百日咳杆菌核酸检测试剂盒
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科华生物:“百日咳杆菌核酸检测试剂盒”等产品取得医疗器械注册证
Xin Lang Cai Jing· 2026-01-22 04:04
据智通财经消息,科华生物(002022.SZ)公告称,公司控股子公司苏州天隆及全资子公司西安科华分别 收到国家药品监督管理局、陕西省药品监督管理局颁发的医疗器械注册证(体外诊断试剂)。包括百日 咳杆菌核酸检测试剂盒、糖类抗原242测定试剂盒、糖类抗原50测定试剂盒。新产品的注册证将丰富公 司产品线,对业务发展具有正面影响,但对未来营业收入的影响尚无法预测。 转自:智通财经 ...
第四批中成药集采或迎新进展;海特生物拟于港交所上市
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-22 01:33
Policy Developments - The National Medical Products Administration (NMPA) held a meeting to promote the boron neutron capture therapy system, emphasizing the need for enhanced coordination in drug and device reviews to accelerate the deployment of advanced medical equipment for cancer treatment [2] Drug and Device Approvals - Kehua Bio announced that its subsidiaries received medical device registration certificates for various in vitro diagnostic reagents, which will enrich the company's product line and positively impact business development, although future revenue impact remains uncertain [4] - Heng Rui Medicine reported that its subsidiaries received clinical trial approval notices for SHR-7787 injection and Abedolizumab injection, with plans to conduct clinical trials soon [5] Capital Market Activities - Hite Bio plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange to enhance its competitiveness and utilize international capital markets for diversified financing [7] - Hualan Biological announced a 450 million RMB capital increase for its wholly-owned subsidiary, Lingqing Intelligent, to strengthen its capabilities in AI drug development and commercialization [8] - Aibo Medical intends to acquire at least 51% of Demai Medical's shares to gain control, aiming to expand into the sports medicine sector [9][10] Industry Events - The fourth batch of traditional Chinese medicine centralized procurement is expected to progress, with significant price reductions observed in previous batches, indicating a shift in the competitive landscape of the industry [12] - Junshi Bioscience established a new technology company in Shanghai with a registered capital of 500 million RMB, focusing on various consulting and import-export services [13] Shareholder Movements - Jiukang Bio reported that a shareholder reduced their holdings by 1.4543 million shares, representing 0.248% of the total share capital, during a period when the stock price increased by 1.95% [15]