Hybio's HY3003 Triple-Target Weight-Loss Innovative Drug Clinical Trial Application Accepted for Review
Recently, Hybio received the Notice of Acceptance issued by the National Medical Products Administration (NMPA), and the Company's clinical trial application for HY3003 Injection has been accepted. The application type is a clinical trial for domestic production drug registration; the registration category is Chemical Drug Class 1; and the dosage form is injection. This marks another key step in the Company's original research exploration in the metabolic disease treatment field, as its GLP-1 pipeline has expanded from generic drugs to original innovative drug R&D.
HY3003 is a novel GLP-1R/GIPR/GCGR triple receptor agonist jointly developed by Hybio and Shenzhen iCarbonX. The project identified novel peptide molecules through artificial intelligence combined with peptide chip technology, and the dosage form submitted this time is injection, intended for the weight-loss indication and indicated for long-term weight management in adults who, in addition to diet control and increased physical activity, have an initial body mass index (BMI) meeting the following criteria: BMI ≥28 kg/m² (obesity), or BMI ≥24 kg/m² (overweight) with at least one weight-related comorbidity, such as hypertension, dyslipidemia, etc. In addition to weight loss, HY3003 is also intended for indications such as type 2 diabetes and metabolic dysfunction-associated steatohepatitis (MASH), making it a flagship innovative drug candidate in the Company's metabolic disease portfolio.
Against the backdrop of an ever-increasing global burden of metabolic diseases and rapid iteration of innovative therapies, products with true long-term competitiveness must pursue original innovation. The HY3003 project is a prime example of the deep collaboration between Hybio and iCarbonX in the "AI + peptide" field. Based on deep complementarity in technology and resources—iCarbonX has advantages in "silicon-based peptide chip technology" and "AI algorithms" and is responsible for molecular screening, while Hybio has deep expertise in peptide drug synthesis, purification, formulation development, and clinical translation and is responsible for preclinical research, IND submission, clinical trials, and product registration filing—the two parties have formed a synergistic pathway that combines "AI + peptide chip screening" with industrialization development.
From entering into a strategic collaboration in October 2024 to explore the application of AI technology platforms and peptide chips in peptide drug development; to formally signing the Joint Development Agreement for a GLP-1R/GIPR/GCGR Triple Agonist Peptide Innovative Drug in May 2025, aiming to incubate China's first triple-target peptide weight-loss original innovative drug; and then to iCarbonX receiving strategic investment from Hybio in July 2025, the collaboration between the two parties has continued to deepen. This path not only reflects Hybio's forward-looking judgment regarding cutting-edge technologies, but also demonstrates the Company's open, collaborative, and co-innovative industry approach.
The acceptance of HY3003's clinical trial application marks a key step forward for Hybio's GLP-1 product matrix. The Company's layout in the GLP-1 track is not limited to a single dosage form; it has systematically built a multi-dosage-form product matrix covering weekly formulations, oral tablets, and ultra-long-acting monthly formulations. Among them, the ultra-long-acting monthly formulation is particularly distinctive—longer dosing intervals are expected to significantly improve patient compliance and even reshape the treatment model for long-term management of metabolic diseases, representing an important strategic move by the Company in differentiated innovation. The addition of HY3003 further strengthens the Company's dual advantages in innovative targets and diversified dosage forms, helping to enhance its innovation capability and product diversity in the metabolic disease treatment field. In the face of unmet clinical needs, Hybio will continue to be anchored in clinical value and propelled by original innovation, driving China's original R&D forces into the deep waters of metabolic disease innovation.