格菲妥单抗
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淋巴瘤创新药“医保新政”落地,全病程保障为患者生命续航
Qi Lu Wan Bao· 2026-01-16 09:30
齐鲁晚报.齐鲁壹点记者焦守广 2026年1月1日,2025年版国家基本医疗保险药品目录正式在全国落地实施,一批针对淋巴瘤的创新药物纳入医保,其 中包括此前备受关注的双特异性抗体类药物。这意味着,继抗体药物偶联物(ADC)等创新药之后,淋巴瘤治疗领域的 核心创新药物已实现从一线到后线的全病程医保覆盖。近日,记者就此对青岛大学附属医院淋巴瘤科主任赵霞进行了 专访。 青岛大学附属医院淋巴瘤科主任赵霞 发病率攀升亚型复杂,淋巴瘤诊疗多重变革 "近年来由于诊疗水平的提升和人口老龄化等因素,淋巴瘤发病率呈逐年上升趋势,已成为全国范围内备受重视的恶 性肿瘤类型。"青岛大学附属医院淋巴瘤科主任赵霞介绍。 在众多淋巴瘤亚型中,弥漫大B细胞淋巴瘤占比最多,例如在赵霞所在科室的住院患者中该类患者占比达到一半。然 而,当前诊疗仍面临严峻挑战,约30%-40%的弥漫大B细胞淋巴瘤患者会进展为复发或难治性疾病。 "一旦进入复发/难治阶段,不仅治疗效果差,医疗费用也会大幅攀升。"赵霞介绍,对于这类患者,年轻且符合条件的 可考虑自体造血干细胞移植,但对于年龄较大、有合并症或无法达到完全缓解而不能移植的患者,新药成为延续生命 的关键。作为目前 ...
罗氏旗下血液全产品亮相进博会 点亮血液疾病治愈蓝图
Zheng Quan Ri Bao Wang· 2025-11-07 06:45
Core Viewpoint - Roche showcases its comprehensive blood product portfolio at the 8th China International Import Expo, emphasizing its commitment to advancing the treatment of blood diseases and contributing to the "Healthy China 2030" initiative [1] Group 1: Innovations in Blood Disease Treatment - Roche has introduced four innovative blood cancer drugs in the last four years, covering a wide range of indications for aggressive and indolent lymphomas, marking a significant expansion in its treatment offerings [2] - The company has actively participated in the establishment of a multi-tiered medical insurance system in China, with its drug MabThera being one of the first original drugs included in the national medical insurance list [2] Group 2: New Drug Developments and Approvals - The company is set to showcase new indications for its foundational drug for indolent lymphoma, Ocrevus, which may soon be approved for treating lupus nephritis [3] - Roche's innovative treatment for hemophilia, NXT007, aims to achieve "zero bleeding" for patients with type A hemophilia, demonstrating its commitment to advancing non-factor preventive therapies [3] Group 3: Strategic Partnerships and Ecosystem Development - Roche aims to enhance the ecological construction of the blood cancer field in China, expanding its focus from lymphoma to multiple myeloma [3] - The company emphasizes its dedication to improving patient accessibility and affordability in China, while also enhancing the international influence of Chinese research [3]
双抗巨变的时代已经来临?
Ge Long Hui· 2025-07-26 20:38
Core Insights - The dual antibody (dual-target) market is experiencing explosive growth in 2023, with major multinational corporations (MNCs) like Roche and Johnson & Johnson leading the charge [1][17] - Roche has successfully launched several dual antibodies in the Chinese market, including Glofitamab and Faricimab, while Johnson & Johnson's Amivantamab targets a $5 billion market in non-small cell lung cancer (NSCLC) [2][13] Group 1: Dual Antibodies in Hematological Malignancies - The dual antibody market began in 2014 with the FDA's accelerated approval of Blincyto for treating acute lymphoblastic leukemia, which generated $583 million in sales in 2022 [5] - Currently, most approved dual antibodies are focused on hematological malignancies, with a significant number targeting CD3 in various combinations [6][8] - The competition between dual antibodies and CAR-T therapies is intensifying, particularly in the CD3/CD20 target combination, which has over 10 candidates in development globally [8][9] Group 2: Broadening Applications in Solid Tumors - Dual antibodies are expanding into various indications, including genetic diseases and solid tumors, with significant potential in the latter [11] - Amivantamab, the first dual antibody approved for solid tumors, is projected to reach peak sales of $5 billion, supported by positive clinical data [13][15] - Roche's Faricimab has also made strides in ophthalmology, achieving $1.788 billion in sales in the first three quarters of 2023 due to its long-lasting efficacy [15] Group 3: Domestic Dual Antibody Development - The domestic dual antibody market is expected to enter a concentrated harvest period in 3-5 years, with over 20 candidates currently in development [18] - Domestic companies are increasingly pursuing international collaborations, with notable deals exceeding $1 billion in potential total transaction value [19] - The first domestic dual antibody, Kadofili monoclonal antibody, was approved in 2022, generating significant revenue and expanding its indications [21][22]
2025年5月第二周创新药周报-20250511
Southwest Securities· 2025-05-11 12:43
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 11, 2025 [1]. Core Insights - The A-share innovative drug sector saw a weekly increase of 2.33%, outperforming the CSI 300 index by 0.33 percentage points, while the biopharmaceutical sector rose by 0.75% [2][17]. - In the past six months, the A-share innovative drug sector has cumulatively increased by 5.43%, outperforming the CSI 300 index by 9.13 percentage points, whereas the biopharmaceutical sector has decreased by 10.55% [2][17]. - The Hong Kong innovative drug sector experienced a decline of 2.14%, underperforming the Hang Seng Index by 3.75 percentage points, with a cumulative increase of 22.08% over the past six months [2][20]. - The XBI index in the US fell by 8.59% this week, with a cumulative decline of 22.72% over the past six months [2][23]. Summary by Sections Domestic Key Innovative Drug Progress - In May, one new drug was approved for market launch in China, with no new indications approved [3][41]. Overseas Key Innovative Drug Progress - In May, there were no NDA or BLA approvals in the US, Europe, or Japan for innovative drugs [4][45]. Global Key Innovative Drug Transaction Progress - A total of 12 key transactions occurred globally this week, with one disclosed transaction amounting to 415 million USD between Alchemab Therapeutics and Eli Lilly [5]. Market Performance - The report indicates that 39 stocks in the innovative drug sector rose while 67 fell during the week, with the top gainers being HaiChuang Pharmaceutical-U (22.76%), Changchun High-tech (8.99%), and Zhongsheng Pharmaceutical (8.98%) [2][16]. - The top decliners included Fuhong Hanlin (-12.64%), Connaught-B (-12.40%), and Boan Biotechnology (-11.77%) [2][16]. Clinical Trials and Approvals - In May, there were 23 newly announced clinical trials in China, including 17 in BE/I phase, 4 in II phase, and 2 in III phase [31].
罗氏格菲妥单抗新适应症在华获批
news flash· 2025-05-07 09:10
Core Viewpoint - Roche Pharmaceuticals China has received approval from the National Medical Products Administration of China for its innovative bispecific antibody Glofitamab (Columvi) for a new indication, which is to be used in combination with Gemcitabine and Oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are unsuitable for autologous stem cell transplantation (ASCT) [1] Group 1 - The new indication for Glofitamab targets a specific patient population with DLBCL NOS [1] - The approval highlights Roche's commitment to expanding treatment options for patients with challenging cancer types [1] - The combination therapy aims to improve outcomes for patients who have limited treatment options [1]