ab 18 July 2025 Global Research China Healthcare China preclinical CRO expert call takeaways H125: slight price & volume recovery; tipping point may not occur until 2026 On 18 July, we invited a senior executive from a domestic medium-sized preclinical CRO firm to share his views. He noted a slight recovery in China's preclinical CRO industry. Overall order inflow has increased modestly YoY for both volume (up <10%) and price (up 5-10%) YTD, with profits staying low. In his view, pharmaceutical R&D is gener ...

Summary of Regeneron's Q1 2025 Earnings Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals - **Date of Call**: Q1 2025 earnings conference call Key Industry Insights - **Branded Anti-VEGF Category**: The overall size contracted due to increased usage of low-cost off-label repackaged Avastin, likely driven by patient affordability issues related to funding gaps at copay assistance foundations [2][11] - **Regulatory Environment**: The FDA issued a complete response letter (CRL) for the ILEA HD pre-filled syringe submission, with the key issue related to a third-party component supplier [3][19] Financial Performance - **Total Revenues**: $3 billion for Q1 2025, driven by higher collaboration revenue and U.S. net sales of ILEA HD [15] - **Net Sales of ILEA**: $736 million, down 39% year-over-year and down 38% sequentially [2][11] - **Net Sales of ILEA HD**: $307 million, up 54% year-over-year, flat sequentially [3][11] - **Diluted Earnings Per Share**: $8.22, with net income of $928 million [15] - **R&D Expenses**: $1.2 billion, reflecting continued investments in the innovative pipeline [15] - **Gross Margin**: 85%, lower than the previous year due to higher inventory write-offs [15][17] Product Performance - **Dupixent**: - Global net product sales grew 20% year-over-year, with U.S. sales growing 19% [4] - Leading in new-to-brand prescription share across all approved indications, except for chronic spontaneous urticaria (CSU) [4][12] - Recently approved for CSU, marking the first new treatment option in over a decade [6][13] - **ILEA and ILEA HD**: - Combined U.S. net sales of $1.04 billion, down 30% sequentially [10] - ILEA HD maintained market leadership with 41% share of the anti-VEGF category despite challenges [11] - **Liptio**: Now second in new-to-brand prescription share in the advanced non-small-cell lung cancer market [5] Pipeline Developments - **Pipeline Candidates**: Approximately 45 product candidates in clinical development [5] - **Upcoming Regulatory Approvals**: Anticipated approvals for Limboseltamib, Ogenexamib, and Dupixent in various indications [5][8] - **Dupixent's Expansion**: Expected approval for bullous pemphigoid, representing a significant opportunity in chronic skin diseases [6][13] - **Idapecimab**: Investigating its role in COPD, with promising phase II data [28] Strategic Initiatives - **Investment in Manufacturing**: Over $7 billion planned for U.S. investments to expand R&D and manufacturing capabilities [16] - **Shareholder Returns**: $1.1 billion in share repurchases in Q1 2025, with a new quarterly dividend initiated [16][17] Challenges and Risks - **Competitive Pressures**: Ongoing competition in the anti-VEGF category and the impact of funding gaps on patient access to treatments [11][12] - **Regulatory Scrutiny**: Increased scrutiny from the FDA on contract manufacturers, leading to multiple CRLs [26][32] Conclusion - **Outlook**: Regeneron remains well-positioned scientifically and financially, with a strong pipeline and commitment to innovation despite facing regulatory and competitive challenges [6][10]

ROCKVILLE, Md. and SUZHOU, China, July 14, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855) (“Ascentage” or the “Company”), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, today announced the pricing of 22 million ordinary shares, par value $0.0001 per share, of the Company (the “Placement Shares”), at a price of HKD68.60 per share, in the offering by Dajun Yang Dynasty Trust, an affiliate of the Company’s Chief Executiv ...

Corporate Presentation April 29th, 2025 Forward Looking Statements and Disclaimer The presentation contains forward-looking statements. Statements made or presented may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential," "should," " ...

Core Viewpoint - Innovent Biologics is set to present multiple clinical study results of mazdutide at the American Diabetes Association's 85th Scientific Sessions, highlighting its potential as a next-generation treatment for Type 2 Diabetes (T2D) and other metabolic diseases [1] Group 1: Clinical Studies and Presentations - The first Phase 3 study of mazdutide in Chinese adults with T2D (DREAMS-1) will be presented orally [1] - Multiple exploratory mechanism of action (MoA) analyses of mazdutide and a preclinical study of IBI3030 will be showcased in poster presentations [1] - The presentations include various studies on mazdutide's effects on liver fat accumulation, hyperuricemia, and cardiovascular risk markers [1][1][1] Group 2: Product Development and Regulatory Status - Mazdutide is currently under review with two New Drug Applications (NDAs) accepted by the National Medical Products Administration (NMPA) [4] - The drug is being evaluated in six Phase 3 clinical studies, with GLORY-1, DREAMS-1, and DREAMS-2 having met their primary endpoints [4] - Innovent has plans for several new clinical studies involving mazdutide, targeting conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF) [7] Group 3: Company Overview and Partnerships - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including oncology and metabolic disorders [4] - The company has launched 15 products and has 3 new drug applications under regulatory review, with 4 assets in Phase III trials and 15 molecules in early clinical stages [4] - Innovent collaborates with over 30 global healthcare companies, including Eli Lilly, to enhance its product offerings and market reach [4]

2025 First Quarter Financial and Corporate Update April 29, 2025 First Quarter 2025 Earnings Call Agenda | Introduction | Greg Shertzer Investor Relations | | --- | --- | | Key Highlights & Commercial | Hervé Hoppenot | | Review | Chief Executive Officer | | Financial Review | Christiana Stamoulis Chief Financial Officer | | R&D Update | Pablo Cagnoni | | | Head of Research & Development | | Closing Remarks | Hervé Hoppenot | | | Chief Executive Officer | | | Matteo Trotta EVP, Head of U.S. Dermatology | | ...