Maze Therapeutics, Inc.

President-elect Donald Trump’s two picks for the Federal Trade Commission are likely to usher in more life sciences deals while maintaining the agency’s pressure on pharmaceutical intermediaries. A review of public statements by Commissioner Andrew Ferguson — Trump’s choice to lead the regulator — and Mark Meador, his pick for another GOP slot, shows a strong focus on big tech and far less about drugmakers. That would be a departure from Biden-era Chair Lina Khan, who has made the pharma industry one of the agency’s primary anti-consolidation targets . Ferguson and Meador have often urged a lighter touch to antitrust, hinting at a more traditional review of consolidation than Khan’s effort to broaden the criteria for challenging biopharma deals . But the two Republicans share Khan’s skeptical view of pharmacy benefit managers, more commonly known as PBMs, that are under the agency’s microscope. Under Khan, the FTC deployed new antitrust theories to challenge pharmaceutical deals with less overlap and transactions involving drugs at early stages of development. Her legal strategy was pulled from a little-noticed workshop that the FTC held in 2022 on antitrust and drug prices, and expressed by challenges of deals between Amgen and Horizon Therapeutics , and Sanofi and Maze Therapeutics . With Ferguson and Meador joining Republican commissioner Melissa Holyoak, experts believe the life sciences industry is now in for an antitrust policy that’s more traditional — though still rigorous at times. “We’re anticipating that merger enforcement will look like the first Trump administration, which was based on traditional legal theories but still aggressive,” said Jeny Maier, a managing partner with Axinn, Veltrop & Harkrider. For example, toward the end of the first Trump administration in 2020, the FTC approved AbbVie’s $65 billion takeover of Allergan, with one stipulation: AbbVie had to divest overlapping drug products. To the majority who approved the deal, that marked an important concession and showed the agency had done its job. But in a blistering dissent that presaged Khan’s more expansive approach, then-Commissioner Rohit Chopra, a Democrat, criticized the FTC for not suing to stop the deal and said the remedy “misses the big picture, allowing pharmaceutical companies to further exploit their dominance.” Chopra’s frustration over the lack of legal action and a perceived failure to look at wider market forces foreshadowed the agency’s 2023 lawsuit to block Amgen’s $28 billion buyout of Horizon. The two companies didn’t sell competing products, but the FTC said that Amgen could use its portfolio of blockbuster medicines to entice payers to favor two Horizon drugs, thwarting potential competition. Ultimately, though, the deal closed with limited concessions. Antitrust expert Michael Carrier, a professor at Rutgers Law School, said he doesn’t expect the FTC to challenge acquisitions like this one in the future. Nor does he anticipate the agency will target deals involving early-stage drugs, like Sanofi’s attempt to acquire a Phase 1 asset from Maze. “Back to traditional pharma antitrust theories like pay for delay, product hopping and citizen petitions,” Carrier said. Under Khan, the FTC wasn’t always as aggressive as some companies feared. Last year, the agency cleared Pfizer’s $43 billion bid for Seagen , after Pfizer agreed to donate the rights to a cancer drug’s royalties to the American Association for Cancer Research. And the agency recently approved Novo Holdings’ $16.5 billion acquisition of Catalent, despite huge political pressure over the price of obesity drugs. But Khan’s FTC likely made some companies think twice about pursuing acquisitions in the first place. The shift in approach under the new picks is anticipated to ease antitrust pressure on dealmaking, experts say. Ferguson, one of two current Republican commissioners on the five-member FTC, in a memo recently obtained by the publication Punchbowl , said he plans to end “Khan’s war on mergers,” including “novel and legally dubious” cases. “Most mergers benefit Americans and promote the movement of capital that fuels innovation. Focus FTC resources on mergers that harm competition and hinder innovation,” the document states. Ferguson will have the power to reopen tougher merger guidelines that the agency debuted last year to crack down on what it called “harmful corporate consolidation.” Two current commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya, in an open letter shared on X , criticized Ferguson’s memo for not mentioning the cost of healthcare or prescription medicines. “The document does propose allowing more mergers, firing civil servants and fighting something called the ‘trans agenda.’ Is all of that more important than the cost of healthcare and groceries and gasoline?” they asked. Bedoya and Slaughter did not respond to a request for comment. Nor did Ferguson or Meador. Meador — a partner at the law firm Kressin Meador Powers, who has worked as an FTC antitrust attorney and former advisor to Sen. Mike Lee (R-UT) — is seen as holding tougher enforcement stances than Ferguson. Still, it’s expected he won’t advance novel theories of harm given his ideological underpinnings. “We will continue to see active merge enforcement, but there’s a lot of traditional, accepted theories that the agency can apply,” former FTC official and antitrust attorney James Fishkin said. (Ferguson can be elevated to FTC chair without US Senate confirmation because of his current role as commissioner, while Meador must undergo a formal confirmation process.) It doesn’t seem the FTC is in for wholesale change when it comes to PBMs, an issue that’s attracted bipartisan support in Congress as well. In September, the agency sued CVS Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum Rx, alleging the companies are artificially inflating the cost of insulin. That followed an interim FTC report that called for further investigation into the consolidated PBM industry that was characterized as pushing around competing pharmacies and extracting favorable financial outcomes. In a statement at the time , Ferguson voiced support for many of the sentiments in the report, but said more needs to be done to “determine whether these findings are representative of market dynamics for other drugs.” “The Commission is responsible for protecting consumers in those markets by enforcing competition among suppliers and middlemen,” he wrote in the statement. “Competition may not be a panacea for rising healthcare prices in America, but we owe it to Congress and the American consumers to do what we can within our statutory mandate to confront this challenge.” Meador authored a 2011 publication in the Annals of Health Law titled “Squeezing the Middleman: Ending Underhanded Dealing in the Pharmacy Benefit Management Industry through Regulation.” “The challenges instigated by the behavior in the PBM industry are not anomalies that may be remedied by occasional litigation,” Meador wrote. “Rather, constant investigation and litigation would be necessary to policy PBMs and prevent or cure unfair and deceptive practices.” Potentially buoying the FTC, PBMs have become a bipartisan target. Last week, Sens. Elizabeth Warren (D-MA) and Josh Hawley (R-MO) introduced a bill in the Senate that would require healthcare companies that own health insurers or PBMs to sell pharmacy assets within three years. The Pharmaceutical Care Management Association, a trade group representing PBMs, didn’t respond to a request for comment. “PBMs are just incredibly unpopular politically, and I think that that is true across both Democrats and Republicans,” Maier said.

▎药明康德内容团队编辑 据创鉴汇不完全统计，上周（12月2日至12月8日）全球大健康领域共披露融资事件22起，总额近55亿元。按照金额划分，亿元及以上融资9起。按照已披露的融资轮次划分，早期融资（B轮以前）7起，中后期融资（B轮及以后）10起。生物医药领域共11家公司获融资，涉及药物类型包括蛋白质类药物、抗体偶联药物、疫苗等。 #01 Nuvig Therapeutics完成1.61亿美元B轮融资 关键词：蛋白质类药物 最新融资：1.61亿美元B轮 本轮投资机构：Leaps by Bayer、Norwest Venture Partners、Novo Holdings、百时美施贵宝、赛诺菲风险投资公司等 12月5日，Nuvig Therapeutics宣布完成1.61亿美元的B轮融资。本次B轮融资获得的资金将用于支持主打在研疗法NVG-2089的临床概念验证研究，并推进Nuvig的临床前产品管线。Nuvig旨在提供无需免疫抑制即可减少自身免疫失调的全新方法。其主要候选药物NVG-2089是一种潜在“first-in-class”的重组Fc片段免疫调节剂，设计用于结合II型Fc受体，激活内源性调节机制，从而改善自身免疫失调。该公司正推进NVG-2089进入治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）和其他未公开适应症的2期临床试验，这些领域急需非免疫抑制且有效的新疗法。 #02 Maze Therapeutics获得1.15亿美元D轮融资 关键词：小分子药物 最新融资：1.15亿美元D轮 本轮投资机构：ARCH Venture Partners、Deep Track Capital、Frazier Life Sciences、Janus Henderson Investors、Logos Capital等 12月3日，Maze Therapeutics宣布获得了1.15亿美元的D轮融资。据新闻稿介绍，Maze公司将利用这笔融资推进其主要资产MZE829和MZE782研发。MZE829是一种口服APOL1抑制剂，正在针对APOL1介导肾病进行评估，2期临床试验将于2025年第一季度开始。MZE782是一种口服SCL6A19抑制剂，目前正在对健康志愿者进行1期临床试验，拟针对慢性肾病和苯丙酮尿症。 #03 亚飞生物完成超4亿元B2轮融资 关键词：小分子药物、抗体偶联药物 最新融资：超4亿元B2轮 本轮投资机构：安信国生基金、国生资本、国投招商、国元创新投资、国证投资等 12月2日，亚飞生物宣布已完成B2轮融资，本轮投资额超过4亿元人民币。亚飞生物为上海亲合力生物医药科技股份有限公司（以下简称“亲合力”）母公司。根据新闻稿介绍，本轮资金的注入将为亲合力在全球创新药物的临床研究进程中提供强劲动力，加速公司技术平台和药物的研究开发，以满足肿瘤治疗领域迫切的临床需求。亲合力致力于研究、开发、生产、商业化及对外合作创新型抗癌药物。该公司打造了只在肿瘤微环境激活的多特异性智能偶联药物技术平台，包括肿瘤微环境激活小分子偶联药物，肿瘤微环境激活抗体、双抗药物和肿瘤微环境激活抗体偶联药物为核心的一体化研发创新体系，已开发20个以上用于治疗肿瘤等重大疾病的创新候选药物。其中，亲合力自主研发的肿瘤微环境特异激活小分子偶联药物莱古比星的注册性临床即将揭盲。 #04 凯德维斯完成近2亿元B轮融资 关键词：溶瘤病毒、疫苗 最新融资：近2亿元B轮 本轮投资机构：宏泰资本、湖北省科投、九州通创投、冷杉溪资本、武汉高科等 12月5日，凯德维斯宣布完成近2亿元B轮融资，将用于公司在妇科肿瘤诊疗领域各产品的临床开发和市场拓展。凯德维斯由著名科学家、中国工程院院士、华中科技大学同济医院马丁教授发起创立，深度布局妇科肿瘤筛查、诊断、预防、治疗全流程。公司2款原研体外诊断试剂盒连续两年分别获批进入国家药监局创新医疗器械审查绿色通道，有望助力子宫内膜癌、宫颈癌等妇科肿瘤及其癌前病变的快速筛查和精准诊疗。同时，公司依托马丁院士团队数十年研究积累，积极开发溶瘤病毒、HPV治疗性疫苗等前沿创新疗法。目前，由公司自主研发的新型重组溶瘤腺病毒产品已获批进入临床1期研究阶段，有望改善现有溶瘤病毒产品广泛存在的疗效问题，突破卵巢癌等实体瘤患者治疗瓶颈。 #05 希格生科获得超7000万元Pre-A轮融资 关键词：AI药物 最新融资：超7000万元Pre-A轮 本轮投资机构：未透露 12月3日，希格生科宣布，公司获得超过7000万元人民币的Pre-A轮融资及项目资助。此次融资用来支持首条管线SIGX1094的一期临床试验以及加速第二条管线的IND申报进程。此外，公司将进一步优化和升级公司的类器官疾病模型平台，以赋能更广泛的新药开发需求。希格生科成立于2020年底，由包括哈佛大学Dana-Farber癌症研究所在内的一支杰出科学家团队共同创立。公司创始人发现弥漫性胃癌全新的靶标，并且利用类器官疾病模型结合AI技术开发针对弥漫性胃癌的靶向药物SIGX1094，该药物目前已获得美国FDA和国家药监局NMPA的IND批件，进入1期临床，并且于近日获得美国FDA孤儿药资格认定。 读者们请星标⭐创鉴汇，第一时间收到推送 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。 更多数据内容推荐 点击“在看”，分享创鉴汇健康新动态

▎药明康德内容团队报道 根据即刻药数数据库，上周（12月2日~12月8日），全球范围内至少有8家致力于创新药研发的新锐公司宣布完成新一轮融资，其中2家来自中国。这些获得资本市场青睐的新锐公司正在开发创新小分子偶联药物、双特异性抗体、多肽药物、小分子激活剂药物等药物类型，专注的疾病领域涵盖癌症、神经系统疾病、代谢性疾病等。 亚飞生物 融资轮次：B2轮 融资金额：超4亿元 12月2日，上海亲合力生物医药科技股份有限公司（简称“亲合力”）母公司亚飞生物宣布已完成B2轮融资，本轮投资额超过4亿元人民币。本轮融资由国投招商领投，华创资本、宏诚投资、国证投资、国生资本、鸿富资产、安信国生微芯基金、国元创新投、弘曜科创等知名投资机构共同参与。亲合力致力于研究、开发、生产、商业化及对外合作创新型抗癌药物，针对靶点机制潜在有效、但毒性较强的分子，进行增效和降毒改造，旨在解决目前肿瘤治疗领域巨大的未被满足的临床需求。 亲和力公司打造了只在肿瘤微环境激活的多特异性智能偶联药物技术平台，包括肿瘤微环境激活小分子偶联药物，肿瘤微环境激活抗体、双抗药物和肿瘤微环境激活ADC为核心的一体化研发创新体系，已开发20个以上用于治疗肿瘤等重大疾病的创新候选药物。其中，该公司自主研发的肿瘤微环境特异激活小分子偶联药物莱古比星的注册性临床即将揭盲。 Jupiter Neurosciences 融资轮次：IPO 融资金额：1100万美元 12月2日，Jupiter Neurosciences宣布1100万美元的首次公开募股定价并在纳斯达克上市。Jupiter是一家临床阶段医药公司，目前专注于中枢神经系统疾病和罕见疾病创新疗法的开发。该公司的JOTROL™给药平台允许白藜芦醇以一种易于消耗的口服软胶囊形式服用。通过JOTROL™平台输送，白藜芦醇注入血浆和中枢神经系统，并穿过血脑屏障，释放该化合物作为治疗神经退行性和神经系统疾病的潜力，而不会引起胃肠道问题。基于该平台，Jupiter公司正在开发一种增强型口服白藜芦醇制剂，旨在提供与治疗相关的安全水平的白藜芦醇。本次IPO募集资金将助力其候选产品在帕金森病患者中的2期临床试验。 希格生科 融资轮次：Pre-A轮 融资金额：超7000万元 12月3日，希格生科宣布获得超过7000万元人民币的Pre-A轮融资及项目资助。此次融资用来支持首条管线SIGX1094的1期临床试验以及加速第二条管线的IND申报进程。希格生科成立于2020年底，由包括哈佛大学Dana-Farber癌症研究所在内的一支杰出科学家团队共同创立。该公司创始人发现了针对弥漫性胃癌的全新靶标，并且利用类器官疾病模型结合AI技术开发首个针对弥漫性胃癌的靶向药物SIGX1094，该药物目前已获得美国FDA和中国NMPA的IND批件，进入1期临床，并且于近日获得美国FDA授予的孤儿药资格。 Maze Therapeutic 融资轮次：D轮 融资金额：1.15亿美元 12月3日，Maze Therapeutics宣布完成1.15亿美元的D轮融资。本轮融资由投资者Frazier Life Sciences和Deep Track Capital共同领投。Maze Therapeutics是一家临床阶段的生物医药公司，旨在利用人类遗传学的力量，为患有肾脏、心血管和代谢疾病的患者开发新颖的小分子精准治疗药物。 根据新闻稿，本轮融资资金将支持Maze公司的主导项目MZE829和MZE782的开发。MZE829是一种口服APOL1抑制剂，目前正在评估用于APOL1肾病（AKD）的治疗，包括局灶节段性肾小球硬化（FSGS）患者，预计将于2025年第一季度开始2期试验。MZE782是一种口服SCL6A19抑制剂，Maze正在进行1期健康志愿者试验，计划评估其作为慢性肾脏疾病（CKD）和苯丙酮尿（PKU）的治疗。第一阶段临床试验的数据预计将于2025年下半年公布。 TRIO Pharmaceuticals 融资轮次：未知轮 融资金额：310万美元 12月3日，TRIO Pharmaceuticals宣布完成由Friedman Bioventure Fund (FBVF)领投的310万美元融资。TRIO Pharmaceuticals专注于开发双特异性抗体癌症免疫疗法。根据新闻稿，本轮融资融资将用于加速TRIO公司的临床试验进程，以及药物平台的开发。该公司正在开发一个双作用肿瘤免疫增强药物的专有平台，旨在通过靶向癌细胞和免疫抑制细胞上的特定抗原来治疗高度未满足医疗需求的癌症。 Refoxy Pharmaceuticals 融资轮次：种子轮 融资金额：910万欧元 12月4日，Refoxy Pharmaceuticals宣布获得了910万欧元的种子扩展融资，由勃林格殷格翰风险投资基金（BIVF）领投，Apollo Heath Ventures等新老投资者加入。Refoxy是一家临床前阶段生物技术公司，旨在开发FOXO3转录因子小分子激活剂，用于治疗与年龄相关的疾病。 FOXO3是与人类寿命更长、更健康密切相关的基因之一，也使其成为药物发现的一个备受关注的靶标。然而，FOXO3复杂的生物学特性限制了对其临床潜力的开发。Victor Bustos博士与世界知名的FOXO3专家Wolfgang Link教授联合Apollo Health Ventures共同创立了Refoxy公司。该公司的战略重点是通过一个专有的药物发现平台FOXO激活剂查找器（F.act finder）来识别FOXO3的激活剂。本轮融资将加速Refoxy公司特发性肺纤维化（IPF）项目的临床前开发，并将其平台扩展到其他与年龄相关的适应症。 Antag Therapeutics 融资轮次：A轮 融资金额：8000万欧元 12月4日消息，Antag Therapeutics宣布完成8000万欧元的A轮融资。此轮融资由Versant Ventures领投，创始投资者Novo Holdings以及新投资者SR One、Dawn Biopharma和Pictet等参与。Antag Therapeutics是一家生物医药公司，旨在开创肥胖症新疗法。根据新闻稿，本轮融资资金将用于AT-7687的临床开发，AT-7687是一种每周一次皮下注射的新型葡萄糖依赖性胰岛素促性多肽受体（GIPR）拮抗剂肽类药物，旨在与当前或未来的肥胖疗法（包括GLP-1药物）联合使用，以为患者提供更好的减肥和代谢益处。Antag公司还将推动每月注射疗法产品线的扩张。 Nuvig Therapeutics 融资轮次：B轮 融资金额：1.61亿美元 12月6日，Nuvig Therapeutics宣布完成1.61亿美元的B轮融资。此次融资由Sanofi Ventures、Blue Owl Healthcare Opportunities和Norwest Venture Partners共同领投，新投资者B Capital、Leaps by Bayer、Global BioAccess Fund、LOTTE Holdings、Alexandria Venture Investments和abrdn Inc.管理的基金，以及现有股东Novo Holdings A/S、Platanus、百时美施贵宝（Bristol Myers Squibb）、Digitalis Ventures和Mission biocital参与。 Nuvig公司旨在提供无需免疫抑制即可减少自身免疫失调的全新方法。本次B轮融资获得的资金将用于支持主打在研疗法NVG-2089的临床概念验证研究，并推进临床前产品管线NVG-2089是一种潜在“first-in-class”的重组Fc片段免疫调节剂，设计用于结合II型Fc受体，激活内源性调节机制，从而改善自身免疫失调。Nuvig公司正推进NVG-2089进入治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）和其他未公开适应症的2期临床试验。 期待在资本市场的助力下，更多前沿技术和创新疗法可以尽快造福患者。 参考资料： [1]各家公司官网及公开资料 本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。