Lazertinib

来源：药研网4月12日，强生公司宣布，旗下创新肺癌治疗药物锐珂®（埃万妥单抗注射液）正式在华上市。锐珂®与卡铂和培美曲塞联合给药，适用于经检测确认携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌成人患者的一线治疗。锐珂®（全人源双特异性抗体）是目前在肺癌治疗领域的一项创新疗法，针对EGFR和MET两个关键靶点，解决了肺癌患者耐药的挑战。EGFR和MET通路的异常是导致非小细胞肺癌（NSCLC）患者耐药的主要原因。锐珂®通过胞外结合，激活免疫细胞，与传统的胞内药物协同抗肿瘤作用，并调动免疫系统抵抗肿瘤，为患者带来了长期获益。在最近的PAPILLON临床Ⅲ期研究中，锐珂®与化疗联合使用，相比单独化疗，能够显著降低疾病进展或死亡的风险高达61%。埃万妥单抗的获批是基于一项随机、开放标签、PAPILLON临床3期研究结果。该研究表明，与单独化疗相比，埃万妥单抗联合化疗可将疾病进展或死亡风险降低61%。研究同时观察到，亚洲人群亚组研究者评估中位 PFS 为 14.1 个月。2025年1月7日，强生宣布，埃万妥单抗（RYBREVANT®）与拉泽替尼（LAZCLUZE™）的联合治疗在III期MARIPOSA研究中显示出显著的整体生存期（OS）改善，较现有标准治疗奥希替尼（Tagrisso®）表现出临床意义和统计学上的显著提高。MARIPOSA研究数据显示，与奥希替尼相比，Rybrevant与Lazcluze联合治疗可将疾病进展或死亡风险降低30%，并显著延长疾病无进展生存期（mPFS：23.7个月 vs. 16.6个月）和疾病控制持续时间（mDOR：25.8个月 vs. 16.7个月）。此外，联合治疗的安全性与单独治疗方案一致，虽然在治疗过程中观察到静脉血栓栓塞事件（VTE）。强生公司表示，除了在NSCLC一线治疗中取得突破外，Rybrevant与Lazcluze联合疗法在NSCLC后线治疗中也取得了积极的临床结果，进一步证明了这一联合治疗的潜力。锐珂®的上市有望重塑我国肺癌治疗格局，充分彰显了强生对肺癌患者的坚定承诺。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们I-RNA 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this year, announcing Tuesday that it will maintain its financial forecast for the year while raising its sales guidance.J&J, which is the first large drugmaker to report results for the first quarter, expects adjusted earnings per share of $10.60 for 2025. That number is the same as the company estimated in January, before President Donald Trump announced sweeping new tariff policies that will tax imports of medical devices along with most other goods.Duties on drugs are likely coming soon, too. The Trump administration disclosed Monday an investigation into the national security effects of pharmaceutical imports in a move that analysts anticipate will result in new levies in the near future.We built into our guidance about $400 million in tariff costs based on what we know today, said J&J CFO Joe Wolk in a CNBC interview Tuesday morning. It was really a pretty healthy beat considering we didnt have those things in January that were now absorbing.Much of that $400 million impact involves J&Js medical device business, Wolk clarified on a company conference call held later on Tuesday morning, and also reflects retaliatory tariffs China has imposed on U.S. goods.Wolk declined to share an annualized estimate for the impact of tariffs, citing the fast-changing nature of the Trump administrations policies.Yet, for an industry shaken by both Trumps tariff threat and a chaotic regulatory restructuring, J&Js stability may be welcome news.[J&J management] downplayed tariff risks this morning, which we view as an important positive development for perception about the threat to [J&J] and the branded biopharma industry at large, wrote Leerink Partners analyst David Risinger in a client note.Recently, J&J said it will spend $55 billion over the next four years on building new drug factories in the U.S., one of several drugmaker announcements of plans to reshore manufacturing to the U.S. something Trump has leaned specifically on the industry to do. After those plants are complete, J&J expects that essentially all of its advanced medicines will be made in the U.S.Speaking on the companys conference call, J&J CEO Joaquin Duato made the case that tax policy, not tariffs, is more effective at spurring capital investment.Tariffs can create disruptions in the supply chain, leading to shortages, Duato said. If what you want is to build manufacturing capacity in the U.S. ... the most effective answer is not tariffs, but tax policy.The pharmaceutical industry benefited mightily from the tax law passed in 2017 during Trumps first administration, and is arguing for its renewal.Its unclear what kind of pharma tariffs might emerge from the newly begun probe by the Department of Commerce. According to a regulatory notice posted Monday, Commerce will look at both branded and generic medicines, as well as the active drug ingredients they contain and the starting materials from which theyre derived.Trump has threatened duties between 50% and 200%, which, if imposed, would dramatically increase costs for an industry that has supply chains spread throughout Europe and Asia. Most precursor chemicals and active ingredients are sourced from China and India, while many branded manufacturers have production facilities in countries like Ireland, Switzerland, the Netherlands and Singapore.Wolk, in his CNBC interview, speculated that the administration might focus on generic medicines and precursor chemicals, but stressed that was only J&Js view of where national security concerns might be most acute.I think its also important that companies in healthcare partner with the administration to look to mitigate some of the vulnerabilities that exist today in other healthcare supply chains, said Duato, on the conference call. It is important for us to partner with the administration ... and we plan to do it.Overall, J&J reported sales of about $21.9 billion during the first three months of the year, an increase of 2.4% from the same period the year prior and higher than consensus Wall Street estimates. Revenue from the companys pharma business also beat expectations, totaling roughly $13.9 billion in the quarter.J&J executives highlighted on the call several of the companys approved medicines and two experimental therapies for which it thinks analysts forecasts are too low. Notably, the company expects sales of its cancer drug combination Rybrevant and Lazcluze to reach about twice as high in 2027 as Wall Streets current estimate of $1.8 billion.Shares were trading down about 0.5% by mid-morning Tuesday. '