Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for AmnealBRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG. Omalizumab, a humanized ...

Summary of CSPC Pharma Earnings Review and Industry Insights Company Overview - **Company**: CSPC Pharma (1093.HK) - **Market Cap**: HK$121.1 billion / $15.5 billion - **Industry**: China Pharma, Biotech & Medtech Key Financial Highlights - **2Q Revenue**: Rmb 6.3 billion, down 14% year-over-year (y/y) - **Finished Drug Sales**: Rmb 4.4 billion, down 27% y/y, below expectations (GSe Rmb 5.4 billion) [1] - **CNS Drug Sales**: Declined by 27% y/y due to stricter regulatory monitoring, particularly affecting capsule sales [1] - **Oncology Sales**: Decreased by 54% y/y, impacted by value-based pricing (VBP) for Duomeisu / Jinyouli [1] - **Earnings**: Rmb 1.1 billion, down 24% y/y or 46% y/y excluding business development (BD) [1] - **R&D Expenses**: Rmb 1.4 billion, up 1% y/y; SG&A savings of 26% y/y partially offset the earnings decline [1] Management Guidance - **Sales Growth Resumption**: Expected in 2H25, with finished drug sales projected to grow by over 5% half-on-half (h/h) [1] - **Collaboration Income**: Potential for higher collaboration income for dividend payouts [1] Business Development (BD) Insights - **BD Progress**: Company is on track with three major BD deals expected in 2025, with one already delivered (platform collaboration with AZ) [3] - **SYS6010 (EGFR ADC)**: Smooth overseas development progress, with FDA approval for including China patients in trials [3][7] Metabolism Franchise Opportunities - **Licensing Deals**: Recent licensing-out deal of oral GLP-1 to Madrigal highlights potential deal-making opportunities [2] - **Pipeline Assets**: Includes oral small molecules for weight loss and muscle enhancement, monthly-dose formulations, and siRNA drugs [2] Earnings Estimates and Price Target - **Revised Earnings Estimates**: Decreased by 5.1% for 2025, 1.8% for 2026, and 9.9% for 2027 to reflect lower expectations on finished drug sales [8] - **12-Month Price Target**: Increased to HK$11.28 from HK$10.55, indicating a potential upside of 7.4% from the current price of HK$10.51 [10] Valuation Methodology - **SOTP Valuation**: - DCF-based valuation for NBP: HK$7.2 billion - New product wave: HK$69.3 billion - Legacy portfolio and generics: HK$37.0 billion - API business: HK$4.0 billion [9] Risks and Considerations - **Key Downside Risks**: - Earlier-than-expected VBP for NBP - Slower-than-expected ramp-up of new products - Failure of major R&D projects - Greater-than-expected price cut impacts on generic drug sales [9] Conclusion CSPC Pharma is navigating a challenging environment with declining sales in key segments but is positioned for potential recovery in the latter half of 2025. The company’s focus on business development and innovative product pipelines may provide avenues for growth despite current headwinds.