康辰藥業(603590.SH):取得特立帕肽商業運營權
格隆匯4月21日丨康辰藥業(603590.SH)公佈,2020年4月21日,公司、康辰生物與Pfenex、泰凌醫藥、泰凌國際簽署《轉移及變更契據》,康辰生物與泰凌醫藥簽署《特立帕肽商業運營權轉移協議》。根據上述協議,康辰生物取得特立帕肽在中國境內、中國香港、新加坡、馬來西亞及泰國的永久獨家商業運營權。
康辰生物將支付許可費用不超過2550萬美元,在特立帕肽實現淨銷售額後,根據雙方約定的比例支付向Pfenex淨銷售額分成。
特立帕肽是一種由34個氨基酸組成的重組人甲狀旁腺激素(PTH)類似物(rhPTH[1-34]),能調節骨代謝、腎小管對鈣和磷的重吸收,以及腸道鈣吸收,適用於治療絕經後婦女高骨折風險的骨質疏鬆症,以及糖皮質激素持續治療誘發的高骨折風險的骨質疏鬆症。特立帕鈦上市後,在美國、歐盟、中國等多個國家和地區都成為當地臨牀診療指南的推薦用藥,其有效性和安全性都得到廣泛認可。
根據IMS的統計數據,2018年特立帕肽全球市場規模達到19.29億美元,市場空間較大。特立帕肽作為國內外唯一上市的骨形成促進劑處方藥,細分市場規模增長較快,且國內市場同類競品較少,除禮來Forteo產品外其他競品均為國內廠家研發的生物類似藥。
康辰生物取得Pfenex研發的特立帕肽商業運營權並完成進口藥品註冊後,將成為國內特立帕肽第二個進口藥品,具有較強的競爭優勢。
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