CompaniesSimcere Pharmaceutical Group

Simcere Pharmaceutical Group

active

Nanjing, China

Founded 1995

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Small Molecules

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Small Molecule PharmaceuticalChina

Clinical Trials (76)

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Total Trials

As Lead Sponsor

As Collaborator

Total Enrollment

16,091

By Phase

PHASE2: 16PHASE1: 35PHASE3: 11PHASE4: 8PHASE2/PHASE3: 4PHASE1/PHASE2: 2

By Status

UNKNOWN: 33COMPLETED: 25RECRUITING: 10NOT_YET_RECRUITING: 3ACTIVE_NOT_RECRUITING: 3TERMINATED: 2

Clinical Trials Pipeline76 trials

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Phase 1/2

Phase 2/3

N/A

Phase

Status

Role

Condition

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Today

NCT01131546

Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

Phase: Phase 4

Role: Lead Sponsor

Start: Dec 31, 2009

Completion: Mar 31, 2011

NCT01109264

Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Phase: Phase 2

Role: Lead Sponsor

Start: Mar 31, 2010

Completion: Aug 31, 2013

NCT01327235

Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

Phase: Phase 2

Role: Lead Sponsor

Start: Mar 31, 2011

Completion: Jul 31, 2014

NCT01368419

Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Phase: Phase 2

Role: Lead Sponsor

Start: May 31, 2011

Completion: May 31, 2013

NCT01410370

Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Phase: Phase 2

Role: Lead Sponsor

Start: Jun 30, 2011

Completion: Jun 30, 2013

NCT01469910

Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

Phase: Phase 1

Role: Lead Sponsor

Start: Sep 30, 2011

Completion: Jun 30, 2012

NCT01531790

A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

Phase: Phase 1

Role: Lead Sponsor

Start: Sep 30, 2011

Completion: Dec 31, 2012

NCT01459081

Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Phase: Phase 3

Role: Lead Sponsor

Start: Oct 31, 2011

Completion: Dec 31, 2012

NCT01909856

The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

Phase: Phase 2

Role: Lead Sponsor

Start: Oct 31, 2011

Completion: Jun 30, 2014

NCT01548001

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase: Phase 4

Role: Lead Sponsor

Start: May 31, 2012

Completion: Jan 31, 2017

NCT01548001

NCT01554917

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Phase: Phase 4

Role: Lead Sponsor

Start: May 31, 2012

Completion: Aug 31, 2015

NCT01893151

Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

Phase: Phase 4

Role: Lead Sponsor

Start: Jul 31, 2012

Completion: Dec 31, 2015

NCT01772732

Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC

Phase: Phase 1

Role: Lead Sponsor

Start: Dec 31, 2012

Completion: Dec 31, 2015

NCT01847118

A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: Apr 30, 2013

Completion: Nov 30, 2015

NCT02004548

Phase I Clinical Study of Metatinib Tromethamine Tablet

Phase: Phase 1

Role: Lead Sponsor

Start: May 31, 2013

Completion: Dec 31, 2015

NCT01929096

Compound Edaravone Injection for Acute Ischemic Stroke

Phase: Phase 2

Role: Lead Sponsor

Start: Aug 31, 2013

Completion: Feb 28, 2015

NCT02275299

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Phase: Phase 4

Role: Lead Sponsor

Start: Sep 30, 2013

Completion: Feb 29, 2016

NCT02088515

Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma

Phase: Phase 4

Role: Lead Sponsor

Start: Dec 31, 2013

Completion: Feb 28, 2017

NCT02269904

Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

Phase: Phase 2

Role: Lead Sponsor

Start: Apr 30, 2014

Completion: Jun 30, 2018

NCT02283476

The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

Phase: Phase 3

Role: Lead Sponsor

Start: Nov 30, 2014

Completion: Nov 30, 2017

NCT02375022

Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

Phase: Phase 2

Role: Collaborator

Start: Mar 31, 2015

Completion: Mar 31, 2016

NCT02430350

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Phase: Phase 3

Role: Lead Sponsor

Start: May 31, 2015

Completion: Dec 31, 2016

NCT02453464

A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

Phase: Phase 1

Role: Lead Sponsor

Start: Aug 31, 2015

Completion: Not specified

NCT02453464

NCT02652234

Study of Endostar Subcutaneous Injection in NSCLC

Phase: Phase 1

Role: Lead Sponsor

Start: Aug 31, 2015

Completion: Sep 30, 2016

NCT02650375

Study of Metatinib Tromethamine Tablet

Phase: Phase 1

Role: Lead Sponsor

Start: Oct 31, 2015

Completion: Feb 28, 2018

NCT02722694

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Phase: Phase 3

Role: Lead Sponsor

Start: Aug 31, 2016

Completion: Dec 31, 2017

NCT02916420

Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma

Phase: Phase 3

Role: Lead Sponsor

Start: Sep 30, 2016

Completion: Jun 30, 2019

NCT02805010

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

Phase: Phase 1

Role: Lead Sponsor

Start: Oct 31, 2016

Completion: Feb 28, 2017

NCT03424928

A Pilot Bioequivalence Study of Pomalidomide

Phase: Phase 1

Role: Lead Sponsor

Start: Jan 19, 2018

Completion: Feb 6, 2018

NCT03763123

A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.

Phase: Phase 1

Role: Lead Sponsor

Start: Apr 24, 2018

Completion: Dec 31, 2020

NCT03577392

Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.

Phase: Phase 2/3

Role: Collaborator

Start: Jul 1, 2018

Completion: Aug 1, 2021

NCT03588494

Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

Phase: Phase 2/3

Role: Collaborator

Start: Aug 1, 2018

Completion: Sep 1, 2021

NCT04413227

A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: Apr 2, 2020

Completion: Sep 30, 2021

NCT04440436

Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

Phase: Phase 1/2

Role: Collaborator

Start: Jun 4, 2020

Completion: Jun 4, 2035

NCT04440436

NCT04671849

An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.

Phase: Phase 1

Role: Lead Sponsor

Start: Dec 21, 2020

Completion: Jan 30, 2024

NCT04714177

Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

Phase: Phase 2

Role: Collaborator

Start: Mar 1, 2021

Completion: Sep 1, 2023

NCT04830644

A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

Phase: Phase 2

Role: Lead Sponsor

Start: Mar 22, 2021

Completion: Jun 30, 2022

NCT04902885

Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients

Phase: Phase 3

Role: Lead Sponsor

Start: May 25, 2021

Completion: Dec 31, 2022

NCT04914598

A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

Phase: Phase 3

Role: Lead Sponsor

Start: May 31, 2021

Completion: Oct 30, 2023

NCT04908787

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

Phase: Phase 3

Role: Lead Sponsor

Start: Jun 11, 2021

Completion: Oct 11, 2024

NCT04942301

PK Study for Endostar Continuous Intravenous Infusion in NSCLC Patients With 1st-line Platinum Based Chemotherapy

Phase: Phase 1

Role: Lead Sponsor

Start: Jul 30, 2021

Completion: Oct 15, 2022

NCT05071703

Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Phase: Phase 4

Role: Lead Sponsor

Start: Aug 11, 2021

Completion: Nov 30, 2022

NCT05200728

The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers

Phase: Phase 1

Role: Lead Sponsor

Start: Dec 6, 2021

Completion: Mar 23, 2023

NCT05148195

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors

Phase: Phase 2

Role: Lead Sponsor

Start: Dec 22, 2021

Completion: Jul 26, 2023

NCT05254665

A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors

Phase: Phase 2

Role: Lead Sponsor

Start: Feb 28, 2022

Completion: Mar 31, 2024

NCT05339646

A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Phase: Phase 1

Role: Lead Sponsor

Start: Apr 7, 2022

Completion: Dec 31, 2022

NCT05369676

To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

Phase: Phase 1/2

Role: Lead Sponsor

Start: May 12, 2022

Completion: Aug 29, 2022

NCT05293964

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Phase: Phase 1

Role: Lead Sponsor

Start: May 18, 2022

Completion: Sep 8, 2025

NCT05528055

A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: May 18, 2022

Completion: Oct 31, 2027

NCT05528055

NCT05373446

Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study

Phase: Phase 2

Role: Lead Sponsor

Start: May 20, 2022

Completion: Mar 31, 2023

NCT05373433

To Evaluate SSD8432/Ritonavir in Adults With COVID-19

Phase: Phase 2/3

Role: Lead Sponsor

Start: May 26, 2022

Completion: Oct 31, 2023

NCT05475834

Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

Phase: Phase 1

Role: Lead Sponsor

Start: Jul 21, 2022

Completion: Aug 7, 2022

NCT05506176

A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19

Phase: Phase 2/3

Role: Lead Sponsor

Start: Aug 19, 2022

Completion: Mar 21, 2023

NCT05569057

A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma

Phase: Phase 1

Role: Lead Sponsor

Start: Sep 30, 2022

Completion: Mar 31, 2025

NCT05665647

Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants

Phase: Phase 1

Role: Lead Sponsor

Start: Dec 29, 2022

Completion: Feb 14, 2023

NCT05731804

Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir

Phase: Phase 1

Role: Lead Sponsor

Start: Mar 1, 2023

Completion: Dec 31, 2023

NCT05781360

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: Mar 8, 2023

Completion: May 25, 2024

NCT05718219

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: Mar 29, 2023

Completion: Dec 30, 2026

NCT05803135

Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

Phase: Phase 4

Role: Collaborator

Start: Mar 31, 2023

Completion: Dec 30, 2025

NCT05826249

Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects

Phase: Phase 1

Role: Lead Sponsor

Start: Apr 7, 2023

Completion: Nov 30, 2023

NCT05885919

Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke

Phase: Phase 3

Role: Collaborator

Start: Jul 1, 2023

Completion: Dec 31, 2024

NCT06022354

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects

Phase: Phase 1

Role: Lead Sponsor

Start: Aug 23, 2023

Completion: Jul 22, 2025

NCT06010693

A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Phase: Phase 3

Role: Lead Sponsor

Start: Aug 28, 2023

Completion: May 10, 2024

NCT06326723

Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

Phase: Phase 1

Role: Lead Sponsor

Start: Sep 4, 2023

Completion: Feb 5, 2024

NCT06186414

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC

Phase: Phase 1

Role: Lead Sponsor

Start: Jan 23, 2024

Completion: Dec 31, 2030

NCT06186414

NCT06331559

Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors

Phase: Phase 1

Role: Lead Sponsor

Start: Mar 19, 2024

Completion: Dec 31, 2027

NCT06370416

the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Phase: Phase 2

Role: Collaborator

Start: Apr 30, 2024

Completion: Dec 31, 2025

NCT06375044

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

Phase: Phase 1

Role: Lead Sponsor

Start: May 24, 2024

Completion: Dec 30, 2028

NCT06375044

NCT06536036

Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

Phase: Phase 1

Role: Lead Sponsor

Start: Jul 23, 2024

Completion: Oct 16, 2024

NCT06698965

Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Phase: Phase 2

Role: Collaborator

Start: Oct 13, 2024

Completion: Oct 31, 2029

NCT06698965

NCT06654791

Mass Balance Clinical Trial of SIM0270

Phase: Phase 1

Role: Lead Sponsor

Start: Oct 17, 2024

Completion: Mar 31, 2025

NCT06680921