Summary of Clinical Trial Pipeline Tracker Industry Overview - **Industry**: Biopharma - **Region**: North America - **Industry View**: In-Line for Biotechnology, Attractive for North America [6][6] Key Changes in Clinical Trials New Trials Initiated 1. **Acadia**: Initiated a Phase 3 trial (NCT07095465) of ACP-204 for Lewy Body Dementia Psychosis [8] 2. **BeOne Medicines**: Initiated a Phase 2 trial (NCT07100938) for BGB-45035 versus placebo in adults with moderate to severe active rheumatoid arthritis [8] 3. **Bristol-Myers Squibb**: - Initiated a Phase 2/3 trial (NCT07100080) of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated non-small cell lung cancer after failure of EGFR TKI therapy [8] - Initiated a Phase 1 trial (NCT07105059) of Teclistamab and Mezigdomide in people with multiple myeloma [8] 4. **Jazz Pharmaceuticals**: Initiated a Phase 2 trial (NCT07102381) of Zanidatamab in combination with chemotherapy for HER2-positive breast cancer [8] 5. **Neurocrine**: Initiated a Phase 3 trial (NCT07105098) for NBI-1117568 in inpatient adults with schizophrenia [8] Trials Currently Recruiting 1. **Abbvie**: Recruiting in a Phase 2 study (NCT07023289) to assess adverse events in adults receiving Telisotuzumab Adizutecan for colorectal cancer [9] 2. **Biohaven**: Recruiting in a Phase 1 study (NCT07054684) of BHV-1400 in IgA nephropathy [9] 3. **Bristol-Myers Squibb**: - Recruiting in a Phase 2 study (NCT06762769) of Isatuximab and Iberdomide for high-risk smouldering myeloma [9] - Recruiting in multiple other studies for various conditions [9][17] Suspended Trials - No specific trials were reported as suspended during this period [3][19] Terminated Trials - No specific trials were reported as terminated during this period [4][21] Other Important Information - The report includes a comprehensive list of trials, their stages, and identifiers for tracking purposes [18][22] - The document emphasizes the potential conflicts of interest due to Morgan Stanley's business relationships with the companies covered [6][6] Conclusion The biopharma industry in North America is actively progressing with numerous new clinical trials, particularly in oncology and neurodegenerative diseases. The ongoing recruitment efforts indicate a robust pipeline, while the industry outlook remains positive.

Core Insights - Regeneron Pharmaceuticals reported strong financial results for Q2 2025, with notable growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo, alongside multiple regulatory approvals [2][3][5] Financial Highlights - Total revenues for Q2 2025 reached $3.68 billion, a 4% increase from $3.55 billion in Q2 2024 [3][12] - GAAP net income was $1.39 billion, down 3% from $1.43 billion in the same quarter last year, while non-GAAP net income increased by 5% to $1.42 billion [3][12] - Non-GAAP net income per share rose 12% to $12.89, compared to $11.56 in Q2 2024 [3][12] Business Highlights - Dupixent global net sales increased by 22% to $4.34 billion, while EYLEA HD U.S. net sales grew by 29% to $393 million [5][12] - The FDA approved Lynozyfic for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria [5][10] - The company has approximately 45 product candidates in clinical development, with significant progress in its oncology portfolio [4][5] Regulatory and Pipeline Updates - The FDA accepted for priority review Libtayo's supplemental Biologics License Application for adjuvant cutaneous squamous cell carcinoma, with a target action date in October 2025 [10][11] - The company reported interim results from the Phase 2 COURAGE trial, showing promising data for obesity treatment [10][11] Capital Allocation - Regeneron returned over $2.3 billion to shareholders through share repurchases and dividends, while committing over $7 billion to U.S. manufacturing investments and business development since the start of 2025 [3][23] - A cash dividend of $0.88 per share was declared, payable on September 3, 2025 [24]

Core Viewpoint - Sandoz has launched WYOST® and Jubbonti®, the first and only interchangeable FDA-approved denosumab biosimilars in the US, aimed at improving access to treatment for osteoporosis and cancer-related skeletal events [2][7]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a growth strategy focused on pioneering access for patients. The company recorded net sales of USD 10.4 billion in 2024 and has a portfolio of approximately 1,300 products [21]. Product Launch Details - WYOST® and Jubbonti® are approved for all indications of the reference medicines XGEVA® and Prolia®, respectively, and are integral to Sandoz's growth strategy in the biosimilar market [2][3]. - The products are designed to provide high-quality, cost-effective treatment options, enhancing patient access and affordability in the US [3][5]. Patient Impact - The introduction of these biosimilars is expected to significantly improve treatment access for over 10 million US adults aged 50 and older living with osteoporosis, as well as for approximately 330,000 individuals with bone metastases [5][6]. - Sandoz is providing comprehensive support resources for patients prescribed these medications, including reimbursement and financial assistance [4]. Regulatory Approval - Both WYOST® and Jubbonti® have been approved as interchangeable with their reference medicines, ensuring they have the same dosage form, route of administration, and dosing regimen [3][6].

Core Viewpoint - A federal court jury found Amgen liable for antitrust violations, awarding Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages due to Amgen's anticompetitive practices that hindered competition for Praluent [1][3]. Summary by Relevant Sections Antitrust Violations - Amgen was found to have violated multiple laws, including the Clayton Act and Sherman Act, by using cross-therapeutic bundled rebates to favor Repatha over Praluent, thereby preventing fair competition [1][2]. Jury Verdict and Damages - The jury awarded Regeneron a total of $406.8 million, comprising $135.6 million in compensatory damages and $271.2 million in punitive damages aimed at deterring similar future conduct [3]. Company Statements - Regeneron emphasized the importance of fair competition in the biotech industry, stating that anticompetitive tactics undermine patient access to innovative therapies and hinder medical advancements [4]. Product Information - Praluent, developed by Regeneron and Sanofi, is designed to lower LDL cholesterol levels by inhibiting PCSK9, and is approved in 60 countries [6][7]. Technology and Innovation - Regeneron's proprietary VelocImmune technology has been instrumental in developing fully human monoclonal antibodies, contributing to a significant portion of FDA-approved treatments [8][9].

Economic Overview - The three major U.S. indexes, S&P 500, Dow Jones Industrial Average, and Nasdaq Composite, experienced declines of 1.36%, 0.90%, and 0.84% respectively last week, influenced by policy shifts and trade tariffs under the Trump administration [1] - Personal consumption expenditure (PCE) rose by 0.3% in January, exceeding the Federal Reserve's 2% inflation target, with an annual rate of 2.5% [2] - Personal income increased by 0.9%, while personal spending unexpectedly declined by 0.2% in January, indicating consumer concerns about future economic conditions [2] - The U.S. economy added 151,000 jobs in February, with the unemployment rate rising to 4.1% from 4% the previous month, highlighting underlying economic weaknesses [3] Stock Performance - NioCorp Developments Ltd. (NB) shares increased by 38.5% since being upgraded to Zacks Rank 2 (Buy) on January 14, outperforming the S&P 500's 1% decrease [4] - TXO Partners, L.P. (TXO) saw a return of 9.8% since its upgrade to Zacks Rank 1 (Strong Buy) on January 14 [5] - The Zacks Model Portfolio, consisting of Zacks Rank 1 stocks, has outperformed the S&P 500 index by almost 13 percentage points since 1988, with an annualized average return of +23.9% compared to +11.3% for the S&P 500 [7] Focus List and Portfolios - Sea Limited (SE) gained 16.7% and Uber Technologies, Inc. (UBER) returned 15.4% over the past 12 weeks, both part of the Zacks Focus List, while the S&P 500 decreased by 5.3% during the same period [11] - The Zacks Focus List portfolio returned +18.41% in 2024, compared to +25.04% for the S&P 500 [12] - The Earnings Certain Admiral Portfolio (ECAP) includes Amgen Inc. (AZO) and Intercontinental Exchange, Inc. (ICE), which returned 19.2% and 9.2% respectively over the past 12 weeks [14] Dividend Portfolio Performance - The Earnings Certain Dividend Portfolio (ECDP) includes Coca-Cola Company (KO) and Johnson & Johnson (JNJ), which returned 14.2% and 11.6% respectively over the past 12 weeks [17] - The ECDP returned +6.95% in 2024, compared to +24.89% for the S&P 500 [18]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 地舒單抗生物類似藥HLX14（重組抗RANKL全人單克隆抗體注射液） 的生物製品許可申請(BLA)獲美國食品藥品管理局(FDA)受理 C. 市場情況 截至本公告日，於全球上市的地舒單抗注射液包括Amgen Inc. 以不同商品名 獲批用於不同適應症的PROLIA/XGEVA、Daiichi Sankyo Company Limited 的PRALIA、Intas Pharmaceuticals Ltd.的ROZEL等。根據IQVIA CHPA與 IQVIA MIDASTM的資料（IQVIA是全球醫藥健康產業專業信息和戰略諮詢服 務提供商），2023年度，地舒單抗注射液於全球範圍內的銷售額約為68.30億 美元。 本公告由上海復宏漢霖生 ...