Bayer Showcases Prostate Cancer Drug Xofigo® at CIIE, with Nubeqa® Anticipated for Approval by Year-End

Bayer Unveiled Flagship Products at Its Booth During the CIIE on November 7Xofigo® (Radium [223Ra] Chloride Injection). This drug is the world's first alpha particleTargeted Therapy Drugs, currently approved in more than 40 countries.

In August this year, Bayer’s Xofigo® finally launched in China for the treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases.Prostate Cancer(CRPC) patients.

Currently, prostate cancer is the second most common malignant tumor in men worldwide, with 1.3 million new cases globally in 2018. In recent years, the incidence of prostate cancer in China has also been rising rapidly. Data from the National Cancer Center in 2015 showed that the incidence rate in China reached 10.23 per 100,000 people, with an average annual growth rate of 12.07%, and the mortality rate reached 4.36 per 100,000 people.

The approval of Xofigo® provides prostate cancer patients with a new treatment option. Bayer’s Xofigo® is an alpha-particle-emitting radiopharmaceutical whose active moiety mimics calcium ions. It exhibits bone-seeking properties by forming complexes with hydroxyapatite (HAP) in bone, particularly in areas of active osteoblastic metastasis.

The α-particles emitted by radium-223 can 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 its α-particles (less than 100 micrometers, or fewer than 10 cell diameters), it minimizes damage to surrounding normal tissues.

Currently, after Xofigo® has been approved in more than 40 countries worldwide, Bayer is also continuing to advance clinical studies of this drug for the treatment of other cancers. Information from Chinadrugtrials shows that clinical studies for the indication of breast cancer are ongoing.

It is reported that in the month following the approval of Xofigo®, Bayer signed an exclusive distribution agreement with China Isotope & Radiation Corporation. Under the exclusive distribution agreement, Bayer will grant China Isotope & Radiation Co., Ltd. the right to sell in ChinaRadioactivityExclusive rights to the therapeutic drug Xofigo®.

According to Bayer, the first prescription in China was issued in November. However, as this drug is a radiopharmaceutical with a half-life, it must be imported from Bayer’s factory in Norway after each prescription is written. It is estimated that the medication will reach patients in China approximately one month after the prescription is issued.

Currently, each box of Xofigo® is priced at approximately USD 25,000 in the United States. According to Dr. Song Shaoli, Deputy Director of the Department of Nuclear Medicine at Fudan University Shanghai Cancer Center, the price of Xofigo® in China is RMB 40,000 per injection/box, administered once a month, with a course of treatment consisting of six injections.Course of Treatment。 

Beyond Xofigo®, Lang Zhihui, Vice President of Bayer’s Prescription Drugs Division, stated that Nubeqa (darolutamide), another Bayer drug for the treatment of early-stage prostate cancer, is currently under regulatory review and is expected to be launched by the end of the year. Nubeqa was co-developed by Bayer and the Finnish pharmaceutical company Orion. It has already been approved in the United States, Brazil, and Japan for the treatment of patients with non-metastatic castration-resistant prostate cancer.

This article is sourced from Iyiou, an original piece by author Lin Yiling. For reprints or collaborations, please click here.Reprint Notice, unauthorized reposting will be subject to legal action.