CSPC Pharmaceutical Group Publishes Phase III Results of Chemically Synthesized Semaglutide Injection (HD1916) for Obesity Treatment in Diabetes, Obesity and Metabolism

MILESTONE

CSPC Pharmaceutical Group has published Phase III clinical trial results for its chemically synthesized semaglutide injection (HD1916) in the journal Diabetes, Obesity and Metabolism, marking a significant milestone for China's domestic GLP-1 receptor agonist development in the obesity treatment space.

The multicenter, randomized study demonstrated that HD1916 achieved an average weight reduction of 13.1% after 44 weeks of treatment in non-diabetic obese Chinese adults. The chemically synthesized formulation met pre-specified equivalence criteria when compared head-to-head against Novo Nordisk's semaglutide—the original biologic version—while demonstrating a similar safety profile and good tolerability.

The findings, published online on October 7, 2026, carry important implications for the competitive landscape of the GLP-1 obesity treatment market, where Novo Nordisk's Wegovy has dominated globally. CSPC's chemically synthesized approach offers distinct manufacturing advantages over traditional biologic fermentation methods, including the elimination of immunogenicity risks associated with biological production processes, more controllable impurity profiles, and greater potential for quality consistency and long-term supply accessibility.

The publication in Diabetes, Obesity and Metabolism—a peer-reviewed journal of pharmacology and therapeutics—represents rigorous clinical validation of HD1916's efficacy and safety profile. The trial, led by corresponding author Linong Ji and colleagues across multiple research centers, provides the evidence base needed for regulatory consideration in one of the world's largest obesity markets.

CSPC has already advanced HD1916 to the regulatory doorstep. The company submitted two New Drug Applications to China's National Medical Products Administration (NMPA)—one for type 2 diabetes and another for overweight/obesity weight management. Both applications have been accepted and are currently under review, positioning HD1916 as a potential near-term entrant in China's rapidly expanding obesity treatment market.

The chemically synthesized semaglutide approach addresses a fundamental challenge in peptide drug manufacturing. Unlike biologics produced through complex fermentation processes, chemical synthesis allows for precise molecular control, batch-to-batch consistency, and the elimination of protein-based impurities that can trigger immune responses. These advantages translate into potential benefits for patients, healthcare systems, and manufacturers alike—offering a pathway to more affordable, scalable production of GLP-1 therapies.

The results arrive at a critical juncture in the global obesity treatment market. GLP-1 receptor agonists have emerged as one of the most significant therapeutic breakthroughs of the decade, with semaglutide-based therapies generating tens of billions of dollars in annual revenue worldwide. China's obesity prevalence continues to rise, creating substantial unmet medical need for effective, accessible treatment options.

For CSPC, the Phase III publication and pending regulatory approvals represent a strategic entry into a high-growth therapeutic category. The company's chemically synthesized approach, if approved, could offer Chinese patients a domestically produced alternative with potential cost advantages over imported biologic semaglutide products, while maintaining comparable efficacy and safety standards.

The achievement underscores China's growing capabilities in pharmaceutical innovation and chemical synthesis, as domestic companies move beyond generic manufacturing to develop novel formulations and delivery approaches for established therapeutic molecules. HD1916's clinical success demonstrates that chemically synthesized peptide drugs can achieve therapeutic equivalence with their biologic counterparts—a finding that could have broader implications for the development of other peptide-based therapeutics.

As regulatory review proceeds, the pharmaceutical industry will watch closely to see whether HD1916 can capture meaningful market share in China's obesity treatment landscape and establish a new paradigm for chemically synthesized GLP-1 therapies.