泰瑞沙

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和黄医药(00013)完成沃瑞沙®和泰瑞沙®联合疗法用于一线治疗特定肺癌患者的SANOVO中国III期研究患者入组
智通财经网· 2025-08-20 00:12
SANOVO研究的顶线结果预计将于2026年下半年公布,并将随即提交研究结果于适当的学术会议发 表。 若取得理想的结果,和黄医药将启动计划向中国国家药品监督管理局(国家药监局)递交新适应症上 市申请。 沃瑞沙是一种强效、高选择性的口服MET酪氨酸激酶抑制剂(TKI) ,由阿斯利康与和黄医药共同开发, 并由阿斯利康商业化。泰瑞沙是一种不可逆的第三代EGFR TKI。 智通财经APP讯,和黄医药(00013)发布公告,沃瑞沙(ORPATHYS,赛沃替尼/ savolitinib)和泰瑞沙 (TAGRISSO,奥希替尼/ osimertinib)的联合疗法用于一线治疗伴有表皮生长因子受体 (EGFR)突变及 MET过表达的特定非小细胞肺癌患者的SANOVO中国III期研究已完成患者入组。该研究的最后一名患 者已于2025年8月18日完成入组。 该项III期研究是一项在伴有EGFR激活突变及MET过表达的未经过治疗的局部晚期或转移性非小细胞肺 癌患者中开展的盲法、随机对照的临床试验。该研究将评估泰瑞沙 与沃瑞沙 联合疗法对比泰瑞沙 单药 (当前此类患者的标准疗法)的疗效及安全性。研究的主要终点是研究者评估的无进展生存 ...
全球制药业洞察 | 生物技术2025年中展望:行业拐点将至,下半年有哪三大焦点?
彭博Bloomberg· 2025-06-20 06:32
Core Insights - The Chinese biotechnology industry is expected to continue its recovery in the second half of 2025, driven by a resurgence in the Hong Kong IPO market and improved earnings outlook for biotech companies [3][15] - Key focus areas include the anticipated approval of new drugs, significant pipeline data releases, and increased merger and acquisition (M&A) activities, particularly related to the PD-1/VEGF pathways [3][15] Group 1: Market Trends - The Hong Kong IPO market is showing signs of recovery, with Hengrui's IPO raising HKD 9.8 billion, marking the largest IPO in the Hong Kong pharmaceutical sector in five years [15] - Investor interest in the biotechnology sector remains high, as evidenced by the successful listing of antibody-drug conjugate pioneer, InnoCare, which saw its share price double on the first trading day [15] - M&A activities are expected to surge in 2025, particularly for companies involved in the PD-1/VEGF pathway, following positive data reported at the ASCO conference [5][15] Group 2: Company Performance and Projections - Chinese biotech companies are reaching a pivotal point of profitability, with Innovent Biologics expected to turn profitable in 2024, supported by the launch of its obesity drug and positive data from IBI 363 at ASCO [6] - BeiGene achieved breakeven in Q1 and is positioned to become a major player in global oncology, although its sales growth from 2025 to 2028 is projected to be below peers [6] - Companies like Akeso and Zai Lab are also expected to achieve profitability by 2025, despite facing valuation pressures due to tariff uncertainties [6] Group 3: Pipeline Developments - Innovent's obesity drug, Mazdutide, is anticipated to launch in China in early 2025, which could attract significant investor interest [9] - BeiGene's Sonrotoclax is expected to file for approval in China for treating relapsed/refractory chronic lymphocytic leukemia and mantle cell lymphoma by mid-2026 [9] - Akeso is advancing multiple drugs through the pipeline, with filings for Cadonilimab and Ivonescimab expected in the second half of 2025 [10][13] Group 4: Valuation Metrics - The enterprise value/sales ratios for several Chinese biotech companies indicate varying growth expectations, with Sichuan Kelun-Biotech showing a high ratio of 35.5x and a projected sales CAGR of 54% from 2025 to 2028 [8] - The average enterprise value/sales ratio for Chinese peers stands at 13.0x, with a median of 11.8x, reflecting the competitive landscape within the industry [8]