TaiRx, Inc. (6580) announces today that its new injection product, Zelnite®, received NDA approval from the Taiwan FDA on January 22nd, 2018. This will allow all TPN patients in Taiwan to receive selenium supplement and maintain selenoprotein function in the body.
Selenium (Se) is a crucial trace element in the human body, selenocysteine has also been dubbed as the 21st amino acid forming over 25 kinds of selenoprotein. These proteins are used to regulate anti-oxidation and anti-inflammation function in the human body. If a human body suffers from selenium deficiency, it will exhibit symptoms like myocarditis, arthritis, abnormal liver function, and hypothyroidism. In addition, aging, stressing, or cancer populations have more free radicals in their bodies, and the need for anti-oxidation of selenium increases.
TaiRx is a new drug development company and has many cancer treatment and sepsis treatment drugs in clinical development. Due to many TPN patients exhibiting complication from selenium deficiency, TaiRx started the development of selenium formulation in 2015. The API was developed in collaboration with Formosa Laboratories, Inc. and the drug product was developed and manufactured by Nang Kuang Pharmaceutical Co., Ltd.. Zelnite® is a NCE developed in Taiwan, it can be used to treat or prevent selenium deficiency. Patients who underwent heart surgery, gastrointestinal surgery or suffers from stroke, brain trauma, and burns may not be able to receive the proper amount of nutrition from food and have to rely on long term TPN and will require higher selenium supplement intake. Many treatment guidance around the world suggests these critically ill patients to receive 350 to 1000 micrograms of selenium from intravenous injection in order to maintain the anti-oxidation and anti-inflammatory function of the body.
Taiwan Ministry of Health and Welfare has been promoting domestic large-scale medical facilities to purchase new medical products developed and produced by domestic manufacturers, and is listed as one of the evaluation criteria. The development of Zelnite® by TaiRx not only fulfills a medical need but is also in line with the government’s efforts to encourage the development of Taiwan’s biotechnology industry. In addition to collaborating with domestic API and drug product manufacturer, TaiRx has also granted Morris Enterprise Co. Ltd. the sales and marketing rights in Taiwan. Morris has a total solution for the promotion of new drugs, from market survey and research to sales teams all over Taiwan and PIC/S GMP warehousing logistics management. Morris has many years of experience in international pharmaceutical drug distribution. The cooperation between the two parties will create economic and medical value for Zelnite®. In order to expand the market of a Taiwanese new drug, TaiRx will also work with Yong Shin Pharmaceutical (Kunshan) Co., Ltd., which was recently listed on NEEQ in China in order to obtain approval in China and the United States. With the R&D capability of Taiwan at its core, Zelnite® will target the international market and create a win-win scenario. TaiRx started out as a new drug development company, by working with Taiwan GMP manufacturer, experienced sales and marketing experts, and strategic alliance with a Taiwanese pharmaceutical company with many years of experience in China. This team effort will create a new operation model for Taiwan’s new drug development.