東生華製藥 開發緩釋新藥 (Dilatrend): 策略 因華模式授權 分潤 人民幣4500萬

(エーブィエ バイオファーム 神戶 -日本 2019.07.08 20:58 更新) 東生華結合因華授權研發中新藥至山東新時代，授權金人民幣4,500萬 東生華製藥結合因華生技，歷經多年成功地將治療高血壓併發心衰竭的藥物-CRTA，原 GSK(GlaxoSmithKline;葛蘭素) 的藥品-Dilatrend/ Coreg (一般劑型，一天服用2次) 改良成為一天一次給藥的緩釋劑型，並且獲得美國、中國大陸及台灣等各國專利。臨床上，目前針對治療高血壓策略中，很重視的原則之一即是強化病人用藥的順服性 (patient adherence)，因為一旦病人缺凡規律性服藥，研究發現其伴隨衍生出慢性腎功能疾病、中風、心肌肥大、心臟衰竭或增加住院風險等更造成社會經濟的衝擊。東生華製藥藉由長期專注於心臟血管藥品市場開發與新劑型新藥創新，並藉由策略模式與大陸新時代藥業簽訂的全球獨家授權，將由新時代藥業執行人體試驗後，循二類新藥或505(b)(2)途徑申請大陸、美國等多國之藥證，預計將於完成相關試驗送申請後一年可取得大陸及美國等之藥證。此次授權，東生華將可透過因華就合約之總價款人民幣4,500萬，自簽約至各藥品開發里程碑達成時，可進行分潤。大陸新時代藥業為魯南製藥集團下的主要公司之一，主要從事藥品之原料及製劑的研發和生產。其隸屬集團-魯南製藥集團是大陸製藥公司競爭力排名第28名之公司，被中國大陸認定為國家創新型企業、國家技術創新示範企業及國家火炬計劃重點高新技術企業。集團擁有超過180個藥品品項，藥品曾鸁得7項大陸國家奬項，透過6千名左右之業務人員銷售全球，年銷售額超過人民幣104億，主力產品之一為心血管用藥－欣康，年銷售額接近人民幣15億。

 

TSH biopharm working together with InnoPharmax and Shandong Newtime Pharmacutical enter into global agreement of commercialization of CRTA 

TSH and InnoPharmax today announced granting Shandong Newtime Pharmaceutical an exclusive rights to commercialize pipeline product CRTA, a treating chronic heart failure of ischemic agent in worldwide. TSH and InnoPharmax successfully improved GSK's product, Dilatrend/Coreg from twice tablet per day to once daily slow-released tablet. CRTA has been granted several patents from US, China, Taiwan etc. Recent clinical observations indicate that the patient adherence to hypertension is crucial and increased chronic kidney disease, stroke, cardiac hypertrophy, heart failure, and hospital admission for population without good compliance. TSH biopharma is devoting on cardiovascular specialty medicine development and featuring on innovative formulation drug technology with unmet clinical need. This collaboration aligns the interests and strengths of TSH and InnoPharmax and Shandong Newtime in actions designed to secure regulatory approval and commercializing CRTA in the world. Shandong Newtime will continue to be responsible for development and registration of CRTA. CRTA is developed through the 505(b)(2) regulatory pathway and expect to get approval within one year after related clinical trial completed. According to the agreement, TSH will receive part of total RMB 45million by milestone.

About TSH Biopharm TSH Biopharm is dedicating to medicines development and innovation in chronic diseases field and continue developing other related health products, especially focusing on cardiovascular, gastrointestinal, and autoimmune diseases. Through self-development and co-development products, TSH biopharm will keep providing economic treatment plan to gain more welfare for chronic patients.