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Over 65% of Patients Reported Reduced Pain and Itching; Zero Disruptions to EGFR Cancer Therapy with ~99% Lower Systemic Exposure NEW YORK , April 1, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) , a clinical-stage biopharmaceutical company, today announced positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of ≤1 by week six. In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001's potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor (EGFR) cancer therapies. Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments. HT-001 was also well tolerated, with no treatment discontinuations reported. Pharmacokinetic (PK) analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery pro to maximize local efficacy while minimizing systemic side effects. Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation. "The achievement of these interim results, combined with strong patient-reported outcomes and the ability to maintain uninterrupted cancer therapy, represents a meaningful advancement for HT-001," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "With over 65% of patients reporting reductions in pain and itching, along with a favorable safety pro expanding global clinical footprint, we believe HT-001 is well positioned as a differentiated therapy addressing a critical unmet need in oncology supportive care." Dermatologic toxicities remain a significant challenge for patients undergoing cancer treatment, often leading to discomfort, reduced quality of life, and in some cases treatment modification or discontinuation. HT-001's ability to demonstrate primary endpoint achievement, meaningful symptom improvement, and zero disruption to EGFR inhibitor therapy may represent a compelling advancement over existing treatment options. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit . Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Contact: LR Advisors LLC Email: investorrelations@hoththerapeutics.com Phone: (678) 570-6791 View original content to download multimedia: SOURCE Hoth Therapeutics, Inc.

精彩内容 日前，国家医保局发布《通过一致性评价企业数较多且尚未纳入国家组织集采的药品》，被业界视为第十二批国采的候选品种名单。151个品种在列，2025年在中国公立医疗机构终端的销售额合计超过1000亿元。若以米内网最新数据（截至今年3月）看，17个品种火爆（达20家及以上），倍特、齐鲁、科伦等数量领跑。 过评企业数较多且尚未纳入国采的药品 注：国家医保局统计口径截至2025年11月 来源：国家医保局、米内网数据库 151个品种冲击超1000亿市场 米内网数据显示，151个品种2025年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额（不区分规格、适应症等）合计超过1000亿元。 从销售额分层情况看，以超1亿元但不足5亿元的品种为主，占比超过“半壁江山”；其次是超5亿元但不足10亿元的品种，占比超过20%；超10亿大品种占比超过15%，包括碘佛醇、头孢他啶阿维巴坦等注射剂，沙库巴曲缬沙坦、他克莫司等口服常释剂型，七氟烷、乙酰半胱氨酸等吸入剂等。 从剂型分布情况看，以片剂、胶囊剂为代表的口服常释剂型最多，占比约37%；注射剂紧接其后，占比约33%；口服液体剂排位第三，占比约8.6%。目前开展的十批化药集采已纳入400余个品种，亦是以口服常释剂型为主。 151个品种剂型分布情况 从治疗领域看，151个品种涵盖13个治疗大类，集中在消化系统及代谢药、心脑血管系统药物、神经系统药物、抗肿瘤和免疫调节剂、全身用抗感染药物等，涉及的品种数分别达24个、21个、19个、18个、16个，占比均超过10%。 151个品种大类分布情况 超20家！17个品种火爆 从截至2025年11月（国家医保局公布）与截至2026年3月（米内网数据库）两个时间节点的企业数量看，151个品种中，有超过一半的品种新增了过评企业。其中，维生素B6注射剂、尼卡地平注射剂、伏诺拉生口服常释剂型、布美他尼注射剂、复合磷酸氢钾注射剂等品种新增过评企业数均达10家及以上。 新增过评企业数达10家及以上的品种 若以截至2026年3月的时间点统计，151个品种中，参比制剂和过评企业数量合计超过20家的品种有17个，超10家但不足20家的品种有55个，7-9家的品种有37个，5-6家的品种有42个。 参比制剂和过评企业数量合计达20家及以上的品种 乳果糖口服液体剂、氨溴特罗口服液体剂、伏诺拉生口服常释剂型遭“哄抢”，目前参比制剂和过评企业数量合计均超过40家。其中，乳果糖口服液体剂以50家企业领跑，该药适用于慢性或习惯性便秘及肝性脑病，2025年在中国公立医疗机构终端的销售额超过18亿元。从厂家格局看，雅培、韩美、费森尤斯卡比依次位列前三，市场份额分别超过32%、28%、11%。 近年来中国公立医疗机构终端乳果糖口服液体剂销售情况（单位：万元） 来源：米内网中国公立医疗机构药品终端竞争格局 维生素B6注射剂的过评企业数由2025年11月的20家增加至2026年3月的37家，新增了17家企业，是151个品种中新增过评企业数最多的品种。该药近年来在中国公立医疗机构终端的市场承压，2025年销售额接近4亿元，瑞阳制药主导市场。 近年来中国公立医疗机构终端维生素B6注射剂销售情况（单位：万元） 来源：米内网中国公立医疗机构药品终端竞争格局 倍特、齐鲁、科伦领跑 从151个品种的过评企业看，倍特药业、齐鲁制药、科伦药业、复星医药、远大健康、国药集团、石四药为“主力军”，目前过评品种数分别有33个、31个、24个、23个、23个、21个、20个。 涉及品种数达20个及以上的企业（以集团计） 倍特药业以33个品种领跑，包括13个注射剂、9个口服常释剂型、8个口服液体剂、2个吸入剂及1个颗粒剂。其中，吡格列酮二甲双胍片为2026年新获批品种，注射用盐酸万古霉素、乳果糖口服溶液、盐酸曲唑酮片、麦考酚钠肠溶片、复方氨基酸注射液(18AA-Ⅶ)、氨氯地平贝那普利胶囊等为2025年新获批品种。 齐鲁制药以31个品种紧接其后，包括12个口服常释剂型、10个注射剂、4个滴眼剂、2个软膏剂、1个口崩片、1个及1个颗粒剂。其中，盐酸尼卡地平注射液、甲苯磺酸艾多沙班片、达格列净二甲双胍缓释片(Ⅰ)等为2025年后新获批品种。 科伦药业以24个品种排位第三，包括13个注射剂、6个口服常释剂型、2个缓释控释剂型、1个外用液体剂、1个口服液体剂及1个散剂。其中，盐酸曲唑酮片、氯化钙注射液、艾拉莫德片等为2026年新获批品种，阿瑞匹坦注射液、醋酸加尼瑞克注射液、甲磺酸多沙唑嗪缓释片等10余个为2025年新获批品种。 资料来源：米内网数据库、国家医保局等 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至3月27日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。 本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦