主要研究目的： 1.定量分析健康男性受试者口服[14C]迈华替尼后排泄物中的总放射性，获得人体放射性排泄率数据和主要排泄途径； 2.定量分析健康男性受试者单次口服[14C]迈华替尼后全血和血浆中的总放射性，获得血浆中总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况； 3.考察男性受试者口服[14C]迈华替尼后人血浆、尿液和粪便的放射性物谱，鉴定主要代谢产物（≥10%总放射性AUC或≥10%给药量），确定主要生物转化途径及消除途径；次要研究目的 1.采用已验证的HPLC-MS/MS方法定量分析血浆中迈华替尼及其代谢产物（如适用）的浓度，获得血浆中迈华替尼及其代谢产物（如适用）的药代动力学参数； 2.观察[14C]迈华替尼单次给药后健康男性受试者的安全性。

[Translation]

Main study objectives: 1. Quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of [14C] Maihuatinib, and obtain the data on human radioactive excretion rate and main excretion pathways; 2. Quantitatively analyze the total radioactivity in whole blood and plasma of healthy male subjects after a single oral administration of [14C] Maihuatinib, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma; 3. Investigate the radioactivity spectrum of human plasma, urine and feces after oral administration of [14C] Maihuatinib to identify the main metabolites (≥10% total radioactivity AUC or ≥10% dose), and determine the main biotransformation pathways and elimination pathways; Secondary study objectives 1. Quantitatively analyze the concentration of Maihuatinib and its metabolites (if applicable) in plasma using a validated HPLC-MS/MS method, and obtain the pharmacokinetic parameters of Maihuatinib and its metabolites (if applicable) in plasma; 2. Observe the safety of healthy male subjects after a single dose of [14C] Maihuatinib.

Start Date21 Nov 2022

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

[+1]

CTR20201075 / CompletedNot Applicable

阿普斯特片在健康受试者中随机、开放、双周期、自身交叉、单剂量在空腹和餐后状态下的人体生物等效性研究

[Translation] A randomized, open-label, two-period, self-crossover, single-dose bioequivalence study of Apremilast tablets in healthy subjects under fasting and fed conditions

采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹及餐后给药条件下，杭州朱养心药业有限公司生产的阿普斯特片（30 mg）与Celgene Corporation持证的阿普斯特片（30 mg，商品名：OTEZLA®）在健康人群中吸收程度和速度的差异，并评价杭州朱养心药业有限公司生产的阿普斯特片（30 mg）的安全性。

[Translation]

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in the extent and rate of absorption of Apremilast Tablets (30 mg) produced by Hangzhou Zhu Yangxin Pharmaceutical Co., Ltd. and Apremilast Tablets (30 mg, trade name: OTEZLA®) certified by Celgene Corporation in healthy people under fasting and postprandial administration conditions, and to evaluate the safety of Apremilast Tablets (30 mg) produced by Hangzhou Zhu Yangxin Pharmaceutical Co., Ltd.

Start Date08 Jun 2020

Sponsor / Collaborator

Chongqing Zein Pharmaceutical Co. Ltd.

[+2]

CTR20200280 / CompletedPhase 1

食物对迈华替尼片在健康受试者中单中心、随机、开放、单制剂、两周期、双交叉、单次给药药代动力学影响研究

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover, single-dose pharmacokinetics study of food on mavartinib tablets in healthy subjects

主要研究目的：评价食物对迈华替尼片（60mg/片，1片/次）在健康受试者体内的药代动力学特征的影响。次要研究目的：评价迈华替尼片（60mg/片，1片/次）在健康受试者中的安全性和耐受性。

[Translation]

Primary study objective: To evaluate the effect of food on the pharmacokinetic characteristics of Maihuatinib tablets (60 mg/tablet, 1 tablet/time) in healthy subjects. Secondary study objective: To evaluate the safety and tolerability of Maihuatinib tablets (60 mg/tablet, 1 tablet/time) in healthy subjects.

Start Date07 May 2020

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

0 Patents (Medical) associated with Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

Literatures (Medical) associated with Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

01 Jul 2022·Food Research International

Advances in sports food: Sports nutrition, food manufacture, opportunities and challenges

Review

Author: Liu, Weilin ; Yu, Mingxiao ; Li, Mengyu ; Liu, Jianhua ; Cui, Pengbo ; Liu, Yefeng ; Ding, Yuting

In recent years, the increase in public awareness of sports has greatly promoted the development of the sports food industry. Sports food provides nutrition to meet the metabolic and energy needs of sports people. The nutritional components of sports food can be divided into basic nutrients and functional factors. Basic nutrients refer to the nutrients or metabolites required by the human body. Functional factors are bioactive ingredients that have potential effects in improving functions of the human body, such as protection of articular cartilage and improving muscle quality. Currently, there are various forms of sports foods in the market, including sports drinks, solid sports foods, semi-solid sports foods, and sports nutrition supplements. The sports food industry has seen many opportunities such as the expanding market, manufacturing technology development, and increasing funds investment. However, it also faces many challenges, such as lack of innovation, insufficient in-depth research, risks, and safety issues. This review would provide theoretical guidance for current sports food manufacture to meet the needs of increasing sports people worldwide.

03 Apr 2022·Expert Opinion on Therapeutic PatentsQ2 · MEDICINE

Discovery of small-molecule ATR inhibitors for potential cancer treatment: a patent review from 2014 to present

Q2 · MEDICINE

Article

Author: Garrido, Carmen ; Xie, Tian ; Hu, Suwen ; Ye, Xiang-Yang ; Duan, Jilong ; Hui, Zi

INTRODUCTIONAtaxia telangiectasia and RAD3-related kinase (ATR) is one of the key phosphatidylinositol 3-kinase-related kinase family members important for DNA damage response and repair pathways. Targeting ATR kinase for potential cancer therapy has attracted a great deal of attention to both pharmaceutical industries and academic community.AREA COVEREDThis article surveys the patents published since 2014 aiming to analyze the structural features of scaffolds and the patent space. It also discusses the recent clinical developments and provides perspectives on the challenges and the future directions.EXPERT OPINIONATR kinase appears to be a viable drug target for anticancer therapy. Similar to DNA-PK inhibitors, the clinical investigation of an ATRi employs both monotherapy and combination strategy. In the combination strategy, an ATRi is typically combined with a radiation or a targeted drug such as chemotherapy agent poly (ADP-ribose) polymerase (PARP) inhibitor, etc. Diverse structures comprising different scaffolds from mono-heteroaryl to bicyclic heteroaryl to tricyclic heteroaryl to macrocycle are capable of achieving good ATR inhibitory activity and good ATR selectivity over other closely related enzymes. There are eight ATR inhibitors currently being evaluated in clinics, with the hope to get approval in the near future.

01 Feb 2017·Cell Chemical BiologyQ1 · BIOLOGY

An Unusual Protector-Protégé Strategy for the Biosynthesis of Purine Nucleoside Antibiotics

Q1 · BIOLOGY

Article

Author: Xu, Gudan ; Deng, Zixin ; Li, Yong-Quan ; Wang, Tingting ; Wu, Pan ; Chen, Wenqing ; Qi, Jianzhao ; Chen, Xiaoxia ; Ma, Hongmin ; Wang, Gui ; Wan, Dan ; Gao, Yaojie ; Zhu, Jian

Pentostatin (PTN, deoxycoformycin) and arabinofuranosyladenine (Ara-A, vidarabine) are purine nucleoside antibiotics used clinically to treat hematological cancers and human DNA virus infections, respectively. PTN has a 1,3-diazepine ring, and Ara-A is an adenosine analog with an intriguing epimerization at the C-2' hydroxyl group. However, the logic underlying the biosynthesis of these interesting molecules has long remained elusive. Here, we report that the biosynthesis of PTN and Ara-A employs an unusual protector-protégé strategy. To our surprise, we determined that a single gene cluster governs PTN and Ara-A biosynthesis via two independent pathways. Moreover, we verified that PenB functions as a reversible oxidoreductase for the final step of PTN. Remarkably, we provided the first direct biochemical evidence that PTN can protect Ara-A from deamination by selective inhibition of the host adenosine deaminase. These findings expand our knowledge of natural product biosynthesis and open the way for target-directed genome mining of Ara-A/PTN-related antibiotics.

100 Deals associated with Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

100 Translational Medicine associated with Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

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Pipeline Snapshot as of 17 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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Mefatinib ( EGFR )	EGFR positive Non-squamous non-small cell lung cancer More	Phase 3
HIF-PH inhibitor(Hangzhou Huadong Medicine Group Pharmaceutical Research Institute) ( EGLN2 )	-	Discovery
S1P1 agonists(Hangzhou Huadong Medicine Group Pharmaceutical Research Institute) ( S1PR1 )	-	Discovery
HD118 ( DPP-4 )	-	Pending
BTK inhibitor ( Hangzhou Huadong Medicine Group Pharmaceutical Research Institute) ( BTK )	-	Pending

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