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Find Oncology Drugs in Phase II Clinical Development in CHINA

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            Lead Product(s): Chidamide

            Therapeutic Area: Oncology Product Name: HBI-8000

            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 September 28, 2020

            Details:

            HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. HBI-8000 targets class I histone deacetylase and suppresses the expression of the viral oncogene HTLV-I bZIP factor, NF-kB and the inflammasome in ATL cells.

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            Lead Product(s): Disitamab vedotin

            Therapeutic Area: Oncology Product Name: RC48

            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 September 25, 2020

            Details:

            U. S FDA has granted Breakthrough Therapy designation for disitamab vedotin, a novel humanized anti-HER2 antibody drug conjugate, for second-line treatment of patients with HER2+ locally advanced/metastatic urothelial cancer, who had received platinum-based chemotherapy.

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            Lead Product(s): LAE005,Afuresertib

            Therapeutic Area: Oncology Product Name: LAE005

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Laekna Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement September 09, 2020

            Details:

            According to the agreement, CMAB will provide a full spectrum of CMC services based on the recognized global quality standards for Laekna Therapeutics’ anti-PD-L1 antibody (LAE005).

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            Lead Product(s): KN046

            Therapeutic Area: Oncology Product Name: KN046

            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 September 03, 2020

            Details:

            The recombinant humanized PD-L1/ CTLA-4 bispecific antibody KN046 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of thymic epithelial tumors.

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            Lead Product(s): Sugemalimab

            Therapeutic Area: Oncology Product Name: CS1001

            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 31, 2020

            Details:

            FDA has completed their review of the Investigational New Drug application for anti-PD-L1 monoclonal antibody sugemalimab (CS1001) monotherapy in the relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) with study may proceed (SMP) letter received.

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            Lead Product(s): Taletrectinib

            Therapeutic Area: Oncology Product Name: AB-106

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $20.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing August 10, 2020

            Details:

            Proceeds from the financing will be used to advance the global Phase 2 trials of taletrectinib, a potent and highly selective next generation ROS1/NTRK inhibitor as well as to further expand AnHeart’s oncology portfolio.

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            Lead Product(s): Taletrectinib

            Therapeutic Area: Oncology Product Name: AB-106

            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 July 21, 2020

            Details:

            This Phase 2 trial will enroll approximately 106 NSCLC patients with ROS1 fusion and is designed as an open-label, single-arm, multi-center study in China.

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            Lead Product(s): Taletrectinib

            Therapeutic Area: Oncology Product Name: AB-106

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: NewG Lab

            Deal Size: $7.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 15, 2020

            Details:

            NewG Lab will be responsible for development, market authorization and commercialization activities for taletrectinib in Korea. AnHeart will allow NewG Lab to join its Phase 2 multi-regional clinical trial (MRCT) for non-small cell lung cancer (NSCLC) with ROS1/NTRK mutations.

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            Lead Product(s): Taletrectinib

            Therapeutic Area: Oncology Product Name: AB-106

            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 26, 2020

            Details:

            The lead clinical candidate taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier.

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            Lead Product(s): HQP1351

            Therapeutic Area: Oncology Product Name: HQP1351

            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 18, 2020

            Details:

            Guangzhou Healthquest Pharma has submitted a NDA to the Center for Drug Evaluation of China National Medical Products Administration for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia and accelerated phase CML.

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