Delving into the Latest Updates on Jiangsu Kingsley Pharmaceutical Co., Ltd. with Synapse

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IL-2R(Interleukin-2 receptor)	1

主要目的：评价广东康大制药有限公司生产的注射用苏拉明钠在中国健康成年人中单次静脉给药的耐受性和安全性。次要目的：评价广东康大制药有限公司生产的注射用苏拉明钠在中国健康成年人中单次静脉给药的药代动力学特征。

[Translation]

Primary objective: To evaluate the tolerability and safety of a single intravenous dose of suramin sodium for injection produced by Guangdong Kangda Pharmaceutical Co., Ltd. in healthy Chinese adults. Secondary objective: To evaluate the pharmacokinetic characteristics of a single intravenous dose of suramin sodium for injection produced by Guangdong Kangda Pharmaceutical Co., Ltd. in healthy Chinese adults.

Start Date20 Dec 2018

Sponsor / Collaborator

Jiangsu Kingsley Pharmaceutical Co., Ltd.

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100 Clinical Results associated with Jiangsu Kingsley Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Jiangsu Kingsley Pharmaceutical Co., Ltd.

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4

Literatures (Medical) associated with Jiangsu Kingsley Pharmaceutical Co., Ltd.

15 Sep 2004·Cancer ResearchQ1 · MEDICINE

PEGylation Confers Greatly Extended Half-Life and Attenuated Immunogenicity to Recombinant Methioninase in Primates

Q1 · MEDICINE

Article

Author: Lian, Changgen ; Chen, Chunmei ; Takimoto, Akio ; Li, Shukuan ; Zhang, Dongdong ; Wang, Junhua ; Yagi, Shigeo ; Tan, Yuying ; Takakura, Tomoaki ; Hoffman, Robert M. ; Sun, Xinghua ; Kobayashi, Yoshinao ; Frenkel, Eugene P. ; Lu, Quan ; Xu, Jinbao ; Yoshioka, Takayuji ; Yang, Zhijian ; Zhang, Ying

AbstractMethionine depletion by recombinant methioninase (rMETase) has been demonstrated previously to be highly effective in tumor-bearing mouse models. However, the therapeutic potential of rMETase has been limited by its short plasma half-life and immunologic effects, including high antibody production in mice and monkeys and anaphylactic reactions in monkeys. To overcome these limits of rMETase, the enzyme has been coupled to methoxypolyethylene glycol succinimidyl glutarate (MEGC-PEG-5000). In this study, we evaluated the pharmacokinetics, antigenicity and toxicity of MEGC-PEG-rMETase in Macaca fascicularis monkeys using an escalating-dose strategy. Dose ranging studies at 1,000, 4,000, and 8,000 units/kg i.v. determined that a single dose of 4,000 units/kg was sufficient to reduce plasma methionine to <5 μmol/L for 12 hours. Pharmacokinetic analysis with the single 4,000 units/kg dose showed that MEGC-PEG-rMETase holoenzyme activity was eliminated with a biological half-life of 1.3 hours, and the MEGC-PEG-rMETase apoenzyme was eliminated with a biological half-life of 90 hours, an ∼36-fold increase compared with non-PEGylated rMETase. A single dose at 2,000 units/kg of MEGC-PEG-rMETase resulted in an apoenzyme half-life of 143 hours. A seven-day i.v. administration of 4,000 units/kg every 12 hours resulted in a steady-state depletion of plasma methionine to <5 μmol/L. The only manifest toxicity was decreased food intake and slight weight loss. Red cell values and hemoglobin declined transiently during treatment but recovered after cessation of treatment. Subsequent challenges on days 29, 50 and, 71 did not result in any immunologic reactions. This result is in contrast to non-PEGylated rMETase, which elicited anaphylactic reactions in monkeys. Anti-MEGC-PEG-rMETase antibodies (at 10−2) were found on day 29, and these increased to 10−3 to 104 on day 71, 100 to 1,000-fold less than antibodies elicited by naked rMETase. Although anti-MEGC-PEG-rMETase antibodies were produced, no neutralizing antibody was identified, and each challenge dose was effective in depleting plasma methionine levels. The results of the present study demonstrate that PEGylation greatly prolongs serum half-life of the rMETase apoenzyme and eliminated anaphylactic reactions. The results indicate a profile with respect to serum half-life, toxicity, and antigenicity that suggest clinical potential of MEGC-PEG-rMETase.

Nanjing Gongye Daxue Xuebao, Ziran Kexueban

Determination of acetonitrile residual in recombinant human interleukin-2 by head-space capillary gas chromatography

Author: Jiang, Liyun ; Fu, Lifeng ; Tang, Qun ; Tu, Chunyan

To establish a method for the determination of acetonitrile residue in recombinant human interleukin-2, the head-space GC method was used with PEG-20000 quartz capillary column (30 m × 0.25 mm × 0.25 μm), high pure N₂ as carrier gas and FID detector.Acetonitrile showed good linearity in the range of 1.014-5.070 μg/mL in sample solution (r = 0.9973).The average recovery rate was 97.2% (RSD = 2.8%).The min. detective limit of acetonitrile was 0.6 μg/mL.This method is sensitive, repeatable, and easy to operate, and is suitable for determining acetonitrile residual of recombinant human interleukin-2.

Zhongguo Shenghua Yaowu Zazhi

Yield improvement of recombinant human interleukin-2

Author: Xu, Jinbao ; Xu, Xuyun

The method to improve the yield of recombinant human interleukin-2 was investigated.2-Mercaptoethanol was used to reduce the mismatched products and dimers collected during the purification of recombinant human interleukin-2, and reduction products were oxidized to obtain renaturation.The yield of recombinant human interleukin-2 was increased from about 40% to above 60% by this method.This method could improve the yield of recombinant human interleukin-2 with good reproducibility.

100 Deals associated with Jiangsu Kingsley Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Jiangsu Kingsley Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 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

Recombinant human interleukin-2(Jiangsu Kingsley Pharmaceutical Co Ltd) ( IL-2R )	Renal Cell Carcinoma More	Approved
Suramin Sodium ( DNA-directed DNA polymerase )	Hand, Foot and Mouth Disease More	Pending