Enhertu联合疗法获FDA优先审评，有望重塑HER2阳性乳腺癌一线治疗

Investment Rating - The report maintains an investment rating of "Positive" for the pharmaceutical and biotechnology sector [2]. Core Insights - The recent FDA priority review of Enhertu in combination with pertuzumab is expected to reshape first-line treatment for HER2-positive breast cancer, with a decision anticipated in Q1 2026 [16][31]. - The pharmaceutical sector has experienced a recent overall pullback, primarily due to a lack of significant business development and catalysts in the innovative drug space during August and September [14]. - The report suggests focusing on stocks with potential high growth or exceeding expectations for Q3 earnings as the third-quarter reports approach [14]. Summary by Sections 1. Industry Overview - The pharmaceutical and biotechnology sector's return was -2.20% last week, underperforming the CSI 300 by 3.27%, ranking 24th among 31 primary sub-indices [13]. - Over the past month, the sector's return was -4.73%, with a relative performance of -6.92% against the CSI 300, ranking 21st [13]. 2. Market Performance - The recent one-month performance of the pharmaceutical sector was -4.73%, with a relative performance of -6.92% against the CSI 300 [38]. - The sector's current PE (TTM) stands at 30.72, which is above the historical average of 29.33 [39]. 3. Focus Areas for Investment - The report highlights several focus areas for investment: 1. Demand recovery in the innovative drug supply chain, particularly in CXO and life sciences [15]. 2. High-end medical device import substitution and accelerated overseas expansion [15]. 3. AI in healthcare, emphasizing the performance of AI-driven pharmaceutical e-commerce and marketing [15]. 4. Innovative drugs with significant breakthroughs in product pipelines, recommending companies like Innovent Biologics and Hengrui Medicine [15]. 4. Enhertu's Clinical Data - Enhertu in combination with pertuzumab demonstrated a significant improvement in median progression-free survival (mPFS) from 26.9 months to 40.7 months, reducing the risk of disease progression or death by 44% [18][31]. - The safety profile of the Enhertu + pertuzumab combination aligns with known safety characteristics of both drugs, showing a lower rate of treatment discontinuation due to adverse events compared to the THP regimen [28][31].