HSHC has been granted approval from the US FDA for a Phase 2, randomized, open-label study to evaluate the efficacy, safety, and tolerability of CA102N combined with Trifluridine/Tipiracil (TAS-102) compared to Bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment.
IBD98-M, the anti-inflammatory drug for the treatment of inflammatory bowel diseases (IBD) was approved for Phase II clinical trial by the investigational new drug (IND) review from China's National Medical Products Administration (NMPA) on May 19, 2023
Phase 1 study of CA120N for mCRC from Holy Stone Healthcare, is published on 《Investigational New Drugs》on 04, Nov 2022.
For more information, please visit https://link.springer.com/article/10.1007/s10637-022-01308-5
February 08, 2022 - Holy Stone Healthcare Co., Ltd. (4194.TW) completed the clinical study report for the Phase 1 clinical study of CA102N which is a new anti-cancer drug for the treatment of colorectal cancer.
Holy Stone Healthcare participated in the National Invention and Creation Awards with its patented invention “Mixture of hyaluronic acid for treating and preventing inflammatory bowel disease”.
I. The company's patented invention “Mixture of hyaluronic acid for treating and preventing inflammatory bowel disease” received a silver award in Invention Awards in the 2020 National Invention and Creation Awards.
II. Holy Stone Healthcare and Gongwin Biopharm signed the cooperation agreement for IBD98-M Phase II Clinical Trial in China.
The results of the study “CA102N suppresses the growth of mouse colon cancer by inhibition of PI3K pathway and immune modulation”, conducted by the company in cooperation with UT MD Anderson Cancer Center, were shared during the Virtual Annual Meeting Ⅱ of American Association of Cancer Research (AACR).
Holy Stone Healthcare has completed the phase IIa clinical trial and the clinical study report of IBD98-M for inflammatory bowel disease.
CA102N (for Colorectal Cancer) received IND approval from FDA
Research report of IBD98-M was published on 《Molecules》, volume 22, issue 6
Pre-clinical (in-vivo & in-vitro) study report of CA102N was published on《Nanomedicine》, volume 2017:12.
Holy Stone Healthcare received “Innovation Award - Special Mention Award” in the 2016 Taipei Biotech Awards.
The company's "Novel targeting polymeric drug delivery system" received an innovation award in the 2016 Taipei Biotech Awards.
HSBT, cooperating with University of St Andrews (Scotland), completed the development of a strain, HSBT1, for sodium hyaluronate fermentation.
The company’s new drug, IBD98-M received approval from U.S. FDA for a Phase IIa clinical trial and approval from the Italian Medicines Agency (AIFA) for conducting a Phase IIa clinical trial in Italy.
The company received a CE certificate for GAF, a medical device for treating anal fissure.
Holy Stone Healthcare completed the FDA-approved Phase I clinical trial of IBD98-M for treatment of Inflammatory Bowel Disease.
Fast Track project "Phase I Clinical Trial for New Compound drug for Inflammatory Bowel Disease, IBD98-M", approved by the Ministry of Economic Affairs and received a 5.6 million TWD support.
Project CA102N approved as additional item of biotech and new pharmaceutical development company by the Ministry of Economic Affairs.
Holy Stone Healthcare’s pilot plant passed the inspection on PIC/s GMP by the Taiwan FDA.
Holy Stone Healthcare was listed on Taiwan’s emerging stock market.
The Financial Supervisory Commission approved the company’s public offering.
MDT Int’l s.a. received a CE certificate for TRUD.
The company’s subsidiary, Holy Stone Biotech, was founded in the U.K. and is the R&D base of the group in Europe.
Holy Stone Healthcare’s PIC/s GMP pilot plant was established in Hsinchu Biomedical Science Park.
Holy Stone Healthcare Co., Ltd. is certified by the Ministry of Economic Affairs as a “Biotech and New Pharmaceutical company”.
MDT Int’l s.a. received a CE certificate for RenehaVis .
MDT Int’l s.a. received an ISO13485 certificate
MDT Int’l s.a. received a CE certificate for SportVis.
The company’s subsidiary, MDT Int'l s.a., was founded in Geneva, Switzerland, and is responsible for R&D and marketing products that are classified as Class III medical devices.
Holy Stone Healthcare signed a contract with Cellestis Limited and became the exclusive distributor for QuantiFERON in Taiwan.
Holy Stone Healthcare was founded in Taipei, Taiwan.