Mabwell Achieves Landmark Approval for Denosumab Injection in Pakistan

Mabwell's Trailblazing Approval of Denosumab in Pakistan

Mabwell, a pioneering biopharmaceutical firm, has recently made a significant breakthrough in the global pharmaceutical landscape with the approval of denosumab injections in Pakistan. This historic moment is not just an achievement for Mabwell, but also a victory for local healthcare, expanding treatment options for patients in need.

On September 5, 2025, Mabwell (688062.SH) announced that its two denosumab products, 9MW0311 and 9MW0321, obtained marketing authorization from Pakistan’s Drug Regulatory Authority (DRAP). This landmark approval marks Pakistan's first for a denosumab biosimilar and signifies Mabwell's inaugural overseas marketing success.

The Importance of Denosumab

Denosumab is a monoclonal antibody that plays an essential role in treating osteoporosis and other bone-related ailments. Its introduction into the Pakistani market will provide crucial treatment options for patients, particularly postmenopausal women at high risk of fractures. With a population exceeding 240 million, the strategic collaboration between Mabwell and The Searle Company Limited (higher known as “Searle”) opens up a promising pharmaceutical market for new therapies. Searle is poised to handle the local fill-finish and commercialization processes for the denosumab products, showcasing an important partnership that aligns with the broader Belt and Road Initiative.

Mr. Hu Huiguo, a board member and senior vice president of Mabwell, stated, “The successful approval of denosumab in Pakistan provides local patients with enhanced treatment options and high-quality biologics, marking another milestone in Mabwell's global commercialization strategy.” This commitment to expanding access not only supports local healthcare demands but also aligns with global trends in providing affordable biosimilar therapies.

Details about Denosumab Products

9MW0311 is a recombinant fully humanized anti-RANKL monoclonal antibody designed as a biosimilar to Prolia®, while 9MW0321 similarly translates to a biosimilar of XGEVA®, a therapy crucial for treating giant cell tumors in adults and skeletally mature adolescents. With additional applications planned for expanding treatment indications, both products are uniquely positioned to meet diverse medical needs. In China, the marketing application for 9MW0311 saw approval back in March 2023, glancing a preview of the robust demand for RANKL monoclonal antibody therapies which alone reached a notable $1.317 billion market size in 2024, according to Frost & Sullivan.

Mr. Tahir Ahmed, CEO of Searle, remarked that “the launch of denosumab significantly improves accessibility and reinforces our position as a trailblazer in biosimilars in Pakistan.” With this collaboration, Searle indicates strong commitment towards enhancing patient care through innovative therapeutic solutions.

Strategic Growth for Mabwell

Mabwell aims to leverage this approval to accelerate the commercialization of denosumab across additional countries, reiterating a global strategy that emphasizes the need for accessible healthcare solutions. Their innovative approach, focused on oncology and age-related diseases, is bolstered by genome-based research and modern biopharmaceutical practices. Mabwell’s expanding international footprint signifies a dedicated intention to meet the growing demands of healthcare systems worldwide.

As the company prepares for further growth, it remains committed to its vision of holistic healthcare improvement, reflecting on its mission to “Explore Life, Benefit Health.” The partnership with Searle not only augments local healthcare capabilities but also symbolizes a noted commitment to international biomedical collaboration, reinforcing regional health systems in a time of growing medical challenges.

In conclusion, the approval of denosumab injections paves the way for further advancements in Pakistan’s healthcare, enhancing available therapeutic options for patients and establishing a foundational partnership between Mabwell and Searle for further innovations in biopharmaceutical treatment. As the global pharmaceutical landscape continues to evolve, Mabwell stands at the forefront of significant change, driven by innovation and dedication to patient health.

About Mabwell

Mabwell is recognized for its innovation-driven approach throughout the entire biopharmaceutical value chain and seeks to address critical global health needs with effective and accessible therapies. More information about their initiatives can be found at Mabwell's official website.