Mabpharm (Stock Code: shturl.) recently issued an official announcement that the New Drug Application (NDA) for CMAB807 Puboli^® (Denosumab Injection), independently developed by the Company, was approved by the National Medical Products Administration (NMPA) in early June. This monoclonal antibody new drug targeting osteoporosis treatment has officially entered the domestic market, marking Mabpharm’s fourth commercialized antibody drug.

About CMAB807 Puboli^® (Denosumab Injection)

CMAB807 Puboli^® (Denosumab Injection) is a human immunoglobulin G2 (IgG2) monoclonal antibody with high affinity and specificity for human Receptor Activator of Nuclear Factor κB Ligand (RANKL). RANKL is a transmembrane or soluble protein essential for the formation, function and survival of osteoclasts—the cells responsible for bone resorption.

CMAB807 Puboli^® (Denosumab Injection) blocks RANKL from binding to and activating RANK, the receptor located on the surface of osteoclasts and their precursors. By inhibiting the interaction between RANKL and RANK, the drug suppresses the formation, functional activity and survival of osteoclasts. This reduces bone resorption while elevating the mass and strength of cortical and trabecular bone.

Excess osteoclast activity triggered by RANKL mediates bone pathological lesions in solid tumors with bone metastasis. Similarly, giant cell tumor of bone consists of stromal cells expressing RANKL and osteoclast-like giant cells carrying RANK receptors; RANK receptor signaling drives bone lysis and tumor proliferation.

About Mabpharm

Listed on the Hong Kong Stock Exchange under stock code shturl., Mabpharm focuses on the research, development and manufacturing of novel drugs and biosimilars for oncology and autoimmune diseases. The Company is committed to delivering high-quality, affordable innovative biopharmaceuticals to the market through an efficient R&D system and low-cost pharmaceutical manufacturing capacity, and leverages its extensive R&D expertise to develop a diversified therapeutic product portfolio.

With years of intensive R&D and innovation in the biopharmaceutical sector, Mabpharm has mastered core technologies for large-scale production of antibody drugs and built a comprehensive high-level platform integrating R&D innovation and industrialization. To date, four monoclonal antibody drugs developed by Mabpharm have obtained marketing approval from the NMPA:

1. CMAB007 Aomaishu^® (Omalizumab α for Injection): The first domestic therapeutic antibody drug approved by the NMPA for allergic asthma treatment, breaking the monopoly of imported medicines and providing affordable treatment options for millions of asthma patients.

2. CMAB008 Leiting^® (Infliximab for Injection): A core therapeutic drug for autoimmune diseases widely applied in rheumatology, immunology and gastroenterology.

3. CMAB009 Enlituo^® (Cetuximab β Injection): Indicated for metastatic colorectal cancer, the first domestically developed anti-EGFR monoclonal antibody new drug with independent intellectual property rights approved by the NMPA for first-line treatment of metastatic colorectal cancer.

Multiple products have been included in the National Reimbursement Drug List (NRDL), with market coverage across thousands of medical institutions at all levels nationwide, earning widespread recognition from clinicians and patients.

About HZSKBIO^Ⓡ

Founded in 2012, Huzhou Shenke Biotechnology Co., Ltd. (shortened as HZSKBIO^Ⓡ) is a national high-tech enterprise and a Ministry of Industry and Information Technology "Specialized, Refined, Unique & Innovative Little Giant" enterprise. The Company operates production and operation bases alongside a provincial-level Research Institute for Biological Product Quality Control in Huzhou, Zhejiang Province, and runs an advanced technology R&D center in Zhangjiang, Shanghai.

Its core business covers R&D and industrialization of pharmaceutical quality control technologies, supplying standardized test kits, testing equipment and technical services targeting host residual nucleic acid/protein, exogenous risk factors, process residues, genetic stability and other indicators.

The Company holds ISO13485 certification and CNAS laboratory accreditation, with core products filed in the U.S. Food and Drug Administration (FDA) Drug Master File (DMF). It delivers systematic solutions combining standardized and customized services to clients across multiple sectors, stabilizing the supply chain for biopharmaceuticals and empowering high-quality industrial development.

Note: All information regarding Mabpharm and CMAB807 Puboli^® (Denosumab Injection) mentioned herein is sourced from publicly released official press releases and documents. HZSKBIO^Ⓡ extends sincere congratulations to Mabpharm on this remarkable achievement!