Group 1 - The company is experiencing a decline in sales of its previously successful drug, Humira [1]

Core Viewpoint - The U.S. government, led by President Trump, is pressuring major pharmaceutical companies to lower drug prices in the U.S. by adhering to the "most-favored-nation" (MFN) pricing policy, which aims to align U.S. drug prices with the lowest prices in other developed countries [1][2][3] Group 1: Government Actions - President Trump has set a deadline of September 29 for pharmaceutical companies to comply with the MFN policy [2] - Multiple federal departments are being mobilized to support this initiative, indicating a coordinated effort to enforce the price reductions [2][3] Group 2: Pharmaceutical Companies Involved - Major pharmaceutical companies receiving Trump's letter include Eli Lilly (LLY.US), Pfizer (PFE.US), Merck (MRK.US), Gilead (GILD.US), Bristol-Myers Squibb (BMY.US), Johnson & Johnson (JNJ.US), Regeneron (REGN.US), Amgen (AMGN.US), AbbVie (ABBV.US), and several European firms such as Merck KGaA, Sanofi (SNY.US), GlaxoSmithKline (GSK.US), AstraZeneca (AZN.US), Novo Nordisk (NVO.US), Roche (RHHBY.US), and Novartis (NVS.US) [1] Group 3: Implications of High Drug Prices - The long-term high drug prices in the U.S. create significant pressure on both public welfare and government finances, making the MFN policy a direct and quantifiable approach to reduce costs [3] - The lack of price regulation in the U.S. compared to other countries contributes to higher drug prices, as U.S. pharmaceutical companies can raise prices without negotiation [3]

Core Viewpoint - The Trump administration is preparing a new executive order targeting the Chinese pharmaceutical industry, particularly focusing on the licensing-out (BD) of innovative drugs, which may restrict U.S. pharmaceutical companies from importing new drugs from China and impose stricter reviews on drug licensing transactions and clinical data from China [1][3]. Group 1: Impact on the Market - Following the news, shares of innovative drug companies in both A-shares and H-shares fell, with companies like BeiGene and Rongchang Bio experiencing declines, while the Hang Seng Biotechnology Index saw a significant drop [1]. - Despite initial declines, the innovative drug sector showed signs of recovery, with a partial rebound observed on September 12 [1]. Group 2: Details of the Proposed Executive Order - The draft executive order includes four main points: limiting U.S. pharmaceutical companies from importing in-development drugs from China, requiring licensing transactions to undergo mandatory review by the Committee on Foreign Investment in the United States (CFIUS), enhancing FDA scrutiny on projects using Chinese clinical data, and promoting domestic drug production in the U.S. [3][5]. - The proposed restrictions are seen as a response to the increasing trend of U.S. pharmaceutical companies acquiring Chinese innovative drug pipelines, which has raised concerns among some U.S. investors [3][4]. Group 3: Industry Reactions and Feasibility - Industry insiders express skepticism about the feasibility of the executive order due to the complex interests involved, suggesting that even if the order is implemented, it may only affect the most sensitive areas like cell therapy and human genetic resources, while allowing other transactions to proceed normally [2][6]. - The potential impact of the order on U.S. pharmaceutical companies is significant, as it could limit their access to innovative drugs and hinder their development capabilities [6][7]. Group 4: Economic Implications - The executive order is perceived as a move that could harm both U.S. and Chinese companies, as it may restrict BD transactions that are crucial for innovation and collaboration in the pharmaceutical sector [2][6]. - The financial stakes in BD transactions are substantial, with the potential for significant profits for multinational companies, as evidenced by BioNTech's recent acquisition and subsequent sale of a Chinese innovative drug [7].

Core Insights - The in vivo CAR-T therapy market is rapidly gaining traction, with significant mergers and acquisitions by major multinational corporations (MNCs) indicating a strategic shift towards this innovative treatment approach [1][2][3] - The advancements in delivery vector technologies are driving the development of in vivo CAR-T therapies, with a focus on improving targeting efficiency and safety [3][4] Group 1: Mergers and Acquisitions - AstraZeneca acquired EsoBiotec for $1 billion to enhance its in vivo CAR-T therapy portfolio [1][2] - AbbVie announced the acquisition of Capstan Therapeutics for up to $2.1 billion, marking a significant investment in the in vivo CAR-T space [1][2] - Gilead's Kite acquired Interius for $350 million, further expanding its capabilities in cell therapy [1][2] Group 2: Technology Platforms - EsoBiotec's core technology is the engineered nanobody lentivirus (ENaBL) platform, which enhances the specificity of immune cell transfection [4] - Interius utilizes a lentiviral vector to deliver CAR genes, generating CAR-T and CAR-NK cells directly in vivo for targeting B-cell malignancies [3][4] - The mRNA-LNP (lipid nanoparticle) delivery system is gaining attention for its safety profile, allowing for transient CAR expression without permanent genetic modification [7][8] Group 3: Clinical Developments - EsoBiotec's product ESO-T01 has shown promising clinical trial results for multiple myeloma, indicating potential effectiveness in treating relapsed or refractory cases [15][17] - Capstan Therapeutics' candidate CPTX2309 is currently in Phase I trials for autoimmune diseases, showcasing the therapeutic potential of the LNP delivery approach [8][9] Group 4: Industry Trends - The shift from ex vivo to in vivo CAR-T therapies is reshaping the ecosystem, with increased collaboration among technology partners and a focus on delivery efficiency [3][6] - The reliance on upstream CXO (Contract Research Organization) services is significant, with over 65% of CGT (Cell and Gene Therapy) projects involving CXO participation [6][12] - The industry is witnessing a dual approach, with companies like AbbVie investing in both lentiviral and mRNA-LNP technologies to mitigate risks associated with single technology pathways [16][17]

智通财经APP获悉，艾伯维公司(AbbVie，ABBV.US)于周四宣布，已与所有涉诉仿制药企业达成和解， 解决了针对"仿制药企业计划推出Rinvoq仿制药"的相关诉讼。Rinvoq是艾伯维免疫治疗产品线中的核心 药物。 这家总部位于美国伊利诺伊州北芝加哥的制药巨头，已将Rinvoq及其"姊妹药"Skyrizi定位为重磅关节炎 药物修美乐(Humira)的潜在替代产品。修美乐于2023年失去了美国市场的独占权(即专利保护到期，仿 制药可合法进入)。 2025年上半年，Rinvoq的净销售额达到27亿美元，同比增长约53%;与之形成对比的是，同期修美乐在 美国市场的销售额同比下滑约63%。 此前，这些仿制药企业已向美国食品药品监督管理局(FDA)提交了"简化新药申请"(Abbreviated New Drug Application，ANDA)，寻求推出这款关节炎治疗药物的非专利版本(即仿制药)。 艾伯维在一份监管文件中表示，得益于此次达成的和解协议与授权协议，预计在2037年4月之前，针对 Rinvoq片剂的仿制药不会进入美国市场。 ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

AbbVie shares rose 4% to a record high on Thursday after the U.S. drugmaker said it expected no generic competition for its blockbuster immunology drug Rinvoq until 2037, a four-year extension, accord... ...

The biopharmaceutical company doesn't expect U.S. generic entry for the drug before 2037 now that it has settled litigation. ...

BREAKING: Core CPI Steady, Jobless Claims Highest Since Oct. 2021 AbbVie (ABBV) stock definitively broke out Thursday after the pharma titan announced it had entered a settlement deal that will stave off generic Rinvoq until April 2037. But Rinvoq and Skyrizi revenue also stepped up markedly. Though they work differently from Humira, the duo treat a number of the same conditions. Last year, Rinvoq brought in $5.97 billion in sales, accounting for almost 11% of total sales. Skyrizi generated $11.72 billion. ...

POLAND - 2025/09/07: In this photo illustration, the AbbVie company logo is seen displayed on a smartphone screen. (Photo Illustration by Piotr Swat/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty Images AbbVie’s stock is on the rise, and for good reason! The company just reached a major agreement with generic drug manufacturers to delay the release of a generic version of its blockbuster drug, Rinvoq, until 2037. This is a huge deal because Rinvoq has been a powerhouse for the co ...