信達生物(01801.HK)與勁方醫藥就GFH925(KRAS G12C抑制劑)達成獨家全球戰略合作
格隆匯9月2日丨信達生物(01801.HK)發佈公吿,公司與勁方醫藥科技(上海)有限公司(一家開發腫瘤和免疫領域的領先療法的臨牀階段生物技術公司)宣佈達成全球獨家授權協議,公司將作為獨家合作伙伴獲得勁方醫藥候選藥物 GFH925(KRAS G12C抑制劑)在中國(包括中國大陸、中國香港、中國澳門及中國台灣)的開發和商業化權利,並擁有全球開發和商業化權益的選擇權。
勁方醫藥自主研發的GFH925已獲得國家藥品監督管理局的臨牀試驗批准。臨牀前實驗數據顯示,GFH925擁有潛在同類最佳的活性,可有效抑制多種攜帶KRAS G12C突變的腫瘤細胞系生長,有利於加速臨牀上的有效性驗證。其他臨牀前試驗也展現了與其他療法的聯用潛力。
根據協議,公司將負責GFH925在中國的臨牀開發及商業化,並保留中國以外地區開發和商業化權益的選擇權。待該候選藥物獲批上市後,公司將利用其經驗豐富的商業化團隊以及廣闊的全國商業渠道覆蓋推廣GFH925。勁方醫藥則繼續在全國範圍內,負責臨牀開發以及商業化階段的藥物生產。
公司將支付勁方醫藥2,200萬美元首付款累計不超過5,000萬美元的全球開發支持費用。如果信達生物行使全球權益的選擇權,勁方醫藥還將獲得取決於達到若干全球開發、註冊及年度銷售里程碑進展,勁方醫藥將有資格獲得來自公司累計不超過2.4億美元的里程碑付款,以及基於中國及全球市場內GFH925的年度銷售淨額的梯度特許權使用費。
KRAS是肺癌和實體瘤的一個重要致癌驅動基因。公司在肺癌等領域裏佈局廣泛,GFH925合作可以在單藥和聯合治療(例如與PD-1聯合用藥)等方向進行臨牀探索,進一步完善我們在大瘤種領域的全面覆蓋。公司希望通過發揮公司在臨牀開發和商業化的協同效應,加速GFH925的開發和上市,儘快惠及廣大中國及全球患者。
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.