Oncology | Phase III Developments | CHINA

BeiGene

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CHINA China

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Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

Lead Product(s): Pamiparib

Therapeutic Area: Oncology Product Name: BGB-290

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 July 27, 2020

Details:

The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020. It is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial.

LintonPharm

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CHINA China

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LintonPharm Gets Authorization From China Health Authority to Proceed With a Global Phase 3 Trial Evaluating Catumaxomab in Advanced Gastric...

Lead Product(s): Catumaxomab

Therapeutic Area: Oncology Product Name: Undisclosed

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 July 15, 2020

Details:

The two-stage, multi-center, open-label, randomized, controlled registrational clinical trial will evaluate the safety and efficacy of an intraperitoneal infusion of the bi-specific antibody catumaxomab into the abdominal cavity in patients with peritoneal carcinomatosis.

CStone Pharmaceuticals

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CHINA China

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CStone Pharma Announces Positive Results from Phase I/II ARROW Trial of Pralsetinib in Chinese Patients with RET-Fusion NSCLC

Lead Product(s): Pralsetinib

Therapeutic Area: Oncology Product Name: BLU-667

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 July 09, 2020

Details:

Pralsetinib was well-tolerated, and showed deep and durable clinical activity in Chinese patients with RET-fusion NSCLC who were enrolled in the global, registrational phase I/II ARROW trial.

Burning Rock Dx

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Burning Rock and CStone Pharmaceuticals reached a strategic collaboration

Lead Product(s): Pralsetinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: CStone Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: collaboration June 29, 2020

Details:

The companies will co-develop and commercialize companion diagnostics (CDx) for pralsetinib, an investigational treatment developed by CStone’s partner Blueprint Medicines, in China for the detection of RET alterations in cancer patients.

Bio-Thera Solutions Ltd

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NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®

Lead Product(s): Bevacizumab

Therapeutic Area: Oncology Product Name: BAT1706

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 June 19, 2020

Details:

China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab).

BeiGene

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BeiGene Announces EMA Acceptance of its Marketing Authorization Application for BRUKINSA for the Waldenström’s Macroglobulinemia

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 June 18, 2020

Details:

BeiGene's Brukinsa (zanubrutinib) has been accepted for review by regulators in Europe to treat patients with Waldenström’s macroglobulinemia (WM).

Shanghai Henlius Biotech

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Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)

Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Product Name: Undisclosed

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 June 01, 2020

Details:

CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for biosimilar HLX02, for the treatment of HER2+ early breast cancer.

BeiGene

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BeiGene Presents Phase 3 Data on Tislelizumab Combined with Chemotherapy for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

Lead Product(s): Tislelizumab,Carboplatin,Paclitaxel

Therapeutic Area: Oncology Product Name: Undisclosed

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 29, 2020

Details:

Phase 3 results comparing tislelizumab plus chemotherapy to chemotherapy alone met its primary endpoint.

Zai Lab

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CHINA China

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Zai Lab Report Positive Topline Results from the NORA Phase 3 Study of ZEJULA® as Maintenance Therapy Platinum-sensitive, Recurrent Ovarian...

Lead Product(s): Niraparib

Therapeutic Area: Oncology Product Name: Undisclosed

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 May 28, 2020

Details:

The NORA study randomized 265 patients at 2:1 to receive ZEJULA or placebo until disease progression. The study meets all primary and secondary endpoints.

Kintor Pharmaceutical

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Kintor Pharmaceuticals Completes $240 Million IPO

Lead Product(s): Proxalutamide

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $240.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 19, 2020

Details:

Kintor is conducting phase-three clinical trials in China on its lead candidate, proxalutamide, and phase-two trials in the United States for late-stage prostate cancer.

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Companies

BeiGene

Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

LintonPharm

LintonPharm Gets Authorization From China Health Authority to Proceed With a Global Phase 3 Trial Evaluating Catumaxomab in Advanced Gastric...

CStone Pharmaceuticals

CStone Pharma Announces Positive Results from Phase I/II ARROW Trial of Pralsetinib in Chinese Patients with RET-Fusion NSCLC

Burning Rock Dx

Burning Rock and CStone Pharmaceuticals reached a strategic collaboration

Bio-Thera Solutions Ltd

NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®

BeiGene

BeiGene Announces EMA Acceptance of its Marketing Authorization Application for BRUKINSA for the Waldenström’s Macroglobulinemia

Shanghai Henlius Biotech

Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)

BeiGene

BeiGene Presents Phase 3 Data on Tislelizumab Combined with Chemotherapy for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

Zai Lab

Zai Lab Report Positive Topline Results from the NORA Phase 3 Study of ZEJULA® as Maintenance Therapy Platinum-sensitive, Recurrent Ovarian...

Kintor Pharmaceutical

Kintor Pharmaceuticals Completes $240 Million IPO