Core Insights - The Phase 3 VERITAC-2 clinical trial results indicate that vepdegestrant monotherapy shows a statistically significant improvement in progression-free survival (PFS) for patients with ESR1 mutations compared to fulvestrant [2][4][6] - Vepdegestrant is positioned as a potential best-in-class treatment option for patients with ER+/HER2- advanced or metastatic breast cancer, particularly in the second-line setting [4][7][12] Group 1: Clinical Trial Results - Vepdegestrant reduced the risk of disease progression or death by 43% in patients with ESR1 mutations, with a median PFS of 5.0 months compared to 2.1 months for fulvestrant [2][3] - In the intent-to-treat population, the median PFS was 3.7 months for vepdegestrant versus 3.6 months for fulvestrant, which did not reach statistical significance [2][4] - The clinical benefit rate (CBR) for vepdegestrant was 42.1% compared to 20.2% for fulvestrant, and the objective response rate (ORR) was 18.6% versus 4.0% respectively [4][6] Group 2: Safety and Tolerability - Vepdegestrant was generally well tolerated, with low rates of gastrointestinal adverse events such as nausea (13.5%), vomiting (6.4%), and diarrhea (6.4%) [3][5] - The incidence of grade 4 treatment-emergent adverse events (TEAEs) was 1.6% in the vepdegestrant arm compared to 2.9% in the fulvestrant arm [3][5] - TEAEs leading to treatment discontinuation occurred in 2.9% of patients taking vepdegestrant versus 0.7% for fulvestrant [3][5] Group 3: Market and Development Potential - Approximately 2.3 million new breast cancer diagnoses were reported globally in 2022, with ER+/HER2- breast cancer accounting for about 70% of cases [6][12] - The companies plan to submit a New Drug Application (NDA) for vepdegestrant to the FDA in the second half of 2025 [7][12] - Vepdegestrant is the first PROTAC evaluated in a Phase 3 clinical trial, indicating a novel approach in treating breast cancer [5][7]

Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing a new class of drugs based on targeted protein degradation [3] - The company is headquartered in New Haven, Connecticut and is listed on Nasdaq under the ticker ARVN [3] Drug Development - Arvinas is pioneering the PROTAC (PROteolysis Targeting Chimera) protein degrader platform, which aims to selectively and efficiently degrade disease-causing proteins [3] - The company is advancing multiple investigational drugs through clinical development, including: - Vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer [3] - ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma [3] - ARV-102, targeting LRRK2 for neurodegenerative disorders [3] Upcoming Events - Management will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5 at 2:35 p.m. ET in New York City [1] - A live audio webcast of the presentation will be available on the company's website [2]

医药 本周医药板块上涨 1.27%，百济 BTK PROTAC 启动头对头 3 期临 床 证券研究报告 | 行业周报 2025 年 05 月 19 日 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 87.7 | 62.64 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 12.83 | 10.97 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | - | - | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.51 | 22.66 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 349. ...

近年来，我国有关部门高度重视医药创新，接连出台系列政策扶持医药创新。创新药行业展现出巨大市 场潜力和广阔的发展前景。2015年，创新药在中国核心医院市场的占比为21%，到了2024年，这一比例 已增长至29%。 兴业证券在研究报告中指出，2000年以前，中国医药市场以低附加值的仿制药为主。经历二十余年发 展，中国创新药行业已经迈入全新发展阶段，能够出海参与全球市场竞争的差异化创新品种数量越来越 多。中国创新药从"Me-too"药物开始向"Me-better"(疗效更优)、"BIC"以及"FIC"药物转变。2024年，中 国企业在研创新药数量达704款，位居全球首位，中国和美国已经成为全球药物研发的主要驱动力。 开拓庞大未满足市场 在一品红目前15个在研创新药项目中，最受市场关注的就是AR882。作为全球在研1类创新药，AR882 主要针对三大适应症——降低血尿酸治疗痛风、溶解痛风石和治疗慢性肾病。 5月18日，由中国医药企业管理协会、中国非处方药物协会主办，赛柏蓝承办的第45届中国医药产业发 展大会开幕。作为开幕式主题演讲嘉宾，一品红（300723）董事长李捍雄在大会上表示，医药企业的核 心竞争力在于创新，一 ...

Arvinas (ARVN) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Company Participants Jeff Boyle - Vice President of Investor RelationsJohn Houston - Chairperson, CEO & PresidentNoah Berkowitz - Chief Medical OfficerAndrew Saik - CFO & TreasurerAndrew Berens - Senior Managing Director, Targeted OncologyManoj Eradath - Senior Biotechnology Equity ResearcherJonathan Miller - Managing DirectorTazeen Ahmad - MD - US Equity ResearchYigal Nochomovitz - DirectorMalcolm Hoffman - Senior BioPharma Equity Research Assoc ...

Arvinas (ARVN) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 It is now my pleasure to turn today's call over to Arvina's Vice President of Investor Relations, Jeff Boyle. Please go ahead. Speaker1 Thank you, and good morning, everyone. Thanks for joining us. Earlier today, we issued a press release with our first quarter twenty twenty five financial results, which is available in the Investor and Media section of our website at arvinas.com. Joining the call today are John Houston, Arvinas' Chief E ...

– Reported positive topline results from the Phase 3 VERITAC-2 trial that support global regulatory filings – – Presented first-in-human data for the Company’s first neuroscience program with ARV-102 showing blood-brain barrier penetration and central and peripheral LRRK2 degradation – – Announced the re-prioritization of its vepdegestrant development plan and research portfolio and initiated cost reductions, including a workforce reduction of approximately one-third, to extend the Company’s cash runway int ...

Core Insights - Arvinas, Inc. presented promising preclinical data for ARV-393, a PROTAC BCL6 degrader, showing strong synergistic antitumor activity in combination with standard-of-care treatments for aggressive B-cell lymphomas [1][2][4] Group 1: Study Findings - ARV-393 demonstrated complete tumor regressions in high-grade B-cell lymphoma and aggressive diffuse large B-cell lymphoma models when combined with standard-of-care chemotherapy and biologics [1][4] - The combination of ARV-393 with R-CHOP chemotherapy resulted in significantly greater tumor growth inhibition compared to R-CHOP or ARV-393 alone, with complete regressions observed in all treated mice [4] - Combinations of ARV-393 with investigational small molecule inhibitors targeting oncogenic drivers like BTK, BCL2, and EZH2 also led to superior tumor growth inhibition and regressions in all treated mice [4] Group 2: Clinical Development - A Phase 1 clinical trial of ARV-393 is currently enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL [2][5] - The preclinical data support the potential for broad combinability of ARV-393, providing a rationale for further exploration of combination strategies in lymphoma treatment [2][5] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies based on targeted protein degradation, with a pipeline that includes ARV-393 for non-Hodgkin lymphoma and other investigational drugs for various conditions [6]

– Oral presentation will serve as first presentation of detailed results from the Phase 3 VERITAC-2 clinical trial – NEW HAVEN, Conn., April 23, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that data from the global Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant versus fulvestrant in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer will be presented as a late-breaking ...

文 ｜ 唐寅灏 韩世通 陈竹 研发速度不及预期或研发失败的风险；产品商业化及销售不及预期的风险；市场竞争加剧的风 险；行业政策超预期变化的风险。 PROTAC药物靶向降解致病蛋白，多重作用优势赋予其巨大临床价值，有望成为口服小分子药物 的重磅机制。其中：ER PROTAC是进展最快的PROTAC靶点，ARV- 4 7 1即将在1Q2 5读出3期临 床数据，并通过联合CDK类抑制剂将适应症向一线拓展；AR PROTAC是全球第二个进入3期临床 的PROTAC靶点，LBD突变患者是其优势人群，有望成为针对前列腺癌的下一代高潜力药物。我 们建议关注ER以及AR PROTAC的临床潜力和商业化价值。 ▍ PROTAC：靶向降解致病蛋白，有望攻克不可成药靶点。 PROTAC通过招募E3泛素连接酶将靶蛋白泛素化，导致靶蛋白被蛋白酶体降解。PROTAC不需要 长时间与靶蛋白高强度结合，有望攻克"不可成药"靶点和发生耐药突变的致病蛋白，消除靶蛋白 的非酶功能；PROTAC靶点选择性较高，具有催化属性，有望实现低剂量、低频次给药。全球目 前AR、ER PROTAC都已经进入3期临床，BTK、STAT6、IRAK4 PROTAC ...