Infections and Infectious Diseases | Phase II Developments | CHINA

Ascentage Pharma

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CHINA China

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Ascentage Pharma Releases Preclinical Results of IAP Antagonist APG-1387 in an Oral Presentation at EASL ILC 2020

Lead Product(s): APG-1387,Entecavir

Therapeutic Area: Infections and Infectious Diseases Product Name: APG-1387

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2020

Details:

Findings from the preclinical study show that APG-1387 is able to clear chronic HBV infection in various mouse models with a unique induction of apoptosis and immunoregulation mechanism.

Ascletis Pharma

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First HBV Patient Dosed in Phase IIa Clinical Trial of ASC22, a Subcutaneously Administered PD-L1 Antibody

Lead Product(s): Envafolimab

Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 17, 2020

Details:

ASC22(Envafolimab) Phase IIa clinical trial is a single dose escalation study with three subcutaneously administered doses (0.3, 1.0 and 2.5 mg/kg) to explore the safety and efficacy of ASC22(Envafolimab) in chronic hepatitis B patients.

CanSino Biologics

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CanSino Vaccine Produces Immune Response

Lead Product(s): Ad5-nCoV

Therapeutic Area: Infections and Infectious Diseases Product Name: Ad5-nCoV

Highest Development Status: Phase II Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

The randomized, double-blind, placebo-controlled, Phase II trial of the vaccine was conducted in Wuhan, China for more than 500 healthy adults aged 18 years or older.

BeiGene

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Assembly Biosciences and BeiGene Announce License and Collaboration Agreement

Lead Product(s): ABI-H0731

Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: BeiGene

Deal Size: $540.0 million Upfront Cash: $40.0 million

Deal Type: Licensing Agreement July 20, 2020

Details:

BeiGene acquires exclusive development and commercialization rights to ABI-H0731, ABIH2158, and ABI-H3733 in China

Ascentage Pharma

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Ascentage Pharma Dosed First Patient in Phase II Clinical Study of IAP Antagonist APG-1387 in Combination with Entecavir for Chronic Hep B

Lead Product(s): APG-1387,Entecavir

Therapeutic Area: Infections and Infectious Diseases Product Name: APG-1387

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

The global multi-center, open-label Phase II study is designed to evaluate the safety and efficacy of APG-1387 in combination with entecavir in patients with CHB who are treatment-naive or -experienced.

Sinovac Biotech

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Sinovac Secures $15 Million in Funding to Accelerate COVID-19 Vaccine Development

Lead Product(s): CoronaVac

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Vaccine

Partner/Sponsor/Collaborator: Advantech Capital

Deal Size: $15.0 million Upfront Cash: Undisclosed

Deal Type: Funding May 22, 2020

Details:

The Funding will provide the Company with the necessary resources to continue its development of an inactivated vaccine against COVID-19 named CoronaVac.

Sinopharm

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China's Inactivated COVID-19 Vaccine Enters 2nd-Phase Clinical Trial

Lead Product(s): Inactivated Covid-19 vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 25, 2020

Details:

96 persons in three age groups have received the vaccine in the first phase of clinical trial as of April 23. The vaccine has shown good safety so far and vaccine receivers are still under observation.

Ascletis Pharma

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Ascletis Receives IND Approval for its HIV Drug ASC09F

Lead Product(s): ASC09,Ritonavir

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2020

Details:

Company got IND approval from National Medical Products Administration (NMPA) for its human immunodeficiency virus (HIV) protease inhibitor ASC09F (ASC09/Ritonavir Fixed-Dose Combination).

CanSino Biologics

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China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data

Lead Product(s): Ad5-nCoV

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 10, 2020

Details:

Based on the preliminary safety data of the phase I trial for Ad5-nCoV, the Company and Academy of Military Medical Sciences plan to initiate phase II clinical trial for Ad5-nCoV in China.

TenNor Therapeutics

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TenNor Therapeutics Received FDA Orphan Drug Designation

Lead Product(s): TNP-2092

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 20, 2020

Details:

TenNor has completed a Phase II clinical trial for TNP-2092 in the United States for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and received positive results.

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Ascentage Pharma

Ascentage Pharma Releases Preclinical Results of IAP Antagonist APG-1387 in an Oral Presentation at EASL ILC 2020

Ascletis Pharma

First HBV Patient Dosed in Phase IIa Clinical Trial of ASC22, a Subcutaneously Administered PD-L1 Antibody

CanSino Biologics

CanSino Vaccine Produces Immune Response

BeiGene

Assembly Biosciences and BeiGene Announce License and Collaboration Agreement

Ascentage Pharma

Ascentage Pharma Dosed First Patient in Phase II Clinical Study of IAP Antagonist APG-1387 in Combination with Entecavir for Chronic Hep B

Sinovac Biotech

Sinovac Secures $15 Million in Funding to Accelerate COVID-19 Vaccine Development

Sinopharm

China's Inactivated COVID-19 Vaccine Enters 2nd-Phase Clinical Trial

Ascletis Pharma

Ascletis Receives IND Approval for its HIV Drug ASC09F

CanSino Biologics

China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data

TenNor Therapeutics

TenNor Therapeutics Received FDA Orphan Drug Designation