近日，人福医药自主研发的新型口服选择性P2X3受体拮抗剂HW091077片在难治性慢性咳嗽或不明原因慢性咳嗽（RCC/UCC）患者中的Ⅱ期临床研究顺利完成首例受试者入组，标志着该产品正式进入以患者疗效探索为核心的临床阶段。
这项全国多中心的Ⅱ期研究由广州医科大学附属第一医院担任组长单位，全国32家研究中心共同参与。研究为随机、双盲、安慰剂对照的剂量探索试验，计划纳入180例RCC/UCC患者，随机分配至试验药物组或安慰剂组，接受为期28天的治疗，旨在初步评估HW091077的有效性与安全性，并探索最佳治疗剂量。
关于难治性慢性咳嗽
难治性慢性咳嗽或不明原因慢性咳嗽（RCC/UCC）是指咳嗽时长超过8周，虽经规范检查与治疗，病因仍不明确或治疗效果不佳的慢性咳嗽。该疾病严重影响患者生活质量，常伴随尿失禁、睡眠障碍、焦虑抑郁等并发症，严重损害患者的生理功能、心理健康与社会功能，给个人及家庭带来显著负担。
目前，国内针对RCC/UCC仍缺乏安全有效的治疗手段，临床常用药物多属于超说明书使用，且存在疗效不明确、耐药或成瘾性等问题，远未满足患者的实际治疗需求。
关于HW091077
HW091077是由人福医药自主研发的1类化学创新药，为新型口服选择性P2X3受体拮抗剂。其作用机制是通过阻断ATP与P2X3受体的结合，降低外周神经敏感性，从而抑制病理性咳嗽。P2X3受体是目前该领域唯一经过临床验证的有效靶点，其有效性和安全性已在同类药物的临床研究中得到证实。
在健康受试者中已完成的I期临床试验中，HW091077展示了良好的安全性和药代动力学特征：大部分不良事件为1级，仅在高剂量组中少数受试者出现轻微、可逆的味觉相关不良事件。Ⅰ期研究结果为推进该药物进入Ⅱ期临床研究提供了充分依据。
作为国内P2X3靶点领域进展领先的创新药物，HW091077片的顺利推进有望为难治性慢性咳嗽患者提供一款疗效明确、安全性良好、给药便捷的全新治疗选择，我们期待加快推进HW091077片的临床研究进程，为患者带来更安全有效的治疗选择。
关于人福医药研究院
人福医药研究院是人福医药集团的中央研发机构，是集团创新发展的核心引擎，承载着集团战略转型使命，为构建全球研发体系、冲刺世界一流生命科技企业提供核心支撑。研究院聚焦创新药研发，以满足未被满足的临床需求为导向，在集团的优势治疗领域持续深耕，凭借强劲的自主研发与转化能力确立和巩固集团在核心细分赛道的研发优势。研究院将以患者需求为初心、科技创新为引擎，深耕生命健康领域，用优质创新药物赋能人类健康事业，助力集团打造全球竞争力。如需了解更多研发动态，欢迎关注“人福医药研究院”微信公众号。
First Patient Enrolled in Phase Ⅱ Trial of Humanwell Healthcare’s HW091077 for RCC/UCC
Recently, the first patient was dosed in the Phase Ⅱ study of HW091077, a novel oral selective P2X3 receptor antagonist independently developed by Humanwell Healthcare, for refractory or unexplained chronic cough (RCC/UCC), which means HW091077 advances into clinical trials in patients.
Led by The First Affiliated Hospital of Guangzhou Medical University, this multicenter Phase Ⅱ study is being conducted across 32 clinical sites nationwide. The randomized, double-blind, placebo-controlled, dose-finding trial is designed to enroll 180 patients with RCC/UCC. Participants will be randomized to receive either the investigational drug or a placebo for a 28-day treatment period. The study aims to evaluate the preliminary efficacy and safety of HW091077 and to identify its optimal therapeutic dose.
About Refractory Chronic Cough
Refractory chronic cough or unexplained chronic cough (RCC/UCC) is a chronic cough lasting more than 8 weeks that, despite standard evaluation and treatment, remains unexplained or refractory. This condition severely impairs patients’ quality of life and is frequently accompanied by complications such as urinary incontinence, sleep disturbances, anxiety, and depression. It significantly compromises physical, mental, and social function, imposing a substantial burden on individuals and their families.
To date, safe and effective therapies for RCC/UCC remain scarce in China. Commonly prescribed medications are often used off-label and are associated with uncertain efficacy, drug tolerance, and dependence. These limitations leave a substantial gap in addressing the actual treatment needs of patients.
About HW091077
HW091077, a small-molecule innovative drug developed in-house by the Humanwell Pharmaceutical R&D Institute, is a novel, orally administered, selective P2X3 receptor antagonist. By blocking the binding of ATP to the P2X3 receptor, it reduces peripheral neuronal sensitization and suppresses pathological cough. Currently, the P2X3 receptor is the only clinically validated target in this therapeutic area, with its efficacy and safety profiles well-established by clinical studies of other agents in the same class.
In a completed Phase Ⅰ study involving healthy volunteers, HW091077 demonstrated a favorable safety and pharmacokinetic (PK) profile. Most adverse events were Grade 1，with mild, reversible taste-related adverse events reported in only a small subset of the high-dose cohort. These Phase Ⅰ results established a robust foundation for advancing the candidate into Phase Ⅱ clinical development.
As a frontrunner among P2X3-targeted innovative therapies in China, HW091077 is anticipated to offer a novel treatment option for patients with refractory or unexplained chronic cough (RCC/UCC), combining robust efficacy, a favorable safety profile, and the convenience of oral administration. Moving forward, Humanwell Healthcare remains committed to accelerating the clinical development of this asset to bring safer and more effective therapeutic solutions to patients worldwide.
About Humanwell R&D Institute
Humanwell Pharmaceutical Research and Development Institute is the central R&D organization of Humanwell Healthcare and the core engine driving Humanwell's innovation-led development. It undertakes Humanwell's strategic transformation mission and provides essential support for building a global R&D system and advancing toward a world-class life sciences enterprise. Focused on innovative drug development and guided by unmet clinical needs, the Institute continues to deepen its expertise in Humanwell's key therapeutic areas, leveraging strong in-house R&D and translational capabilities to establish and reinforce Humanwell's research advantages in core niche segments. With patient needs as its founding mission and technological innovation as its driving force, the Institute is committed to advancing the field of life and health sciences, empowering human health through high-quality innovative medicines, and helping Humanwell build global competitiveness. For more updates on our R&D progress, follow the official WeChat account "Humanwell Pharmaceutical Research Institute".
声明：
1. 本资讯旨在分享医药领域的科研进展与前沿信息，仅供医疗卫生专业人士进行学术交流与参考，不构成任何广告或产品推荐。
2. 本资讯中涉及的信息不能替代专业医疗指导，所有医疗决策请遵从医疗卫生专业人士的意见或指导。
3. 本资讯任何前瞻性陈述均基于当前预测，实际结果可能存在不确定性。
4. 对于依赖本文信息作出的任何决定或行动，本公司不承担相关责任。
