Delving into the Latest Updates on Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd with Synapse

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Endocrinology and Metabolic Disease

Small molecule drug

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Endocrinology and Metabolic Disease	1

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Small molecule drug	1

主要研究目的:研究静脉注射受试制剂维生素K1注射液（规格：1ml:10mg）与参比制剂维生素K1注射液（规格：1ml:10mg）在健康受试者体内的药代动力学，评价静脉注射两种制剂的生物等效性。次要研究目的:观察受试制剂维生素K1注射液（1ml:10mg）与参比制剂维生素K1注射液 (1ml:10mg)在健康成年受试人群中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation vitamin K1 injection (specification: 1ml:10mg) and the reference preparation vitamin K1 injection (specification: 1ml:10mg) in healthy subjects and evaluate the bioequivalence of the two preparations for intravenous injection. The secondary purpose of the study is to observe the safety of the test preparation vitamin K1 injection (1ml:10mg) and the reference preparation vitamin K1 injection (1ml:10mg) in healthy adult subjects.

Start Date08 Nov 2024

Sponsor / Collaborator

Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

CTR20243598

/ CompletedNot Applicable

健康成年受试者空腹和餐后状态下口服维生素K1注射液的单中心、随机、开放、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study of oral vitamin K1 injection in healthy adult subjects in the fasting and fed state

主要研究目的:研究空腹和餐后状态下口服受试制剂维生素K1注射液（规格：1ml:10mg）与参比制剂维生素K1注射液（规格：1ml:10mg）在健康受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的:观察受试制剂维生素K1注射液（1ml:10mg）与参比制剂维生素K1注射液 (1ml:10mg)在健康成年受试人群中的安全性。

[Translation]

The main purpose of the study: To study the pharmacokinetics of the test preparation vitamin K1 injection (specification: 1ml:10mg) and the reference preparation vitamin K1 injection (specification: 1ml:10mg) in healthy subjects in the fasting and postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state. Secondary purpose of the study: To observe the safety of the test preparation vitamin K1 injection (1ml:10mg) and the reference preparation vitamin K1 injection (1ml:10mg) in healthy adult subjects.

Start Date06 Nov 2024

Sponsor / Collaborator

Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

CTR20242302

/ CompletedNot Applicable

丙戊酸钠缓释片（Ⅰ）（0.5 g）随机、开放、两序列、四周期、完全重复交叉单次给药空腹/餐后状态下在健康受试者中的生物等效性试验

[Translation] A randomized, open-label, two-sequence, four-period, completely repeated crossover single-dose bioequivalence study of sodium valproate extended-release tablets (I) (0.5 g) in healthy subjects under fasting/fed conditions

在健康男性与女性受试者中于空腹/餐后条件下，评价受试制剂丙戊酸钠缓释片（Ⅰ）【规格：0.5 g，持证商：燃点（南京）生物医药科技有限公司】和赛诺菲（杭州）制药有限公司为持证商的参比制剂丙戊酸钠缓释片（Ⅰ）（德巴金®，规格：0.5 g）的生物等效性。

[Translation]

The bioequivalence of the test preparation, sodium valproate extended-release tablets (I) [Specification: 0.5 g, licensee: Randian (Nanjing) Biopharmaceutical Technology Co., Ltd.] and the reference preparation, sodium valproate extended-release tablets (I) (Depakin®, specification: 0.5 g), licensee: Sanofi (Hangzhou) Pharmaceutical Co., Ltd., was evaluated in healthy male and female subjects under fasting/postprandial conditions.

Start Date18 Jul 2024

Sponsor / Collaborator

Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

100 Clinical Results associated with Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

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0 Patents (Medical) associated with Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

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Literatures (Medical) associated with Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

01 May 2025·European Journal of Pharmaceutics and Biopharmaceutics

A novel long-acting phospholipid phase transition gel with progesterone effectively promoted uterine development

Article

Author: Zuo, Jianfeng ; Qi, Lianwen ; Qin, Bing ; Qin, Yong ; Yu, Mengling

Progesterone (PRG), a steroidal hormone, is commonly utilized in the clinical practice of obstetrics and gynecology. The high frequency of PRG injections, however, has brought significant pain and inconvenience to patients. In this study, we developed a long-acting injection leveraging the phase transition mechanism for the long-term treatment in Assisted Reproductive Technology (ART). The components we selected all possess excellent biocompatibility. Pharmacokinetic studies revealed that the PRG-loaded phospholipid phase transition gels (PRG-PPTGs) released the PRG continuously for over 7 days. Notably, pharmacological investigation demonstrated that PRG-PPTGs, when administered weekly, effectively promoted uterine development. Our findings suggested that PRG-PPTGs successfully achieve both the prevention of burst release and the reduction of dosing frequency, highlighting the potential of PPTGs as promising long-acting composite system for hydrophobic drugs.

100 Deals associated with Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

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100 Translational Medicine associated with Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

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Pipeline

Pipeline Snapshot as of 13 May 2025

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

Discovery

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