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
三元基因公告,公司近日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》。此次批准通知修订了说明书中的【注意事项】项,将"3.本品仅 供外用,切勿入口,避免接触眼睛。"修订为"3.本品仅供外用,严格遵照医嘱使用,避免接触眼 睛。"该药品于2011年首次批准上市,用于治疗由病毒引起的初发或复发性面部单纯疱疹,具有抗病毒 和免疫调节双重作用。2024年,该产品成功中选江西省医保局发布的《干扰素省际联盟集中带量采购中 选结果通知》,约定采购期4年。 ...
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]