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百利天恒:后线HR+乳腺癌PFS展现优势,BL-B01D1疗效再获验证

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 268.33 RMB, compared to the last closing price of 199.80 RMB [1][8]. Core Views - The efficacy of BL-B01D1 in treating HR+ breast cancer has been validated, showing advantages in progression-free survival (PFS) [4][7]. - The company has initiated Phase 3 clinical trials for BL-B01D1 targeting HR+ breast cancer and triple-negative breast cancer (TNBC) [4][7]. - The report highlights the promising data from the 2024 SABCS conference regarding BL-B01D1's performance in various breast cancer subtypes [4][7]. Summary by Sections Company Overview - The total share capital is 4.01 billion shares, with a market capitalization of 801.2 billion RMB [3]. - The stock has seen a 12-month high of 246.31 RMB and a low of 96.21 RMB [3]. Clinical Data - BL-B01D1 shows a clinical overall response rate (cORR) close to 50% across three breast cancer subtypes, with no interstitial lung disease (ILD) events reported [4]. - Specific results include: - TNBC: cORR of 34.1%, median duration of response (mDOR) of 11.5 months, and mPFS of 5.8 months [4]. - HR+/HER2- breast cancer: cORR of 37.7%, mDOR of 7.4 months, and mPFS of 7.0 months [4]. - HER2+ breast cancer: cORR of 47.5%, mDOR of 7.4 months, and mPFS of 7.0 months [4]. Financial Projections - Revenue projections for 2024 are expected to reach 58.64 billion RMB, with a significant growth rate of 943.67% compared to the previous year [10]. - The net profit for 2024 is projected to be 39.98 billion RMB, indicating a growth rate of 612% [10]. - The diluted earnings per share (EPS) for 2024 is estimated at 9.97 RMB [10]. Future Outlook - The report emphasizes the importance of upcoming data releases for BL-B01D1's overseas Phase 1 clinical trials and the initiation of the first overseas Phase 3 clinical trial in 2025 [7][8]. - The company is also focusing on the data readout for BL-B01D1 in combination with osimertinib for EGFR-mutant non-small cell lung cancer (NSCLC) in the first half of 2025 [7].