君實生物(688180.SH):與Hikma簽署許可與商業化協議
格隆匯12月25日丨君實生物(688180.SH)公佈,2022年12月23日,公司Hikma MENA FZE(簡稱“Hikma”)簽署了《獨佔許可與商業化協議》。根據許可與商業化協議,公司將授予Hikma特瑞普利單抗注射液(產品代號:TAB001/JS001)在約旦、沙特阿拉伯、阿聯酋、卡塔爾、摩洛哥、埃及等中東和北非地區共20個國家(簡稱“Hikma區域”)開發和商業化的獨佔許可,並可獲得合計最高達1200萬美元的付款,外加銷售淨額近20%的階梯分成,此外,公司還授予Hikma三項研發階段藥物在Hikma區域內一個或多個國家未來商業化權益的優先談判權。
特瑞普利單抗注射液是中國首個批准上市的以PD-1為靶點的國產單抗藥物,曾榮膺國家專利領域最高獎項“中國專利金獎”,至今已在全球(包括中國、美國、東南亞及歐洲等地)開展了覆蓋超過15個適應症的30多項由公司發起的臨牀研究。正在進行或已完成的關鍵註冊臨牀研究在多個瘤種範圍內評估特瑞普利單抗的安全性及療效,包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、腎癌及皮膚癌等。
截至該公吿披露日,特瑞普利單抗的6項適應症已於中國獲批。2020年12月,特瑞普利單抗注射液首次通過國家醫保談判,目前已有3項適應症納入國家醫保目錄(2021年版),是國家醫保目錄中唯一用於治療黑色素瘤和鼻咽癌的抗PD-1單抗藥物。
公司表示,該次許可與商業化協議的簽署是公司持續拓展全球商業化網絡的重要實踐,將加快特瑞普利單抗及公司其他產品在海外的市場開拓,併為中東和北非地區患者提供優質的治療選擇,預計將對公司的持續經營產生積極影響。
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.