You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
邁博藥業-B(02181.HK):國家藥品監督管理局接納核心產品CMAB007(奧馬珠單抗)上市註冊申請(NDA)
格隆匯 10-15 20:04

格隆匯10月15日丨邁博藥業-B(02181.HK)公吿,近日,公司核心產品之一,CMAB007(奧馬珠單抗)的上市註冊申請(NDA)獲中國國家藥品監督管理局("NMPA")受理,用於治療過敏性哮喘,為中國首個遞交NDA的國產過敏性哮喘治療性抗體新藥。

CMAB007(奧馬珠單抗)為一種重組人源化抗免疫球蛋白E("IgE")單克隆抗體,用於治療經過中╱高劑量吸入型皮質激素加長效β腎上腺素受體激動劑治療後仍然得不到充分控制的哮喘病人的單克隆抗體新藥。我們相信,一旦CMAB007獲得國家藥監局的上市批准,其將成為首個由中國國內公司開發並在中國上市的單克隆抗體("mAb")哮喘療法。CMAB007與遊離IgE相結合,形成抗IgE複合物,能抑制高親和力IgE受體,從而防止過敏反應。

CMAB007的安全性及療效已經由共4項臨牀試驗,合共824名受試者接受CMAB007給藥的結果所證實,該等試驗為中國規模最大的治療哮喘的單抗臨牀試驗。我們的臨牀試驗結果顯示,CMAB007能以較低劑量的吸入糖皮質激素改善哮喘病人的病情及降低急性哮喘發病的概率。

CMAB007未來預計拓展適應症到慢性特發性蕁麻疹、季節性過敏性鼻炎以及食物過敏。我們目前預計CMAB007可以在2022年第四季度獲國家藥監局批准上市。該藥物上市後將有望為超過2,000萬中國過敏性疾病患者提供療效更佳的可負擔的生物特效治療藥物。

公司以高質量創新藥物為根,將以更加經濟的供藥方案及全力參與中國國家醫療制度改革舉措,為廣大中國病患提供可負擔的創新抗體藥物供應;公司亦計劃與擁有長期積累豐富海外市場資源的合作伙伴的合作,迅速拓展海外市場。

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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
uSMART
Wealth Growth Made Easy
Open Account