Adamerck specializes in the creation of novel pharmaceuticals that are patented and unique to the company. They have successfully developed over ten such drugs that address critical medical needs on a global scale, demonstrating significant commercial potential. These drugs span various therapeutic areas, including anesthesia, cardiovascular and cerebrovascular conditions, oncology, and more.

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Drugs associated with Hangzhou Adamerck Pharmlabs, Inc.

Adamgammadex Sodium

Target-

Mechanism

Muscle relaxation antagonists

Active Org.

Hangzhou Adamerck Pharmlabs, Inc. [+1]

Originator Org.

Hangzhou Adamerck Pharmlabs, Inc.

Active Indication

Reversal of Neuromuscular Blockade

Inactive Indication-

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

Aom-0187

Target-

Mechanism-

Active Org.

Hangzhou Adamerck Pharmlabs, Inc.

Originator Org.

Hangzhou Adamerck Pharmlabs, Inc.

Active Indication

Dry Eye Syndromes

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date-

Aom-0207

Target-

Mechanism-

Active Org.

Hangzhou Adamerck Pharmlabs, Inc.

Originator Org.

Hangzhou Adamerck Pharmlabs, Inc.

Active Indication

Dysentery

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Hangzhou Adamerck Pharmlabs, Inc.

CTR20240231 / CompletedPhase 1

一项评价单剂量奥美克松钠静脉注射给药在轻中度肾功能不全和健康受试者中的开放、平行对照的安全性和药代动力学研究

[Translation] An open-label, parallel-controlled safety and pharmacokinetics study evaluating the safety of single-dose intravenous omepromazine sodium in subjects with mild to moderate renal impairment and healthy subjects

评价奥美克松钠静脉注射单次给药后，在不同程度肾功能不全和肾功能正常健康受试者中的药代动力学特征，评估不同程度肾功能不全对药物药代动力学的影响，为肾功能不全患者的临床用药提供依据。

[Translation]

To evaluate the pharmacokinetic characteristics of omexin sodium after a single intravenous administration in subjects with different degrees of renal insufficiency and healthy subjects with normal renal function, assess the effects of different degrees of renal insufficiency on drug pharmacokinetics, and provide a basis for clinical medication in patients with renal insufficiency.

Start Date30 Jan 2024

Sponsor / Collaborator

Hangzhou Adamerck Pharmlabs, Inc.

[+1]

CTR20213282 / CompletedPhase 3

一项拟行全麻下择期手术 ASA 1～3 级患者给予罗库溴铵后 PTC=1～2 时接受注射用奥美克松钠逆转神经肌肉阻滞作用的前瞻性、多中心、随机、盲法、阳性药平行对照的 III 期临床研究

[Translation] A prospective, multicenter, randomized, blinded, positive drug parallel controlled phase III clinical study on the effect of omexin sodium injection on reversal of neuromuscular blockade in ASA 1-3 patients undergoing elective surgery under general anesthesia after receiving rocuronium bromide at PTC = 1-2

主要研究目的：比较给予罗库溴铵后深度神经肌肉阻滞自然恢复到 PTC 1~2 时注射用奥美克松钠与舒更葡糖钠注射液（布瑞亭®）逆转罗库溴铵诱导的神经肌肉阻滞的有效性。次要研究目的： 1.比较全麻下择期手术受试者在罗库溴铵诱导的深度神经肌肉阻滞自然恢复到 PTC 1~2时给予 8 mg/kg 注射用奥美克松钠或 4 mg/kg 舒更葡糖钠后 5 min 内成功拮抗神经肌肉阻滞使 TOFr 恢复到≥0.9 的拮抗成功率。 2.比较注射用奥美克松钠与舒更葡糖钠注射液给药后 30 min 内的再箭毒化发生率。 3.评价注射用奥美克松钠逆转罗库溴铵诱导的深度神经肌肉阻滞的安全性。

[Translation]

Primary study objectives: To compare the effectiveness of omepromazine sodium injection and sugammadex sodium injection (Buretin®) in reversing rocuronium-induced neuromuscular blockade when deep neuromuscular blockade recovers naturally to PTC 1-2 after rocuronium administration. Secondary study objectives: 1. To compare the success rate of antagonism within 5 minutes after 8 mg/kg omepromazine sodium injection or 4 mg/kg sugammadex sodium injection in subjects undergoing elective surgery under general anesthesia when deep neuromuscular blockade induced by rocuronium recovers naturally to PTC 1-2. 2. To compare the incidence of recurarization within 30 minutes after administration of omepromazine sodium injection and sugammadex sodium injection. 3. To evaluate the safety of omepromazine sodium injection in reversing rocuronium-induced deep neuromuscular blockade.

Start Date19 Jun 2022

Sponsor / Collaborator

Hangzhou Adamerck Pharmlabs, Inc.

[+1]

CTR20220203 / CompletedNot Applicable

瑞巴派特片（100mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of rebamipide tablets (100 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择大塚制薬株式会社（OTSUKA PHARMACEUTICAL Co.,Ltd.）生产的瑞巴派特片（商品名： Mucosta®，规格：100mg/片）为参比制剂，对浙江金华康恩贝生物制药有限公司生产、杭州默银医药技术有限公司提供的受试制剂瑞巴派特片（规格：100mg/片）进行空腹及餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹及餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂瑞巴派特片（规格： 100mg/片）和参比制剂瑞巴派特片（商品名：Mucosta®，规格：100mg/片）的安全性。

[Translation]

Main research purposes: According to the regulations on bioequivalence testing, rebamipide tablets (trade name: Mucosta®, specifications: 100 mg/tablet) produced by OTSUKA PHARMACEUTICAL Co., Ltd. were selected as the reference preparation. , conduct human bioequivalence tests on fasting and postprandial administration of the test preparation rebamipide tablets (specification: 100mg/tablet) produced by Zhejiang Jinhua Conba Biopharmaceutical Co., Ltd. and provided by Hangzhou Moyin Pharmaceutical Technology Co., Ltd. , compare whether the difference in absorption speed and degree of drug in the test preparation and the reference preparation is within the acceptable range, and compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: Observe the safety of the test preparation rebamipide tablets (specification: 100mg/tablet) and the reference preparation rebamipide tablets (trade name: Mucosta®, specification: 100mg/tablet) taken orally by healthy volunteer subjects.

Start Date04 Mar 2022

Sponsor / Collaborator

Hangzhou Moyin Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Hangzhou Adamerck Pharmlabs, Inc.

0 Patents (Medical) associated with Hangzhou Adamerck Pharmlabs, Inc.

Literatures (Medical) associated with Hangzhou Adamerck Pharmlabs, Inc.

01 Jan 2024·British Journal of Anaesthesia

Phase III clinical trial comparing the efficacy and safety of adamgammadex with sugammadex for reversal of rocuronium-induced neuromuscular block

Article

Author: Guo, Qulian ; Lei, Qian ; Liu, Bin ; Zhang, Wensheng ; Zhang, Yujun ; Liu, Jin ; Wang, Qin ; Jiang, Yingying ; Hong, Yi ; Li, Yalan ; Sun, Qiang ; Wang, Shoushi ; Ou, Yangwen ; Li, Hong ; Li, Chaoyu ; Lin, Han ; Chen, Zhigang ; Huang, Yidan ; Jin, Shu'an ; Zou, Xiaohua ; Jie, Qing ; Qi, Youmao ; Min, Su

BACKGROUNDPreliminary clinical trials of adamgammadex, a new cyclodextrin-based selective reversal agent, have demonstrated its efficacy in reversing neuromuscular block by rocuronium.METHODSThis multicentre, randomised, double-blind, positive-controlled, non-inferiority phase III clinical trial compared the efficacy and safety of adamgammadex and sugammadex. We randomised 310 subjects to receive adamgammadex (4 mg kg^-1) or sugammadex (2 mg kg^-1) at reappearance of the second twitch of the train-of-four (TOF), and standard safety data were collected.RESULTSFor the primary outcome, the proportion of patients with TOF ratio ≥0.9 within 5 min was 98.7% in the adamgammadex group vs 100% in the sugammadex group, with a point estimate and 95% confidence interval (CI) of 1.3% (-4.6%, +1.3%); the lower limit was greater than the non-inferiority margin of -10%. For the key secondary outcome, the median (inter quartile range) time from the start of administration of adamgammadex or sugammadex to recovery of TOF ratio to 0.9 was 2.25 (1.75, 2.75) min and 1.75 (1.50, 2.00) min, respectively. The difference was 0.50 (95% CI: 0.25, 0.50); the upper limit was lower than the non-inferiority margin of 5 min. In addition, there were no inferior results observed in secondary outcomes. Adamgammadex had a lower incidence of adverse drug reactions compared with sugammadex (anaphylactic reaction, recurarisation, decreased heart rate, and laryngospasm; P=0.047).CONCLUSIONSAdamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex. Adamgammadex may have a potential advantage in terms of its overall risk-benefit profile.CLINICAL TRIAL REGISTRATIONChinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.

Zhongguo Yaolixue Yu Dulixue Zazhi

Muscle relaxant effect of new γ-cyclodextrin derivatives Aom0498-1 and Aom0498-3

Author: Qi, You-mao ; Qi, Ying-bei ; Ding, Ding ; Jie, Qing ; Yu, Bao-chun ; Zhang, Feng-min

To explore and screen the candidates of the selective muscle-relaxant antagonist against amino-steroid nondepolarizing muscle relaxants.Two 6-deoxy-6-thioether-acetylglycine-γ-cyclodextrin derivatives, Aom0498-1 and Aom0498-3 were synthesized using one-pot reaction.(1) γ-Cyclodextrin, Aom0498-1, Aom0498-3 and sugammadex 1.8, 3.6 and 5.4μmol·L^-1 were added to phrenic-nerve-diaphragm preparation of mice accordingly and the reversal rate of muscle contraction was recorded.(2) Guinea pigs were iv administered with γ-cyclodextrin, Aom0498-1, Aom0498-3 and sugammadex 2 mg·kg^-1 accordingly and recovery time of train-of-four ratio to 50% and 75% was recorded.(3) Rabbits were iv administered with γ-cyclodextrin, Aom0498-1, Aom0498-3 and sugammadex 6 mg·kg^-1 accordingly after paralysis and recovery time of the ear pinch reflex was recorded.(4) Aom0498-1 and Aom0498-3 2, 4 and 8 g·kg^-1 were iv given once time accordingly and clin. signs were monitored.(1) In mouse phrenic-nerve-diaphragm preparation model, the reversal rates of muscle contraction in Aom0498-1 1.8, 3.6 and 5.4μmol·L^-1 groups[(2.5±1.0)%, (6.9±2.6)% and(24.5±9.1)%] and those in Aom0498-3 groups[(17.4±1.7)%, (65.5±0.6)% and(100±8.9)%]were significantly higher than those in the corresponding groups of γ-cyclodextrin[(1.1±0.5)%, (2.6±0.7)%, and(10.3±6.1)%](P<0.05).The reversal rates of muscle contraction in Aom0498-3 1.8, 3.6 and 5.4μmol·L^-1 groups were significantly higher than those in sugammadex groups.The reversal rates of muscle contraction in Aom0498-1 1.8, 3.6 and 5.4μmol·L^-1 groups were significantly lower than those in sugammadex groups.(2) In the guinea pig model, the time for recovery of the train-of-four ratio to 50% and 75% in Aom0498-3 2 mg·kg^-1 group was significantly shorter than that in γ-cyclodextrin 2 mg·kg^-1 group(P<0.05), and was equivalent to that in sugammadex 2 mg·kg^-1 group.The recovery time of the train-of-four ratio to 50% in Aom0498-1 2 mg·kg^-1 group was significantly shorter than that in γ-cyclodextrin 2 mg·kg^-1 group, and the recovery time of the train-of-four ratio to 75% in Aom0498-1 2 mg·kg^-1 group was significantly longer than that in sugammadex 2 mg·kg^-1 group.(3)In the rabbit model, the recovery time in Aom0498-1 6 mg·kg^-1 group and in Aom0498-3 6 mg·kg^-1 group was significantly shorter than that in γ-cyclodextrin 6 mg·kg^-1 group(P<0.05).And the recovery time in Aom0498-3 6 mg·kg^-1 group was significantly shorter than that in sugammadex 6 mg·kg^-1 group.Single dose toxicity test showed that more mice in sugammadex 2, 4 and 8 g·kg^-1 groups with transient to mild side effects were observed when compared with those in the corresponding dose groups of Aom0498^-1 or Aom0498-3.Aom0498-1 and Ao0498-3 are of high reversal activities against sugammadex, indicating that the series of γ-cyclodextrin derivatives might be served as potential candidates of selective muscle-relaxant antagonists.

Frontiers in Medicine

Efficiency and Safety of the Selective Relaxant Binding Agent Adamgammadex Sodium for Reversing Rocuronium-Induced Deep Neuromuscular Block: A Single-Center, Open-Label, Dose-Finding, and Phase IIa Study

Author: Chen, Sifan ; Zhao, Yanhua ; Huai, Xiaorong ; Qi, Youmiao ; Qing, Jie ; Yu, Weifeng ; Su, Diansan ; Yu, Zhangjie

Background: Rapid reversal of neuromuscular block after surgery and anesthesia is often necessary. Here, we reported the primary efficacy and safety data from a phase IIa study on adamgammadex sodium, a newly developed modified γ-cyclodextrin derivative.Methods: This was a phase IIa, single-center, randomized, open-label, and dose-finding study that enrolled 35 patients under general anesthesia who received the neuromuscular blocking agent rocuronium for induction and maintenance of neuromuscular blockade. The subjects were randomized to one of the five adamgammadex dose groups (2, 4, 6, 8, and 10 mg kg−1) and to the 4 mg kg−1 sugammadex group. Pharmacological efficacy was the recovery time from the start of adamgammadex or sugammadex administration to train-of-four (TOF) ratio ≥0.9, 0.8, and 0.7 among the different dose groups. Adverse events were recorded throughout the study.Results: The efficacy in reversing deep neuromuscular block was the same between 4 mg kg−1 sugammadex and adamgammadex. However, in the lowest dose groups of 2 and 4 mg kg−1 adamgammadex, adequate reversal could not be achieved in all subjects. The recovery time of TOF ratio to 0.9, 0.8, and 0.7 was shorter in the adamgammadex 10 mg kg−1 group than in the sugammadex 4 mg kg−1 group. The average values of the TOF ratio after 3 min of administration of adamgammadex 8 and 10 mg kg−1 and sugammadex 4 mg kg−1 were >90%. There were no serious adverse events after the use of adamgammadex, and no subjects had to be withdrawn from the trial.Conclusions: Adamgammadex enabled quick, predictable, and tolerable reversion of rocuronium-induced deep neuromuscular block in a dose-dependent manner. Adamgammadex doses of 6–10 mg kg−1 might be the recommended dose range for further exploration of efficacy. Clinical Trial Registration: This study was registered at chictr.org.cn, identifier: ChiCTR2000038391.

100 Deals associated with Hangzhou Adamerck Pharmlabs, Inc.

100 Translational Medicine associated with Hangzhou Adamerck Pharmlabs, Inc.

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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

Discovery

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Adamgammadex Sodium	Reversal of Neuromuscular Blockade More	NDA/BLA
Aom-0207	Dysentery More	Discovery
Aom-0187	Dry Eye Syndromes More	Discovery
Bisulfate Cefdinir Sodium ( PBPs )	Bacterial Infections More	Discontinued
Aom-0763 ( XO )	Gout More	Pending

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