Key Takeaways Amgen acquired Dark Blue Therapeutics for about $840M, strengthening its oncology pipeline.AMGN gains a preclinical small-molecule degrader targeting MLLT1/3 proteins tied to certain AML types.Amgen has no marketed AML therapy, but sells Blincyto for ALL and has early AML bispecifics.Amgen (AMGN) announced that it has acquired U.K.-based private biotech company, Dark Blue Therapeutics, for approximately $840 million.The acquisition will strengthen Amgen’s oncology pipeline by adding Dark Blue’ ...

Shares of Greenwich LifeSciences Inc. (GLSI) have been on a tear over the past ten days as the clinical-stage biotech pushes ahead with its financing strategy and prepares to implement risk-reducing modifications to the phase III trial of its investigational breast cancer immunotherapy, GLSI-100, upon the regulatory go-ahead.GLSI-100 is a combination of GP2 peptide vaccine and GM-CSF, an immune system booster, which is designed to help the body recognize and fight cancer cells that express the HER2/neu pro ...

Core Insights - Pfizer anticipates a significant revenue decline due to the loss of exclusivity for key products between 2026 and 2030, including Eliquis, Vyndaqel, Ibrance, Xeljanz, and Xtandi, all facing patent expirations [1][9] - The company has bolstered its R&D pipeline through mergers and acquisitions, successful data readouts, and pivotal program initiations, positioning itself for sustainable growth post-LOE [1][7] Oncology Pipeline - Pfizer has advanced its oncology pipeline with several candidates in late-stage development, including vepdegestrant for ER+/HER2- metastatic breast cancer, atirmociclib for HR+/HER2- metastatic breast cancer, and sigvotatug vedotin for metastatic non-small cell lung cancer [2] - By 2030, Pfizer expects to have eight or more blockbuster oncology medicines in its portfolio [4] Non-Oncology Developments - In non-oncology areas, Pfizer is developing an mRNA flu/COVID combination vaccine and osivelotor for sickle cell disease, both in late-stage development [4] - The company is also expanding the labels of approved products like Padcev, which was recently approved by the FDA in combination with Merck's Keytruda for specific bladder cancer patients [5] Obesity Market Expansion - Pfizer is strengthening its presence in the obesity market, currently dominated by Eli Lilly and Novo Nordisk, through the $10 billion acquisition of Metsera and the in-licensing of YP05002, an oral GLP-1 receptor agonist [6] - The Metsera acquisition added four novel clinical-stage programs for obesity, expected to generate billions in peak sales [6] Competitive Landscape - Pfizer faces revenue headwinds from patent expirations but is positioned for long-term growth through its expanding late-stage pipeline in oncology and investments in obesity, vaccines, and rare diseases [7] - The oncology market is competitive, with major players like AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers also focusing on oncology sales [10][11][12][13] Financial Performance - Pfizer's stock has declined 7% over the past year, while the industry has seen a 16% increase [14] - The company's shares are trading at a forward price/earnings ratio of 8.18, below the industry average of 17.40 and its own 5-year mean of 10.39, indicating attractive valuation [16] - The Zacks Consensus Estimate for 2025 earnings has increased slightly to $3.10 per share, while the estimate for 2026 has decreased to $3.04 per share [18]

ADC又在ILD上摔了一跤。 近日，默沙东与第一三共联合开发的B7-H3 ADC药物I-Dxd，针对复发性小细胞肺癌患者的二线3期临床试验IDeate-Lung02宣告全球暂停，原 因是5级以上间质性肺病（ILD）发生率高于预期。 5级 ILD 在医学毒性分级中是对应死亡结局。这意味着，承载着两家巨头巨大期望的220亿美元ADC合作项目，再遭重创。 毕竟，在此之前默沙东与第一三共合作的另一款ADC Patritumab deruxtecan，因总生存期表现不佳撤回上市申请，其临床中发生了2例患者因 ILD死亡事件。 两款药物接连折戟背后，致命性不良反应再度引发行业对ADC安全性的审视。这究竟是第一三共的技术问题，还是Dxd毒素导致暂无明确结 论。 可以明确的则是，在越来越多严重ILD出现的情况下，监管对ADC的"容忍"持续降低。这又会对后续ADC玩家带来哪些挑战与机会？ 01 又摔了一跤 Padvec+ K药联合治疗的成功，无疑让默沙东感受到了ADC"精准化疗"的威力。于是，默沙东开始了ADC押注。 2023年，默沙东与第一三共就3款ADC（I-Dxd、Patritumab deruxtecan、R-DXd） ...

Core Insights - AstraZeneca PLC and Daiichi Sankyo received FDA approval for Enhertu as a first-line treatment for HER2-positive breast cancer, in combination with Roche's Perjeta [2][7] - The approval is based on the DESTINY-Breast09 study, which showed a significant improvement in progression-free survival (PFS) [5][8] - AstraZeneca will pay Daiichi Sankyo a $150 million milestone payment following this approval [3][7] Regulatory Approval - Enhertu was reviewed under the FDA's real-time oncology review (RTOR) program [3] - The drug is already approved in over 85 countries for second-line treatment of HER2-positive breast cancer and for other cancers [3] Clinical Study Results - The DESTINY-Breast09 study demonstrated a median PFS of 40.7 months for the Enhertu-Perjeta combination, compared to 26.9 months for the standard regimen [5][8] - The combination reduced the risk of disease progression by 44% compared to the current standard treatment [5][7] Market Performance - Over the past year, AstraZeneca's shares increased by 36.3%, outperforming the industry average rise of 12.1% [4]

Key Takeaways FDA grants Enhertu a Breakthrough Therapy designation for early HER2-positive breast cancer.AZN noted the decision was based on DESTINY-Breast05 results showing lower invasive disease recurrence.AZN's phase III LATIFY study with Imfinzi combo missed its primary overall survival goal in lung cancer.AstraZeneca (AZN) and its Japan-based partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (“BTD”) to their blockbuster antibody-drug conjugate (ADC), Enhertu, ...

抗体偶联药物（ADC）凭借将细胞毒性药物精准递送至癌细胞的能力，正成为推动肿瘤领域新药研发的重点方向之一。公开资料显示，全球范围内有数百 款ADC疗法处于积极的临床研究阶段，其中包含了数十款双抗ADC，靶点涵盖了EGFR、HER2、HER3、c-Met 、ROR1、PD-L1、B7-H4、B7-H3等等，临 床开发适应症涉及一系列实体瘤和血液系统恶性肿瘤。 2025年以来，ADC新药研发管线迎来一系列新进展。其中，多款创新ADC获监管机构批准上市，为不同类型的乳腺癌、非小细胞肺癌等患者带来了新的治 疗选择。 比如，12月，美国FDA批准由阿斯利康和第一三共联合开发的靶向HER2的ADC疗法Enhertu联合帕妥珠单抗，用于一线治疗经FDA批准检测确定为不可切除 或转移性HER2阳性（IHC 3+或ISH+）乳腺癌的成人患者。 再如，10月，FDA批准葛兰素史克（GSK）靶向BCMA的ADC药物Blenrep，联合硼替佐米和地塞米松，用于治疗至少接受过两种既往疗法的复发或难治性 多发性骨髓瘤成年患者。5月，FDA批准艾伯维（AbbVie）靶向c-Met的ADC药物Emrelis上市，用于治疗c-Met蛋白高度表 ...

Investment Rating - The report assigns an investment rating of "Outperform the Market" for the pharmaceutical sector, indicating a relative performance better than the benchmark index [8]. Core Insights - The pharmaceutical sector has shown resilience, with the SW Pharmaceutical Bio Index declining only 0.14% compared to the Shanghai and Shenzhen 300 Index's decline of 0.28% during the week of December 15-21 [2]. - The report highlights significant developments in AI healthcare, particularly with the launch of Ant Group's upgraded AI health app "Antifufu," which aims to enhance health management for users [2]. - Insilico Medicine's IPO is anticipated to drive innovation in drug development, with a focus on its AI-driven platform Pharma.AI and promising clinical results for its lead product Rentosertib [2]. - The approval of the Enhertu and trastuzumab combination therapy for HER2-positive breast cancer is expected to redefine first-line treatment standards in this area [2]. - The report emphasizes the potential of Chinese innovative drugs in international markets and suggests continued monitoring of key sectors such as ADCs, bispecific antibodies, and weight-loss drugs [2]. Summary by Sections Industry Performance - The pharmaceutical sector's weekly trading volume was 389.82 billion yuan, showing a slight decline compared to previous weeks, indicating a need for recovery in market sentiment [2]. AI Healthcare Developments - The "Antifufu" app connects users with 300,000 real doctors for online consultations and has over 15 million monthly active users, with 55% from lower-tier cities, showcasing the app's broad reach [2]. IPO and Drug Development - Insilico Medicine's IPO is set for December 30, with a total fundraising target of 2.277 billion HKD, primarily for clinical research of its drug pipeline [2][5]. Treatment Innovations - The Enhertu and trastuzumab combination therapy has shown a significant improvement in progression-free survival rates, marking a major advancement in treatment options for HER2-positive breast cancer [2].

3. 武田银屑病新药试验告捷，2026 年冲刺 FDA 获批 武田制药的口服 TYK2 抑制剂 zasocitinib（一款有望对标百时美施贵宝 Sotyktu 的药物），在中重度斑 块状银屑病的两项 III 期试验中表现优异。用药 16 周后，该药在医生整体评估达标率、银屑病面积严重 程度改善 75% 以上两项关键指标上，均显著优于安慰剂。武田计划 2026 年向 FDA 提交获批申请。 （来源：抗体圈） 2025 年 12 月 19 日，《亚洲医药快报》（Fierce Pharma Asia）发布年度最后一期行业周报，聚焦制药 领域关键进展：第一三共（Daiichi Sankyo）两款抗体偶联药物（ADC）迎来一喜一忧，武田 （Takeda）银屑病新药试验成功，同时行业并购、跨国合作及政策变动多点开花。以下是核心信息的通 俗解读： 1. 乳腺癌新药组合获批，十年首破治疗格局 阿斯利康与第一三共合作的 Enhertu，联合罗氏的 Perjeta，获美国 FDA 批准成为 HER2 阳性转移性乳腺 癌的一线新疗法 —— 这是该领域十多年来首个新一线治疗方案。临床试验显示，该组合比传统 THP 疗 法降低 44 ...

Key Takeaways Enhertu-Perjeta gets FDA nod as first-line option for unresectable or metastatic HER2-positive breast cancer.Phase III DESTINY-Breast09 showed PFS of 40.7 months vs 26.7 months, reducing progression risk by 44%.Following approval, Daiichi is entitled to receive a $150 million milestone under the Enhertu collaboration.AstraZeneca PLC (AZN) and its Japan-based partner Daiichi Sankyo announced that the FDA has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, for first-line use i ...