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CANbridge Pharmaceutical Submits New Drug Application for NERLYNX® (neratinib) in China

2018年10月02日 PM09:02
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BEIJING

CANbridge Pharmaceutical Inc., a biopharmaceutical company developing Western drug candidates in China and North Asia, announced that it has filed a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. The NMPA has accepted the IND application. 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. CANbridge licensed exclusive development rights to NERLYNX, which CANbridge is developing as CAN030, in greater China (China, Taiwan, Hong Kong and Macao) from Puma Biotechnology, Inc. earlier this year.

“The fact that CANbridge has so rapidly advanced CAN030, our first Western-approved targeted therapy, along the regulatory pathway in China demonstrates our capacity to bring new medical breakthroughs to China swiftly, where they have the potential to address the unmet needs of millions,” said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceutical Inc. “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,” said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. “This is a testament to their dedication to helping breast cancer patients in China. We are very pleased to see this dedication to patients, which helps Puma to recognize its goal of making NERLYNX available to patients worldwide. We look forward to CANbridge’s continued progress in this regulatory process for NERLYNX.”

About CANbridge Pharmaceutical Inc.

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). CANbridge 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. CANbridge 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). NERLYNX has been approved in the United States for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and in the European Union for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer. CANbridge is developing NERLYNX as CAN030 and plans to target HER2-positive cancers, including breast and gastric. CANbridge has a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, in greater China, which CANbridge is developing as CAN008, for the treatment of glioblastoma multiforme (GBM). CANbridge received the National Medical Products Administration (NMPA) approval to commence a Phase II/III GBM Trial in mainland China, which it expects to initiate later this year. CANbridge has a world-wide license (ex-North America) to develop, manufacture and commercialize AVEO Oncology’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, which it is developing as CAN017. CANbridge also has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments. Caphosol has been approved for commercialization by the NMPA.

Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions.

CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Pharmaceutical Inc., please go to www.canbridgepharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181002005126/en/

CONTACT

CANbridge Pharmaceutical Inc.
James Xue
CEO
+8610.8414.8018
781.995.0074
or
Media
Planet
Communications
Deanne Eagle
917.837.5866
deanne@planetcommunications.nyc

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