Hangzhou Jiuyuan Genetic Biopharmaceutical Announces Key Milestone for Jikeqin®

Marketing Application for Biosimilar GLP-1 Receptor Agonist Accepted by NMPA

Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. (Stock code: 2566) has released a voluntary announcement regarding a significant business development that could materially impact its share value. The company’s board of directors has confirmed that the marketing application for Jikeqin®, a biosimilar drug developed by the Group, has been officially accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China.

Key Points for Investors

• Jikeqin® is a biosimilar of semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist widely used for weight management in individuals with obesity or overweight.
• The product is registered under Category 3.3 of biological drug registration, specifically targeting the growing obesity and overweight population in China.
• Mechanism of Action: Jikeqin® mimics endogenous GLP-1 hormone, promoting insulin secretion, inhibiting glucagon release, suppressing appetite, and delaying gastric emptying. This multifaceted approach improves blood sugar control and helps achieve significant weight management outcomes.
• Clinical Results: The Phase III clinical trial for Jikeqin® was a randomized, open-label, active-controlled, parallel-designed equivalence study, focused on subjects with obesity. The trial demonstrated clinical equivalence to the reference drug (semaglutide) in both efficacy (percent change in body weight from baseline after 44 weeks of treatment) and safety, with favorable tolerability and efficacy profiles.
• Regulatory Timeline:
  • Received drug clinical trial approval notice from NMPA in January 2024.
  • Completed enrollment of all Phase III subjects in December 2024.
  • Phase III trial is now complete, and market approval application materials have been submitted to the Center for Drug Evaluation of NMPA for review.
• Potential Market Impact: The acceptance of the marketing application marks a major milestone in the commercialization of Jikeqin®. If approved, Jikeqin® would provide a cost-effective, clinically equivalent alternative to existing semaglutide products for weight management, potentially capturing significant market share in a rapidly expanding therapeutic area.

Important Considerations for Shareholders

• Share Price Sensitivity: The acceptance of the marketing application by NMPA is a price-sensitive event that could drive investor interest and impact the company’s valuation, especially given the high commercial potential of GLP-1 drugs for obesity and diabetes management.
• Regulatory Risk: Final market approval is still pending NMPA review. Investors should monitor for further updates regarding regulatory decisions, as approval or rejection will have direct implications for future revenues and share price.
• Clinical Success: Demonstrated clinical equivalence to the reference drug in both efficacy and safety reduces development risk and enhances the product’s competitive positioning.
• Investor Caution: The company advises shareholders and potential investors to exercise caution when dealing in shares, underscoring the importance of regulatory outcomes and market dynamics.

Board and Management

The announcement was signed by Fu Hang, Executive Director, Chairman of the Board, and General Manager. The board comprises a mix of executive, non-executive, and independent directors, ensuring robust corporate governance.

Summary

The acceptance of Jikeqin®’s marketing application represents a pivotal step toward commercialization in a lucrative market. With strong clinical results and regulatory progress, Hangzhou Jiuyuan Genetic Biopharmaceutical is positioned for potential growth pending final NMPA approval. Shareholders should closely monitor subsequent announcements for regulatory milestones that will directly influence the company’s market prospects.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research and consult with professional advisors before making any investment decisions. Regulatory approval and market conditions may affect the company’s future performance and share price.

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