China-Based Biotech Selects Medidata Technology Platform to Simplify Complexity in Oncology R&D


Company News Release

Shanghai Henlius Biotechnology Optimizes Phase III Oncology Study with Medidata’s Unified, Cloud-Based Solution for Electronic Data Capture, Randomization and Supply Management


NEW YORK, N.Y. – March 23, 2016 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that its industry-leading technology platform has been adopted by China-based Shanghai Henlius Biotechnology Co. Ltd (“Henlius”). Focused on monoclonal antibody drug development, Henlius is utilizing the Medidata Clinical Cloud® platform to bring operational efficiencies to its complex Phase III oncology clinical trial in China.


“To meet the specific and intricate requirements of our oncology study, as well as continue driving innovation for the patients we serve, it’s imperative that we combine our therapeutic expertise with the industry’s most cutting-edge technology,” said Dr. Yin Liu, director of Henlius’ clinical and medical department. “Medidata’s unified, robust technology platform provides our team with real-time visibility into clinical data and trial operations. This visibility enables better trial oversight and opportunities to make earlier, more informed decisions.”


A joint venture between Shanghai Fosun Pharmaceutical, one of the largest pharma companies in China, and Henlius Biopharmaceuticals, a top Chinese biotechnology company, Shanghai Henlius Biotech was founded in 2009. The organization focuses on the development, production and commercialization of monoclonal antibody drugs for a number of therapeutic areas, including oncology and auto-immune diseases. To optimize trial operations and streamline process workflows in an upcoming Phase III oncology study, Henlius is using Medidata’s unified cloud-based solution for electronic data capture (Medidata Rave®) and randomization and trial supply management (Medidata Balance®).


“By offering a single, integrated system for capturing clinical data, randomizing patients and dispensing treatment doses, Medidata’s cloud-based platform is enabling Henlius to streamline study operations and easily make mid-study supply adjustments-reducing costs, trial risk and overall timelines,” said Edwin Ng, Medidata’s vice president of field operations, APeJ (Asia Pacific except Japan). “We look forward to enriching Henlius’ deep therapeutic expertise with our robust technology, helping its research team conduct faster, more efficient and more meaningful trials that ultimately result in more effective treatments for patients.”


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About Shanghai Henlius Biotechnology

Shanghai Henlius Biotech Co., Ltd. is a joint venture company formed by Shanghai Fosun Pharmaceutical Co., Ltd. and Henlius Biopharmaceuticals Co., Ltd. in December 2009. The company focuses on the development, production and commercialization of mAb biosimilar drugs, bio-betters and novel mAbs using cutting-edge technology. Registered in Shanghai Zhangjiang, the company has so far invested over 400 million RMB in the early development of monoclonal antibody drugs.


Products currently in development cover a variety of therapeutic areas including oncology and autoimmune diseases. Henlius' R&D management team has extensive experience in the development and commercialization of a range of monoclonal antibody drugs in such leading international pharmaceutical and biotech companies as Genentech, Amgen, BMS, Eli Lilly and Chiron. The concept of Henlius' drug development lies in global integrative innovation, and the company has a total of 3 R&D laboratories located in China (Shanghai), the US (California) and Taiwan (Taipei).


About Medidata

Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.


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