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佐力藥業(300181.SZ):從技術上來説公司“烏靈參的工業化生產關鍵技術及其臨牀應用”系國家祕密技術,迄今未收到要求解祕通知
格隆匯 02-22 22:10

格隆匯2月22日丨佐力藥業(300181.SZ)近日接受機構調研時表示,根據北京大學人民醫院藥劑科專家在2022年4月的《臨牀藥物治療雜誌》上發表的《2017-2020年我國9城市121家醫院安神類中成藥使用分析》相關數據顯示,烏靈膠囊用藥金額及DDDs(用藥頻數)始終處於第1位,用藥金額約為安神類中成藥市場份額的35%,臨牀使用率高。除療效確切外,烏靈膠囊不良反應症狀輕,均能自行緩解,發生概率低,安全性得到臨牀證實。烏靈膠囊是藥用真菌生物發酵中藥製劑,最開始屬於浙江省的保健產品,經過多年的臨牀研究後,在1998年批准為國家一類新藥,1999年正式獲得藥準字批文,其作用機理明確,安全性高,患者的依從性好。

公司主要的優勢是烏靈系列產品均使用到公司獨家的國家一類新藥烏靈菌粉,從技術上來説,公司“烏靈參的工業化生產關鍵技術及其臨牀應用”系國家祕密技術,迄今未收到要求解祕通知,仍嚴格按國家祕密技術要求管理。烏靈菌粉是由公司獨家生產的一類新中藥,與化藥的一致性評價不同,其他企業若要仿製生產烏靈菌粉,按現行藥品註冊管理法規,只有獲得我司出具的認同工藝一致性的説明,仿製核心藥材烏靈菌粉才有可能批准,所以烏靈系列產品有長期的市場獨佔性和較高的技術壁壘,產品有很高的護城河。

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