A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 0.5%, 1.0%, and 1.5% BT01001 Ophthalmic Solution in Healthy Adult Volunteers

This Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers. The primary objectives are to assess the safety and tolerability of single and multiple ascending doses and to characterize the pharmacokinetics of BT01001 Ophthalmic Solution following topical ocular administration.
This is a randomized, double-blind, placebo-controlled, dose-escalation trial consisting of four ascending dose cohorts. Each cohort will enroll eight participants, including six receiving BT01001 Ophthalmic Solution and 2 receiving Placebo.

开始日期2025-11-17

申办/合作机构

苏州必扬医药科技有限公司

100 项与 BT01001 相关的临床结果

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100 项与 BT01001 相关的转化医学

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100 项与 BT01001 相关的专利（医药）

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项与 BT01001 相关的新闻（医药）

2025-10-30

·beyangtx.com

Beyang Therapeutics Launches Phase I Clinical Trial of BT01001 Ophthalmic Solution in China, Advancing a Novel Therapy for Diabetic Retinopathy

Shanghai, October 30, 2025 — Beyang Therapeutics Co., Ltd. today announced the initiation of its Phase I clinical trial in China for of BT01001 Ophthalmic Solution, a novel therapy to treat diabetic retinopathy (DR) through non-invasive topical administration. This milestone follows the approval of its Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) in September 2025. BT01001 is a dual VEGFR/FGFR inhibitor developed as a topical ophthalmic solution to achieve high drug exposure in the posterior segment, offering a safer and more convenient alternative to intravitreal injections. The Phase I study (BT01001-101), conducted in Shanghai, will evaluate the safety, tolerability, and pharmacokinetics of BT01001 in healthy volunteers, under a single- and multiple-ascending dose (SAD/MAD) design. The results will guide dose selection and clinical development in DR patients. BT01001 has received IND approvals in both the U.S. (FDA) and China (NMPA), underscoring its global development potential. Qiyue Hu, Founder and CEO of Beyang Therapeutics, stated: "The initiation of this Phase I trial marks a pivotal milestone in our global strategy. Following dual IND approvals, the rapid progress of our China program underscores our team’s execution excellence and commitment to innovation in ophthalmic drug development." A launch symposium for BT01001-101 was held at Shanghai First People's Hospital, where Beyang and clinical partners reviewed key protocols and quality standards to ensure successful trial execution. About Beyang Beyang Therapeutics is an AI-driven innovative drug R&D company, aiming to become the "DreamWorks" in the field of innovative Drug Discovery. The company focuses on the development of drugs with clear mechanisms of action (MOA) and high potential for clinical translation, in the areas with unmet medical needs. Based on its proprietary ExCEED platform (molecular design, druggability assessment, and biological research), Beyang boasts industry-leading preclinical pipeline conversion rates. The core team comprises experienced scientists from leading pharmaceutical companies such as Pfizer, Merck, and Hengrui. They have participated in the R&D of three globally-launched small molecule drugs and successfully advanced over 10 projects into clinical trials. With strict target selection standards and an "AI + experience-driven" model, the company is actively deploying in high-potential fields, accelerating the development of effective drugs to address unmet patient needs while maximizing commercial value. Contact： Minghui Tong, PhD Tel：+86-13265738517 Email：tongmh@beyangtx.com Website：Beyang Therapeutics Co., Ltd.

临床申请临床1期

2025-09-14

·信狐药迅

8个仿制药上市申请获得通知件| 新获批(9.8-9.14）

每周药品注册获批数据，分门别类呈现，一目了然。(9.8-9.14）新药上市申请无新药临床申请药品名称企业注册分类受理号 BW-40202注射液上海舶望制药有限公司 1 CXHL2500668 LSCCB-PtNNN注射液金铂药业(深圳)有限公司 1 CXHL2500653 TT-00420片药捷安康(南京)科技股份有限公司 1 CXHL2500658 TT-00420片药捷安康(南京)科技股份有限公司 1 CXHL2500657 TT-00420 片药捷安康(南京)科技股份有限公司 1 CXHL2500656 HRS-3095片成都盛迪医药有限公司 1 CXHL2500655 HRS-3095片成都盛迪医药有限公司 1 CXHL2500654 硫酸酯化聚古罗糖醛酸钠颗粒中国科学院上海药物研究所 1 CXHL2500650 SYH2066片石药集团欧意药业有限公司 1 CXHL2500649 SYH2066片石药集团欧意药业有限公司 1 CXHL2500648 P052注射液惠升生物制药股份有限公司 1 CXHL2500638 P052注射液惠升生物制药股份有限公司 1 CXHL2500637 ST114注射液杭州瑞奥生物医药有限公司 1 CXHL2500643 注射用ST205 杭州瑞奥生物医药有限公司 1 CXHL2500642 CB03-154片上海挚盟医药科技有限公司 1 CXHL2500635 ALK2401片艾立康(合肥)医药科技有限公司 1 CXHL2500628 ALK2401片艾立康(合肥)医药科技有限公司 1 CXHL2500627 QLH12016胶囊齐鲁制药有限公司 1 CXHL2500625 QLH12016胶囊齐鲁制药有限公司 1 CXHL2500624 TP1001 片生元泽通(上海)医药有限公司 1 CXHL2500623 TP1001 片生元泽通(上海)医药有限公司 1 CXHL2500622 BT01001滴眼液苏州必扬医药科技有限公司 1 CXHL2500613 BT01001滴眼液苏州必扬医药科技有限公司 1 CXHL2500612 BT01001滴眼液苏州必扬医药科技有限公司 1 CXHL2500611 JMKX003002片浙江杭煜制药有限公司 1 CXHL2500606 JMKX003002片浙江杭煜制药有限公司 1 CXHL2500605 JMKX003002片浙江杭煜制药有限公司 1 CXHL2500604 注射用KLA478 湖南科伦制药有限公司 2.1;2.2 CXHL2500645 注射用KLA478 湖南科伦制药有限公司 2.1;2.2 CXHL2500644 盐酸恩沙替尼胶囊贝达药业股份有限公司 2.4 CXHL2500647 盐酸恩沙替尼胶囊贝达药业股份有限公司 2.4 CXHL2500646 戊二酸利那拉生酯胶囊上海生诺医药科技有限公司 2.4 CXHL2500620 戊二酸利那拉生酯胶囊上海生诺医药科技有限公司 2.4 CXHL2500619 流感病毒裂解疫苗(高剂量) 武汉生物制品研究所有限责任公司 3.2 CXSL2500509 GR1803注射液智翔(上海)医药科技有限公司 1 CXSL2500553 HEC-151注射液东莞市东阳光生物药研发有限公司 1 CXSL2500549 GZR101-80注射液甘李药业山东有限公司 1 CXSL2500543 注射用MCLA-129 贝达药业股份有限公司 1 CXSL2500542 SHR-1139注射液广东恒瑞医药有限公司 1 CXSL2500536 BBT002注射液杉竹曜(北京)生物医药科技有限公司 1 CXSL2500529 9MW4611注射液迈威(上海)生物科技股份有限公司 1 CXSL2500524 注射用QLC5508 齐鲁制药有限公司 1 CXSL2500519 GR2303注射液智翔(上海)医药科技有限公司 1 CXSL2500512 ALMB-0166注射液上海恩乐迈生物科技有限公司 1 CXSL2500510 VUM02注射液武汉光谷中源药业有限公司 1 CXSL2500507 异体人成纤维细胞注射液椎元医学技术(上海)有限公司 1 CXSL2500513 T3011疱疹病毒注射液苏州亦诺微医药科技有限公司 1 CXSL2500502 仿制药申请药品名称企业注册分类受理号对乙酰氨基酚颗粒上海上药信谊药厂有限公司 3 CYHS2404121 盐酸纳美芬注射液海南元盈医药科技有限公司 3 CYHS2403823 萘普生钠片浙江赛默制药有限公司 3 CYHS2402037 萘普生钠片浙江赛默制药有限公司 3 CYHS2402036 呋塞米口服溶液江苏康缘药业股份有限公司 3 CYHS2400080 羧基麦芽糖铁注射液仁合益康集团有限公司 4 CYHS2404236 羧基麦芽糖铁注射液仁合益康集团有限公司 4 CYHS2404235 阿司匹林肠溶片天津力生制药股份有限公司 4 CYHS2400508 盐酸普拉格雷片重庆医药(集团)股份有限公司 3 CYHL2500120 盐酸普拉格雷片重庆医药(集团)股份有限公司 3 CYHL2500119 雌三醇乳膏湖南派格兰药业有限公司 4 CYHL2500123 QL2106注射液齐鲁制药有限公司 3.3 CXSL2500545 司美格鲁肽注射液太极集团重庆涪陵制药厂有限公司 3.3 CXSL2500551 司美格鲁肽注射液太极集团重庆涪陵制药厂有限公司 3.3 CXSL2500550 进口申请药品名称企业注册分类受理号 ALXN2420注射液 Alexion Pharmaceuticals, Inc. 1 JXHL2500162 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500161 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500160 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500159 阿布昔替尼口服混悬液 Pfizer Inc. 2.2;2.4 JXHL2500154 Trontinemab注射液 F. Hoffmann-La Roche Ltd. 1 JXSL2500119 PF-07868489 Pfizer Inc. 1 JXSL2500114 ALPN-303注射液 Vertex Pharmaceuticals Incorporated 1 JXSL2500110 中药相关申请药品名称企业注册分类受理号补肾痹通丸新疆维吾尔自治区中医医院 1.1 CXZL2500042 注：橙色字体部分结论为不批准或收到通知件；

疫苗申请上市

2025-09-11

·beyangtx.com

Beyang Therapeutics Announces NMPA Clearance of IND for BT01001 Topical Ophthalmic Solution

Shanghai, CHINA — September 11, 2025 — Beyang Therapeutics Co., Ltd., a clinical-stage AI-driven biotechnology company, today announced that China’s National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for BT01001, a first-in-class ophthalmic solution for the treatment of diabetic retinopathy (DR). This milestone follows the U.S. Food and Drug Administration (FDA) IND clearance for BT01001, received earlier this year. The successful IND clearances in both the U.S. and China mark significant progress in the global development strategy for BT01001 and underscore its potential as a promising therapeutic candidate. BT01001 is a proprietary small-molecule ophthalmic solution formulated to achieve high posterior eye tissue exposure via the trans-scleral vascular pathway. As a potent dual-inhibitor of VEGFR and FGFR kinases, BT01001 aims to provide a non-invasive, effective treatment for DR, potentially improving patient compliance and reducing the risks associated with intravitreal injections. "The NMPA's approval of BT01001 IND application represents a critical breakthrough in Beyang's global R&D strategy and demonstrates the success of our research capabilities and regulatory strategy. " said Qiyue Hu, founder and CEO of Beyang Therapeutics. "Diabetic retinopathy has significant unmet clinical needs worldwide, and we will accelerate clinical development to bring breakthrough therapies to patients globally." About Beyang Beyang Therapeutics is an AI-driven innovative drug R&D company, aiming to become the "DreamWorks" in the field of innovative Drug Discovery. The company focuses on the development of drugs with clear mechanisms of action (MOA) and high potential for clinical translation, in the areas with unmet medical needs. Based on its proprietary ExCEED platform (molecular design, druggability assessment, and biological research), Beyang boasts industry-leading preclinical pipeline conversion rates. The core team comprises experienced scientists from leading pharmaceutical companies such as Pfizer, Merck, and Hengrui. They have participated in the R&D of three globally-launched small molecule drugs and successfully advanced over 10 projects into clinical trials. With strict target selection standards and an "AI + experience-driven" model, the company is actively deploying in high-potential fields, accelerating the development of effective drugs to address unmet patient needs while maximizing commercial value. Contact： Minghui Tong, PhD Tel：+86-13265738517 Email：tongmh@beyangtx.com Website：Beyang Therapeutics Co., Ltd.

临床申请

100 项与 BT01001 相关的药物交易

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