礼来指出，虽然无进展生存期(PFS)这一次要终点的数据尚未成熟，但已显示出有利于吡妥布替尼的趋 势。这家总部位于印第安纳州的制药巨头表示，后续分析将进一步验证PFS优势。在安全性方面， Jaypirca的表现与既往研究结果一致。公司计划在今年晚些时候的医学会议上公布详细数据。 目前，Jaypirca与Imbruvica均是美国FDA批准的口服靶向药物，获批适应症包括CLL和SLL等血液系统 恶性肿瘤。 这项名为BRUIN CLL-314的三期研究直接比较了Jaypirca(吡妥布替尼)与Imbruvica(伊布替尼)在初诊或未 接受过BTK抑制剂治疗的CLL/SLL患者中的疗效。根据公布的顶线数据，吡妥布替尼在总体缓解率 (ORR)方面展现出统计学优势，无论是针对预先治疗组还是意向治疗人群，均达到非劣效性主要终点。 礼来(LLY.US)周二宣布，其经美国食品药品监督管理局(FDA)批准的布鲁顿酪氨酸激酶抑制剂Jaypirca在 针对慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)患者的三期头对头临床试验中，达到了主要研 究终点，成功挑战了强生(JNJ.US)与艾伯维(ABBV.US)的同类重磅药物Im ...

Core Viewpoint - The patent dispute between BeiGene and AbbVie regarding BTK inhibitors has reached a significant milestone, with the U.S. Patent and Trademark Office declaring AbbVie's Pharmacyclics' patent invalid, although an appeal is possible [1][3]. Group 1: Patent Dispute Details - The dispute began on June 13, 2023, when Pharmacyclics claimed that BeiGene's drug, Zebutinib, infringed on its patent for Ibrutinib [3]. - The U.S. Patent and Trademark Office's final decision on April 30, 2024, invalidated the entire rights of the '803 patent, which was under scrutiny [1][3]. - AbbVie has not yet responded regarding whether it will appeal the decision [1]. Group 2: Market Context - The global market for BTK inhibitors is projected to exceed 10 billion by 2024, with the U.S. being the largest market [7]. - As of 2024, Ibrutinib remains the top-selling BTK inhibitor, but its market share is being eroded by Zebutinib, which has shown significant growth [7]. - Ibrutinib's revenue is expected to decline by 6.9% in 2024, with U.S. sales dropping by 8.1% [7]. Group 3: Company Performance - BeiGene's Zebutinib is projected to achieve global sales of 2.6 billion in 2024, with U.S. sales reaching 2 billion, a 106.3% increase from the previous year [10]. - AstraZeneca's Acalabrutinib generated 3.129 billion in revenue in 2024, marking a 24% increase [13]. - The competitive landscape is intensifying, with multiple companies, including AbbVie, BeiGene, and Eli Lilly, having launched BTK inhibitors in the U.S. market [7]. Group 4: Ongoing Legal Issues - AbbVie has also filed a lawsuit against BeiGene for alleged theft of trade secrets related to BTK degraders, involving the compounds ABBV-101 and BGB-16673 [13]. - BeiGene asserts that its development of BGB-16673 predates AbbVie's patent application and is confident in its compliance with ethical standards [13].