Innovent Biologics

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Innovent Announces First Patient Dosed in a Phase 1b Clinical Trial of Sintilimab plus Surufatinib in Advanced Malignancies in China

Lead Product(s): Sintilimab,Surufatinib

Therapeutic Area: Oncology Product Name: Tyvyt

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 08, 2020

Details:

CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimab plus surufatinib in the treatment of patients with advanced malignancies.

Innovent Biologics

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Innovent Announces First Patient Dosed in A Phase 1b/2 Clinical Trial of IBI362, a Dual GLP-1 and Glucagon Receptor Agonist, in China

Lead Product(s): IBI362

Therapeutic Area: Nutrition and Weight Loss Product Name: IBI362

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

Details:

CIBI362B101 is a multiple-dose, safety and tolerability, pharmacokinetics and pharmacodynamics clinical study of IBI362 conducted in overweight or obese subjects in China.

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Innovent Announces the Preliminary Results of the Anti-CTLA-4 Monoclonal Antibody IBI310 in a Phase 1 Clinical Study

Lead Product(s): IBI310,Sintilimab

Therapeutic Area: Oncology 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 03, 2020

Details:

The study is an open-label study and was consisted of two parts, Phase 1a study and Phase 1b study, designed to evaluate the tolerability, safety and anti-tumor activity of IBI310 and its combination with sintilimab in the treatment of subjects with advanced malignant tumors.

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Innovent Announces the Preliminary Results of the Anti-PD-1/PD-L1 Bispecific Antibody IBI318 in a Phase 1 Clinical Study

Lead Product(s): IBI318

Therapeutic Area: Oncology 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 02, 2020

Details:

The preliminary results from study show that IBI318, a first-in-class bispecific antibody, has an acceptable safety profile. We are hopeful to see positive results from the following studies to help more patients in need.

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Innovent Announces First Patient Dosed in A Phase 1 Clinical Trial of Anti-TIGIT Monoclonal Antibody in China

Lead Product(s): IBI939

Therapeutic Area: Oncology 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 May 25, 2020

Details:

CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies.

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Innovent Biologics and MD Anderson Enter a Strategic Collaboration to Develop anti-PD-1 Therapy TYVYT in Rare Cancers

Lead Product(s): Sintilimab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Undisclosed Product Type: Large molecule

Partner/Sponsor/Collaborator: MD Anderson

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration May 18, 2020

Details:

The collaboration aims at providing opportunities for Innovent to pursue approval of sintilimab by the U.S. FDA for multiple rare cancer indications in addition to larger cancer indications for sintilimab that Innovent is independently pursuing for approval as well.

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TYVYT ORIENT-2 Study Met its Primary Endpoint in the Second-Line Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Lead Product(s): Sintilimab,Cisplatin,Paclitaxel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Data highlighted shows continued progress on clinical trials for the KEYTRUDA LENVIMA combination across multiple tumor types, including presentation on Phase 2 results of the metastatic clear cell renal cell carcinoma cohort of a Phase 1b/2 study of KEYTRUDA + LENVIMA.

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Tyvyt (Sintilimab Injection) Combined with Gemzar (Gemcitabine for Injection) and Platinum Chemotherapy Met the Predefined Primary Endpoint

Lead Product(s): Sintilimab,Gemcitabine,Platinum

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

Details:

TYVYT in combination with gemcitabine+ platinum chemotherapy demonstrated significant improvement in PFS compared to placebo+ gemcitabine and platinum chemotherapy.

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Innovent Announces First Patient Dosed in a Pivotal Trial of Parsaclisib in Patients with Indolent Lymphoma in China

Lead Product(s): Parsaclisib

Therapeutic Area: Oncology 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 27, 2020

Details:

Company achieved first patient dosing in a pivotal Phase 2 registrational trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor, in China.

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Innovent and Eli Lilly Announce NMPA Acceptance of Supplemental New Drug Application for Sintilimab in Combination with ALIMTA and Platinum

Lead Product(s): Sintilimab,Pemetrexed,Platinum

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

Details:

The NDA was based on the pre-specified interim analysis of a Phase 3 clinical trial Tyvyt or placebo in combination with ALIMTA and platinum as first-line therapy for Non-squamous NSCLC.

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Innovent Biologics

Innovent Announces First Patient Dosed in a Phase 1b Clinical Trial of Sintilimab plus Surufatinib in Advanced Malignancies in China

Innovent Biologics

Innovent Announces First Patient Dosed in A Phase 1b/2 Clinical Trial of IBI362, a Dual GLP-1 and Glucagon Receptor Agonist, in China

Innovent Biologics

Innovent Announces the Preliminary Results of the Anti-CTLA-4 Monoclonal Antibody IBI310 in a Phase 1 Clinical Study

Innovent Biologics

Innovent Announces the Preliminary Results of the Anti-PD-1/PD-L1 Bispecific Antibody IBI318 in a Phase 1 Clinical Study

Innovent Biologics

Innovent Announces First Patient Dosed in A Phase 1 Clinical Trial of Anti-TIGIT Monoclonal Antibody in China

Innovent Biologics

Innovent Biologics and MD Anderson Enter a Strategic Collaboration to Develop anti-PD-1 Therapy TYVYT in Rare Cancers

Innovent Biologics

TYVYT ORIENT-2 Study Met its Primary Endpoint in the Second-Line Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Innovent Biologics

Tyvyt (Sintilimab Injection) Combined with Gemzar (Gemcitabine for Injection) and Platinum Chemotherapy Met the Predefined Primary Endpoint

Innovent Biologics

Innovent Announces First Patient Dosed in a Pivotal Trial of Parsaclisib in Patients with Indolent Lymphoma in China

Innovent Biologics

Innovent and Eli Lilly Announce NMPA Acceptance of Supplemental New Drug Application for Sintilimab in Combination with ALIMTA and Platinum