Top 5 Target	Count

HCN channels(Hyperpolarization-activated cyclic nucleotide-gated channel)	2
CaSR(Calcium sensing receptor)	2
GHSR(Ghrelin/growth hormone secretagogue receptor)	1
κ opioid receptor(Kappa opioid receptor)	1

Drugs associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

Chloral Hydrate

Target-

Mechanism-

Active Org.

Chengdu Shuode Pharmaceutical Co.,Ltd. [+7]

Originator Org.-

Active Indication

Sedation

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date30 Dec 2019

Ivabradine Hydrochloride

Target

HCN channels

Mechanism

HCN channels blockers

Active Org.

Les Laboratoires Servier SAS [+8]

Originator Org.

Les Laboratoires Servier SAS

Active Indication

Angina Pectoris [+4]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

EU [+3]

First Approval Date25 Oct 2005

BTP0717

Target-

Mechanism-

Active Org.

Jiangsu Nuohe Bituo New Drug Research and Development Co., Ltd [+1]

Originator Org.

Jiangsu Nuohe Bituo New Drug Research and Development Co., Ltd

Active Indication

Gout [+2]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

CTR20242980 / RecruitingPhase 1

一项随机、双盲、安慰剂对照、剂量递增研究评价单/多次口服BTP0209片在中国健康受试者中的安全性、耐受性、药代动力学特征及食物对其药代动力学特征的影响

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetic characteristics of single/multiple oral administration of BTP0209 tablets in healthy Chinese subjects and the effect of food on its pharmacokinetic characteristics

主要目的：评价健康受试者单/多次空腹口服不同剂量BTP0209片的安全性和耐受性。次要目的：评价健康受试者单/多次空腹口服不同剂量BTP0209片的药代动力学特征以及考察食物对健康受试者单次口服BTP0209片药代动力学特征的影响。

[Translation]

Primary purpose: To evaluate the safety and tolerability of single/multiple oral administration of different doses of BTP0209 tablets on an empty stomach in healthy subjects. Secondary purpose: To evaluate the pharmacokinetic characteristics of single/multiple oral administration of different doses of BTP0209 tablets on an empty stomach in healthy subjects and to investigate the effect of food on the pharmacokinetic characteristics of single oral administration of BTP0209 tablets in healthy subjects.

Start Date20 Aug 2024

Sponsor / Collaborator

Jiangsu Nuohe Bituo New Drug Research and Development Co., Ltd

CTR20240580 / RecruitingNot Applicable

依折麦布阿托伐他汀钙片人体生物等效性研究

[Translation] Study on the bioequivalence of ezetimibe and atorvastatin calcium tablets in healthy volunteers

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定北京阳光诺和药物研究股份有限公司持证，安徽佳和药业有限公司生产的依折麦布阿托伐他汀钙片给药后血浆中的依折麦布、总依折麦布（依折麦布+依折麦布-葡萄糖苷酸结合物）和阿托伐他汀在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以Organon Healthcare GmbH持证，Merck Sharp & Dohme B.V.生产的依折麦布阿托伐他汀钙片【商品名：Atozet®，规格：每片含依折麦布10 mg与阿托伐他汀钙20 mg（以阿托伐他汀计）】为参比，评价制剂间的生物等效性，并观察依折麦布阿托伐他汀钙片在中国健康受试者中的安全性。

[Translation]

Healthy Chinese subjects were used as the experimental subjects. A self-crossover experimental design was adopted to determine the time course of plasma concentrations of ezetimibe, total ezetimibe (ezetimibe + ezetimibe-glucuronide conjugate) and atorvastatin in healthy subjects after administration of ezetimibe atorvastatin calcium tablets certified by Beijing Sunshine Novo Pharmaceutical Research Co., Ltd. and produced by Anhui Jiahe Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Ezetimibe atorvastatin calcium tablets [trade name: Atozet®, specification: each tablet contains 10 mg ezetimibe and 20 mg atorvastatin calcium (calculated as atorvastatin)] certified by Organon Healthcare GmbH and produced by Merck Sharp & Dohme B.V. were used as reference to evaluate the bioequivalence between the preparations and observe the safety of ezetimibe atorvastatin calcium tablets in healthy Chinese subjects.

Start Date06 Mar 2024

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

CTR20240481 / CompletedPhase 1

评价在健康受试者口服 BTP0611的单中心、随机、开放空腹和餐后状态下单、多次给药、两制剂、两序列、两周期、双交叉生物利用度的I期临床研究

[Translation] A single-center, randomized, open-label, single-dose, multiple-dose, two-formulation, two-sequence, two-cycle, double-crossover phase I clinical study to evaluate the oral bioavailability of BTP0611 in healthy subjects under fasting and fed conditions

评价空腹和高脂餐后条件下单、多次口服BTP0611的药代动力学特征，并与盐酸伊伐布雷定片作对比，比较在成年健康受试者中单、多次给药的药代动力学特征差异、相对生物利用度和安全性

[Translation]

To evaluate the pharmacokinetic characteristics of BTP0611 after single and multiple oral administrations under fasting and high-fat meal conditions, and compare it with ivabradine hydrochloride tablets to compare the differences in pharmacokinetic characteristics, relative bioavailability and safety of single and multiple administrations in healthy adult subjects

Start Date21 Feb 2024

Sponsor / Collaborator

Jiangsu Nuohe Bituo New Drug Research and Development Co., Ltd

[+1]

100 Clinical Results associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

0 Patents (Medical) associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

Literatures (Medical) associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

01 Apr 2024·Talanta

Determination of parabens in breast milk using stir bar sorptive extraction coupled with UHPLC-UV

Article

Author: Li, Kefeng ; Bian, Linlin ; Wang, Mingjuan ; Feng, Senwei ; Ge, Xue ; Wang, Xu

We developed an analytical method based on ultra-high performance liquid chromatography with UV detection, using a stir bar coated with amino/hydroxyl bifunctional microporous organic network (B-MON), for the analysis of parabens in breast milk samples. B-MON demonstrated superior performance with maximal methylparaben adsorption of 112.15 mg/g. Kinetic fitting revealed that outer diffusion was the key limiting step, and the adsorption was chemisorption. The thermodynamic analysis demonstrated that increased methylparaben adsorption was found at higher temperatures in spontaneous processes. The developed approach showed excellent linearity (R² ≥ 0.9964) and a low detection limit (0.01 μg/L). Recoveries ranged from 85.8 to 105.5 % and the relative standard deviation was lower than 9.2 %. Based on the daily exposure assessment, these pollutants do not pose unacceptable health hazards to babies. However, the high detection frequencies (41.9%-93.5 %) suggest that breast milk still should be monitored.

01 Mar 2024·Talanta

Characterization of polymerized impurities in cefoxitin sodium for injection by two-dimensional chromatography coupled with time-of-flight mass spectrometry

Article

Author: Ji, Feng ; Wang, Mingjuan ; Zhang, Wenlong ; Yuan, Weifeng ; Adams, Erwin ; Wang, Meng ; Li, Xiaodong

Polymerized impurities in β-lactam antibiotics can induce allergic reactions, which seriously threaten the health of patients. In order to study the polymerized impurities in cefoxitin sodium for injection, a novel approach based on the use of two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry (2D-LC-TOF MS) was applied. In the 1st dimension, high performance size exclusion chromatography (HPSEC) with a TSK-G2000SWxl column was employed. Column switching was applied for the desalination of the mobile phase used to separate polymerized impurities in the 1st dimension before they were transferred to the 2nd dimension which utilized reversed phase liquid chromatography (RP-LC) and TOF MS for further structural characterization. The structures of four polymerized impurities (which were all previously unknown) in cefoxitin sodium for injection were deduced based on the MS² data. One novel polymerized impurity (PI-I), with 2H less than the molecular weight of two molecules of cefoxitin (Mr. 852.09), was found to be the most abundant (>50 %) in almost all the samples examined and could be regarded as the marker polymer of cefoxitin sodium for injection. This work also showed the great potential of the 2D-LC-TOF MS approach in structural characterization of unknown impurities separated with a mobile phase containing non-volatile phosphate in the 1st dimension.

01 Mar 2024·International Journal of Pharmaceutics

Activate the endogenous Cu2+ switch for Zn(DDC)2 liposomes conversion: Providing a safer and less toxic alternative in cancer therapy

Article

Author: Zhang, Jie ; Gou, Jingxin ; Tang, Xing ; Yin, Tian ; Yuan, Wei ; Lu, Qianru ; Yan, Mingjiao ; Li, Chunxue ; Ji, Muse ; He, Haibing ; Liang, Xinxin ; Zhang, Yu

The ancient anti-alcohol drug disulfiram (DSF) has gained widespread attention for its highly effective anti-tumor effects in cancer treatment. Our previous studies have developed liposome of Cu (DDC)₂ to overcome the limitations, like the poor water solubility. However, Cu (DDC)₂ liposomes still have shown difficulties in severe hemolytic reactions at high doses and systemic toxicity, which have limited their clinical use. Therefore, this study aims to exploratively investigate the feasibility of using DSF or DDC in combination also can chelate Zn²⁺ to form zinc diethyldithiocarbamate (Zn (DDC)₂). Furthermore, this study prepared stable and homogeneous Zn (DDC)₂ liposomes, which were able to be released in the tumor microenvironment (TME). The released Zn (DDC)₂ was converted to Cu (DDC)₂ with the help of endogenous Cu²⁺-switch enriched in the TME, which has a higher stability constant compared with Zn (DDC)₂. In other words, the Cu²⁺-switch is activated at the tumor site, completing the conversion of the less cytotoxic Zn (DDC)₂ to the more cytotoxic Cu (DDC)₂ for effective tumor therapy so that the Zn (DDC)₂ liposomes in vivo achieved the comparable therapeutic efficacy and provided a safer alternative to Cu (DDC)₂ liposomes in cancer therapy.

100 Deals associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

100 Translational Medicine associated with Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 Nov 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

Discovery

Preclinical

IND Application

IND Approval

Phase 1 Clinical

Phase 2 Clinical

NDA/BLA

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Chloral Hydrate	-	NDA/BLA
BTP0717	Gout More	Phase 2
STC007 ( κ opioid receptor )	Pain, Postoperative More	Phase 2
NKH0209	Angina, Unstable More	Phase 1
STC-008	Stomach Cancer More	Phase 1

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