Mabwell Bioscience Passes First PIC/S Member GMP Inspection for Denosumab Biosimilars in Jordan

Key Takeaways

• Mabwell Bioscience’s subsidiary Taikang Bio successfully passed Jordan FDA’s GMP inspection for two denosumab injection biosimilars
• This marks the company’s first GMP approval from a PIC/S member country, validating international quality standards
• The biosimilars target Prolia® and Xgeva® markets, with strategic partnerships now covering 33 countries globally

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Mabwell Achieves International Quality Milestone

Shanghai-based Mabwell Bioscience (688062.SH) announced that its wholly-owned subsidiary Taikang Bio has successfully passed a Good Manufacturing Practice (GMP) inspection by the Jordan Food and Drug Administration (JFDA) for two denosumab injection products. The approved biosimilars include 9MW0311 (Prolia® biosimilar, domestic brand name: Mailishu) and 9MW0321 (Xgeva® biosimilar, domestic brand name: Maiweijian).

Significance of PIC/S Approval

This achievement represents Mabwell’s first successful GMP inspection by a regulatory authority from a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country. PIC/S serves as the global authority for pharmaceutical GMP inspections, working to harmonize inspection standards and strengthen international cooperation. Jordan’s membership in PIC/S ensures its drug quality regulatory system aligns with international standards.

Global Expansion Strategy

The approval significantly strengthens Mabwell’s international market position. To date, the company has established strategic partnerships for its denosumab injection products covering 33 countries, submitted marketing applications in 8 countries, and received market approval in Pakistan in 2025.

Market Impact and Future Outlook

Denosumab biosimilars represent a significant opportunity in the global osteoporosis and bone metastases treatment market. Prolia® and Xgeva®, the reference products, generate billions in annual revenue worldwide. Mabwell’s successful navigation of PIC/S standards positions the company to compete effectively in regulated international markets.

Hu Huiguo, Director, Senior Vice President, and Board Secretary of Mabwell Bioscience, emphasized that this PIC/S member approval demonstrates growing recognition of the company’s quality management system by high-standard overseas regulatory agencies, facilitating accelerated product launches in additional markets.

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Frequently Asked Questions

What does this GMP approval mean for patients?

This approval means patients in Jordan and potentially other PIC/S member countries will have access to more affordable biosimilar alternatives to expensive denosumab treatments like Prolia® and Xgeva®, while maintaining the same quality and safety standards.

When will these denosumab biosimilars be available globally?

Mabwell has already received approval in Pakistan in 2025 and has submitted applications in 8 countries. The Jordan approval may accelerate approvals in other PIC/S member countries, though specific timelines depend on individual regulatory processes.

How do these biosimilars compare to the original Prolia® and Xgeva®?

Biosimilars must demonstrate equivalent efficacy, safety, and quality to their reference products. Mabwell’s denosumab biosimilars (9MW0311 and 9MW0321) have met these stringent requirements while potentially offering more affordable treatment options for osteoporosis and bone metastases.