Good News comes in Pairs for Holy Stone Healthcare
02, Apr 2014
Good news comes in pairs for Holy Stone Healthcare! Holy Stone Healthcare’s Hsinchu Plant has passed GMP pilot plant evaluation, and “The new drug development plan of the new compound IBD98-M on inflammatory bowel diseases” was also granted subsidies after passing the review screening.
By passing the GMP pilot plant evaluation, Holy Stone Healthcare Hsinchu Plant is capable of independently constructing the formulation techniques for Hyaluronan Drug Delivery (HDD) platform in the future. Holy Stone Healthcare’s next step will be looking to apply for the qualification of c-GMP under the U.S. FDA. Other than developing for the new production technology used in clinical studies Phase I – III for the new formulation IBD98-M , the Hsinchu Plant will also be responsible for the future developments of other technology used in products.
Holy Stone Healthcare uses Hyaluronic Acid (HA) as the transport carrier for the drug delivery platform. After more than five years of dedication from the R&D team, the new formula “IBD98-M” was developed to fight against Inflammatory Bowel Disease. An application for “The new drug development plan of the new compound IBD98-M on inflammatory bowel diseases” was filed at the Ministry of Economic Affairs’ (MOEA) Industrial Technology Development Program (ITDP) a few days earlier. The development is estimated to take 20 months with total expenditure of NT$41 million, among which NT$12.3 million is subsidized by the MOEA Science and Technology Advisory Office recently granted on February 19. Holy Stone Healthcare is aiming to apply IBD98-M for the U.S. FDA Investigational New Drug (IND) review under 505(b)(2)within 2014. This subsidiary has brought a wave of positivity for every stage of the trial.