BLA Accepted in China for Boan Biotech's Denosumab Injection (BA1102) for the Oncology Indications

YANTAI,China,March 21,2023 --Luye Pharma Group today announced that the Biologics License Application (BLA) for BA1102 (Denosumab Injection),a biosimilar for the oncology indications developed by its subsidiary Boan Biotech,has been accepted in China by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

BA1102 is a biosimilar of XGEVA®. Its active ingredient is denosumab,a fully human IgG2 anti-RANKL monoclonal antibody. Denosumab binds to RANKL,a transmembrane or soluble protein essential for the formation,function,and survival of osteoclasts,the cells responsible for bone resorption,thereby modulating calcium release from bone. Increased osteoclast activity,stimulated by RANKL,is a mediator of bone pathology in solid tumors with osseous metastases. Similarly,giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor,and signaling through the RANK receptor contributes to osteolysis and tumor growth. Denosumab prevents RANKL from activating its receptor,RANK,on the surface of osteoclasts,their precursors,and osteoclast-like giant cells.

BA1102 is indicated for the treatment of patients with bone metastases from solid tumors and patients with multiple myeloma,to delay or reduce the risk ofskeletal-related events(SREs) (e.g. pathologic fractures,spinal cord compression,bone radiotherapy or bone surgery). The drug is also indicated for the treatment of adults and skeletally mature adolescents (defined as having at least one mature long bone and with body weight ≥ 45 kg) with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.

BA1102 follows the relevant research guidelines for biosimilars,through a series of step-by-step comparative analytical,non-clinical,human pharmacokinetics and clinical studies which rigorously and completely prove the overall similarity between BA1102 and the original reference drug: the quality,safety and efficacy of the two drugs are highly similar,and there is no clinically meaningful difference between them. Two key clinical studies of BA1102 versus the reference product reached all the endpoints: (1) the study comparing their pharmacokinetics (PK),pharmacodynamics (PD),safety,tolerability,and immunogenicity in healthy subjects proved that BA1102 is bioequivalent to the reference product in terms of PK and PD; (2) the study comparing their efficacy and safety in patients with bone metastases from solid tumors proved that BA1102 is highly similar to the reference productin terms of efficacy,and immunogenicity.

There are a large number of patients with bone metastases from solid tumors,and the subsequent SREs such as pathologic fractures and spinal cord compression seriously compromise their quality of life. Patients with multiple myeloma also have a higher risk of SREs.1 GCTB is locally aggressive,and has a propensity for local recurrence and distant metastases,which can become life-threatening in severe cases.2 Denosumab injection provides an effective therapy for these diseases.

Denosumab has been used for more than 10 years with abundant clinical evidence. It has been recommended by multiple guidelines in China and abroad,including those from American Society of Clinical Oncology (ASCO)3,European Society of Medical Oncology (ESMO)4,National Comprehensive Cancer Network (NCCN)5,and Chinese Society of Clinical Oncology (CSCO)2. In addition to specific chemotherapies and targeted therapies for primary tumors,Chinese and foreign guidelines also recommend the use of denosumab as a first-line therapy to prevent or delay the occurrence of SREs in patients with bone metastases from solid tumors and those with multiple myeloma. Furthermore,denosumab is currently a preferred treatment for GCTBs that cannot be resected or the surgical resection of which is likely to result in severe morbidity.

Driven by multiple factors including patient demand and clinical value,the future is very promising for denosumab. The market size for XGEVA® and its biosimilars in China is expected to be around RMB 2.84 billion by 2030.6

Dr. Dou Changlin,R&D President and Chief Operating Officer of Boan Biotech,said: "BA1102 is the third biologic drug for which Boan Biotech has filed a BLA to the NMPA. The other two are for Boyounuo® and Boyoubei®,both of which have been approved and launched. BA1102 and Boyoubei® have the same active ingredient: denosumab. The drug registration testing for BA1102 has been successfully completed by China's National Institutes for Food and Drug Control before the drug registration application is accepted. Given our strong CMC capabilities and sound quality management system,I am confidently looking forward tothe marketing authorization of BA1102so that it can add to the company's existing oncology portfolio to benefit patients in need."

References:

QiuLouguiet al. Chinese Guidelines for Diagnosis and Treatment of Bone Disease with Multiple Myeloma. Chinese Journal of Hematology,2022,43(12): 979-985

Chinese Society of Clinical Oncology (CSCO). Guidelines for the Diagnosis and Treatment of GCTB (2020).

Anderson K,Ismaila N,Flynn PJ,et al. Role of Bone-Modifying Agents in Multiple Myeloma: American Society of Clinical Oncology Clinical Practice Guideline Update. Journal of Clinical Oncology. 2018,36:8,812-818

Coleman R,Hadji P,Body JJ,et al. Bone health in cancer: ESMO Clinical Practice Guidelines [J]. Ann Oncol,2020,31(12):1650-1663.

NCCN Guidelines for Patients,Bone Cancer. Version 2. 2023

Forrester & Sullivan.

About Boan Biotech

As a subsidiary of Luye Pharma Group,Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing,manufacturing,and marketing biologics,with a focus on oncology,autoimmune diseases,ophthalmology,and metabolic diseases. The company discovers antibodies on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform,Bispecific T-cell Engager Technology Platform,and ADC Technology Platform. The company's portfolio currently includes two commercialized products,multiple investigational antibodies protected for their international intellectual property rights,and a number of biosimilar candidates.

Boan Biotech operates across the entire value chain of the industry from antibody discovery,cell line development,upstream and downstream process development,analytical and bio-analytical method development,and technology transfer to pilot and commercial production. In addition to China,the company is also developing biopharmaceutical products in overseas markets,including the U.S. and the EU.