Oncology | Phase III Developments | CHINA

Innovent Biologics

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CHINA China

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ASCO 2020

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Tyvyt (Sintilimab Injection) Combined with Gemzar (Gemcitabine for Injection) and Platinum Chemotherapy Met the Predefined Primary Endpoint

Lead Product(s): Sintilimab,Gemcitabine,Platinum

Therapeutic Area: Oncology

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.

Shanghai Junshi Biosciences

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CHINA China

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Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

Lead Product(s): Toripalimab

Therapeutic Area: Oncology

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 30, 2020

Details:

The sNDA is the world’s first new drug application of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

I-Mab Biopharma

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I-Mab and MorphoSys Announce First Patient Dosed in Phase 3 Clinical Trial of TJ202/MOR202 in r/r Multiple Myeloma in Mainland China

Lead Product(s): MOR202,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology

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 27, 2020

Details:

First patient has been dosed in a ph 3 clinical study to evaluate MorphoSys’ TJ202/MOR202 in combination with lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma.

Innovent Biologics

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ASCO 2020

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Innovent and Eli Lilly Announce NMPA Acceptance of Supplemental New Drug Application for Sintilimab in Combination with ALIMTA and Platinum

Lead Product(s): Sintilimab,Pemetrexed,Platinum

Therapeutic Area: Oncology

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.

Tot Biopharm

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TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin) Meets Primary Endpoint in Phase III Clinical Trial

Lead Product(s): Bevacizumab

Therapeutic Area: Oncology

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 21, 2020

Details:

Randomized Phase III clinical trial of TAB008 (Pusintin®) has reached the predefined primary endpoint. The Company will continue to push forward the new drug application of Pusintin®) as scheduled.

BeiGene

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ASCO 2020

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BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy

Lead Product(s): Tislelizumab,Carboplatin,Paclitaxel

Therapeutic Area: Oncology

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 20, 2020

Details:

IND application has been accepted for GEN-001 for combination treatment with avelumab in patients with solid cancers.

BeiGene

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ASCO 2020

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BeiGene’s Tislelizumab gets Chinese Approval to Treat Locally Advanced/metastatic Urothelial Carcinoma

Lead Product(s): Tislelizumab,Carboplatin,Cisplatin

Therapeutic Area: Oncology

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 13, 2020

Details:

Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with NSCLC met its primary endpoint.

Zai Lab

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Zai Lab Announces Acceptance of sNDA Submission of ZEJULA

Lead Product(s): Niraparib

Therapeutic Area: Oncology

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 March 16, 2020

Details:

ZEJULA treatment resulted in a 38% reduction in the risk of disease progression or death in the overall study population when compared to placebo.

Fosun Kite Biotechnology

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Fosun Kite’s New Drug Application (NDA) Filing For Axicabtagene Ciloleucel Accepted For Review By China NMPA

Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine

Therapeutic Area: Oncology

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 February 24, 2020

Details:

The NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876.

BeiGene

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BeiGene downgrades late-stage study of PARP inhibitor in gastric cancer

Lead Product(s): Pamiparib

Therapeutic Area: Oncology

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 January 24, 2020

Details:

The global Phase 3, is designed to compare the efficacy and safety of pamiparib to placebo as maintenance therapy in approximately 540 patients with advanced gastric cancer.

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Innovent Biologics

Tyvyt (Sintilimab Injection) Combined with Gemzar (Gemcitabine for Injection) and Platinum Chemotherapy Met the Predefined Primary Endpoint

Shanghai Junshi Biosciences

Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

I-Mab Biopharma

I-Mab and MorphoSys Announce First Patient Dosed in Phase 3 Clinical Trial of TJ202/MOR202 in r/r Multiple Myeloma in Mainland China

Innovent Biologics

Innovent and Eli Lilly Announce NMPA Acceptance of Supplemental New Drug Application for Sintilimab in Combination with ALIMTA and Platinum

Tot Biopharm

TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin) Meets Primary Endpoint in Phase III Clinical Trial

BeiGene

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy

BeiGene

BeiGene’s Tislelizumab gets Chinese Approval to Treat Locally Advanced/metastatic Urothelial Carcinoma

Zai Lab

Zai Lab Announces Acceptance of sNDA Submission of ZEJULA

Fosun Kite Biotechnology

Fosun Kite’s New Drug Application (NDA) Filing For Axicabtagene Ciloleucel Accepted For Review By China NMPA

BeiGene

BeiGene downgrades late-stage study of PARP inhibitor in gastric cancer