Holy Stone Healthcare invests the pilot GMP plant
03, Feb 2013
In line with Governmental policy to promote biotech industry and provide the Company’s testing drug required for clinical trials, Holy Stone Healthcare Co., Ltd. (Holy Stone Healthcare) acquired a qualification of a "Biotech and New Pharmaceutical company" from the Ministry of Economic Affairs in August 2011. Holy Stone Healthcare also passed a review conducted by the Hsinchu Science Park, and has officially stationed at the Hsinchu Biomedical Science Park in January 2012. Holy Stone Healthcare will begin its c-GMP pilot plant for software and hardware construction with expected completion date in 2013 for Taiwan and the U.S. FDA inspection on GMP. In addition to the Company’s future needs in terms of drugs for clinical trials, the c-GMP pilot plant also provides services for domestic pharmaceutical companies on sample tests for clinical trials, as well as CMC document preparation and other services.
Holy Stone Healthcare R&D team has developed its own Hyaluronan Drug Delivery Technology (HDD) platform, which improves gastrointestinal therapeutic efficacy of new drugs and reduce side effects.The Company's first drug developed using the HDD technology platform is IBD98 for the treatment of inflammatory bowel disease (IBD). The animal studies of IBD98 have been completed with confirmed results and optimization of manufacture processes is underway. IBD98 is a new treatment approach which can significantly improve the side effects of IBD drug treatment, as well as increase the ease of use and patients’ safety. In addition, IBD98 has been filed for patent all over the world.
IBD is an idiosyncratic inflammatory disease which might be due to allergens in the intestine causing immune diseases, including ulcerative colitis and Crohn’s disease. General symptoms include intestinal mucosal ulceration, swelling, and bleeding of intestinal mucosal which leads to fluid and electrolyte loss. According to Visiongain 2011 annual market survey and forecast, IBD’s global market in 2010 was US$5.01 billion, and by 2015 it will grow to US$6.94 billion.
Holy Stone Healthcare, a subsidiary of the Holy Stone Enterprise Group, was established in January 2001. Holy Stone Healthcare has potential to develop medical products, with a goal to become an international biotechnology company. Since establishment, under the leadership of the founder, Holy Stone Healthcare has developed and launched several patented biotech products. In addition to the establishment of a domestic marketing team, an international marketing team in Europe was also formed.