Bayer's Xofigo® (Radium-223 Dichloride) Approved in China for Treatment of Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases

Beijing, August 27, 2020 /PRNewswire/ -- Bayer announced today that Xofigo^®(Radium Chloride [²²³Ra] Injection) has been approved by the National Medical Products Administration for the treatment of patients with castration-resistant prostate cancer (CRPC) who have symptomatic bone metastases and no known visceral metastases. Xofigo^®is an alpha-particle-emitting radiopharmaceutical therapeutic agent; the pivotal Phase III ALSYMPCA study demonstrated that Xofigo, compared with placebo,^®Significant survival benefit, favorable safety profile, and improved quality of life (QoL) for patients: this treatment offers a triple benefit for prostate cancer patients.

“Over the past decade, with the intensifying aging of the population, the incidence of prostate cancer in China has risen rapidly. Metastatic castration-resistant prostate cancer (mCRPC) is a type of cancer that has spread beyond the prostate and is resistant to both medical and surgical castration.”^【1】Professor Ye Dingwei, Chairman of the Urological and Male Genitourinary Oncology Committee of the China Anti-Cancer Association, stated, “Approximately 90% of men with metastatic castration-resistant prostate cancer (mCRPC) have radiological evidence of bone metastasis, which may lead to an increased frequency of skeletal-related events and has been proven to be a major cause of morbidity and mortality in patients with CRPC.”^【2】Therefore, early diagnosis and treatment of bone metastases are crucial for patients with CRPC.

Xofigo^®It is an alpha particle-emitting radiopharmaceutical therapeutic agent. Its active moiety mimics calcium ions and exhibits osteotropism by forming complexes with hydroxyapatite (HAP) in bone, particularly in areas of active osteoblastic pathology associated with bone metastases. The alpha particles emitted by radium-223 induce high-frequency double-strand DNA breaks in adjacent tumor cells, thereby producing a potent cytotoxic effect. Meanwhile, due to the short emission range of alpha particles (less than 100 micrometers, or fewer than 10 cell diameters), damage to surrounding normal tissues is minimized.

Xofigo^®This approval is based on data from the pivotal Phase III ALSYMPCA study and the Phase III Study 15397 conducted in Asia. In this study, compared with placebo, Xofigo^®Significantly improved overall survival (OS) while delaying the time to first symptomatic skeletal events (SSEs). The incidence of adverse events in the treatment group was similar to or even lower than that in the placebo group, suggesting that Xofigo^®It has a good safety profile. Furthermore, the quality of life (QoL) of patients in the treatment group was significantly improved.

Jiang Wei, Global Executive Vice President of Bayer AG’s Pharmaceuticals Division and President of China and Asia-Pacific, as well as President of Greater China for Bayer AG, stated: “Xofigo”^®Enhancing the efficacy and safety of treatment for prostate cancer patients in a novel way. Accompanied by Xofigo^®With this approval, Bayer’s Oncology division will launch a new therapeutic area in prostate cancer in China, providing treatment options for Chinese patients at different stages of the disease. “Bayer remains committed to meeting the treatment needs of Chinese patients with innovative medicines, and this approval represents another fulfillment of that commitment.”

About Bayer's Oncology Business Division

Bayer upholds its mission of “Science for a Better Life” by continuously optimizing its portfolio of innovative products. Bayer’s Oncology division currently comprises six oncology products and several other compounds at various stages of clinical development. Together, these products reflect the company’s research approach that prioritizes targets and signaling pathways with the potential to transform cancer treatment.

About Bayer

As a multinational corporation, Bayer possesses core competencies in health and nutrition within the life sciences sector. The company is dedicated to helping people overcome the major challenges posed by global population growth and aging through its products and services, thereby benefiting humanity. Meanwhile, the Group enhances profitability and creates value through technological innovation and business growth. Bayer is committed to sustainable development. Worldwide, the Bayer brand stands for trustworthiness, reliability, and quality. In the 2019 fiscal year, Bayer had approximately 104,000 employees, with sales amounting to €43.5 billion, capital expenditures of €2.9 billion, and research and development investments of €5.3 billion. For more information, please seewww.bayer.com。

Forward-Looking Statements

This press release contains forward-looking statements made by the management of Bayer AG based on current assumptions and forecasts. Various known and unknown risks, uncertainties, and other factors could cause the company’s actual future operating results, financial position, development, or performance to differ materially from the estimates presented in such forward-looking statements. These factors include those described on Bayer’s official websitehttp://www.bayer.com/Bayer’s various reports publicly disclosed. The Company has no obligation to update these forward-looking statements or to conform them to future events or developments.

References:

1.   American Cancer Society. Prostate cancer that remains or recurs after treatment. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-treating-recurrence. Accessed July 23, 2013.

2.   World Cancer Research Fund International. Prostate Cancer. http://www.wcrf.org/cancer_statistics/data_specific_cancers/prostate_cancer_statistics.php. Accessed July 2018.