Milestone represents first-time approval of biologics CTP for a joint multinational-local company venture in China
SHANGHAI and GAITHERSBURG, Md., Jan 18, 2016 -- WuXi AppTec, a global R&D enabling platform company, and MedImmune, the global biologics research and development arm of AstraZeneca, announced today that an Investigational New Drug (IND) application for WBP216 (MEDI5117), a novel anti-IL-6 antibody for rheumatoid arthritis (RA) and other autoimmune disorders—developed by their joint venture, WuXi MedImmune—has been approved by the China Food and Drug Administration (CFDA) as a class I biologic to enter Phase 1 clinical trials in China.
The CFDA’s decision represents the first time that a clinical trial permit (CTP) has been approved for a biologic produced jointly between a multinational corporation and a Chinese company. WuXi has been providing local regulatory, manufacturing, pre-clinical and clinical trial services for the advancement of WBP216.
“We are very pleased that WuXi MedImmune has advanced this important new medicine to a critical milestone,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “WuXi is committed to offering a global enabling platform with the highest quality standards to accelerate the advancement of innovative products to benefit patients in China and around the world.”
“MedImmune and WuXi’s partnership is breaking new ground, not only innovating to potentially address critical patient needs in rheumatoid arthritis, but also leading in the industry as the first multinational-local corporate venture to earn approval of a biologic IND in China,” said Dr. Bahija Jallal, Executive Vice President, MedImmune. “This milestone continues a legacy of firsts that our partnership has established, as our venture was also the first such collaboration in China between a global company and a Chinese company to develop novel biologics. We are pleased to begin the next chapter in our collaboration with WuXi AppTec, a company with strong leadership in the Chinese biopharmaceutical sector, with the aim of accelerating Chinese patients’ access to innovative medicines and addressing unmet medical needs around the globe.”
RA is a chronic systemic disease affecting the joints, connective tissues, muscle, tendons, and fibrous tissue, often causing pain and deformity. RA affects approximately 5 million patients in China. Currently, the pathology of RA has not been fully determined in the scientific and medical communities, making the development of effective RA therapies a major challenge in the field of rheumatology.
WBP216 (also known as MEDI5117) is currently being studied in autoimmune and inflammatory diseases such as rheumatoid arthritis. WBP216, a novel investigational biologic, is a fully humanized monoclonal IgG antibody that depletes IL-6 and bears MedImmune's proprietary half-life extending mutation on its Fc region (known as the "YTE" technology) designed to give a long duration of action. IL-6 is known to be an important mediator in the production of inflammation and pain in a variety of pathologic states.
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics, WuXi platform is enabling nearly 3000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated." Please visit http://www.wuxiapptec.com.
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.
Rebecca Einhorn, MedImmune
Sunnie Sun, WuXi AppTec