研發概況

研發時程

產品
藥品開發
臨床前試驗
第一期臨床試驗
第二期臨床試驗
第三期臨床試驗
新藥查驗登記
進程
IBD98-M
第二期臨床試驗
IBD98-M
Inflammatory bowel diseases (IBD), which consists of ulcerative colitis (UC) and Crohn's disease (CD), is are characterized by chronic inflammation of the gastrointestinal tract in genetically susceptible individuals exposed to environmental risk factors that affect 5 million people worldwide (1.4 million in the U.S. alone).

IBD98-M, a Delayed-Release Capsule, containing mesalamine, and sodium hyaluronate, is being developed by Holy Stone Healthcare (Holy Stone) as a combination therapy for treatment of patients with mild to moderate UC. The mechanisms of action of IBD98-M Delayed-Release Capsule is as a combination therapy are to combine the therapeutic effects of mesalamine and a barrier effect of sodium hyaluronate to protect the damaged mucosa. Mesalamine has been widely utilized for decades as an anti-inflammatory agent, in treating mild to moderate active CD and UC. At the same time, sodium hyaluronate may act as a protective barrier to the lining of the colon affected by UC, and therefore provides additional therapeutic benefits either by enhancing the efficacy of mesalamine or allowing a reduction of mesalamine dose and its associated toxicity.
2014-08-06 Holy Stone Healthcare Receives FDA Approval to Initiate Phase 1 study of IBD98-M IBD98-M product was approved by the US Food and Drug Administration for the Investigational New Drug (IND) 505(b)(2) application to conduct the PK and safety in Phase 1 clinical trials.
2015-11-09 Holy Stone Healthcare’s IBD98-M Approved for Phase IIa Clinical Trial in Italy It was announced that IBD98-M product has been granted the approval to conduct a Phase IIa clinical trial in Italy by the Italian Medicines Agency (AIFA) on the 6th Nov., 2015.
CA102N
臨床前試驗
CA102N
Colorectal cancer is the third most common cancer worldwide. It starts in the colon or rectum which are parts of the large intestine. Most colorectal cancers are adenocarcinomas often beginning as a polyp, which is growth on the inner wall of the colon or rectum, and some polyps become cancerous over time.
Hyaluronic acid (HA), a biocompatible linear polysaccharide, has recently been utilized as a drug delivery vehicle. HA conjugated drugs (HACD) are drug delivery systems for targeted transport of anticancer therapeutics to tumor cells through interaction of HA with the cells CD44 receptor. HA-Conjugated drugs represent a new generation of targeted cancer therapeutics with enhanced anti-tumor efficacy and low undesirable side effects.
Nimesulide, one of the most potent non-steroidal anti-inflammatory drugs (NSAIDs) studied so far in cancer chemotherapy, has been shown to inhibit tumor progression in several in vitro and in vivo studies.
CA102N is the conjugation of HA and a derivative of Nimesulide which not only targets tumor cell surface receptor CD44, but also undergoes enzymatic degradation within the lysosomal compartment eventually resulting in tumor growth inhibition.
CA102N IV infusion solution is being developed by Holy Stone Healthcare (Holy Stone) as a therapy for treatment of patients with colorectal cancer.

End of 2013 Holy Stone Healthcare Starts to develop a novel technique of HACD
2014 CA102N, uses HACD system allowing targeted release of drug to treat colorectal cancer, was in preclinical stage.