Mabwell Secures Pakistan's First Denosumab Injection Approval

SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, hereinafter "Searle") jointly announced that two denosumab products, 9MW0311 and 9MW0321, have received marketing authorization from Drug Regulatory Authority of Pakistan (DRAP). This marks both Pakistan's first regulatory approval for a denosumab biosimilar and Mabwell's first overseas marketing authorization for its products.

As a key Belt and Road Initiative partner with a population of 240 million, Pakistan presents substantial pharmaceutical market potential, aligning with Mabwell's strategic expansion into high-growth emerging markets. Earlier, Mabwell entered into a licensing agreement with Searle to facilitate local fill-finish and commercialization of Denosumab in Pakistan.

Mr. Hu Huiguo, Board Member, Senior Vice President and Board Secretary of Mabwell, said, "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. Moving forward, we remain committed to expanding the product's commercialization to additional countries, thereby improving global accessibility to denosumab injections and meeting the therapeutic needs of more patients worldwide."

"With the launch of denosumab, we improve the accessibility of this product, and reaffirm our position as a pioneer in biosimilars in Pakistan," said Tahir Ahmed, CEO of Searle, "This approval is a testament to our continued dedication to bringing high-quality, life-saving therapeutics to the region. We remain focused on improving patient outcomes through continued scientific excellence and strategic collaboration."

About 9MW0311

9MW0311 is a recombinant fully humanized anti-RANKL monoclonal antibody injection (60mg), developed as a Prolia® biosimilar. On March 28, 2023, the marketing application for 9MW0311 was approved by the National Medical Products Administration (NMPA) for the treatment of postmenopausal women with osteoporosis at high risk of fracture in China. Additional supplemental applications are planned to expand indications, including: osteoporosis in men at high risk of fracture, and glucocorticoid-induced osteoporosis in patients at high fracture risk. According to Frost & Sullivan data, the global market size for RANKL monoclonal antibody therapies in osteoporosis treatment has reached $1.317 billion in 2024.

About 9MW0321

9MW0321 is a recombinant fully humanized anti-RANKL monoclonal antibody injection (120mg) developed as a XGEVA® biosimilar. The NMPA of China granted marketing approval for 9MW0321 on March 29, 2024, establishing it as China's first approved XGEVA® biosimilar. It is indicated for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Mabwell is currently advancing supplementary applications to extend 9MW0321's indications to include malignancies associated with bone metastasis. BeOne Medicines and Amgen reported commercial performance data showing XGEVA® achieved annual sales of RMB 1.598 billion in China and USD 2.225 billion globally during 2024, with first half 2025 sales reaching RMB 1.090 billion in China and USD 1.098 billion worldwide. Future growth is anticipated to be predominantly driven by expansion in China and emerging markets.

About Searle

Established in 1965, The Searle Company Limited is among Pakistan's leading pharmaceutical companies, with eight state-of-the-art manufacturing facilities, including a dedicated biotechnology plant. With operations in over 20 countries and rapid expansion across multiple global regions, Searle is committed to delivering innovative treatments for life-threatening conditions. The company's biosimilar portfolio is among the most comprehensive in the region.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. The company provides more effective and accessible therapy and innovative medicines to fulfill global medical needs, focusing on oncology and aging-related disease indications. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en.

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SOURCE Mabwell