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美股异动 | 减肥药概念股走强 硕迪生物(GPCR.US)涨超5%
智通财经网· 2025-12-10 15:39
智通财经APP获悉,周三,美股减肥药概念股走强,截至发稿,硕迪生物(GPCR.US)涨超5%,诺和诺德 (NVO.US)涨超3.5%,罗氏(RHHBY.US)涨超3%,礼来(LLY.US)微涨。消息面上,此前硕迪生物公布其 每日一次、口服小分子GLP-1受体激动剂aleniglipron在ACCESS临床项目中取得积极顶线结果。 ...
Genentech's Giredestrant Reduced Risk of Invasive Disease Recurrence or Death by 30% in ER-positive Early-Stage Breast Cancer
Businesswire· 2025-12-10 13:20
Core Insights - Genentech, a member of the Roche Group, announced positive data from the Phase III lidERA Breast Cancer study evaluating giredestrant as an adjuvant endocrine treatment for early-stage breast cancer [1] Group 1: Study Results - The interim analysis indicated that adjuvant giredestrant significantly reduced the risk of invasive disease [1]
Roche breast cancer pill cuts risk of disease recurrence by 30% in trial
Reuters· 2025-12-10 13:16
Core Insights - Roche's experimental oral drug giredestrant has demonstrated a 30% reduction in the risk of breast cancer recurrence compared to standard endocrine therapy, marking a significant advancement in treatment options [1] Company Summary - Roche is advancing its portfolio in oncology with giredestrant, which is positioned as a potential alternative to existing therapies [1] Industry Summary - The development of giredestrant represents a notable shift in breast cancer treatment paradigms, potentially impacting market dynamics and patient outcomes in the oncology sector [1]
Roche's giredestrant reduced risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer
Globenewswire· 2025-12-10 13:15
Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1-3Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease1ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or after adjuvant endocrine therapy treatment4-7Data will be featured in an oral pres ...
Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE Mark
Globenewswire· 2025-12-09 06:10
The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. The test will help improve diagnostic accuracy for millions of women1 affected by vaginitis annually, delivering more accurate and specific results.This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample. Basel, 9 December 2025 - Roch ...
European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis
Globenewswire· 2025-12-09 06:00
Core Viewpoint - Roche's Gazyva®/Gazyvaro® (obinutuzumab) has received European Commission approval for treating adult patients with active Class III or IV lupus nephritis, potentially establishing a new standard of care in Europe [1][2][7]. Approval and Clinical Significance - The approval is based on positive results from phase II NOBILITY and phase III REGENCY studies, showing that 46.4% of patients on Gazyva/Gazyvaro achieved a complete renal response compared to 33.1% on standard therapy alone [2][7]. - Gazyva/Gazyvaro may help delay or prevent progression to end-stage kidney disease (ESKD), which affects a significant portion of lupus nephritis patients [2][3][7]. Patient Impact - Lupus nephritis predominantly affects women of color and childbearing age, with an estimated 135,000 individuals in the European Union currently living with the condition [3][10]. - Current treatments lead to up to one-third of patients progressing to ESKD within 10 years, highlighting the need for effective new therapies [3][9]. Previous Approvals and Future Research - Gazyva/Gazyvaro was previously approved by the US FDA for the same indication in October 2025, indicating a growing recognition of its therapeutic potential [4]. - Ongoing investigations include studies in children and adolescents with lupus nephritis and adults with membranous nephropathy, aiming to expand its application in immune-mediated diseases [5][6]. Mechanism of Action - Gazyva/Gazyvaro is a humanized monoclonal antibody designed for direct B cell death, enhancing antibody-dependent cellular cytotoxicity (ADCC) [6]. Study Details - The REGENCY study involved 271 participants and was designed to reflect the real-world population of lupus nephritis patients, reinforcing the robustness of the findings [8].
European Commission approves Roche's Gazyva/Gazyvaro for adults with active lupus nephritis
Globenewswire· 2025-12-09 06:00
Core Viewpoint - Roche's Gazyva®/Gazyvaro® (obinutuzumab) has received European Commission approval for treating adult patients with active Class III or IV lupus nephritis, potentially establishing a new standard of care in Europe [1][2]. Group 1: Approval and Impact - The approval is a significant advancement for lupus nephritis treatment in Europe, aiming to delay or prevent progression to end-stage kidney disease [2]. - Gazyva/Gazyvaro demonstrated a complete renal response in 46.4% of patients compared to 33.1% on standard therapy alone, indicating its efficacy [2][5]. - The treatment could benefit approximately 135,000 individuals in the European Union currently living with lupus nephritis [5]. Group 2: Clinical Studies - The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies, with REGENCY showing statistically significant improvements in renal response and reduced corticosteroid use [2][6]. - The REGENCY study involved 271 participants and was designed to reflect real-world lupus nephritis populations [6]. Group 3: Disease Context - Lupus nephritis is a serious condition affecting predominantly women of color and childbearing age, with a significant risk of progressing to end-stage kidney disease [7]. - Current treatments leave up to one-third of patients progressing to end-stage kidney disease within 10 years, highlighting the need for effective new therapies [7]. Group 4: Future Investigations - Gazyva/Gazyvaro is under investigation for use in children and adolescents with lupus nephritis and adults with membranous nephropathy, indicating Roche's commitment to advancing treatments in immune-mediated diseases [3][4].
Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas
Globenewswire· 2025-12-08 21:30
Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm US cohort of phase III CELESTIMO study1Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with R/R large B-cell lymphoma2,3Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma earlier in their disease Basel, 8 December ...
Genentech Presents Lunsumio Data Showing Potential Across Earlier Treatment Lines in Indolent and Aggressive Lymphomas
Businesswire· 2025-12-08 21:30
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data highlighting the potential of Lunsumio (mosunetuzumab- axgb) in earlier treatment lines for people living with different types of lymphoma, presented at the 67th American Society of Hematology Annual Meeting and Exposition, December 6-9, 2025 in Orlando, Florida. "These data underscore the potential of Lunsumio to support more people living with lymphoma, building on th ...