FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Clinical Drug Pipeline Developments & Deals by Innovent Biologics

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            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.

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            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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            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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            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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            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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            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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            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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            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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            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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            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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