SHANGHAI, China, May 20, 2026
Mabwell announced that China’s National Medical Products Administration (NMPA) has approved the supplemental application for additional indications of MAIWEIJIAN (Denosumab Injection), significantly expanding the therapy’s use in oncology care. The approval allows MAIWEIJIAN to be used for the treatment of patients with bone metastases from solid tumors and multiple myeloma to delay or reduce the risk of serious skeletal-related events including pathological fractures, spinal cord compression, bone surgery, and bone radiotherapy. The decision strengthens Mabwell’s oncology portfolio and reinforces the growing role of biosimilar therapies in improving patient access to advanced cancer treatments across China and international markets. The approval also positions MAIWEIJIAN as a stronger competitor in the rapidly expanding bone-targeted cancer therapy segment, where demand continues to rise due to increasing global cancer incidence and longer patient survival rates.
MAIWEIJIAN is among the first approved biosimilars of Xgeva® in China, giving Mabwell an important first-mover advantage in the market. The product initially received NMPA approval in March 2024 for the treatment of unresectable giant cell tumor of bone in adult and skeletally mature adolescent patients. Since then, Mabwell has aggressively expanded its commercialization footprint globally. In August 2025, MAIWEIJIAN became the first biosimilar of Xgeva approved in Pakistan, and the therapy has already entered commercial supply in that market. The company has also signed commercialization agreements across 33 countries, including Brazil, Saudi Arabia, Egypt, Indonesia, Thailand, Vietnam, Singapore, Malaysia, Colombia, and Peru. Regulatory applications are currently under review in multiple additional countries, highlighting Mabwell’s broader ambition to become a major international biosimilar player in oncology and aging-related diseases.
Denosumab Demonstrates Strong Clinical Advantages Over Traditional Therapies
Denosumab has become an increasingly important therapy in cancer care because of its ability to directly target the RANKL signaling pathway, which is heavily involved in bone destruction caused by metastatic cancers. By blocking the RANKL/RANK/OPG pathway, denosumab helps prevent serious skeletal complications that frequently occur in patients with advanced cancers that spread to bone tissue. Mabwell emphasized that denosumab provides several important advantages over traditional bisphosphonate-based therapies, which have historically been used to manage cancer-related bone disease. According to the company, denosumab offers superior clinical efficacy, including effectiveness in patients who previously experienced treatment failure with bisphosphonates.
The company also highlighted the therapy’s favorable safety profile, particularly regarding kidney function. Unlike bisphosphonates, denosumab is not eliminated through renal pathways, reducing the likelihood of nephrotoxic adverse reactions in vulnerable cancer patients. These clinical advantages have contributed to denosumab’s inclusion in multiple international treatment guidelines and oncology expert consensus recommendations. Mabwell further strengthened confidence in MAIWEIJIAN through extensive clinical validation studies comparing the biosimilar directly against the reference product. Phase I and Phase III trial results published in International Immunopharmacology and JAMA Oncology demonstrated strong similarity between MAIWEIJIAN and the original biologic in pharmacokinetics, pharmacodynamics, efficacy, and safety. The studies included head-to-head clinical comparisons in patients with solid tumor bone metastases, helping confirm the biosimilar’s reliability and therapeutic equivalence.
China’s Oncology Biosimilars Market Continues to Accelerate
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The latest approval reflects the broader transformation underway in China’s pharmaceutical industry, where domestic companies are rapidly advancing high-value biologic and biosimilar development programs. Oncology biosimilars have become a critical growth area as healthcare systems seek lower-cost alternatives to expensive branded biologics while expanding access to advanced therapies for larger patient populations. Bone metastases remain a major complication in advanced cancers, particularly in breast cancer, lung cancer, prostate cancer, and multiple myeloma, making bone-targeting therapies an increasingly important segment of global oncology treatment.
For Mabwell, the expanded indications for MAIWEIJIAN could significantly increase product adoption in hospitals and oncology centers across China while strengthening international licensing opportunities. The company’s growing global partnership network and continued regulatory expansion suggest it is positioning itself as a long-term competitor in the international biosimilars industry. As demand for targeted oncology therapies continues rising worldwide, approvals like this are expected to accelerate market competition while improving affordability and patient access to biologic cancer treatments.
Source: Mabwell, press release
