天士力與日本EA製藥株式會社簽署藥物引進授權合約 7月18日，天士力醫藥集團股份有限公司（以下簡稱"天士力"）與日本EA製藥株式會社（以下簡稱"EA製藥"）在天士力國際交流展示中心簽署授權合約。天士力將引進EA製藥研發的一款針對晚期腎功能損害及血液透析所導致的繼發性甲狀旁腺功能亢進症（SHPT）患者的治療藥品——鈣感應受體的變構調節劑（簡稱"AJT240"）。該藥目前正在進行全球多中心臨床II期試驗。未來，天士力將擁有其大中華地區的開發、生產和商業化權益。天士力控股集團董事局執行主席閆凱境、EA製藥董事長&CEO Yuji Matsue分別代表雙方企業簽署協定，天士力研究院執行院長周水準、天士力醫藥集團股份有限公司常務副總經理劉金平，EA製藥執行副總裁Akira Shinji、EA製藥BD總經理Takashi Shibano等共同見證了簽約儀式。 AJT240由EA製藥研發並擁有全球智慧財產權，是一款針對晚期腎功能損害及血液透析所導致的繼發性甲狀旁腺功能亢進症(SHPT)患者的靜脈注射藥物，具有持久穩定降低甲狀旁腺激素(PTH)的作用，有利於提高透析患者的藥物依從性,減少現有口服SHPT藥物治療中觀察到的如噁心、嘔吐等胃腸副作用。該藥物臨床II期試驗研究預計2018年在日本完成，爭取儘早在華上市。EA製藥是衛材和味之素兩家大型日本公司的合資企業，兩家企業在生物藥領域均已積累深厚基礎。通過此次與EA製藥合作、引進創新藥物，可與天士力現有產品管線形成戰略協同，豐富公司現有心腦血管及消化代謝相關治療領域產品組合，進一步拓寬整個慢病市場的產品管線，同時將世界最前沿領域藥品引入中國，為中國患者提供更多世界水準的創新藥物。此次合作也將成為天士力實施國際化戰略的重要里程碑。此前天士力國際化聚焦美國市場，此次與日本藥企合作是天士力全面國際化戰略特別是開拓亞洲市場的重要一環，將持續擴大天士力國際化品牌影響力，助力國際藥企更好地瞭解天士力的創新藥合作開發能力和在華市場開拓能力，為未來引入更多世界前沿產品奠定良好基礎。
Secondary hyperparathyroidism (SHPT) is one of the complications that occurs with progression of chronic renal disease (chronic renal failure). In SHPT, the parathyroid glands excessively secrete parathyroid hormone (PTH). Excessive PTH promotes efflux of phosphorus and calcium from bone into the blood. This increases the risk of bone fracture or causes deposition of phosphorus and calcium salts in non-bone tissues, i.e., ectopic calcification, which leads to bone pain, joint pain and other symptoms. Particularly, there has been reported that, when the deposition occurs in the cardiovascular system, the risk of cardiovascular diseases including arteriosclerosis increases and even can affect prognosis.
AJT240 directly acts on the calcium-sensing receptor expressed on the cell membrane of parathyroid glands and suppresses the excessive secretion of parathyroid hormone. AJT240 is an intravenous injection that can be administered through the dialysis circuit intravenously after a dialysis session. This is expected improve medication adherence of patients receiving maintenance dialysis and reduce the gastrointestinal side effects such as nausea, vomiting and the like that are observed in treatment with existing oral SHPT drugs.
On April 1, 2016, the Eisai Group's gastrointestinal disease business built up over 60 years and the Ajinomoto Group's gastrointestinal disease business with amino acid technologies at its core will be integrated to establish EA Pharma, a gastrointestinal specialty pharma with a full value chain including research and development, production and logistics, sales and marketing. EA Pharma will strive toward realizing an Enterprise Architecture that will create new innovation from the two companies' combined knowledge.
October 31, 2017, EA Pharma Co., Ltd. (President, Yuji Matsue; Headquarters, Tokyo, Japan) (hereinafter "EA Pharma"), the gastrointestinal disease area subsidiary of Eisai Co., Ltd.,. announced today that EA Pharma signed yesterday a license agreement with JW Pharmaceutical CORPORATION (Representative Directors, Kyung Ha Lee, Sung Kwon Han; Headquarters, Seoul, Korea) (hereinafter "JWP") to grant JWP the rights to develop and market a secondary hyperparathyroidism treatment agent (Code: AJT240) in Korea for patients receiving hemodialysis.
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