BeiGene Announces Commercial Launch of XGEVA® (Denosumab Injection) in China for Giant Cell Tumor of Bone

BEIJING, China and CAMBRIDGE, Mass., July 1, 2020 /PRNewswire/ -- BeOne Medicines (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on the development and commercialization of innovative molecularly targeted and tumor immunology drugs for cancer treatment, today announced Anjia Wei^®(Denosumab Injection) Officially Commercially Launched in China for the Treatment of Giant Cell Tumor of Bone (GCTB). This marks the first Amgen-manufactured drug to be officially commercially launched in China by BeOne Medicines, following the global oncology strategic collaboration reached between BeOne Medicines and Amgen in January 2020. Xgeva^®In May 2019, it received approval from the National Medical Products Administration (NMPA) for the treatment of giant cell tumor of bone that is unresectable or where surgical resection may result in severe functional impairment, including adult and adolescent patients with skeletal maturity (defined as having at least one mature long bone and a body weight ≥45 kg). In addition, the supplemental New Drug Application (sNDA) for denosumab for the new indication of preventing skeletal-related events in patients with bone metastases from multiple myeloma and solid tumors was formally accepted in April 2020 and is currently under technical review by the Center for Drug Evaluation.

Professor Niu Xiaohui, Director of the Department of Bone Tumor Surgery at Beijing Jishuitan Hospital and Chairman of the Sarcoma Expert Committee of the Chinese Society of Clinical Oncology (CSCO), stated: “Previously, the treatment of giant cell tumor of bone was mainly based on surgery and other adjuvant therapies (such as radiotherapy and embolization), while Angavi^®The approval of Xgeva fills a gap in the pharmacological treatment of giant cell tumor of bone.^®“It exerts a dual effect of inhibiting tumor growth and reducing bone destruction, facilitating multidisciplinary collaborative diagnosis and treatment of giant cell tumor of bone. It has demonstrated good tolerability in clinical trials and can control disease progression.”

Anjawei^®Approval was based on the results of two open-label trials (NCT00396879 and NCT00680992) in patients with giant cell tumor of bone that is recurrent, unresectable, or where planned surgical resection is likely to result in severe functional impairment. In patients with unresectable disease, Xgeva^®Long-term disease control can be achieved, with a 5-year progression-free survival (PFS) rate of 88%; furthermore, among patients with resectable tumors, 80% received neoadjuvant Anagwei.^®Improvement was observed in treated subjects: 44% of subjects underwent downstaged surgery, and 37% avoided surgery.^[1]. The most common adverse reactions (≥10%) are generally mild or moderate, including arthralgia, headache, nausea, back pain, fatigue, and pain in extremities.

Dr. Wu Xiaobin, General Manager of BeOne Medicines’ China Region and President of the Company, stated: “Xgeva^®The official commercial launch in China marks a new milestone in the strategic collaboration between BeOne Medicines and Amgen, but even more encouraging is Xgeva^®As the first and currently only drug approved in China for the treatment of giant cell tumor of bone, it will bring patients more innovative treatment options. Our commercialization team in China currently has over 1,200 employees, and we look forward to bringing Xgeva^®as well as the company’s other multiple cancer therapies to patients in need.”

“Amgen officially launches Xgeva^®“The commercialization handover in China to BeOne Medicines marks a significant step forward in our efforts to accelerate the introduction of more of Amgen’s innovative oncology products, thereby benefiting patients in China. We look forward to working with BeOne Medicines to jointly advance the development of Amgen’s cutting-edge oncology pipeline in both the Chinese and global markets, bringing meaningful change to the lives of millions of cancer patients,” said Ms. Mei-Ling Ke, Vice President of Amgen and General Manager of Amgen China. “This strategic partnership will also reinforce Amgen’s commitment to the Chinese market by building a stronger and more comprehensive chronic disease portfolio to address the substantial unmet medical needs driven by an aging population, such as cardiovascular diseases and fragility fractures.”

About Giant Cell Tumor of Bone

Giant Cell Tumor of Bone: A Histologically Benign but Often Aggressive Skeletal Tumor Predominantly Affecting Young Adults Aged 20–40 Years^[2],[3], with a slightly higher incidence in females than in males, accounting for approximately 56.4%^[4]. Globally, giant cell tumor of bone accounts for approximately 4%-5% of all primary bone tumors.^[4], it is more common in China than in European and American populations, accounting for approximately 20% of all primary bone tumors^[5]. Although the vast majority of giant cell tumors of bone are benign, if left untreated, they often cause complete destruction of the affected bone, leading to fracture, joint dysfunction, or amputation.

Giant cell tumor of bone predominantly occurs in the long bones of the extremities, with pulmonary metastasis being extremely rare. Although the disease progresses slowly, it is often associated with severe bone pain, swelling, loss of mobility, and pathological fractures. In Angwei^®Prior to approval, no drugs had been approved for the treatment of giant cell tumor of bone (GCTB). For resectable GCTB, surgery is the primary treatment option. However, some patients require procedures such as joint resection or amputation, which result in significant postoperative functional impairment. A substantial proportion of patients experience recurrence after initial surgery, making subsequent management more challenging and increasing the risk of metastasis.

About Anjawei^®(Denosumab Injection)

Anjawei^®(English name: XGEVA^®, generic name: Denosumab Injection), is a fully human IgG2 monoclonal antibody. Xgeva^®Binds specifically to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts; osteoclasts are responsible for bone resorption, thereby regulating the release of calcium from bone. Studies have shown that in giant cell tumor of bone, stromal cells produce RANKL to stimulate the composition of osteoclast-like giant cells expressing the RANK receptor, thereby inducing RANK receptor expression. Signaling through the RANK receptor promotes osteolysis and tumor growth. Xgeva^®It can block RANKL from activating RANK on the surface of osteoclasts, osteoclast precursors, and osteoclast-like giant cells.

About BeOne Medicines

BeOne Medicines is a global, commercial-stage biotechnology company dedicated to researching, developing, manufacturing, and commercializing innovative medicines to improve therapeutic outcomes and drug accessibility for patients worldwide. Currently, BeOne Medicines employs over 3,800 people across mainland China, the United States, Australia, and Europe, and is accelerating the advancement of its diversified pipeline of novel cancer therapies. At present, two of BeOne Medicines’ independently developed drugs, the BTK inhibitor Brukinsa^®(Zanubrutinib Capsules) are being sold in the United States and China; anti-PD-1 antibody drug Baizean^®(Tislelizumab Injection) is marketed in China. In addition, BeOne Medicines is currently marketing or plans to market in China a portfolio of oncology drugs licensed from Amgen, Celgene Logistics S.à r.l. (a subsidiary of Bristol-Myers Squibb Company), and EUSA Pharma. For more information, please visitwww.beigene.cn。

Forward-Looking Statements 

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the commercial launch of Angavir and its potential benefits, as well as BeOne Medicines’ commercialization plans or expectations for the Company and other oncology therapies and pipeline candidates of Amgen. Actual results may differ materially from those in the forward-looking statements due to various important factors. These factors include risks related to: BeOne Medicines’ ability to demonstrate the efficacy and safety of its drug candidates; the possibility that clinical results for drug candidates may not support further development or regulatory approval; regulatory actions that may impact the initiation, timing, and progress of clinical trials and product marketing approvals; the ability of BeOne Medicines’ marketed products and drug candidates (if approved) to achieve commercial success; BeOne Medicines’ ability to obtain and maintain protection for its technology and drug intellectual property rights; BeOne Medicines’ reliance on third parties for drug development, manufacturing, and other services; BeOne Medicines’ limited operating history and its ability to secure additional operating funds to complete the development and commercialization of its drug candidates; the impact of the coronavirus pandemic on the Company’s clinical development, commercial activities, and other business operations; and the various risks more fully discussed in the “Risk Factors” section of BeOne Medicines’ most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in subsequent filings made by BeOne Medicines with the U.S. Securities and Exchange Commission. All information in this press release is current only as of the date of this press release, and BeOne Medicines undertakes no obligation to update such information except as required by law.

Xgeva^®Registered Trademark of Amgen Inc.

[1] Thomas D, Henshaw R, Skubitz K, et al. Lancet Oncol 2010;11:275–80

[2] Mendenhall WM, et al. Am J Clin Oncol. 2006;29:96-99.

[3] Oncology Progress. 2005, 3(4) :316-319. DOI: 10.3969/j.issn.1672-1535.2005.04.004

[4] Hoch B. Inwards C, Sundaram M, et al. Multicentric giant cell tumor of bone. Clinicopathologic analysis of thirty cases. J Bone Joint Surg Am, 2006, 88(9):1998-2008.

[5] Szendroi M. Giant-cell tumor of bone. J Bone Surg Br, 2004, 86(1):5-12.