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Find Oncology Drugs in Phase III Clinical Development in CHINA

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            Lead Product(s): Sugemalimab

            Therapeutic Area: Oncology Product Name: CS1001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: $480.0 million Upfront Cash: Undisclosed

            Deal Type: Collaboration September 30, 2020

            Details:

            This collaboration provides financing to support CStone’s development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others.

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            Lead Product(s): Toripalimab,Gemcitabine

            Therapeutic Area: Oncology Product Name: JS001

            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 September 29, 2020

            Details:

            The results of the study showed that Toripalimab in combination with Gemcitabine/Cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly extended the progression-free survival than Gemcitabine/Cisplatin.

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            Lead Product(s): Sintilimab,Bevacizumab

            Therapeutic Area: Oncology Product Name: Tyvyt

            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 September 28, 2020

            Details:

            The ORIENT-32 trial evaluating TYVYT® in combination with BYVASDA® as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of progression-free survival (PFS) and overall survival (OS) in an interim analysis.

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            Lead Product(s): Sugemalimab,Oxaliplatin,Capecitabine

            Therapeutic Area: Oncology Product Name: CS1001

            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 September 24, 2020

            Details:

            CS1001-201 study demonstrated an objective response rate of 44.7% , a complete response rate of 31.6%, mOS of 19.7 months and an one-year overall survival rate of 55.5% in patients with relapsed or refractory extranodal natural killer /T cell lymphoma treated with sugemalimab.

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            Lead Product(s): Sintilimab,Pemetrexed Disodium,Platinum

            Therapeutic Area: Oncology Product Name: Tyvyt

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            The ORIENT-11 primary clinical results were released during the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium as an oral presentation and simultaneously published by the Journal of Thoracic Oncology.

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            Lead Product(s): Sintilimab,Gemcitabine,Platinum

            Therapeutic Area: Oncology Product Name: Tyvyt

            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 September 21, 2020

            Details:

            ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT® or placebo in combination with GEMZAR® and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer.

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            Lead Product(s): Toripalimab

            Therapeutic Area: Oncology Product Name: JS001

            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 September 17, 2020

            Details:

            This is the third such designation granted to Toripalimab. The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

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            Lead Product(s): Tislelizumab,Carboplatin,Paclitaxel

            Therapeutic Area: Oncology Product Name: BGB-A317

            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 September 17, 2020

            Details:

            Tislelizumab in combination with pemetrexed and platinum chemotherapy has demonstrated encouraging results among advanced NSCLC patients with non-squamous histology, including a median progression-free survival of 9.7 months and an overall response rate of 57.4 percent.

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            Lead Product(s): Zanubrutinib

            Therapeutic Area: Oncology Product Name: Brukinsa

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 09, 2020

            Details:

            The Health Canada has accepted for review and granted priority review status to BeiGene's marketing application seeking approval of BTK inhibitor Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Oncology Product Name: BAT1706

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: BeiGene

            Deal Size: $165.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement August 24, 2020

            Details:

            Under the terms of the agreement, Bio-Thera has agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan.

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