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Last update 08 May 2025

Shanghai Pharma Rare Disease Medicine Co., Ltd.

Private Company|2020|Shanghai Shi, China

Last update 08 May 2025

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Deal

Translational Medicine

Overview

Clinical Trials associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

CTR20243379

/ Not yet recruitingNot Applicable

青霉胺胶囊（250mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of penicillamine capsules (250 mg) in healthy Chinese subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择Valeant Pharmaceuticals International为持证商的青霉胺胶囊（商品名：Cuprimine，规格：250mg）为参比制剂，对上海上药信谊药厂有限公司生产、上海上药睿尔药品有限公司持证的受试制剂青霉胺胶囊（规格：250mg）进行空腹给药条件下的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，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂青霉胺胶囊（规格：250mg）和参比制剂青霉胺胶囊（商品名：Cuprimine，规格：250mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the penicillamine capsule (trade name: Cuprimine, specification: 250mg) of Valeant Pharmaceuticals International as the licensee was selected as the reference preparation, and the test preparation penicillamine capsule (specification: 250mg) produced by Shanghai SPH Xinyi Pharmaceutical Co., Ltd. and licensed by Shanghai SPH Ruier Pharmaceutical Co., Ltd. was tested in human body under fasting administration conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation penicillamine capsule (specification: 250mg) and the reference preparation penicillamine capsule (trade name: Cuprimine, specification: 250mg) by healthy subjects.

Start Date-

Sponsor / Collaborator

Shanghai Pharma Rare Disease Medicine Co., Ltd.

CTR20222670

/ CompletedNot Applicable

马昔腾坦片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验研究方案

[Translation] Study plan for a single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence trial of macitentan tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂马昔腾坦片（持证商：上海上药睿尔药品有限公司）与参比制剂马昔腾坦片（持证商：Actelion Pharmaceuticals Ltd，商品名：傲朴舒®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂马昔腾坦片和参比制剂马昔腾坦片在健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation, Macitentan Tablets (licensed by: Shanghai SPH Ruier Pharmaceutical Co., Ltd.) and the reference preparation, Macitentan Tablets (licensed by: Actelion Pharmaceuticals Ltd., trade name: Aposhu®) in healthy subjects after oral administration in the fasting/postprandial state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation, Macitentan Tablets, and the reference preparation, Macitentan Tablets in healthy subjects.

Start Date24 Oct 2022

Sponsor / Collaborator

Shanghai Pharma Rare Disease Medicine Co., Ltd.

CTR20222114

/ CompletedNot Applicable

上海上药睿尔药品有限公司持证的依维莫司片（5 mg）与Novartis Pharma Schweiz AG持证的依维莫司片（商品名：Afinitor，5 mg）在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究

[Translation] A single-dose, randomized, open-label, two-period, double-crossover, fasting and fed bioequivalence study of everolimus tablets (5 mg) licensed by Shanghai SPH Ruier Pharmaceuticals Co., Ltd. and everolimus tablets (trade name: Afinitor, 5 mg) licensed by Novartis Pharma Schweiz AG in healthy Chinese subjects

主要研究目的：以Novartis Pharma Schweiz AG持证的依维莫司片（商品名：Afinitor）为参比制剂，以上海上药睿尔药品有限公司持证的依维莫司片为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the Everolimus Tablets (trade name: Afinitor) licensed by Novartis Pharma Schweiz AG as the reference preparation and the Everolimus Tablets licensed by Shanghai Haiyao Ruier Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date22 Aug 2022

Sponsor / Collaborator

Shanghai Pharma Rare Disease Medicine Co., Ltd.

100 Clinical Results associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

0 Patents (Medical) associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

Literatures (Medical) associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

01 Jan 2023·Frontiers in aging neuroscience

"Huoling Shengji granule" for amyotrophic lateral sclerosis: protocol for a multicenter, randomized, double-blind, riluzole parallel controlled clinical trial.

Article

Author: Fan, Dongsheng ; Qin, Tingting ; Shan, Lei ; Feng, Yi ; Lei, Xiang ; Wen, Bin ; Liu, Xiaolu ; Li, Tao ; Yin, Ping ; Xu, Xin

BackgroundThere is still a large demand for effective treatments to delay disease deterioration in amyotrophic lateral sclerosis (ALS). Typical symptoms of ALS are considered "flaccidity syndrome" in traditional Chinese medicine (TCM). Huoling Shengji Granule (HLSJ) is a TCM formula used to treat flaccidity syndrome. Results of preclinical tests and a previous clinical study support HLSJ as a novel drug for ALS patients. This trial proposed to examine whether a 48-week course of HLSJ is effective and safe for ALS patients diagnosed with the Chinese medicine syndrome of spleen qi insufficiency and kidney yang deficiency.Methods and analysisIn this phase II, multicenter, randomized, double-blind, riluzole parallel-controlled, superiority-design study, eligible participants had the equal opportunity to be assigned to receive either HLSJ or riluzole randomly. Eleven specialized ALS centers in Mainland China will recruit 144 patients for this trial. The primary and secondary outcomes included the change in the ALSFRS-R score and the Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) from baseline to Week 48.DiscussionHere, we endeavored to evaluate TCM for ALS using a standard evidence-based approach for the first time. In addition, the ROADS, a self-report linear-weighted questionnaire, was selected as a secondary outcome measure. We expect to offer a new reference for the outcome evaluation of ALS trials.Clinical trial registration:http://www.Chictr.org.cn, identifier ChiCTR2100044085.

Scientific Reports

Establishment of an α-thalassemia mouse model through fetal liver cell transplantation and analysis of hematological parameters

Article

Author: Fu, Wencheng ; Xu, Xin ; Ye, Wenrui

Clinically, α-thalassemia is stratified into mild, intermediate, and severe forms, differentiated by the degree of anemia severity. Specifically, severe α-thalassemia manifests in homozygous individuals, characterized by a profound α globin deficit. The presence of two α0 alleles, resulting in a complete four-gene defect (α^--/--), constitutes a lethal in utero condition known as Hemoglobin (Hb) Barts hydrops fetalis syndrome. This arises from the inability of hemoglobin, deficient in α chains, to adequately transport oxygen. Consequently, this severe variant typically onsets during fetal development, often culminating in intrauterine death towards the end of gestation or dying shortly postpartum due to the compounded effects of severe anemia and resultant hypoxia. This study endeavors to establish an α-thalassemia mouse model via transplantation of embryonic liver cells harboring a dual α allele knockout, with a subsequent focus on comprehensively characterizing its hematological parameters and associated phenotypic indicators. To generate an α-globin chain-deficient mouse model, we transplanted fetal liver cells (harvested at embryonic day 13.5 from homozygous C57BL/6J-CD45.2-HBA-DKO mice) into C57BL/6 wild-type recipients preconditioned with 800 cGy irradiation. Multiple blood routine indicators, blood smear assessments, and spleen weight measurements, were subsequently conducted to characterize the model. Initially, model mice exhibited elevated white blood cell and lymphocyte counts relative to controls, potentially indicative of a possible immune reaction, though this response waned over time. Characteristic of the disease, these mice displayed significantly diminished mean corpuscular hemoglobin content and concentration, alongside heightened numbers of HbH inclusions and spleen weights. Furthermore, red blood cellindices, such as red blood cell count, hematocrit, red cell distribution width-coefficient of variation, and red cell distribution width-standard deviation, were all markedly increased in the model mice. Notably, model mice demonstrated significantly elevated values for mean platelet volume, platelet distribution width, and platelet large cell ratio percentage, reflective of aberrant platelet characteristics. Concurrently, a time-dependent increase in basophil percentages accompanied decreases in platelet count, platelet crit, and platelet larger cell count, collectively implying a progressively severe anemic state. Moreover, the progression from low to high levels of reticulocyte percentage and absolute reticulocyte count further corroborated an escalating tendency towards hemolysis. The model mice also experienced a substantial decline in body weight, underscoring the profound impact of disease progression on their health.

100 Deals associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

100 Translational Medicine associated with Shanghai Pharma Rare Disease Medicine Co., Ltd.

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Shanghai Pharma Rare Disease Medicine Co., Ltd.

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