奧賽康(002755.SZ)：麥芽酚鐵膠囊已獲臨牀試驗批准
格隆匯 3 月 29日丨奧賽康(002755.SZ)公佈，公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)下發的麥芽酚鐵膠囊《藥物臨牀試驗批准通知書》，由子公司申報的麥芽酚鐵膠囊已獲臨牀試驗批准。
麥芽酚鐵膠囊由英國Shield TX(UK) Limited研發，2016年、2019年先後經歐洲藥品管理局(EMA)和美國食品藥品監督管理局(FDA)批准上市，用於成人鐵缺乏症的治療。麥芽酚鐵膠囊的活性成分麥芽酚鐵(ferric maltol)是一種鐵與麥芽酚形成的化學性質穩定的新型非鹽複合物，具有獨特的吸收機制。經過一系列臨牀試驗證實，麥芽酚鐵膠囊是一種不良反應發生率低，生物利用度高且不易發生鐵過載、耐受性良好的治療成人鐵缺乏症的口服藥物。對於現有口服鐵製劑不耐受或治療效果不佳的患者，麥芽酚鐵膠囊是理想的替代藥物。此外，臨牀研究還證實：麥芽酚鐵膠囊是一種替代靜脈鐵劑療法的可信賴藥物，具有很好的順應性和依從性，並且具有經濟學優勢，有望改變鐵缺乏症患者的治療模式。
世界衞生組織(WHO)指出，缺鐵是世界上最常見和最普遍的營養失調。鐵缺乏和缺鐵性貧血與許多慢性疾病相關，在中國，婦女、老人、慢性腎病患者、心衰患者、克羅恩病患者更是鐵缺乏症的高發人羣。目前，中國鐵製劑的市場規模已超過30億元，且潛在患者羣及市場規模大。
子公司於2020年1月8日和英國Shield TX (UK) Limited簽署協議，經授權獲得了麥芽酚鐵膠囊及其未來可拓展的劑型、適應症等在中華人民共和國(包括中國大陸、中國香港、中國澳門、中國台灣)的獨家開發、生產和市場推廣權益。根據協議，雙方積極推進了麥芽酚鐵膠囊在中國的臨牀試驗申請工作，公司及子公司將按國家藥品註冊的相關規定和要求開展後繼開發，如果最終研發成功，將為鐵缺乏症患者提供更多的治療藥物選擇，提高用藥可及性和經濟性。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
