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Find Oncology Drugs in Phase II Clinical Development in CHINA

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            Lead Product(s): Efineptakin alfa

            Therapeutic Area: Oncology

            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 May 21, 2020

            Details:

            China National Medical Products Administration (NMPA) has cleared the initiation of a Phase 2 clinical trial of TJ107/HyLeukin-7™ (Efineptakin alfa), in lymphopenic patients with newly-diagnosed glioblastoma multiforme (GBM).

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            Lead Product(s): HQP1351

            Therapeutic Area: Oncology

            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 May 04, 2020

            Details:

            HQP1351 is the first 3rd generation BCR-ABL inhibitor developed in China targeting drug-resistant CML. A pivotal Phase II study is currently under way to test HQP1351. Ascentage plans to file an NDA.

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            Lead Product(s): Disitamab vedotin

            Therapeutic Area: Oncology

            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 April 29, 2020

            Details:

            The IND clearance for RC48's first US-based trial arrives on the heels of RemeGen's recently completed $100 million plus financing, led by Lilly Asia Ventures and Lake Bleu Capital.

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            Lead Product(s): Parsaclisib

            Therapeutic Area: Oncology

            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): KN046

            Therapeutic Area: Oncology

            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 April 16, 2020

            Details:

            KN046's Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.

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            Lead Product(s): Toripalimab,Axitinib

            Therapeutic Area: Oncology

            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 March 30, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma.

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            Lead Product(s): Orelabrutinib

            Therapeutic Area: Oncology

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $289.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering March 20, 2020

            Details:

            Half of the listing proceeds will be used to fund the development of orelabrutinib in China and the US and the rest for developing other drugs.

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            Lead Product(s): Onapristone

            Therapeutic Area: Oncology

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Context Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 12, 2020

            Details:

            Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs.

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            Lead Product(s): Tucidinostat

            Therapeutic Area: Oncology

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Meiji Seika Pharma Co Ltd.

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 08, 2020

            Details:

            HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights.

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            Lead Product(s): MOR202,Lenalidomide,Dexamethasone

            Therapeutic Area: Oncology

            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 January 03, 2020

            Details:

            I-Mab initiated two registrational trials with TJ202/MOR202 in relapsed or refractory MM in Taiwan in early 2019 &expanded these trials into mainland China in late 2019, after receiving IND clearance from the (NMPA)