Mabpharm-B (HKEX: 02181) has announced that its pipeline product, CMAB807 (Denosumab Injection), has received marketing authorization approval from China's National Medical Products Administration (NMPA).

The approved indications for CMAB807, branded as Puboli®, are: (i) treatment of osteoporosis in postmenopausal women at high risk for fracture, where it can significantly reduce the risk of vertebral, non-vertebral, and hip fractures; (ii) treatment of osteoporosis in men at high risk for fracture; and (iii) treatment of glucocorticoid-induced osteoporosis in patients at high risk for fracture.

CMAB807 is a human immunoglobulin G2 (IgG2) monoclonal antibody with high affinity and specificity for human RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL is a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL from activating the RANK receptor on osteoclasts and their precursors, CMAB807 inhibits osteoclast activity, thereby reducing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

CMAB807 Puboli® is indicated for osteoporosis. Another specification of the same product, CMAB807X Leishu® (Denosumab Injection), is expected to be approved soon for treating conditions such as bone metastases from solid tumors and giant cell tumor of bone. These therapeutic areas collectively involve tens of millions of patients in China.

Major Milestone for the Company

CMAB807 represents the fourth product from Mabpharm-B to receive marketing approval in China. The company stated it will work closely with its partners to swiftly advance the product's inclusion in China's national medical insurance reimbursement scheme and expand its market access channels. This strategy aims to achieve rapid market coverage and sales volume growth for the product, which is anticipated to contribute significantly to the company's future drug sales and profit growth.

International Expansion Plans

Mabpharm-B has also initiated international market promotion and registration activities for CMAB807, expecting it to achieve solid sales performance in overseas markets as well.

Company Background and Pipeline

Mabpharm-B focuses on monoclonal antibody development, supported by a seasoned R&D team whose core members possess over 22 years of experience in antibody drug development and have led major national research projects. The company boasts strong in-house capabilities in drug research, manufacturing, and preclinical and clinical development. It employs a business collaboration model, partnering with leading and proactive drug sales companies globally to commercialize its developed drugs.

The company's current pipeline includes several monoclonal antibody drugs. Besides CMAB807, its other approved products are CMAB009 (Cetuximab Beta Injection), CMAB008 (Infliximab for Injection), and CMAB007 (Omalizumab Alpha for Injection).

Competitive Positioning

The company believes its solid foundation in equipment, technology, and quality control for antibody drug manufacturing will provide it with a strong competitive edge in future national reimbursement negotiations and potential volume-based procurement discussions in China.