share_log

復星醫藥：海外監管公告 - 關於控股子公司獲藥品註冊申請受理的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement in Relation to the Acceptance of a Subsidiary''s Drug Registration Application

香港交易所 ·  Apr 8 05:09
Summary by Moomoo AI
上海復星醫藥（集團）股份有限公司（「復星醫藥」）宣布其控股子公司上海復星醫藥產業發展有限公司自主研發的兩款新藥——地拉羅司顆粒和地拉羅司片的藥品註冊申請，已於近日獲國家藥品監督管理局受理。這兩款新藥主要用於治療慢性鐵過載，包括輸血導致的慢性鐵過載和非輸血依賴性地中海貧血綜合徵中的慢性鐵過載。截至2024年2月，復星醫藥對這兩款新藥的累計研發投入分別約為人民幣792萬元和1130萬元。目前，中國境內已有數款地拉羅司制劑獲批上市，2022年銷售額約為人民幣1.20億元。復星醫藥提醒投資者，新藥商業化生產前尚需通過多項程序，包括GMP符合性檢查和藥品註冊批准，且本次申請受理不會對集團當前業績產生重大影響。由於市場的不確定性，具體銷售情況存在變數，投資者應注意投資風險。
上海復星醫藥（集團）股份有限公司（「復星醫藥」）宣布其控股子公司上海復星醫藥產業發展有限公司自主研發的兩款新藥——地拉羅司顆粒和地拉羅司片的藥品註冊申請，已於近日獲國家藥品監督管理局受理。這兩款新藥主要用於治療慢性鐵過載，包括輸血導致的慢性鐵過載和非輸血依賴性地中海貧血綜合徵中的慢性鐵過載。截至2024年2月，復星醫藥對這兩款新藥的累計研發投入分別約為人民幣792萬元和1130萬元。目前，中國境內已有數款地拉羅司制劑獲批上市，2022年銷售額約為人民幣1.20億元。復星醫藥提醒投資者，新藥商業化生產前尚需通過多項程序，包括GMP符合性檢查和藥品註冊批准，且本次申請受理不會對集團當前業績產生重大影響。由於市場的不確定性，具體銷售情況存在變數，投資者應注意投資風險。
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCED THAT ITS HOLDING SUBSIDIARY SHANGHAI FUSTAR PHARMACEUTICAL INDUSTRY DEVELOPMENT CO., LTD. HAS RECENTLY BEEN ACCEPTED BY THE NATIONAL PHARMACEUTICAL REGULATORY AUTHORITY FOR THE DEVELOPMENT OF TWO NEW DRUGS, TIRALOZ GRANULES AND TILARO TABLETS. The two new drugs are primarily used to treat chronic iron overload, including transfusion-induced chronic iron overload and chronic iron overload in non-transfusion-dependent Mediterranean anemia syndrome. As of February 2024, Fustar Pharmaceuticals invested in the cumulative R&D of these two new drugs of approximately RMB 792 million and RMB 1130 million, respectively. At present, several Tiralose preparations have been approved for sale in China, with sales of about RMB1.20 billion in 2022. Fustar Pharmaceuticals reminds investors that a number of processes, including GMP compliance checks and drug registration approval, are still required before commercialization of the new drug, and acceptance of this application will not have a significant impact on the Group's current performance. Investors should be aware of investment risks due to market uncertainties and specific sales conditions.
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCED THAT ITS HOLDING SUBSIDIARY SHANGHAI FUSTAR PHARMACEUTICAL INDUSTRY DEVELOPMENT CO., LTD. HAS RECENTLY BEEN ACCEPTED BY THE NATIONAL PHARMACEUTICAL REGULATORY AUTHORITY FOR THE DEVELOPMENT OF TWO NEW DRUGS, TIRALOZ GRANULES AND TILARO TABLETS. The two new drugs are primarily used to treat chronic iron overload, including transfusion-induced chronic iron overload and chronic iron overload in non-transfusion-dependent Mediterranean anemia syndrome. As of February 2024, Fustar Pharmaceuticals invested in the cumulative R&D of these two new drugs of approximately RMB 792 million and RMB 1130 million, respectively. At present, several Tiralose preparations have been approved for sale in China, with sales of about RMB1.20 billion in 2022. Fustar Pharmaceuticals reminds investors that a number of processes, including GMP compliance checks and drug registration approval, are still required before commercialization of the new drug, and acceptance of this application will not have a significant impact on the Group's current performance. Investors should be aware of investment risks due to market uncertainties and specific sales conditions.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more