[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial of loxoprofen sodium eye drops in the treatment of inflammation and pain after cataract surgery

探索洛索洛芬钠滴眼液治疗白内障术后炎症和疼痛的最佳剂量浓度和用药频次，并初步评价洛索洛芬钠滴眼液治疗白内障术后炎症和疼痛的有效性及安全性。

[Translation]

To explore the optimal dose concentration and frequency of loxoprofen sodium eye drops in the treatment of inflammation and pain after cataract surgery, and to preliminarily evaluate the efficacy and safety of loxoprofen sodium eye drops in the treatment of inflammation and pain after cataract surgery.

Start Date30 Dec 2022

Sponsor / Collaborator

Guangzhou Aobo Medical Technology Co., Ltd.

[+1]

CTR20212538 / CompletedPhase 1

一项洛索洛芬钠滴眼液单次/多次给药在健康受试者中的安全性、耐受性和药代动力学特征的I期临床试验

[Translation] A phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of single/multiple administration of loxoprofen sodium eye drops in healthy subjects

主要目的：评价洛索洛芬钠滴眼液单次/多次给药在健康受试者中的安全性和耐受性，为后期临床研究提供剂量设置依据。次要目的：评价洛索洛芬钠滴眼液单次/多次给药在健康受试者中的药代动力学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of single/multiple administration of loxoprofen sodium eye drops in healthy subjects, and to provide a basis for dose setting for later clinical studies. Secondary objective: To evaluate the pharmacokinetic characteristics of single/multiple administration of loxoprofen sodium eye drops in healthy subjects.

Start Date19 Oct 2021

Sponsor / Collaborator

Guangzhou Aobo Medical Technology Co., Ltd.

[+1]

CTR20192482 / Active, not recruitingPhase 2

连翘苷胶囊（KD-1胶囊）治疗急性流行性感冒发热症状的有效性及安全性、随机、双盲、安慰剂平行对照、剂量探索、多中心Ⅱ期临床试验

[Translation] Efficacy and safety of Forsythiaside Capsules (KD-1 capsules) in the treatment of fever symptoms in acute influenza: a randomized, double-blind, placebo-controlled, dose-finding, multicenter phase II clinical trial

主要目的：观测流感发热患者的体温复常时间，评价连翘苷胶囊相较于安慰剂治疗流感相关发热症状消退时间方面的有效性。次要目的：（1）通过观测流感发热患者体温复常后的发热复发率、即刻退热时间、流感临床痊愈时间、流感症状缓解时间、流感症状改善程度、流感病毒转阴率、血清细胞因子-白细胞介素6（IL-6）水平，进一步评估连翘苷胶囊与安慰剂相比的有效性；（2）通过观测流感发热患者的不良事件等安全性评价指标，评估连翘苷胶囊的安全性和耐受性；（3）探索连翘苷胶囊治疗流感引起发热的最适剂量。

[Translation]

Main purpose: To observe the time for the body temperature of patients with influenza fever to return to normal, and to evaluate the effectiveness of Forsythiaside Capsules compared with placebo in treating the time for the resolution of influenza-related fever symptoms. Secondary purpose: (1) To further evaluate the effectiveness of Forsythiaside Capsules compared with placebo by observing the fever recurrence rate, immediate fever reduction time, clinical recovery time, influenza symptom relief time, influenza symptom improvement degree, influenza virus negative conversion rate, and serum cytokine-interleukin 6 (IL-6) level after the body temperature of patients with influenza fever returned to normal; (2) To evaluate the safety and tolerability of Forsythiaside Capsules by observing safety evaluation indicators such as adverse events in patients with influenza fever; (3) To explore the optimal dose of Forsythiaside Capsules for the treatment of fever caused by influenza.

Start Date04 Jan 2020

Sponsor / Collaborator

Dalian Fusheng Natural Medicine Development Co., Ltd.

[+1]

100 Clinical Results associated with Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.

0 Patents (Medical) associated with Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.

Literatures (Medical) associated with Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.

01 Sep 2024·Vaccine

A quadrivalent recombinant influenza Hemagglutinin vaccine induced strong protective immune responses in animal models

Article

Author: Xu, Yuhua ; Peng, Tao ; Guo, Jianmin ; Du, Yingying ; Chen, Liyun ; Wei, Hailiu ; Dai, Cailing ; Jiang, Xiaojun ; Feng, Jin ; Su, Wenhan ; Liu, Aijiao

Globally, influenza poses a substantial threat to public health, serving as a major contributor to both morbidity and mortality. The current vaccines for seasonal influenza are not optimal. A novel recombinant hemagglutinin (rHA) protein-based quadrivalent seasonal influenza vaccine, SCVC101, has been developed. SCVC101-S contains standard dose protein (15μg of rHA per virus strain) and an oil-in-water adjuvant, CD-A, which enhances the immunogenicity and cross-protection of the vaccine. Preclinical studies in mice, rats, and rhesus macaques demonstrate that SCVC101-S induces robust humoral and cellular immune responses, surpassing those induced by commercially available vaccines. Notably, a single injection with SCVC101-S can induce a strong immune response in macaques, suggesting the potential for a standard-dose vaccination with a recombinant protein influenza vaccine. Furthermore, SCVC101-S induces cross-protection immune responses against heterologous viral strains, indicating broader protection than current vaccines. In conclusion, SCVC101-S has demonstrated safety and efficacy in preclinical settings and warrants further investigation in human clinical trials. Its potential as a valuable addition to the vaccines against seasonal influenza, particularly for the elderly population, is promising.

01 Jul 2024·Acta Pharmaceutica Sinica B

A novel marine-derived anti-acute kidney injury agent targeting peroxiredoxin 1 and its nanodelivery strategy based on ADME optimization

Article

Author: Lu, Jindi ; Liang, Weimin ; Zhou, Xuefeng ; Zhang, Xi ; Gu, Tanwei ; Guo, Jianmin ; She, Jianglian ; Rao, Yueyang ; Tu, Yingfeng ; Liu, Yonghong ; Yang, Wei ; Yu, Ping ; Tang, Lan ; Jiang, Huanguo

Insufficient therapeutic strategies for acute kidney injury (AKI) necessitate precision therapy targeting its pathogenesis. This study reveals the new mechanism of the marine-derived anti-AKI agent, piericidin glycoside S14, targeting peroxiredoxin 1 (PRDX1). By binding to Cys83 of PRDX1 and augmenting its peroxidase activity, S14 alleviates kidney injury efficiently in Prdx1-overexpression (Prdx1-OE) mice. Besides, S14 also increases PRDX1 nuclear translocation and directly activates the Nrf2/HO-1/NQO1 pathway to inhibit ROS production. Due to the limited druggability of S14 with low bioavailability (2.6%) and poor renal distribution, a pH-sensitive kidney-targeting dodecanamine-chitosan nanoparticle system is constructed to load S14 for precise treatment of AKI. l-Serine conjugation to chitosan imparts specificity to kidney injury molecule-1 (Kim-1)-overexpressed cells. The developed S14-nanodrug exhibits higher therapeutic efficiency by improving the in vivo behavior of S14 significantly. By encapsulation with micelles, the AUC_0‒t , half-life time, and renal distribution of S14 increase 2.5-, 1.8-, and 3.1-fold, respectively. The main factors contributing to the improved druggability of S14 nanodrugs include the lower metabolic elimination rate and UDP-glycosyltransferase (UGT)-mediated biotransformation. In summary, this study identifies a new therapeutic target for the marine-derived anti-AKI agent while enhancing its ADME properties and druggability through nanotechnology, thereby driving advancements in marine drug development for AKI.

01 Dec 2023·Journal of Ocular Pharmacology and Therapeutics

Pharmacokinetics of Sirolimus Eye Drops Following Topical Ocular Administration in Rabbits

Article

Author: Guo, Jianmin ; Yang, Wei ; Zhang, Jiawei ; Huang, Yuankeng ; Lin, Baoqin ; Lu, Ziqi ; Wang, Yandong ; Lin, Junli

Purpose: To evaluate the pharmacokinetics of sirolimus eye drops following topical instillation in rabbits. Methods: The study included 2 experiments. In single-dose pharmacokinetic study, rabbits received a single bilateral instillation of 0.05% sirolimus eye drops (0.5 mg/mL, 50 μL/eye). In repeat-dose pharmacokinetic study, 0.05% sirolimus eye drops (0.5 mg/mL, 50 μL/eye/time) were instilled into both eyes of rabbits four times a day for 6 consecutive days and one time on day 7. Whole blood, tears, aqueous humor, cornea, and conjunctiva samples were collected. Sirolimus concentration was determined by a validated liquid chromatography-tandem mass spectrometry. Results: Sirolimus was hardly detected in plasma or aqueous humor after either single or repeated dosing. The C_max of sirolimus in tears, cornea, and conjunctiva after a single instillation was 163.34 ± 69.30 μg/g, 150.56 ± 84.98 ng/g, and 113.22 ± 49.82 ng/g, respectively. As the number of instillation elevated, the C_max of sirolimus was increased to 486.18 ± 297.93 μg/g, 418.63 ± 41.07 ng/g, and 314.25 ± 63.74 ng/g, respectively. In repeat-dose administration, the steady state of sirolimus concentration was achieved on the third day. Ocular exposure to sirolimus after single and repeated dosing, based on AUC_0-t, was highest in tears, followed by cornea and conjunctiva. Compared with single administration, a significant increase in sirolimus exposure as measured by AUC_0-t was observed in tears, cornea, and conjunctiva following repeated administration. Conclusions: Topical administration of sirolimus eye drops results in extensive distribution of sirolimus in tears, cornea, and conjunctiva, while aqueous humor and systemic exposure were negligible. Repeat-dose administration increases sirolimus exposure in tears, cornea, and conjunctiva.

100 Deals associated with Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.

100 Translational Medicine associated with Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.

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Drug(Targets)	Indications	Global Highest Phase

Loxoprofen Sodium Hydrate ( COX )	Pain, Postoperative More	Phase 3

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