On October 2, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that it has been advised that its licensing partner CANbridge Pharmaceutical Inc received confirmation that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy (Press release, Puma Biotechnology, OCT 2, 2018, View Source [SID1234529704]). NERLYNX was approved in the United States for the same indication in July 2017 and in the European Union for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in September 2018.
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James Xue, PhD, Founder, Chairman and CEO of CANbridge Pharmaceutical Inc, said, "The fact that CANbridge has so rapidly advanced CAN030 (neratinib), our first Western-approved target therapy, along the regulatory pathway in China demonstrates our capacity to new bring medical breakthroughs to China swiftly, where they can potentially address the unmet needs of millions. HER2-positive breast cancer is on the rise in China, particularly in younger women, and the patient outcomes, with limited current treatment options relative to Western countries, are not as good. We are committed to bringing this important new treatment to these patients, as well as to exploring its potential application in other HER2-positive cancers, such as gastric."
"We are very pleased with the progress that CANbridge has made in the regulatory process for NERLYNX in greater China. This is a testament to their dedication to helping breast cancer patients in China and we are very pleased to see this dedication to the patients, which helps Puma to recognize its goal of making NERLYNX available to patients worldwide," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We look forward to CANbridge’s continued progress in this regulatory process for NERLYNX."
About HER2-Positive Breast Cancer
Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.
About CANbridge Pharmaceutical
CANbridge Pharmaceutical Inc is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). The company develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia, or address medical needs that are underserved in the region. It also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China).
CANbridge is privately-held and headquartered in Beijing, China. Further information may be found at www.canbridgepharma.com.