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苑東生物(688513.SH):力爭納美芬注射液儘快上市
格隆匯 05-05 14:57

格隆匯5月5日丨有投資者向苑東生物(688513.SH)提問:公司鹽酸納美芬注射液的競爭格局?

苑東生物回覆:鹽酸納美芬注射液用於完全或部分逆轉阿片類藥物的作用,包括由天然的或合成的阿片類藥物引起的呼吸抑制,治療已知或疑似阿片類藥物過量。目前該產品在美國為短缺產品,僅有普渡藥業一家鹽酸納美芬注射液獲批上市,公司的鹽酸納美芬注射液或將成為美國FDA第二個批准上市的該品種仿製藥。過去十餘年,美國市場承擔阿片解毒相關治療需求的主要藥物為納洛酮。彭博數據庫顯示,目前美國市場納洛酮銷售規模在 5 億美金左右。臨牀數據表明,納美芬在逆轉急性阿片類藥物過量相關的呼吸抑制時, 作用持續時間更長,且副作用相對較少。療效上的優勢,使得納美芬在美國上市後有望對納洛酮形成有力替代,市場空間廣闊。普渡藥業定價納美芬注射液(大規格)為31.05美金/支,公司擁有納美芬原料藥,具有成本優勢,根據公司內部測算,參照普渡藥業上述定價有一定的盈利空間。公司目前第一步力爭納美芬注射液儘快上市,第二步做好規格升級(納美芬預灌裝注射液和納美芬鼻噴劑),第三步做好市場教育。通過這三部,使得納美芬逐步替代納洛酮的市場,為公司國際化打開成長空間。

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