple discovery and clinical development teams in diabetes, oncology, neuroscienceand infectious disease. Huadong founded Shenox Pharmaceuticals, dedicated to developing the transdermal delivery of ketamine for treatment of major depressive disorders. He led the IND/regulatory affairs and clinical studies of the ketamine program.

Michael Mayersohn, Ph.D.

Chief Strategy Officer

Michael earned his Ph.D. in Pharmaceutical Sciences at SUNY Buffalo. Michael was a professor at the University of Arizona for 40 years, and the Strategy Officer of GDB from 2017. He was a fellow of the American Association of Pharmaceutical Scientists and a fellow of American Association of Clinical Pharmacology, and the former advisor to PharmaceuticalSciences of FDA and USP Pharmaceutical Sciences. Michael is a highly sought expert in PK/formulation as a witness for IP litigations for numerous marketed drugs with a total value over 10 billion USD.

Wenfei Liang

President of China district

Wenfei obtained his bachelor and master degrees from School of Pharmacy, Peking University. He worked for BaiyunshanPharmaceutical as a lead formulation scientist. He joined GDB in 2018, led the development of the MO-PION technology platform and took the leadership of development of GDB in China. Wenfei is a formulation expert with extensive experience in GLP/GMP management experience.