CD19靶向治疗
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诺诚健华涨超6% 坦昔妥单抗全国多省市首批处方落地
Zhi Tong Cai Jing· 2025-09-30 02:40
Core Viewpoint - Nuo Cheng Jian Hua (09969) has seen a stock increase of over 6%, currently up 6.55% at HKD 18.87, with a trading volume of HKD 115 million [1] Company Developments - The company announced that its CD19 monoclonal antibody, Tafa-sitamab, has received its first prescriptions in multiple hospitals across various provinces in China, marking its official entry into clinical application [1] - Tafa-sitamab is the first and only CD19 monoclonal antibody approved globally for the treatment of lymphoma, and it is also the first approved CD19 monoclonal antibody for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China [1] - This development fills a gap in CD19 targeted therapy in China and is expected to provide better treatment options for DLBCL patients [1]
港股异动 | 诺诚健华(09969)涨超6% 坦昔妥单抗全国多省市首批处方落地
智通财经网· 2025-09-30 02:38
智通财经APP获悉,诺诚健华(09969)涨超6%,截至发稿,涨6.55%,报18.87港元,成交额1.15亿港元。 消息面上,据诺诚健华官微消息,近日,公司宣布,靶向CD19单抗明诺凯®(坦昔妥单抗,tafasitamab) 近日在北京、上海、广东、黑龙江、福建、山东、广西、安徽、江西、湖北、浙江等全国多个省市医院 开出首批处方,标志着这款创新药在中国正式进入临床应用阶段。据介绍,坦昔妥单抗是全球首个且唯 一获批治疗淋巴瘤的CD19单抗,也是中国首个获批治疗复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)的CD19单抗,填补了国内CD19靶向治疗的空白,将为DLBCL患者带来更好的治疗选择。 ...
更深缓解、更长生存——诺诚健华明诺凯 (坦昔妥单抗)全国首批处方落地
Zheng Quan Shi Bao Wang· 2025-09-25 10:54
Core Insights - The article highlights the official launch of Tafasitamab (Minokai), a CD19 monoclonal antibody, in China for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), marking a significant milestone for the company and the industry [1][12]. Group 1: Product Launch and Significance - Tafasitamab is the first and only CD19 monoclonal antibody approved for treating lymphoma globally and the first in China for R/R DLBCL, filling a critical gap in targeted therapy for this condition [1][2]. - The rapid prescription of Tafasitamab across multiple provinces in China signifies its clinical application and the company's commitment to improving patient access to innovative therapies [1][12]. Group 2: Clinical Need and Patient Demographics - DLBCL accounts for 31%-34% of non-Hodgkin lymphoma (NHL) cases globally, with a higher prevalence in China at 45.8% of all NHL cases [2]. - Approximately 30%-40% of patients face recurrence or treatment resistance after first-line therapy, indicating a significant unmet clinical need for effective second-line treatments [2][3]. Group 3: Treatment Efficacy and Benefits - Tafasitamab, in combination with Lenalidomide, has shown a high overall response rate (ORR) of 67.5% and a complete response (CR) rate of 52.5% in R/R DLBCL patients, demonstrating its potential for deep remission [5][7]. - The five-year overall survival (OS) rate for patients treated with Tafasitamab is promising, with a median OS of 33.5 months reported, indicating long-term benefits [7][8]. Group 4: Safety and Tolerability - Tafasitamab has a favorable safety profile compared to traditional chemotherapy, with lower incidence and severity of adverse events, making it more tolerable for patients, especially the elderly [10][12]. - The drug's mechanism of action through immune effects provides a new non-chemotherapy treatment option for patients who are not suitable for transplantation [10][12].