Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, a targeted CAR-T cell therapy product for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in adult patients [2][3]. Product Information and Research Status - FKC889 is a CAR-T cell therapy product targeting CD19, developed by Fosun Kerry based on technology transferred from Kite Pharma, Inc., a subsidiary of Gilead Sciences, Inc. Tecartus, the original product, was approved for marketing in the US and Europe in July and December 2020, respectively [3]. - As of September 24, 2025, FKC889 is in the bridging clinical trial phase for another indication, which is for adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have previously received second-line or higher treatment [3]. - The cumulative R&D investment for FKC889 by the group is approximately RMB 183 million (unaudited) as of August 2025 [3]. - Multiple CAR-T cell therapy products, including Fosun Kerry's Yikaida (Acilin injection), have been approved for marketing in mainland China, but the overall market situation is difficult to ascertain due to limitations in public database coverage [3].

Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance for the drug registration application of FKC889, a CAR-T cell therapy for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Company Summary - Fosun Kairui is developing FKC889, a targeted CD19 CAR-T cell therapy, based on technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - The product has been authorized for development and local production in China, including Hong Kong and Macau [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020, respectively [1] Industry Summary - The application for FKC889 is classified as a therapeutic biological product (Category 3.2) [1] - Before commercial production, the product must pass GMP compliance checks and obtain drug registration approval [1] - The acceptance of the drug registration application is not expected to have a significant impact on the group's current performance [1]

截至 2025 年 8 月，该集团(即公司及控股子公司/单位，下同)现阶段针对该产品的累计研发投入约为人 民币 1.83 亿元(未经审计)。 智通财经APP讯，复星医药(02196)公布，近日，公司控股子公司复星凯瑞(上海)生物科技有限公司(以下 简称"复星凯瑞")就布瑞基奥仑赛注射液(项目代号：FKC889，申请注册分类：治疗用生物制品 3.2 类; 以下简称"该产品")的药品注册申请获国家药品监督管理局受理，本次申报适应症为用于治疗复发或难 治性前体 B 细胞急性淋巴细胞白血病(ALL)成人患者。 该产品系复星凯瑞基于自 Kite Pharma,Inc.(系 Gilead Sciences, Inc.的控股子公司)引进的 Tecartus 经技术 转移并获授权于中国(包括香港、澳门)进行开发及本地化生产的靶向 CD19 的 CAR-T 细胞治疗产品。 Tecartus 已于 2020 年 7 月及 12 月先后于美国、欧洲获批上市。 截至本公告日期(即 2025 年 9 月 24 日，下同)，该产品的另一适应症(即用于治疗既往接受过二线及以上 治疗后复发或难治性套细胞淋巴瘤(r/r MCL)成人患者)于中 ...

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, aimed at treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in adult patients [1] Group 1 - The product FKC889 is a targeted CD19 CAR-T cell therapy developed and localized in China based on the Tecartus technology licensed from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus was approved for market launch in the United States and Europe in July and December 2020, respectively [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, aimed at treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adult patients [1] Group 1 - The product FKC889 is a targeted CD19 CAR-T cell therapy developed and localized in China based on the technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020 respectively [1]

Core Insights - Gilead Sciences, Inc. (GILD) shares fell 2.2% following CVS Health's decision not to include GILD's new HIV prevention drug, Yeztugo, in its commercial plans for the time being [1][8] - CVS Health's decision was influenced by clinical, financial, and regulatory factors, and Yeztugo will not be covered under its Affordable Care Act formularies [2] - GILD is negotiating with CVS regarding Yeztugo, which has a U.S. list price exceeding $28,000 annually [2] Gilead's Product Developments - Yeztugo received FDA approval in June 2025 for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg, and it is the first and only twice-yearly HIV PrEP option available in the U.S. [3][5] - GILD aims to secure 75% insurer coverage for Yeztugo by year-end 2025 and 90% within 12 months [3] Market Context - Currently, GILD markets two FDA-approved daily oral medications for PrEP: Truvada and Descovy [4] - GILD's shares have increased by 25.7% year-to-date, outperforming the industry growth of 4% [5] Acquisition Activity - Gilead's subsidiary, Kite, announced an agreement to acquire Interius BioTherapeutics for $350 million, which focuses on developing in vivo CAR therapeutics [7][9] - This acquisition is expected to impact GILD's earnings per share by approximately $0.23-$0.25 [8][9] Competitive Landscape - Gilead currently holds a Zacks Rank 3 (Hold), while CorMedix (CRMD) and ANI Pharmaceuticals (ANIP) have better rankings with Zacks Rank 1 (Strong Buy) [10] - CorMedix's earnings per share estimates have increased significantly, and its shares have rallied 49.1% year-to-date [11] - ANI Pharmaceuticals has also seen a slight increase in earnings estimates and a year-to-date share increase of 29.4% [12]

Core Viewpoint - Analysts expect Gilead Sciences (GILD) to report quarterly earnings of $1.95 per share, reflecting a year-over-year decline of 3%, with revenues projected at $6.95 billion, down 0.1% from the previous year [1]. Earnings Estimates - The consensus EPS estimate has been revised 1.1% higher in the last 30 days, indicating a collective reevaluation by analysts [1][2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock performance [2]. Revenue Projections - Analysts project 'Revenues- Royalty contract and other revenues' to reach $38.09 million, indicating a decline of 7.1% year-over-year [3]. - The average prediction for 'Total product sales- Total' is $6.91 billion, showing no change from the prior year [4]. Product Sales Estimates - 'Product Sales- Oncology- Cell Therapy- Tecartus- Total' is estimated at $92.76 million, reflecting a decrease of 13.3% from the previous year [4]. - 'Product Sales- Veklury- Total' is expected to be $211.34 million, down 1.2% year-over-year, while 'Product Sales- HIV- Odefsey- U.S.' is projected at $215.50 million, down 7.5% [5]. - 'Product Sales- Other- Other- U.S.' is anticipated to be $54.28 million, indicating a significant decline of 44.6% [5]. - 'Product Sales- HIV- Descovy- U.S.' is expected to reach $509.35 million, reflecting a growth of 17.4% year-over-year [6]. - 'Product Sales- Oncology- Trodelvy- U.S.' is projected at $224.58 million, showing a slight increase of 0.3% [6]. - 'Product Sales- Oncology- Cell Therapy- Tecartus- U.S.' is estimated at $49.56 million, down 21.3% year-over-year [7]. - 'Product Sales- Liver Disease- Sofosbuvir / Velpatasvir- U.S.' is expected to be $225.96 million, down 15.4% [7]. - 'Product Sales- HIV- Genvoya- U.S.' is projected at $333.57 million, reflecting a decline of 10.3% [8]. - 'Product Sales- Veklury- U.S.' is expected to reach $69.13 million, down 9% year-over-year [8]. Market Performance - Gilead shares have increased by 1.3% over the past month, compared to a 0.6% increase in the Zacks S&P 500 composite [8].

Core Viewpoint - Gilead Sciences, Inc. is set to report its Q2 2025 results on August 7, with consensus estimates for sales at $6.95 billion and earnings per share (EPS) at $1.95, reflecting a positive trend in earnings estimates for 2025 and 2026 [1][4][6]. Financial Performance - The earnings estimate for 2025 has risen to $8.02 from $7.91 per share over the past 60 days, while the estimate for 2026 has increased to $8.53 from $8.39 [1]. - Gilead's earnings surprise history shows that the company has beaten estimates in three of the last four quarters, with an average surprise of 16.48% [2][3]. Sales Drivers - Strong sales from Gilead's HIV drugs, particularly Biktarvy and Descovy, are expected to support top-line growth in Q2, with estimates for Biktarvy at $3.4 billion and Descovy at $577 million [4][8]. - The company has recently received FDA approval for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, which is anticipated to enhance its HIV portfolio [8][16]. Market Dynamics - The introduction of a new Medicare Part D model may have impacted HIV sales due to increased cost-sharing obligations for low-income patients, which could affect overall sales [7][6]. - Gilead's liver disease portfolio is expected to benefit from higher demand for viral hepatitis medicines, with incremental sales from the newly approved drug Livdelzi [9][10]. Competitive Landscape - Gilead's cell therapy sales, particularly for Yescarta and Tecartus, are likely to have declined due to competitive pressures in both the U.S. and global markets [11][17]. - The oncology portfolio, including Trodelvy, is showing strong demand, although the cell therapy segment faces ongoing challenges [13][17]. Stock Performance and Valuation - Gilead's shares have increased by 22.5% year-to-date, outperforming the industry and the S&P 500 [14]. - The stock currently trades at a price/earnings ratio of 13.60x forward earnings, which is higher than its historical mean but lower than the large-cap pharma industry average [15]. Strategic Outlook - Gilead's strategic deals and acquisitions are seen as positive for diversifying its business, with ongoing collaborations to enhance its HIV treatment offerings [18][22]. - The company is viewed as a safe haven for investors in the biotech sector, with a strong dividend yield adding to its attractiveness [19][23].

Core Viewpoint - Gilead Sciences, Inc. reported disappointing first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.81 and total revenues of $6.7 billion, both missing consensus estimates [1][2][3] Financial Performance - Adjusted EPS of $1.81 missed the Zacks Consensus Estimate by a penny, compared to a loss per share of $1.32 in the same quarter last year [1] - Total revenues of $6.7 billion were flat year over year and missed the Zacks Consensus Estimate of $6.8 billion [1] - Total product sales decreased 1% year over year to $6.6 billion, while excluding Veklury, product sales increased 4% to $6.3 billion [3] Product Sales Breakdown - HIV product sales grew 6% year over year to $4.6 billion, exceeding both the Zacks Consensus Estimate and model estimate of $4.5 billion [3] - Biktarvy sales increased 7% year over year to $3.15 billion but missed the Zacks Consensus Estimate of $3.2 billion [4] - Descovy sales surged 38% year over year to $586 million, beating the Zacks Consensus Estimate of $479 million [5] - Liver Disease portfolio sales rose 3% to $758 million, driven by higher demand for HBV and HDV drugs [6] - Veklury sales plummeted 45% to $302 million, missing the Zacks Consensus Estimate of $387 million [7] - Cell Therapy product sales decreased 3% to $464 million, missing the Zacks Consensus Estimate of $491 million [7] Cost and Margin Analysis - Adjusted product gross margin slightly increased to 85.5% from 85.4% in the year-ago quarter [11] - Research and development expenses totaled $1.3 billion, down from $1.4 billion in the previous year [11] - SG&A expenses amounted to $1.2 billion, down from $1.3 billion [11] Dividend and Guidance - Gilead declared a quarterly dividend of $0.79 per share for Q2 2025, payable on June 27, 2025 [12] - The company reiterated its 2025 guidance, projecting product sales between $28.2 billion and $28.6 billion, with adjusted EPS anticipated in the range of $7.70-$8.10 [13] Pipeline Updates - The FDA accepted new drug application submissions for lenacapavir for HIV prevention, with a target action date of June 19, 2025 [14] - Gilead received conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis [14] Overall Performance Assessment - Gilead's first-quarter results were disappointing, particularly due to a decline in oncology drugs affecting revenue growth [15] - Despite challenges, Biktarvy maintained its dominant position in the HIV market, and Descovy showed strong performance [15] - The potential approval of lenacapavir could further strengthen Gilead's HIV franchise amid increasing competition [16]