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重组人干扰素α1b喷雾剂
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三元基因:重组人干扰素α1b喷雾剂获得《药品补充申请批准通知书》
Zheng Quan Ri Bao Wang· 2025-07-29 13:11
证券日报网讯7月29日晚间,三元基因发布公告称,近日,公司收到国家药品监督管理局核准签发的重 组人干扰素α1b喷雾剂(25万IU(25μg):5ml/支)《药品补充申请批准通知书》。 ...
三元基因:重组人干扰素α1b喷雾剂获得批准通知书
news flash· 2025-07-29 08:42
Core Insights - The company has received approval from the National Medical Products Administration for its recombinant human interferon α1b spray (250,000 IU (25μg): 5ml/bottle) [1] - The approval notification revised the instructions, changing the usage warning from "for external use only, do not ingest, avoid contact with eyes" to "for external use only, strictly follow medical advice, avoid contact with eyes" [1] - The product was first approved for market in 2011 and is used to treat initial or recurrent facial herpes simplex caused by viruses, possessing both antiviral and immune-regulating properties [1] - In 2024, the product was successfully selected in the Jiangxi Provincial Medical Insurance Bureau's announcement of the "Interferon Interprovincial Alliance Centralized Procurement Selection Results," with a procurement period of four years [1]
三元基因(837344) - 投资者关系活动记录表
2025-05-20 11:15
Group 1: Investor Relations Activities - The investor relations activity was an earnings briefing held from May 15 to May 16, 2025, via an online platform [3][4] - Attendees included various investment firms and asset management companies, indicating a broad interest in the company's performance [5] Group 2: Company Developments - The completion of a new intelligent production and R&D base marks a significant upgrade in production capacity and innovation, supporting the company's growth in the biopharmaceutical sector [7] - The new facility has been recognized as a "2024 Beijing Intelligent Factory and Digital Workshop," enhancing the company's production efficiency and product quality [7] Group 3: Financial Performance - In 2024, the company reported a revenue of CNY 257 million, reflecting a year-on-year growth of 4.83% [12] - The company experienced a significant increase in tax expenses, amounting to CNY 4.0471 million, a 200.14% rise due to the new facility's operational status [11] - Financial expenses surged by CNY 8.0055 million, marking a 1,297.12% increase, primarily due to the capitalization of interest expenses related to the new facility [13] Group 4: R&D and Product Development - The company is expanding its R&D projects, focusing on recombinant protein products and aiming to enter the consumer healthcare market [9] - The antiviral oral spray product, "Lishuxing®," has received market approval, enhancing the company's competitive edge in the disinfection and prevention sector [10] - The company is advancing its clinical research on a new interferon product for chronic hepatitis B, with a focus on achieving functional cure [12] Group 5: Market Expansion and Strategy - The company successfully secured a spot in the "National Specialized and Innovative 'Little Giant' Enterprises" list, boosting its brand credibility and market reach [11] - The company has expanded its medical terminal access to over 6,000 hospitals, with an additional 1,100 new medical terminals added in 2024 [12][15] - The company is leveraging its procurement advantages to enhance market penetration, despite facing pricing pressures [12] Group 6: Intellectual Property and Innovation - The company has made strides in intellectual property management, being recognized as a "Patent Industrialization Model Enterprise" [14] - Collaborations with authoritative institutions have been established to enhance the company's patent capabilities and brand influence [14] Group 7: Clinical Applications and Future Prospects - The company is developing a new drug for treating respiratory syncytial virus (RSV) in children, addressing a significant market need [17] - The ongoing clinical trials for γδT cell therapy in cancer treatment show promising results, with several patients achieving partial remission [19][20]