Doxorubicin Hydrochloride

在肿瘤治疗领域，几十年来科学家不断追求更精准、更安全、更高效的疗法。从靶向药物到免疫治疗，再到抗体药物偶联物（ADC）技术，每一步进展都极大改善了患者的预后与生活质量。然而，传统治疗仍面临一个核心难题：如何在 最大限度杀灭肿瘤细胞的同时最大限度减少对正常细胞的损伤？ 今天我们要介绍的美国生物技术公司 Shasqi, Inc.，正试图以一种全新的科学方式回答这个问题 —— 利用2022年诺贝尔化学奖相关技术 点击化学（Click Chemistry），实现药物在体内的“精准激活”，重新定义癌症药物的送达方式。 一、什么是 Shasqi？ Shasqi 成立于 2015 年，总部位于美国旧金山，是一家 临床阶段的生物技术公司，专注于开发基于点击化学的精准激活肿瘤治疗策略。其使命是： 让癌症药物只在身体中需要的地方发挥作用——也就是说通过化学反应，在肿瘤部位激活药物，而不让它损害健康组织。  Shasqi 的名称灵感来源于 印加帝国的“chasqui”快马信使 —— 在帝国内快速、安全地传递信息与物资，这正象征着 Shasqi 的技术理念：精准“送达”、只在目标处释放药效。  公司创始人兼 CEO José M. Mejía Oneto. 既有有机化学背景，又有临床医学训练。他在医学实践中深刻体会到现有药物对身体的毒副作用，尤其是传统化疗药物的严重不良反应。因此，他决心寻找一种方式，使有效药物 只对肿瘤发挥作用，而不伤害健康组织。  Shasqi 以其独特的科学策略迅速引起行业关注，并成为早期进入 Y Combinator 冬季项目的生命科学创业公司之一。  二、Shasqi 的核心技术：CAPAC 平台 Shasqi 的技术核心称为 CAPAC® 平台，全称为 Click Activated Protodrugs Against Cancer（点击活化肿瘤原药）。这一平台的关键区别在于它 不依赖生物学机制，而是运用化学反应在体内实现药物激活。  1. CAPAC平台的作用机制 点击化学是一种 高度特异的化学反应方式，两个分子在生理条件下迅速、可靠结合，并生成稳定产物。Shasqi 将这一化学原理用于肿瘤治疗，其核心是通过体内四嗪（Tetrazine）与反式环辛烯（TCO）的高效共价反应实现化疗药物的局部激活：先在肿瘤区域定位一种 “可点击” 试剂（通常通过注射或系统输注的方式），随后再给入一种 “前药形式”的抗癌药物（protodrug）。当这两个成分在肿瘤区域相遇并发生点击反应时，前药便被转化为 活性药物；而在其他部位，没有这样的反应发生，因此对健康组织的毒性显著降低。  CAPAC平台作用机制 2. CAPAC 平台的三大优势 高选择性激活： 只在肿瘤区域产生有效药物，减轻全身毒性。  可扩展性强： 既可以结合多种药物载体（包括小分子、肽类、抗体片段）和不同机制的抗肿瘤分子。  克服 ADC 局限： 与抗体药物偶联技术相比，CAPAC 平台可在体内动态调整靶向剂和药物载体的比例，在临床上提供更大的优化空间。  总结来说，CAPAC 平台为精准激活肿瘤药物提供了 一种通用、模块化、可临床化的解决方案。 三、关键产品与临床进展 目前，Shasqi 的研发管线中最有代表性的候选药物是 SQ3370。 1. SQ3370：首个基于点击化学的临床程序 SQ3370 是 Shasqi 的旗舰临床候选药物，它将可激活的前药与注射于肿瘤区域的生物聚合物结合，通过点击反应释放高剂量的化疗药物 多柔比星（doxorubicin）。  这一项目的临床试验数据表明： 在体内模型中，点击化学策略能够将多柔比星在肿瘤部位的暴露量提高数倍甚至更高。  初步研究显示，在安全范围内放大有效药物剂量的同时显著减少了对全身组织的副作用。  这一方案不仅是 首个进入人体临床研究的点击化学肿瘤治疗策略，而且也被界定为一种全新的治疗范式。  2. 临床进程与试验布局 到目前为止，SQ3370 已经进入 Phase 1/2a 多中心临床试验（主要针对实体瘤患者），并在多个癌症中心开展，包括美国 MD 安德森癌症中心等机构。  这意味着，Shasqi 不再停留在实验室验证阶段，而是将这一技术推进至实际的患者应用，这是其商业化和社会影响的决定性一步。 四、研发扩展与战略合作 为了推进技术研发并加速临床转化，Shasqi 不断扩大外部合作和内部团队力量。  与强生（Johnson & Johnson）建立合作 2023 年，Shasqi 与 Johnson & Johnson Enterprise Innovation Inc. 建立了研究合作，旨在将 CAPAC 平台应用于更广泛的癌症药物开发。  该合作突出了 Shasqi 的优势：从单一药物激活扩展至更多靶点与载体组合 Shasqi的管线 总结 目前，Shasqi的核心技术仍处于临床验证阶段，但从已有的研究数据来看，其在提升治疗效果、降低副作用方面的表现令人期待。如果临床试验取得成功，这项技术将有望颠覆传统化疗模式，为全球数百万癌症患者带来新的生机。 对于Shasqi而言，未来的发展不仅面临着临床验证的挑战，还需要应对市场推广、产能扩张等一系列问题。但凭借其独特的技术优势和强大的资本支持，这家小而精的生物科技公司，有望在未来几年内实现跨越式发展。有行业分析师预测，一旦Shasqi的技术成功商业化，其市场规模有望突破数十亿美元，成为精准抗癌领域的领军企业。 参考文献： 1、Shasqi官网 https://www.shasqi.com/ 2、Srinivasan, Sangeetha, et al. "SQ3370 Activates Cytotoxic Drug via Click Chemistry at Tumor and Elicits Sustained Responses in Injected and Non‐Injected Lesions." Advanced therapeutics 4.3 (2021): 2000243. 3、Bui N, Kwatra V, Ryan C W, et al. Phase 2a results of SQ3370, a doxorubicin-based click chemistry therapeutic in patients with advanced STS: Planned interim analysis[J]. 2024. 4、Yee, Nathan, et al. "SQ3370 enhances the safety and therapeutic index of cytotoxic agents via local activation therapy with improved local and systemic immune response." Cancer Research 80.16_Supplement (2020): 6245-6245. 5、Srinivasan, Sangeetha, et al. "SQ3370, the first clinical click chemistry-activated cancer therapeutic, shows safety in humans and translatability across species." BioRxiv (2023): 2023-03. 封面图片：Shasqi官网 作者|幕斜知风骤 我们已经建立了医药交流群，群里有各大著名企业和重点高校的研究人员。大家可以一起讨论医药热点，分享经验，共同进步。想加入的话，扫码或添加小编微信（VX：Moon20240816），拉您进群！ 推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。 原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览 保留所有权利 往期链接 “小小疫苗”养成记 | 医药公司管线盘点  人人学懂免疫学| 人人学懂免疫学（语音版） 综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学 温馨提示 医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群请扫描上方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。 简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览”   ②至右上角“...”  ③点击“设为星标

The Company’s abstract, Evaluation of Teverelix in Healthy Female Volunteers, has been accepted for presentation at American Association of Clinical Endocrinology (AACE) Annual meeting 2026PHILADELPHIA, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that detailed clinical data on Teverelix, its long-acting gonadotropin-releasing hormone (GnRH) antagonist, have been accepted for e-Poster presentation at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026, to be held April 22–24 in Las Vegas, Nevada. The Company’s accepted abstract: “Evaluation of Teverelix, a Long-Acting GnRH Antagonist: Pharmacokinetics, Pharmacodynamics, Bone Turnover and Safety in Two Phase 1 studies in Healthy Female Volunteers” contains results from two randomized, placebo-controlled Phase I clinical studies involving 48 healthy premenopausal women, designed to evaluate how Teverelix is absorbed, how it suppresses reproductive hormones, its effects on bone turnover markers, and its overall safety following single subcutaneous injections. Phase 1 Results Demonstrate Rapid, Reversible Hormone Suppression with Stable Bone Markers Across both studies, 48 healthy premenopausal women received single subcutaneous doses of Teverelix (30 mg, 45 mg, or 60 mg) or placebo and were followed for approximately one month. Key findings reported in the abstract include: Rapid suppression of LH and FSH within 24 hours of dosingDose-dependent and reversible estradiol (E2) suppression, with multiple participants achieving levels within the clinically relevant Barbieri window (30–50 pg/mL), a range associated with symptom control while mitigating bone loss riskSustained pharmacodynamic activity, with hormone suppression lasting up to two to three weeks following a single injection at higher dosesStable bone turnover markers, suggesting no evidence of short-term bone lossFavorable safety profile, with no drug-related serious adverse events and only mild-to-moderate treatment-emergent adverse events reported “We believe that these findings reinforce the versatility of Teverelix as a long-acting GnRH antagonist platform,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO, “In addition to its development in prostate cancer and acute urinary retention relapse prevention, we believe these Phase 1 results support advancement into women’s health indication, endometriosis, a condition, affecting ~10% of women of reproductive age worldwide, where controlled, reversible hormone suppression and bone safety are critical. We are currently engaged in a regulatory planning for a Phase 2, Genomics-informed study of Teverelix in women with symptomatic endometriosis in United Arab Emirates (UAE)”. Teverelix: Differentiated Mechanism with Cardiovascular Relevance Teverelix trifluoroacetate is a long-acting injectable GnRH antagonist formulated as a microcrystalline suspension. Unlike GnRH agonists, which induce an initial hormonal surge, Teverelix produces immediate receptor antagonism, enabling rapid suppression of LH, FSH, and downstream sex hormones without flare. This mechanism may be clinically relevant in advanced prostate cancer patients with elevated cardiovascular risk, where emerging evidence suggests persistent FSH exposure may contribute to adverse cardiovascular outcomes. While further clinical validation is required, prior Teverelix studies so far have not demonstrated significant cardiovascular safety signals. Strategic Focus on Phase 2 De-Risking and Partnering Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization. The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model. SkinJect™ Phase 2 Program on Track for Near-Term Data Readout In parallel, Medicus continues to advance SkinJect™, its proprietary dissolvable microneedle array platform delivering doxorubicin for the non-invasive treatment of basal cell carcinoma (BCC). Phase 2 enrollment (SKNJCT-003) completed with 90 patients across nine U.S. sitesTopline decision-grade data expected in Q1 2026End-of-Phase 2 Food and Drug Administration (“FDA”) meeting planned for the first half of 2026. Previously disclosed positively trending interim findings demonstrated greater than 60% clinical clearance in an exploratory analysis conducted after more than 50% of patients of the then-targeted 60 patients in the study had been randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. For further information contact: Carolyn Bonner, President and Chief Financial Officer(610) 636-0184cbonner@medicuspharma.com Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162adjokovic@medicuspharma.com About Medicus Pharma Ltd. Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents. SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates. In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed. In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate. Antev’s flagship drug candidate is Teverelix trifluoroacetate, a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes. In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by Day 42. In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev’s proposed Phase 3 trial design for Teverelix. This milestone supports the Company’s clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk. In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients. In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome. Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect™ in this rare disease population. In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards. In December 2025, the Company announced that it has successfully completed enrolment of ninety (90) patients in the United States for phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026. In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner. Cautionary Notice on Forward-Looking Statements Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company’s submission for approval in the FDA Commissioner's National Priority Voucher program, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectation to release topline results for SKNJCT-003 in the first quarter of 2026 and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", “could,” “designed,” "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.