Alliance announces latest progress in clinical development of China's Oxygent

Pharmaceutical Alliance Corppreviously announced that its recently produceddrug for the Oxygent trialused the Alliance's Chinese partner, Beijing Shuanghe Pharmaceutical Co., Ltd., in a new drug application filed with the State Administration of FoodmedicinessupervisionIn accordance with the current regulations of the State Administration of Foodmedicines, experimental drugs for application and clinical development of new drugs must be manufactured in factories in ChinaAs a result, Alliance has agreed to accelerate the transfer of technology to Shuanghe, which was originally planned to take place when China begins phase III trialsBecause of its extensive experience in manufacturing high-capacity injections and IV solutions products, Shuanghe has indicated to Alliance that it believes the drug will be put into production quicklyShuanghe has also expressed a willingness to provide Alliance with oxygent experimental and commercial drugs manufactured in its factories, which will depend on Shuangcrane's compliance with the current Code of Quality Management for Pharmaceutical Production (c
GMP) and its registration with the U.SFood and Drug Administration (FDA)Shuanghe has indicated that once the company manufactures experimental drugs, it will submit an application for a new drug in the study to begin implementing aclinical development program that has been agreed uponOnce China's State Food and Drug Administration approves the application, Shuanghe will begin clinical trials immediately Double Crane wants to make the need for blood transfusions during and after surgery its main goal Shuanghe's clinical development plan will be incorporated into a new draft that aims to expand the phase II and III clinical trials previously conducted by Alliance In these studies, Oxygent was statistically more effective than blood in terms of drug activity, for example, its ability to provide oxygen at lower levels during surgery to maintain physiological stability Importantly, the Shuanghe study will not use any blood collection techniques (e.g., acute isometric blood dilution or self-transfusion during surgery), one of the safety concerns involved in previous Phase III clinical trials at Alliance (Xinhua Meitong)