Infections and Infectious Diseases | Phase I Developments | CHINA

Shanghai Junshi Biosciences

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Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of SARS-CoV-2 Neutralizing Antibody JS016 in China

Lead Product(s): JS016

Therapeutic Area: Infections and Infectious Diseases Product Name: JS016

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 12, 2020

Details:

The study is a randomized, double-blind, placebo-controlled Phase I trial is intended to investigate the safety and tolerability of single dose JS016 intravenous injection (IV) in 40 healthy subjects.

Clover Biopharmaceutical

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CEPI to Invest $66 Million to Boost Clover's COVID-19 Vaccine Trial

Lead Product(s): S-Trimer COVID vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: CEPI

Deal Size: Undisclosed Upfront Cash: $66.0 million

Deal Type: Funding July 08, 2020

Details:

Funding will support clinical development in parallel with scale-up of manufacturing capacity to potentially produce hundreds of millions of doses per year.

Clover Biopharmaceutical

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Clover Biopharmaceuticals Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate

Lead Product(s): COVID-19 S-Trimer vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: SCB-2019

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 19, 2020

Details:

First participants have been dosed in the Phase 1 first-in-human study evaluating the company’s COVID-19 S-Trimer subunit vaccine candidate (SCB-2019), which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform.

Shanghai Junshi Biosciences

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Junshi Biosciences Doses First Healthy Volunteer in Phase I Clinical Study of SARS-CoV-2 Neutralizing Antibody JS016 in China

Lead Product(s): JS016

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 07, 2020

Details:

JS016 is a recombinant fully human monoclonal neutralizing antibody that blocks the binding of the SARS-CoV-2 virus to the host cell surface receptor ACE2.

CanSino Biologics

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First human trial of COVID-19 Vaccine from CanSino Biologic finds its Safe and Induces Rapid Immune Response

Lead Product(s): Adenovirus vector based SARS-CoV-2 vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

The vaccine candidate met the initial end points regarding adverse events and safety and provide evidence of immunogenicity against the target protein.

CanSino Biologics

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Health Canada Approves First Covid-19 Vaccine Trials

Lead Product(s): Ad5-nCoV

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

The Canadian Center for Vaccinology at Dalhousie University has received approval from Health Canada to conduct the country’s first clinical trials of a potential Covid-19 vaccine, Ad5-nCoV, developed under CanSino Biologics.

CanSino Biologics

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Cansino Biologics and Institute Of Biotechnology, Academy Of Military Medical Sciences Developing Novel Coronavirus Vaccine

Lead Product(s): Ad5-nCoV

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 17, 2020

Details:

Joint developers submitted pre-investigational new drug review application for AD5-NCOV to regulatory authorities.

I-Mab Biopharma

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I-Mab Biopharma Announces Development of TJM2 to Treat Cytokine Release Syndrome in COVID-19

Lead Product(s): TJM2

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 13, 2020

Details:

The development will start following the FDA acceptance of I-Mab’s Investigational New Drug application, and the study will commence initially in the U.S. with plans to expand into other countries.

Shanghai Zhimeng Biopharma

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Zhimeng Biopharma Announces the First-in-Human Dosing in Phase I Clinical Trial of ZM-H1505R

Lead Product(s): ZM-H1505R

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 05, 2020

Details:

Primary results showed that the drug is safe and well tolerated in health volunteers tested.

Ascletis Pharma

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Ascletis Received Approval of Clinical Trials in HBV Patients for ASC22, a Subcutaneously Administered PD-L1 Antibody

Lead Product(s): ASC22

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 2020

Details:

ASC22 is a first-in-class, subcutaneously administered PD-L1 antibody approved for such clinical trials in HBV patients on a global basis.

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Shanghai Junshi Biosciences

Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of SARS-CoV-2 Neutralizing Antibody JS016 in China

Clover Biopharmaceutical

CEPI to Invest $66 Million to Boost Clover's COVID-19 Vaccine Trial

Clover Biopharmaceutical

Clover Biopharmaceuticals Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate

Shanghai Junshi Biosciences

Junshi Biosciences Doses First Healthy Volunteer in Phase I Clinical Study of SARS-CoV-2 Neutralizing Antibody JS016 in China

CanSino Biologics

First human trial of COVID-19 Vaccine from CanSino Biologic finds its Safe and Induces Rapid Immune Response

CanSino Biologics

Health Canada Approves First Covid-19 Vaccine Trials

CanSino Biologics

Cansino Biologics and Institute Of Biotechnology, Academy Of Military Medical Sciences Developing Novel Coronavirus Vaccine

I-Mab Biopharma

I-Mab Biopharma Announces Development of TJM2 to Treat Cytokine Release Syndrome in COVID-19

Shanghai Zhimeng Biopharma

Zhimeng Biopharma Announces the First-in-Human Dosing in Phase I Clinical Trial of ZM-H1505R

Ascletis Pharma

Ascletis Received Approval of Clinical Trials in HBV Patients for ASC22, a Subcutaneously Administered PD-L1 Antibody