HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS CONFERENCE CALENDAR
LATEST UPDATES » Volume 20, No. 9, September 2016 – Infectious Diseases       » Curcumin Derivatives May Prevent Alzheimer's Disease by Promoting Amyloid-β Clearance       » Varian Chosen to Equip First Government Owned Proton Centre in China       » Medtronic and SingHealth Collaborate on a Centre of Excellence to Fight Diabetes       » NCCS Awards Contract for Proton Beam Therapy System to Hitachi Asia      
EYE ON CHINA
EntreMed files new drug clinical trial application for ENMD-2076 with China SFDA to advance global development strategy
EtreMed, Inc. (ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, announced their submission of a new drug clinical trial application with China's State Food and Drug Administration (SFDA) for its proprietary drug candidate, ENMD-2076, to conduct global clinical trials in triple-negative breast cancer patients.

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, “We are very pleased with SFDA's acceptance of our application package and look forward to working with the SFDA to move the process forward towards approval. SFDA's approval of our application would pave the way for us to conduct global clinical trials in China and advance our ongoing Phase II triple-negative breast cancer trial currently underway at the University of Colorado and Indiana University.

“Our filing with SFDA represents an important milestone for us. As a clinical-stage drug development company, competition in patient recruitment, time, and costs can be challenging when advancing clinical programs. We address this by building a value-added platform via a joint US-China drug development model that will enable us to do the trials with lower study costs and faster patient recruitment. The data we obtain may be used to support both global drug development and China import drug registration as appropriate.”

Dr. Ren continued, “We will also pursue developing ENMD-2076 in other indications where activity has been shown, including ovarian cancer, sarcoma and liver cancer, based on our prioritized product development plan. We believe positive results from these efforts will add value to our patients, shareholders, as well as to the company.

“In addition, we have initiated local manufacturing and pre-clinical activities of ENMD-2076 in China to target specific unmet medical needs, such as hepatocellular carcinoma, which could support a new drug trial application with SFDA. Our local development activities demonstrate EntreMed's commitment to develop a strong presence in the Chinese market, which has been projected to become the second largest pharmaceutical market in coming years. We believe we are on track with our development plan and are grateful to our shareholders for their enthusiasm, patience, and long term support.”

Click here for the complete issue.

NEWS CRUNCH  
news Enterprise meets technology: More than 300 enabling innovations showcased at TechInnovation
news CPhI's Pre-Connect Congress outlines current trends in pharma
news World Population Day 2016
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  

Lady Ganga: Nilza'S Story
COLUMNS  
Subscribe to APBN E-Newsletter
Find us under 'Others' option to receive APBN e-newsletters thrice a month!

APBN Editorial Calendar 2016
January:
Guest Editorial - Biotechnology In Korea
February:
Guest Editorial - Biomedical Research Governance
March:
Guest Editorial - Life-Saving Opportunities: A Guide to Regenerative Medicine
April:
Leading-Edge ONCOLOGY
May:
Healthcare Systems & Policies in Asia
June:
Medical Devices & Healthcare Technology
July:
Water Technology and Management
August:
Novel Technologies for Antibody Drug Discovery in Japan
September:
Infectious Diseases
October:
Medical Tourism
November:
Big Data in Healthcare
December:
Orthopaedics
Editorial calendar is subjected to changes.
– Editor: Carmen, Jia Wen Loh
MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Instructions to Authors
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» For Editorial Enquiries:
   biotech_edit@wspc.com or Ms Carmen
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   biotech_ad@wspc.com
Copyright© 2016 World Scientific Publishing Co Pte Ltd  •  Privacy Policy