Henlius Received Acceptance Notification for Clinical Trial Application from NMPA for its Denosumab Biosimilar HLX14

March 10, 2020 I

HLX14 can prevent RANKL/RANK mediated bone-related diseases
HLX14, a recombinant anti-RANKL (receptor activator of nuclear factor kappa B ligand) human monoclonal antibody (mAb) injection, is a biosimilar of Denosumab (Trade Name: Prolia®) developed in accordance with Biosimilar Guidelines. HLX14 can specifically bind to RANKL and block the interaction between RANKL and RANK, which is expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, maturation and activation of osteoclasts, thereby reducing bone resorption and the incidence of skeletal-related events [1].

Several studies have shown the similarity between HLX14 and its original drug
Currently, the original drug of HLX14, Denosumab has been approved in the United States and the European Union, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, as well as for the treatment of patients with giant cell tumor of bone and patients with osteoporosis at high risk for fracture. Denosumab can increase the bone density and reduce the risk of fracture for these patient populations. In China, Denosumab has already been approved to treat giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, while the other indications like osteoporosis have not been approved. Developed in accordance with Biosimilar Guidelines and via step-by-step comparison, HLX14 was proved to be in high similarity with Denosumab in preclinical pharmacology, toxicology and pharmacokinetic studies.

Increasing medical needs endow HLX14 a broad market prospect
Nowadays, the serious problem of osteoporosis is arising throughout the world. Among all countries, China has the largest population that is suffering from osteoporosis, which mainly occurs in postmenopausal women and elderly people [2]. Health problems caused by osteoporosis, like facture, can result in significant loss of quality of life. Nonetheless, the percentage of patients with osteoporosis that have received standardized treatment is relatively low. With the increasing patient number and improved diagnosis of osteoporosis in China, the huge unmet medical needs in the treatment of osteoporosis are urgently to be addressed [3].

The original drug of HLX14, Denosumab, can also be used in the treatment of bone metastasis from solid tumors. Bone is a frequent site of metastases in cancer patients, but the overall incidence of bone metastasis is not known. The relative incidence of bone metastasis by type of tumor, in patients with advanced metastatic disease, is: 65-75% in BC; 65-75% in prostate; 60% in thyroid; 30-40% in lung; 40% in bladder; 20-25% in renal cell carcinoma and 14-45% in melanoma [4]. Another indication of Denosumab is giant cell tumor of bone, which is a benign but usually aggressive neoplasm of bone [5]. Globally, giant cell tumor accounts for 4% to 5% of primary bone tumors [6]. Compared with western population, the incidence of giant cell tumor is relatively higher in Chinese population, accounting for 20% of primary bone tumors [7]. Despite the fact that most giant cell tumors are benign, without proper treatment, they often causes serious damage of the affected bone and can finally result in bone fracture, joint dysfunction or even amputation.

The development of HLX14 expands Henlius’ portfolio to cover more disease areas

On top of biosimilar, Henlius has built an extensive pipeline in bio-innovative and combination therapy. While quickly driving clinical studies of novel products in different countries and areas, Henlius is also actively diversifying versatile in-house combination therapy portfolio with a focus on anti-PD-1/PD-L1 mAbs to capture future immuno-oncology opportunities. Looking forward, Henlius will continue to advance the development of innovative biologics by virtue of its established and integrated innovation platform, underscoring its long-term commitment to providing affordable and effective therapies for patients worldwide.

SOURCE: Fosun Pharma

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