[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of CRB4101 tablets in healthy adult subjects

评估健康成人单次服用CRB4101片后的安全性和耐受性。次要目的：评估健康成人单次服用CRB4101片后的药代动力学（PK）和药效动力学（PD）特征。探索性目的：1.探索性分析CRB4101（及其主要代谢产物，如必要）的血药浓度与QTc间期的关系；2.探索性分析CRB4101单次给药后的代谢与排泄特征（如必要）；3.探索性分析CRB4101主要代谢产物的药代动力学特征（如必要）；4.药物基因组学对药代动力学特征的影响（如必要）。

[Translation]

To evaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults. Secondary objective: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single dose of CRB4101 tablets in healthy adults. Exploratory objectives: 1. To explore the relationship between the blood concentration of CRB4101 (and its main metabolites, if necessary) and the QTc interval; 2. To explore the metabolism and excretion characteristics of CRB4101 after a single dose (if necessary); 3. To explore the pharmacokinetic characteristics of the main metabolites of CRB4101 (if necessary); 4. The effect of pharmacogenomics on pharmacokinetic characteristics (if necessary).

Start Date16 Nov 2022

Sponsor / Collaborator

China Pharmaceutical Research & Development Center Co., Ltd.

CTR20220597

/ RecruitingPhase 1

评价NIP142胶囊在EGFR突变阳性的局部晚期/转移性非小细胞肺癌患者中的安全性、耐受性、药代动力学特征和有效性的单臂、开放、多中心的Ia/Ib期临床试验

[Translation] A single-arm, open-label, multicenter Phase Ia/Ib clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of NIP142 capsule in patients with locally advanced/metastatic non-small cell lung cancer with EGFR mutation-positive

试验对象1：EGFR突变阳性的局部晚期/转移性NSCLC患者试验对象2：EGFR ex20ins的局部晚期/转移性NSCLC患者 Ia期主要目的： 1.评价NIP142胶囊在试验对象1中的安全性与耐受性。 2.探索NIP142胶囊在试验对象1中的DLT和MTD。次要目的： 1.评价NIP142胶囊及其主要代谢产物（如数据允许）在试验对象1中的PK特征。 2.初步评价NIP142胶囊在试验对象1中的ORR、DOR、DCR、PFS和OS [仅适用于EGFR ex20ins患者]。 Ib期主要目的：评价NIP142胶囊在试验对象2中的ORR。次要目的 1.确定NIP142胶囊在试验对象2中的RP2D。 2.评价NIP142胶囊在试验对象2中的DOR、DCR、PFS和OS。 3.评价NIP142胶囊在试验对象2中的安全性。 4.基于群体PK分析方法，探索NIP142胶囊在试验对象2中的PK特征（如数据允许）。

[Translation]

Subject 1: Patients with locally advanced/metastatic NSCLC who are EGFR mutation-positive Subject 2: Patients with locally advanced/metastatic NSCLC who have EGFR ex20ins Phase Ia Primary objectives: 1. Evaluate the safety and tolerability of NIP142 capsules in subject 1. 2. Explore the DLT and MTD of NIP142 capsules in subject 1. Secondary objectives: 1. Evaluate the PK characteristics of NIP142 capsules and their major metabolites (if data permit) in subject 1. 2. Preliminary evaluation of ORR, DOR, DCR, PFS and OS of NIP142 capsules in subject 1 [only for patients with EGFR ex20ins]. Phase Ib Primary objectives: Evaluate the ORR of NIP142 capsules in subject 2. Secondary objectives 1. Determine the RP2D of NIP142 capsules in subject 2. 2. Evaluate the DOR, DCR, PFS and OS of NIP142 capsules in subject 2. 3. Evaluate the safety of NIP142 capsules in trial subject 2. 4. Based on the population PK analysis method, explore the PK characteristics of NIP142 capsules in trial subject 2 (if data permit).

Start Date11 May 2022

Sponsor / Collaborator

China Pharmaceutical Research & Development Center Co., Ltd.

CTR20220772

/ CompletedPhase 1

一项随机、双盲、安慰剂对照、多次给药、剂量递增的Ib期临床研究评价NIP046在健康受试者中的安全性、耐受性以及药代动力学特征

[Translation] A randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation Phase Ib clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of NIP046 in healthy subjects

评价NIP046多次给药在健康受试者中的安全性、耐受性。次要目的：（1）评价NIP046多次给药在健康受试者中的药代动力学（PK）特征；（2）探索性目的：评价NIP046的生物标志物（靶点占有率）。

[Translation]

To evaluate the safety and tolerability of multiple administrations of NIP046 in healthy subjects. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of multiple administrations of NIP046 in healthy subjects; (2) Exploratory objectives: To evaluate the biomarkers (target occupancy) of NIP046.

Start Date07 Apr 2022

Sponsor / Collaborator

China Pharmaceutical Research & Development Center Co., Ltd.

100 Clinical Results associated with China Pharmaceutical Research & Development Center Co., Ltd.

0 Patents (Medical) associated with China Pharmaceutical Research & Development Center Co., Ltd.

Literatures (Medical) associated with China Pharmaceutical Research & Development Center Co., Ltd.

Journal of Applied Pharmaceutical Science

Phytochemical, pharmacognostic and elemental analysis of Cayratia gracilis (Guill. & Perr.) suesseng

Author: Kudirat, Mustapha B. ; Samuel, Okhale E. ; Uche, Ezenwa O. ; Henry, Egharevba O. ; Jemilat, Ibrahim A.

The plant Cayratia gracilis (Guill. & Perr.) Sues., family Vitaceae, is renowned for its numerous medicinal application in folks medicine especially for its analgesic properties.Phytochem., physicochem., microscopic and elemental analyses were carried out on the plant to establish basic monograph information for authentication of the plant samples.The moisture content was 12.7%, water extractive value was 19%, and alc. extractive value was 3.9% in the leaves and the moisture content of 8.8%, water extractive value of 14.8% and alc. extractive value of 1.3% in the stem.Phytochem. screening revealed the presence of 8 secondary metabolites for the leaves and 6 for the stem.The thin-layer chromatog. (TLC) profile of the stem revealed 4, 3, and 2 spots for the hexane, Et acetate and methanol extracts resp., while the leave revealed 5, 2 and 4 clear spots for hexane, Et acetate and methanol extracts resp.Atomic Absorption Spectroscopy (AAS) of the plant shows the presence Zn, Cu, Mn, Mg, Fe, Na, and absence of metals like Pb and Cr.The study reveals microscopic characters that are useful as diagnostic parameters for Cayratia gracilis.Information obtained from this study is important in establishing diagnostic indexes for identification, standardization, and also in monograph development of the plant which has ethno-medicinal uses.

ChatMolData: a Multimodal Agent for Automatic Molecular Data Processing

Author: Li, Yaqin ; Chen, Bo ; Wang, Huien ; Yu, Yi ; Zong, Libin ; Yu, Xiaohui

In recent years, the development of large language models (LLMs) has revolutionized various fields of natural science, yet their application in molecular data processing remains constrained due to the reliance on single-modality inputs and outputs. To bridge the gap between experimenters and computational tools, we introduce ChatMolData, a novel LLM-based multimodal agent designed to handle diverse molecular data forms, including molecular databases, images, structure-specific files and unstructured & structured documents. ChatMolData integrates the capabilities of LLMs (e.g., GPT-4 and GPT-3.5) with robust toolset that supports data retrieval, structuring, prediction, visualization, and search tasks. Our agent employs a systematic cycle of reasoning and action to efficiently process complex tasks in molecular science. The evaluation demonstrates that ChatMolData achieves over 90% accuracy for 128 diverse tasks, significantly lowering barriers for researchers without computer science background. Our findings highlight the agent's potential in advancing molecular research through improved data accessibility and usability.

Xiandai Yaowu Yu Linchuang

Synthesis of 3-{[(tert-butyldimethylsilyl) oxy] methyl} cyclobutane-1-carboxylic acid

Author: Wang Lu-feng ; Xu Xu ; Yin Li-he ; Chu Guo-biao ; Zhang Zhi-gang ; Li Chuan-kuan ; Dou Hao-shuai

Objective To study the synthetic routes of 3-{[(tert-butyldimethylsilyl) oxy] methyl} cyclobutane-1-carboxylic acid.Methods With 3-methylenecyclobutane-1-carbonitrile as the starting material, 3-{[(tert-butyldimethylsilyl) oxy] methyl} cyclobutane-1-carboxylic acid was synthesized through optimized synthetic procedures by using tipical synthetic operations including: hydrolysis, reduction, protection, oxidationResults The target mol. was successfully synthesized and the structure was confirmed by NMR and HR-MS spectroscopy.Conclusion The synthesis process of 3-{[(tert-butyldimethylsilyl) oxy] methyl} cyclobutane-1-carboxylic acid has good operability, mild conditions without using expensive transion metals and column-purification, which is quite suitable for industrial production

100 Deals associated with China Pharmaceutical Research & Development Center Co., Ltd.

100 Translational Medicine associated with China Pharmaceutical Research & Development Center Co., Ltd.

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Pipeline

Pipeline Snapshot as of 03 Feb 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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ginsenosides Orally Disintegrating Tablets	Angina, Stable More	Phase 2
NIP003 ( Factor XIa )	Venous Thrombosis More	Phase 1
NIP-046	Rheumatoid Arthritis More	Phase 1
Shaogan Tablets	Primary dysmenorrhea More	Phase 1
NIP-142 ( EGFR exon 20 x HER2 exon 20 )	EGFR-mutated non-small Cell Lung Cancer More	Phase 1

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