Aug 4 2010
China Nuokang Bio-Pharmaceutical Inc. (Nasdaq:NKBP) ("Nuokang" or the "Company"), a leading China-based biopharmaceutical company focused on the research, development, manufacture, marketing and sales of hospital-based medical products, today announced that two of its product pipeline candidates recently advanced through the next respective stages of the State Food and Drug Administration ("SFDA") review process. The Company provided the following updates on its key product candidate Kaitong, a product in-licensed from the Company's partner, Jilin Yuhua, and Dipyridamole Aspirin, a product developed internally by Nuokang:
- Kaitong: Nuokang's development partner for Kaitong, Jilin Yuhua, received a notice from the SFDA to progress to the on-site inspection of its manufacturing facilities. As such, the SFDA has completed its technical review and Kaitong's development is moving forward as planned. Nuokang continues to expect to receive the manufacturing license for Kaitong by the end of 2010.
- Dipyridamole Aspirin: The SFDA recently completed its onsite inspection, a final step in the SFDA review process. The Company also continues to expect to receive the manufacturing license for Dipyridamole Aspirin by the end of 2010.
BaiZhong Xue, the Company's Chairman and CEO, commented, "We are pleased with today's news that our two product candidates are moving forward as planned. The technical review of Kaitong was completed successfully and we will continue to work closely with Jilin Yuhua to obtain the manufacturing license as expeditiously as possible, with our goal still being to receive the license by the end of this year. Once the license is received, we are well prepared to quickly and effectively launch the product across our distribution network."
Source:
China Nuokang Bio-Pharmaceutical Inc.