Bayer receives approval for Xofigo® in China

Berlin, August 27, 2020 – The Chinese National Medical Products Administration (NMPA) has approved Xofigo® (radium-223 dichloride) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. The drug is already approved in more than 50 countries worldwide, including the U.S., the EU and Japan.

“With the aging of population, the incidence of prostate cancer has increased rapidly in China in recent years. Metastatic castration-resistant prostate cancer (mCRPC) is a form of cancer that has spread beyond the prostate and is resistant to medical or surgical treatments that lower testosterone,” said Prof. Ye Dingwei, head of China Anti-Cancer Association-Genitourinary Cancer Committee. “Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events and have been shown to be the main cause of morbidity and death in patients with CRPC.”

Xofigo® is the only approved Targeted Alpha Therapy that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo in men with castration-resistant prostate cancer and symptomatic bone metastasis, as shown in the pivotal Phase III ALSYMPCA trial. The approval of Xofigo in China is based on the ALSYMPCA data as well as the Phase III 15397 trial operated in Asia.

“With our globally growing prostate cancer portfolio, we are pleased that Xofigo with its distinct mode of action is now available for patients in China,” said Scott Z. Fields, M.D., senior vice president and head of Oncology Development of Bayer AG's Pharmaceutical Division. “We remain committed to bringing additional therapeutic options to the increasing number of men living with prostate cancer in China to address their unmet medical needs.”

About Xofigo® (radium-223 dichloride)
Radium-223 dichloride (radium-223) is a Targeted Alpha Therapy. It selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha particles leads to a high frequency of double-strand DNA breaks in adjacent tumor cells, resulting in a potent cytotoxic effect. The alpha particle range from radium-223 is less than 100 micrometers, which minimizes damage to the surrounding normal tissue.

ALSYMPCA Trial Design
The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study of Xofigo with best standard of care vs. placebo with best standard of care in symptomatic castration-resistant prostate cancer (CRPC) patients with bone metastases. Interim and updated analyses of the trial showed Xofigo significantly improved overall survival.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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