Delving into the Latest Updates on Shanghai Huiyong Pharmaceutical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Shanghai Huiyong Pharmaceutical Co., Ltd., based in Shanghai, was established on May 10, 2018. The company is registered at the full building of 118 Meiyao Road, located within the China (Shanghai) Pilot Free Trade Zone.

Tags

Neoplasms

Infectious Diseases

Small molecule drug

Disease domain score

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Technology Platform

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Targets

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Disease Domain	Count

Neoplasms	1
Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

HSPA5(78 kDa glucose-regulated protein)	1

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下皮下注射受试制剂黄体酮注射液（规格：1.112ml：25mg，持证商：上海惠永制药有限公司）与参比制剂黄体酮注射液（规格：1.112ml：25mg，商品名：Prolutex®，持证商：IBSA Farmaceutici Italia srl）后在健康绝经后女性受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂黄体酮注射液和参比制剂黄体酮注射液在健康绝经后女性受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation progesterone injection (specification: 1.112ml: 25mg, licensee: Shanghai Huiyong Pharmaceutical Co., Ltd.) and the reference preparation progesterone injection (specification: 1.112ml: 25mg, trade name: Prolutex®, licensee: IBSA Farmaceutici Italia srl) in healthy postmenopausal female subjects after subcutaneous injection in the fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation progesterone injection and the reference preparation progesterone injection in healthy postmenopausal female subjects.

Start Date13 Sep 2024

Sponsor / Collaborator

Shanghai Huiyong Pharmaceutical Co., Ltd.

CTR20241902 / CompletedNot Applicable

琥珀酸美托洛尔缓释胶囊在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验研究

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of metoprolol succinate sustained-release capsules in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂琥珀酸美托洛尔缓释胶囊（生产厂家：上海惠永制药有限公司）与参比制剂琥珀酸美托洛尔缓释胶囊（持证商：SunPharmaceutical Industries, Inc.，商品名：Kapspargo Sprinkle®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂琥珀酸美托洛尔缓释胶囊和参比制剂琥珀酸美托洛尔缓释胶囊在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation metoprolol succinate sustained-release capsules (manufacturer: Shanghai Huiyong Pharmaceutical Co., Ltd.) and the reference preparation metoprolol succinate sustained-release capsules (licensed by Sun Pharmaceutical Industries, Inc., trade name: Kapspargo Sprinkle®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation metoprolol succinate sustained-release capsules and the reference preparation metoprolol succinate sustained-release capsules in healthy subjects.

Start Date13 Jun 2024

Sponsor / Collaborator

Shanghai Huiyong Pharmaceutical Co., Ltd.

CTR20241280 / RecruitingPhase 1

注射用 LN005 在恶性肿瘤患者中安全性、耐受性、药代动力学特征和有效性的I 期临床研究

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and efficacy of LN005 for injection in patients with malignant tumors

主要研究目的剂量递增阶段：评估注射用 LN005 治疗恶性肿瘤患者的安全性、耐受性，确定最大耐受剂量（MTD）剂量扩展阶段：评估注射用 LN005 治疗恶性肿瘤患者的安全性、耐受性，确定 II 期推荐剂量（RP2D）次要研究目的剂量递增阶段：评估注射用 LN005 在恶性肿瘤患者中的药代动力学特征；评估注射用 LN005 在恶性肿瘤患者中的免疫原性；评估注射用 LN005 治疗恶性肿瘤患者的初步疗效。剂量扩展阶段：评估注射用 LN005 治疗恶性肿瘤患者的初步疗效和安全性。探索性研究目的剂量递增阶段：评估 GRP78 蛋白表达与注射用 LN005 疗效的相关性。

[Translation]

Main study objectives Dose escalation phase: Evaluate the safety and tolerability of LN005 for injection in the treatment of patients with malignant tumors and determine the maximum tolerated dose (MTD) Dose expansion phase: Evaluate the safety and tolerability of LN005 for injection in the treatment of patients with malignant tumors and determine the recommended dose for Phase II (RP2D) Secondary study objectives Dose escalation phase: Evaluate the pharmacokinetic characteristics of LN005 for injection in patients with malignant tumors; Evaluate the immunogenicity of LN005 for injection in patients with malignant tumors; Evaluate the preliminary efficacy of LN005 for injection in the treatment of patients with malignant tumors. Dose expansion phase: Evaluate the preliminary efficacy and safety of LN005 for injection in the treatment of patients with malignant tumors. Exploratory study objectives Dose escalation phase: Evaluate the correlation between GRP78 protein expression and the efficacy of LN005 for injection.

Start Date14 May 2024

Sponsor / Collaborator

Shanghai Huiyong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanghai Huiyong Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Shanghai Huiyong Pharmaceutical Co., Ltd.

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100 Deals associated with Shanghai Huiyong Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shanghai Huiyong Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 29 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

1

2

Phase 1

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