禾生技 竹北先導廠: 台灣衛生署查廠 !!

禾生技新藥 下季申請臨床一期 2013年12月16日 04:10 禾伸堂生技（4194）挾著開發用於治療炎性腸道疾病新藥「IBD98-M」，預計將以505（b）（2）的途徑申請美國FDA新藥審查，並規劃明年第一季送件申請美國一期臨床，當年年底可望完成2a臨床，由於對產品進度把握度高，該公司預計明年下半年遞件申請上櫃。以58元登錄興櫃的禾生技，在新藥股的本夢比行情中，昨日掛牌氣勢如虹，終場以91.5元作收。禾生技成立於2001年，目前資本額6.06億元，是首家由電子業主導創立的生醫公司，在瑞士日內瓦設有子公司，2009年開始，禾生技決定以生物性高分子（Bioploymer）的藥物傳輸平台為發展重心，整合瑞士子公司對透明質酸物化特性的基礎研究，陸續開發出SportVis（適應症為踝扭傷、網球肘；針劑）、RenehaVis （適應症為退化性關節炎；針劑）、TRUD （適應症為炎性腸道疾病；直腸灌注液）等醫療器材。該公司不僅開發用於治療炎性腸道疾病新藥「IBD98-M」，也在竹北生醫園區亦依PIC/s GMP規範建立自主的先導工廠，除了開發「IBD98-M」新劑型所需的製程技術，以供給PhaseⅠ～Ⅲ期的臨床用藥外，亦肩負開發未來其它新藥所需的製程技術，該廠規劃2014年年底申請美國FDA查廠審查。

How does TRUD™ work?  TRUD™ contains 2 different specific types of Sodium Hyaluronate (also known as Hyaluronic Acid, or Hyaluronan) as well as a natural muco-adhesive agent (a substance that will ensure the adherence of Sodium Hyaluronate to the mucosa for a longer period). Sodium Hyaluronate has two very important properties which could explain why TRUD™ has shown effectiveness in treating patients with mild to moderate UC. These properties are specific to the size of the Sodium Hyaluronate. The 2 properties are: Facilitate healing/ Protection

Low molecular weight Sodium Hyaluronate  The low molecular weight (small sized) Sodium Hyaluronate that can be found in TRUD™ is able to help improve the healing rate of the affected region (in the colon). This is done through a process called epithelial restitution. That is, these small sized Sodium Hyaluronate molecules promote the rate of healing at the muscosal level which is affected by UC.

High molecular weight Sodium Hyaluronate  The high molecular weight (large sized) Sodium Hyaluronate is able to adhere specifically to where the colon is affected and protect this inflamed and ulcerated area whilst the healing is taking place. This is important as the colon contains a lot of bacteria and toxins which could be accidentally absorbed in the ulcerated area or, could cause further inflammation.