SHANGHAI
Boehringer Ingelheim and CANbridge Life Sciences announced that both parties have signed an agreement for the manufacture of CAN-017, an ErbB3 (HER3) inhibitory antibody to treat esophageal squamous cell cancer (ESCC), CANbridge plans to initiate a Phase IIa clinical trial for the treatment of ESCC in Greater China.
ESCC is the most prevalent form of esophageal cancer worldwide, with a high incidence in China and other Asian and developing countries. Every year, there are over 450,000 new cases diagnosed and over 50% of these case are occurring in China.
CANbridge acquired worldwide rights (exclusive of North America) to CAN-017 from the US company AVEO Oncology, where it was being developed as AV-203, and had completed a successful Phase I study in patients with solid tumor cancers. With the acquistion of CAN-017, CANbridge plans to expand outside of Asia for the first time, bringing the therapy to regions where ESCC patients have few options, after demonstrating proof-of-concept in China.
“Boehringer Ingelheim is a truly global manufacturer of biologics, capable of executing the intricacies of CAN-017 manufacture and meeting the requirements of the regulatory authorities,” said James Xue, CANbridge Chairman and CEO. “It is a powerful ally for CANbridge as we look to advance the promising Western drug candidates we develop in Asia to other parts of the world, where patients are underserved. With the help of the manufacturing agreement with Boehringer Ingelheim, we look forward to bringing the new drug to China as early as possible.”
“We are excited to enter into this important agreement with CANbridge Life Sciences. Boehringer Ingelheim is a leading player in developing and manufacturing biopharmaceuticals,” said David Preston, Chairman and CEO of Boehringer Ingelheim mainland China, Hong Kong and Tai Wan, commented. “With our world-class bioprocess capabilities, we will help CANbridge and more biopharma enterprises step up efforts to bring innovative bio-medicines to the market and benefit patients quickly.
China initiated a pilot Marketing Authorization Holder (MAH) program in 10 provinces and municipalities recently, providing breakthrough policies breakthrough and a legal basis for biopharma CMO. Boehringer Ingelheim China was selected as one of the first biopharma CMO pilot projects in China as part of the MAH trial. Boehringer Ingelheim Biopharmaceuticals China will leverage its advanced manufacturing platform and management expertise to help Chinese enterprises bring their products into the global markets.
About Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
Boehringer Ingelheim China Biopharmaceuticals site currently operates at 100L and 500L manufacturing scales for GMP clinical material supply at BioLab, Shanghai. Boehringer Ingelheim is also constructing a new facility Oasis in Shanghai with startup of GMP operations targeted for begin of 2017. The Oasis site will include 2000L single-use bioreactor and fill/finish capabilities. Further expansion in Shanghai will depend upon business growth. For more information, please visit http://www.bioxcellence.com.
About CANbridge Life Sciences
CANbridge Life Sciences, Ltd. 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 an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge has exclusive worldwide rights (exclusive of North America) to CAN-017, an ErbB3 (HER3) inhibitory antibody, which it intends to develop in China first for esophageal squamous cell cancer (ESCC).
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 Life Sciences, please go to www.canbridgepharma.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160811005520/en/
CONTACT
CANbridge Life Sciences
James Xue, +8610-8414-8018 or 781-995-0074
CEO
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Planet
Communications
Deanne Eagle, 917-837-5866
