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同源康醫藥-B:截至2024年12月31日止年度年度業績公告;非執行董事辭任;及建議修訂組織章程細則

TYK MEDICINES-B: ANNUAL RESULTS ANNOUNCEMENTFOR THE YEAR ENDED DECEMBER 31, 2024;RESIGNATION OF NON-EXECUTIVE DIRECTOR;ANDPROPOSED AMENDMENTS TO THE ARTICLES OF ASSOCIATION

HKEX ·  Mar 27 13:50

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同源康醫藥公佈2024年度業績,全年收入10.7萬元,淨虧損3.88億元,同比增加1.2%。研發支出23.5億元,同比減少5.5%。公司現金及銀行結餘4.6億元,較2023年底增長146.5%。公司已於2024年8月在港交所主板上市,全球發售募資5.79億港元。核心產品TY-9591用於EGFR突變肺癌腦轉移的關鍵II期臨床試驗已完成224例患者入組,預計2025年第二季度提交附條件上市NDA申請。另一項用於EGFR L858R突變晚期肺癌的III期臨床試驗已完成528例患者入組,預計2025年完成全部入組,2026年提交NDA。此外,TY-9591聯合化療方案的II期試驗已於2025年2月啟...展開全部
同源康醫藥公佈2024年度業績,全年收入10.7萬元,淨虧損3.88億元,同比增加1.2%。研發支出23.5億元,同比減少5.5%。公司現金及銀行結餘4.6億元,較2023年底增長146.5%。公司已於2024年8月在港交所主板上市,全球發售募資5.79億港元。核心產品TY-9591用於EGFR突變肺癌腦轉移的關鍵II期臨床試驗已完成224例患者入組,預計2025年第二季度提交附條件上市NDA申請。另一項用於EGFR L858R突變晚期肺癌的III期臨床試驗已完成528例患者入組,預計2025年完成全部入組,2026年提交NDA。此外,TY-9591聯合化療方案的II期試驗已於2025年2月啟動。公司其他在研產品進展順利,包括TY-302乳腺癌II期臨床試驗、TY-2699a實體瘤I期試驗、TY-0540實體瘤I期試驗等。公司已建立初步商業化團隊,並計劃於2026年完成固體製劑工廠一期項目建設及GMP認證。同時積極探索對外合作機會,尋求全球市場機遇。
Tongyuan Kang Pharmaceutical announced its 2024 annual results, with total revenue of 0.107 million yuan, a net loss of 0.388 billion yuan, an increase of 1.2% year-on-year. R&D expenses amounted to 2.35 billion yuan, a decrease of 5.5% year-on-year. The company's cash and bank balance is 0.46 billion yuan, an increase of 146.5% compared to the end of 2023. The company has been listed on the Main Board of the Hong Kong Stock Exchange in August 2024, raising 0.579 billion HKD from a global offering.The key Phase II clinical trial for the core product TY-9591, used for EGFR mutant lung cancer brain metastases, has completed enrollment of 224 patients, and the NDA application for conditional listing is expected to be submitted in the second quarter...Show More
Tongyuan Kang Pharmaceutical announced its 2024 annual results, with total revenue of 0.107 million yuan, a net loss of 0.388 billion yuan, an increase of 1.2% year-on-year. R&D expenses amounted to 2.35 billion yuan, a decrease of 5.5% year-on-year. The company's cash and bank balance is 0.46 billion yuan, an increase of 146.5% compared to the end of 2023. The company has been listed on the Main Board of the Hong Kong Stock Exchange in August 2024, raising 0.579 billion HKD from a global offering.The key Phase II clinical trial for the core product TY-9591, used for EGFR mutant lung cancer brain metastases, has completed enrollment of 224 patients, and the NDA application for conditional listing is expected to be submitted in the second quarter of 2025. Another Phase III clinical trial for EGFR L858R mutant advanced lung cancer has completed enrollment of 528 patients, expected to complete full enrollment in 2025, with the NDA submission planned for 2026. Additionally, the Phase II trial of the TY-9591 combined chemotherapy regimen was initiated in February 2025.The company has made smooth progress with other products in development, including the Phase II clinical trial of TY-302 for breast cancer, the Phase I trial of TY-2699a for solid tumors, and the Phase I trial of TY-0540 for solid tumors. The company has established an initial commercialization team and plans to complete the construction and GMP certification of the solid preparation factory's Phase I project by 2026. At the same time, it actively explores external cooperation opportunities and seeks global market prospects.
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