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Find Oncology Drugs in Phase II Clinical Development in CHINA

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            Lead Product(s): CNCT19

            Therapeutic Area: Oncology Product Name: CNCT19

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $65.0 million Upfront Cash: Undisclosed

            Deal Type: Financing November 18, 2020

            Details:

            Juventas has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL).

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            Lead Product(s): Chidamide,Nivolumab

            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 November 09, 2020

            Details:

            Study confirms tolerability and significant anti-tumor activity of HBI-8000 in combination with nivolumab in checkpoint naive melanoma patients.

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            Lead Product(s): Olverembatinib

            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 November 09, 2020

            Details:

            The results that will be released through the oral presentation are from the two pivotal Phase II trials of HQP1351 in patients with TKI-resistant and T315I-mutant CML. Results from those two trials of HQP1351 have shown favorable efficacy and tolerability.

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            Lead Product(s): Zanubrutinib

            Therapeutic Area: Oncology Product Name: Brukinsa

            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 November 05, 2020

            Details:

            Multiple clinical presentations on company's BTK inhibitor BRUKINSA® (zanubrutinib) and non-clinical data on its anti-PD-1 antibody tislelizumab will be presented in an oral presentation and four posters at the 62nd ASH Annual Meeting.

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            Lead Product(s): Orelabrutinib

            Therapeutic Area: Oncology Product Name: ICP-022

            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 November 05, 2020

            Details:

            Orelabrutinib is a selective BTK inhibitor to treat cancers and autoimmune diseases, which has been supported by the national special project for the development of major new drugs. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile.

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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 October 29, 2020

            Details:

            In the two Phase 1 studies, taletrectinib demonstrated meaningful clinical activity in advanced ROS1+ NSCLC patients who are ROS1 TKI-naïve or crizotinib-refractory and had a manageable safety profile.

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            Lead Product(s): Olverembatinib

            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 October 21, 2020

            Details:

            Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of the company, priority review to its New Drug Application (NDA) for Olverembatinib (HQP1351).

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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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