In Taiwan, three kinds of lypophilized antivenins, including antivenin of A. acutus, antivenin of B. multicincutus and N. naja atra, and antivenin of Tr. Mucrosquamatus and Tr. Gramineus, are available and all currently being produced by Taiwan Centers for Diseases Control (Taiwan CDC).Recently, the Bureau of Pharmaceutical Affairs, Department of Health issued the license for the fourth antivenin developed by Taiwan CDC, the antivenin of D. russellii.In facilitating the availability of the antivenins, Taiwan CDC does not only show its determinations to protect the health of all people but also affirms its ability to develop biologics and antivenins that conforms to Good Manufacturing Practice (GMP).
D. russellii is one of the six venomous snakes found in Taiwan.The venom exhibits characteristics of both neurotoxins and hemorrhagic toxins and possesses a very strong toxicity, resulting in high mortality in snakebite patients.The primary habitat of D. russellii formosensis is distributed in the southeastern part of Taiwan, including Hualien, Taitung, Kaosiung, and Pingtung provinces.To be able to provide prompt and effective treatment to snakebite patients, Taiwan CDC began developing antivenin of D. russellii during the era of the Institute of Preventive Medicine, the former organization that Taiwan CDC descended from.In July, 1999, with the assistance of Taichung Veterans General Hospital, Taiwan CDC implemented clinical trials of the self-developed antivenin.In December the same year, Taiwan CDC obtained approval from the Department of Health to use the antivenin to treat patients carelessly bitten by D. russellii.Furthermore, in 2004, Taiwan CDC was honored with a Service Prize by “The Third Award Session for Manufacturers and Researchers Producing and Developing Medicine to Treat Rare Disorders”.By August, 2005,Taiwan CDC accumulated sufficient amount of clinical records to apply for drug registration due to a decrease in the number of snakebite patients.After following up on the safety and efficacy of the antivenin for three years, the antivenin has been recently approved and the license for the antivenin has been granted.As of now, the antivenin of D. russellii made by Taiwan CDC has successfully cured about 50 patients.
In the past 8 years, antivenins were only available in the hospitals participating in the clinical trials.As the license for the antivenin has been obtained, Taiwan CDC plans to expand the number of disposition stations.Since the specificities of snake venom from each area in the world vary, the antivenin of D. russellii made by Taiwan CDC is unavailable for purchase from outside Taiwan.
According to the World Health Organization estimate, about 125,000 deaths are resulted from snakebites annually due to lack of effective treatment.Therefore, it is important to establish a local manufacturing facility for developing therapeutic antiserums that treat local snake venoms.However, many countries around the world still have not acquired such production technology.To promote international exchange of biotechnology information, Taiwan CDC has taken the liberty to report the news about the self-developed antivenin to the World Health Organization and the diplomatically friendly countries.
During 2002 and 2005, the antivenins made by Taiwan CDC have cured 3,885 snakebite patients.In order to ensure the health and wellbeing of all, Taiwan CDC will continue to consistently supply biological products of excellent quality.