通化東寶(600867.SH)：URAT1抑制劑(THDBH130片)申報臨牀獲得批准
格隆匯12月16日丨通化東寶(600867.SH)公佈，根據公司全資子公司東寶紫星(杭州)生物醫藥有限公司(“東寶紫星”)與上海藥明康德新藥研發公司(“上海藥明”)於2021年6月30日簽署的《THDB130/THDB131一類新藥研發項目技術轉讓合同書》約定，東寶紫星委託上海藥明通過其指派的關聯公司向國家藥品監督管理局藥品審評中心提交申報臨牀的申請。
2021年12月15日，東寶紫星作為委託人收到國家藥品監督管理局藥品審評中心簽發的關於URAT1抑制劑(THDBH130片)的藥物臨牀試驗批准通知書，受理號為CXHL2101548、CXHL2101549。
截至本公吿日，公司在該項目中已投入研發費用人民幣約2000萬元。按照上述2021年6月30日簽署的技術轉讓合同書約定，東寶紫星需支付給上海藥明的技術轉讓費用首付款總計為4000萬元。
此次通化東寶的THDBH130產品獲批的適應症為高尿酸血癥和痛風。高尿酸血癥(HUA)是指在正常嘌呤飲食狀態下，無論男性還是女性，非同日兩次空腹血尿酸水平均高於420μmol/L，即稱為高尿酸血癥。高尿酸血癥是痛風的發病基礎，但不足以導致痛風。
痛風是一種晶體性關節炎，由於嘌呤代謝紊亂和/或尿酸排泄障礙所致，以特徵性急、慢性關節炎為臨牀表現，特徵性急、慢性關節炎由高尿酸血癥和尿酸鹽結晶沉積(痛風石)所致。除在關節、肌腱及其周圍可沉積痛風石外，還可在腎臟沉積痛風石，並可發生尿酸鹽腎病、尿酸性尿路結石等，嚴重者可出現腎功能不全。痛風常與肥胖、糖尿病、高血壓、高脂血症以及心腦血管病伴發。
目前以URAT1為靶點的排尿酸藥物主要有苯溴馬隆和雷西那德，雷西那德尚未在國內上市。根據藥智網信息，2020年國內城市公立醫院痛風藥品銷售額為19.1億元，國內城市零售藥店銷售額為8.3億元。其中2020年公立醫療機構終端苯溴馬隆佔15.91%的份額。由於苯溴馬隆潛在的肝損傷風險，在最近幾年的增長較為緩慢。
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