TAIPEI, TAIWAN--(Marketwire - March 23, 2012) - ScinoPharm (TWSE1789), a leading active pharmaceutical ingredient (API) and contract research and manufacturing (CRAM) service provider to the global pharmaceutical and biotechnology industry, today announced its CRO project, DBPR108, commissioned by the National Health Research Institutes (NHRI), has received approval by Taiwan and the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical trial.
Dr. Jo Shen, president and CEO of ScinoPharm, remarked, "We are proud of this fruitful partnership with the NHRI. DBPR108 is an excellent example of collaboration with Taiwan's domestic pharmaceutical industry and further highlights Taiwan's overall competitive strength and expertise in the international community."
Commissioned by the NHRI in 2010, ScinoPharm provided CRO services in developing the DBPR 108. After the NHRI completed preclinical trials and clinical trial planning, applications were filed in Taiwan and with the U.S. FDA for Investigational Brand drug (IND) in November 2011. Approval from both sides was obtained early 2012. The Phase 1 clinical trial implementation will launch in the upcoming months.
ScinoPharm partners with other leading pharmaceutical companies for custom contract services ranging from clinical materials to commercial. The company has handled more than 70 NCE projects, with 5 currently in phase III and 3 already approved for launch. NDAs are expected to be filed with the U.S. FDA in the next 2 to 3 years.
ScinoPharm is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. For more information, please visit the Company's website at www.scinopharm.com.