NLRP3 inhibitor(Takeda pharm)

✧ BGE-102是一种强效、结构新颖、具有脑渗透性的口服小分子NLRP3抑制剂，其苗头化合物通过成都先导的DEL技术平台筛选获得，目前已进入用于降低心血管风险的II期概念验证临床试验QUELL-CV。 ✧ QUELL-CV试验旨在为BGE-102的III期临床研究剂量选择以及在心血管疾病领域的后续开发路径提供依据。顶线数据预计于2026年下半年公布。 中国成都，2026年7月14日——成都先导药物开发股份有限公司（以下简称“成都先导”，股票代码：688222.SH）祝贺合作伙伴BioAge Labs, Inc.（以下简称“BioAge”，纳斯达克股票代码：BIOA）于近日启动BGE-102的II期概念验证临床试验QUELL-CV并完成首例受试者给药。BGE-102是一种强效、结构新颖、具有脑渗透性的口服小分子NLRP3抑制剂，其苗头化合物是通过成都先导行业领先的DNA编码化合物库（DEL）技术平台筛选获得。 BGE-102为每日一次的口服给药方案，首要适应症为降低心血管风险。BioAge此前公布的I期临床研究数据显示，BGE-102是潜在的同类最优NLRP3抑制剂，在每日一次口服给药方案中实现了高敏C反应蛋白（hsCRP）水平显著降低，且耐受性良好。QUELL-CV是一项随机、双盲、安慰剂对照、剂量探索的II期概念验证临床试验，旨在评估BGE-102在心血管风险升高受试者中的疗效；该试验将为BGE-102的III期临床研究剂量选择以及在心血管疾病领域的后续开发路径提供依据。顶线数据预计于2026年下半年公布。 成都先导与BioAge自合作以来，已取得一系列成果：2021年4月，双方共同宣布成功筛选出具有开发潜力的苗头化合物；2024年2月，双方在《Bioorganic & Medicinal Chemistry Letters》期刊上联合发表题为“The discovery of novel and potent indazole NLRP3 inhibitors enabled by DNA-encoded library screening”（“利用DEL技术发现重要靶点NLRP3的新颖、高效、电中性小分子抑制剂”）的文章，之后双方共同提交了关于DEL筛选发现的新颖结构化合物的专利申请。目前，双方正继续推进合作，利用成都先导的DEL技术平台开展更多新靶点的药物发现研究。 “BGE‑102是一款极具潜力的候选药物，我们非常高兴地看到其顺利进入II期临床研究，”成都先导董事长兼首席执行官李进博士表示。“这不仅进一步证明了成都先导DEL技术平台针对挑战性靶点筛选出新颖小分子的能力，也再次反映出我们与BioAge合作模式的优势所在。我们将继续深化合作，也期待看到BGE‑102的后续开发进展。” “启动II期临床研究对于BGE-102本身以及我们与成都先导的合作而言，都是一个重要里程碑，”BioAge首席执行官兼联合创始人Kristen Fortney博士表示。“通过成都先导DEL技术平台筛选出的结构新颖的NLRP3抑制剂苗头化合物，由我们的药物化学团队进一步开发为BGE-102。BGE-102是一种口服、具有脑渗透性的分子，能够作用于NLRP3的新颖结合位点，在I期临床研究中实现了hsCRP水平显著降低。我们期待延续双方的合作，为BioAge管线中的更多靶点找到新颖的起点化合物。” 成都先导依托国际领先的DEL核心技术平台以及一系列衍生新药研发技术平台，打造了独特的新药“种子”发现“引擎”，向全球医药工业提供治疗性分子与新型工具分子。其DEL平台拥有包含超过1.2万亿DNA编码化合物的实体分子库，DEL产品以及高效筛选能力已经服务于全球多个机构和组织的新药发现项目。截至2025年底，公司已累计为全球超过600家客户赋能了数千个创新药研发项目。 关于成都先导 成都先导药物开发股份有限公司（股票代码：688222.SH）致力于成为具有全球影响力的创新型生物医药企业，为解决未满足的临床需求提供创新治疗方案，为人类健康与生命质量的提升做出贡献。公司以国际领先的DEL（DNA编码化合物库）技术为核心，拓展了基于分子片段和三维结构信息的药物设计，以及基于寡核苷酸的药物研发技术、临近诱导药物研发技术和类环肽等衍生技术平台，并自主研发了“DEL+AI+自动化”一体化分子优化平台HAILO，构建起独特的新分子发现体系，向全球医药工业提供治疗性分子与新型工具分子。成都先导总部位于中国成都，在英国剑桥、美国休斯顿设有子公司，业务网络辐射全球。通过新药研发服务、不同阶段在研项目转让及远期的药物上市等商业模式，成都先导与全球众多制药公司、生物技术公司、化学公司、基金会以及科研机构建立了广泛合作，截至2025年底，已累计为全球超过600家客户赋能了数千个创新药研发项目。公司拥有多个内部新药项目，分别处于临床及临床前不同阶段。 关于BioAge Labs, Inc. BioAge是一家临床阶段的生物医药公司，致力于针对人类衰老生物学机制开发心血管代谢疾病治疗候选药物。公司的主要候选药物BGE-102是一种强效、结构新颖、具有脑渗透性的口服小分子NLRP3抑制剂，正在开发用于降低心血管风险以及治疗包括糖尿病性黄斑水肿在内的视网膜疾病。BGE-102已完成I期单次/多次剂量递增（SAD/MAD）研究，在肥胖及炎症水平升高的受试者中表现出良好的耐受性，并在高敏C反应蛋白（hsCRP）及其他炎症标志物方面实现了潜在的同类最优抑制作用。II期心血管风险概念验证临床试验数据预计于2026年底公布，Ib/IIa期糖尿病性黄斑水肿概念验证临床试验数据预计于2027年中公布。同时，公司正在开发用于治疗肥胖症的长效注射型和口服小分子APJ激动剂。此外，BioAge依托其专有的人类长寿数据研究平台，持续推进针对代谢衰老关键通路的多个临床前研究项目。 HitGen Partner BioAge Labs Doses First Participant in Phase 2 Trial of BGE-102, a Novel Oral NLRP3 Inhibitor for Cardiovascular Risk Reduction ✧ BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor developed from a hit identified via HitGen's DEL technology platform, has advanced into a Phase 2 proof-of-concept trial for cardiovascular risk reduction. ✧ The QUELL-CV trial is designed to inform optimal dose selection in Phase 3 and BGE-102's path forward in cardiovascular disease. Topline data are anticipated in the second half of 2026. Chengdu, China, July 14, 2026 – Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH), congratulates its partner BioAge Labs, Inc. ("BioAge", NASDAQ: BIOA), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, on dosing the first participant in QUELL-CV, a Phase 2 proof-of-concept clinical trial of BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor. BGE-102 was developed from a hit compound identified via HitGen's industry-leading DEL (DNA-Encoded Library) technology platform. It is being developed as a once-daily oral therapy, with cardiovascular risk reduction as the lead indication. The Phase 1 results reported by BioAge have positioned BGE-102 as a potential best-in-class NLRP3 inhibitor, with profound hsCRP reductions on a well-tolerated, once-daily oral dose. QUELL-CV is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 proof-of-concept trial evaluating BGE-102 in participants at elevated cardiovascular risk; the trial is designed to inform optimal dose selection in Phase 3 and BGE-102's path forward in cardiovascular disease. Topline data are anticipated in the second half of 2026. The collaboration between HitGen and BioAge has previously resulted in the successful identification of promising hit molecules announced in April 2021, a joint publication in Bioorganic & Medicinal Chemistry Letters in February 2024 entitled "The discovery of novel and potent indazole NLRP3 inhibitors enabled by DNA-encoded library screening", and joint patent filings covering the structurally novel compounds discovered through the DEL screening process. The two companies continue to collaborate on additional drug discovery programs for other novel targets using HitGen's DEL platform. "We are very pleased to see BGE‑102 reach the Phase 2 milestone," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc. "This achievement not only underscores the power of our DEL platform in generating novel small‑molecule leads against challenging targets, but also highlights the strength of our collaborative model with BioAge. We are excited to continue our partnership and watch this promising candidate progress further." "Reaching Phase 2 is an important milestone for BGE-102 and for our collaboration with HitGen," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "HitGen's DEL platform helped us identify structurally novel NLRP3 inhibitor hits. Our medicinal chemistry team advanced those hits into BGE-102, an oral, brain-penetrant molecule that engages a novel NLRP3 binding site and that produced profound hsCRP reductions in our Phase 1 trial. We look forward to continuing our collaboration with HitGen to identify novel starting points against additional targets across our pipeline." Leveraging its internationally recognized DEL technology platform and a suite of complementary drug discovery platforms, HitGen has established a distinctive discovery engine that delivers both therapeutics molecules and novel tool molecules to the global pharmaceutical industry. Its DEL platform includes over 1.2 trillion small molecules, and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations worldwide. As of the end of 2025, the company has partnered with over 600 clients globally and contributed to thousands of their innovative drug development projects. About HitGen Inc. HitGen Inc. (SSE: 688222.SH) is dedicated to building a world-class innovative biopharmaceutical enterprise. Driven by the mission to advance human health and quality of life, it provides innovative therapeutic solutions to address unmet medical needs. Centered on its internationally leading DEL (DNA-encoded Library) technology, the Company has expanded into Fragment-Based Drug Discovery and Structure-Based Drug Design and a suite of complementary platforms based on Oligonucleotide-based Therapeutics, Targeted Proximity Drugs, and Cyclic Peptidomimetics, and has developed HAILO, a proprietary "DEL+AI+Automation" molecular optimization platform, thereby establishing a distinctive novel molecule discovery engine that delivers both therapeutics molecules and tool molecules to the global pharmaceutical industry. Headquartered in Chengdu, China, HitGen maintains subsidiaries in Cambridge, UK, and Houston, USA, with its operational network spanning the globe. Through diversified and flexible business models including technical services, project out-licensing and product sales, the Company has forged extensive collaborations with a broad range of pharmaceutical and biotechnology companies, chemical firms, foundations, and research institutions. As of the end of 2025, it has empowered over 600 clients globally and contributed to thousands of their innovative drug development projects. HitGen also advances multiple internal programmes at various clinical and preclinical stages. For more information, please visit www.hitgen.com. About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated by end of year 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid-2027. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging. 获取更多信息，请致电+86-28-85197385或访问www.hitgen.com。 媒体查询：media@hitgen.com 投资者咨询：investors@hitgen.com 商务开发：bd@hitgen.com