China's NMPA Accepts Mabwell's Supplemental Application for Denosumab Biosimilar MAIWEIJIAN to Prevent Skeletal Events in Cancer Patients
核心洞察
China's National Medical Products Administration has accepted Mabwell (搜索)'s supplemental biologics license application for MAIWEIJIAN (搜索), expanding its use to prevent skeletal-related events in multiple myeloma (搜索) and solid tumor bone metastases (搜索) patients.
MAIWEIJIAN (搜索) represents China's first approved denosumab biosimilar (120mg), initially approved in March 2024 for giant cell tumor of bone (搜索) treatment and subsequently approved in Pakistan.
The biosimilar demonstrates superior clinical efficacy compared to bisphosphonates (搜索) through targeted RANKL (搜索) binding and offers improved safety with reduced renal toxicity.
Mabwell (搜索)'s wholly-owned subsidiary T-mab (搜索) has achieved a significant regulatory milestone as China's National Medical Products Administration (NMPA) accepted the supplemental Biologics License Application for MAIWEIJIAN (搜索) (denosumab injection, R&D code: 9MW0321). The application seeks approval for preventing skeletal-related events in patients with multiple myeloma (搜索) and bone metastases (搜索) from solid tumors (搜索).
First-in-Class Biosimilar Achievement
MAIWEIJIAN (搜索) holds the distinction of being China's first approved denosumab biosimilar (120mg). The product initially received NMPA approval in March 2024 for treating adults and skeletally mature adolescents with giant cell tumor of bone (搜索) that is unresectable or where surgical resection would likely result in severe morbidity. The treatment is indicated for patients defined as having at least one mature long bone and weighing ≥ 45 kg.
The biosimilar's international expansion has progressed rapidly, with Pakistan's Drug Regulatory Authority approving MAIWEIJIAN (搜索) in August 2025 as the country's first denosumab biosimilar (120mg). Supply to Pakistan has commenced, marking the product's entry into international markets.
Mechanism of Action and Clinical Advantages
Denosumab operates through a targeted mechanism, specifically binding to RANKL (搜索) and blocking the RANKL/RANK (搜索)/OPG (搜索) signaling pathway. This targeted action prevents and treats skeletal-related events caused by bone metastases (搜索), offering distinct advantages over traditional bisphosphonate therapy.
Clinical data demonstrates that denosumab provides significantly better clinical efficacy than bisphosphonates (搜索) and remains effective in patients who have failed bisphosphonate therapy. The treatment also offers a favorable safety profile, as it is not cleared by the kidneys, resulting in fewer renal toxicity side effects compared to bisphosphonate treatments.
Robust Clinical Evidence
Mabwell (搜索) has published comprehensive clinical study results for MAIWEIJIAN (搜索) in peer-reviewed journals, including Phase I results in International Immunopharmacology and Phase III results in JAMA Oncology. Through head-to-head pharmacokinetic comparisons and clinical efficacy studies in patients with bone metastases (搜索) from solid tumors (搜索), the biosimilar has been systematically demonstrated to be similar to the reference product across multiple parameters including pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.
Global Market Strategy
The company has established an extensive international presence through formal cooperation agreements in 33 countries, including Brazil, Saudi Arabia, and Indonesia. Additionally, Mabwell (搜索) has submitted registration applications in 8 countries, positioning MAIWEIJIAN (搜索) for broader global market access.
Denosumab's therapeutic benefits have gained recognition through recommendations in multiple expert consensuses and treatment guidelines. As China's first denosumab biosimilar (120mg) to market, MAIWEIJIAN (搜索) possesses early-mover advantages in the Chinese market and expanding international territories.