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Product pipeline diagram
  • Product
    Target/MoA
    Type
    Pre-clinical
    Dose Escalation
    Ph Ia
    Dose Expansion
    Ph Ib
    Ph IIa
    Pivotal
    Ph IIb
    Ph III
    NDA/BLA
    Marketed
    Rights
    Partnership
  • Conmana?/ 凱美納 (Icotinib)
    EGFR
    Small Molecule
    1ST Line Treatment of NSCLC
    2nd/3rd Line Treatment of NSCLC
    Adjuvant Therapy after Surgery for NSCLC
  • Conmana?/ 凱美納 (Icotinib)Project Description
  • Ensacove?/ 貝美納 (Ensartinib)
    ALK
    Small Molecule
    2nd Line Treatment of NSCLC
    1st Line Treatment of NSCLC (China)
    1st Line Treatment of NSCLC (US)
  • Ensacove?/ 貝美納 (Ensartinib)Project Description

    Ensartinib (X-396, ) is a novel, potent and highly selective next-generation inhibitor of anaplastic lymphoma kinase (ALK), which has a potency more than ten-times greater than crizotinib in enzymatic assays. Ensartinib targets ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Ensatinib has shown good efficacy in in vitro and in vivo studies, including those tumors that are already resistant to clozatinib, and has inhibitory effects on c-Met, TRK 1/ 2/ 3, ROS1, etc. A phase III head to head trial is evaluating ensartinib as the first-line treatment in patients with ALK-positive non-small cell lung cancer as compared with crizotinib.

  • MIL60
    VEGF
    Monoclonal Antibody
    Metastatic Colorecta
  • MIL60Project Description

    MIL60 is a targeted antibody drug for human vascular endothelial growth factor (VEGF). It is a bevacizumab biosimilar, which can be used to treat non-small cell lung cancer, colorectal cancer and other solid tumor indications. MIL60 can inhibit tumor angiogenesis by inhibiting the binding of VEGF and VEGFR, so as to cut off tumor feeding and prevent tumor growth. A phase III clinical trial is evaluating the first-line treatment of MIL60 combined with carboplatin and paclitaxel in advanced, metastatic or recurrent NSCLC.

  • BPI-D0316
    EGFR
    Small Molecule
    1st Line Treatment of NSCLC
    2nd Line Treatment of NSCLC2
  • BPI-D0316Project Description

    BPI-3016 is a novel diabetes drug independently developed by Betta. It is the first super long-term glucagon like peptide-1 (GLP-1) analogue obtained by structural modification of the main chain of natural GLP-1 in China. BPI-3016 retains the multiple effects of natural GLP-1, and overcomes its easily degradable characteristics. It not only has good biological activity, but also can reduce body weight and improve the function of β cells. Meanwhile, BPI-3016 has good subcutaneous absorption and long half-life, supporting the design expectation of weekly administration with good safety. It has unique advantages in the treatment of type II diabetes as well as prevention and treatment of cardiovascular risk. At present, clinical research is being promoted.

  • CM082
    (Vorolanib)
    VEGFR
    Small Molecule
    Renal Cell Carcinoma
    wAMD
  • CM082 (Vorolanib)Project Description

    Vorolanib (CM082) is a novel next-generation of multi-target kinase inhibitor, which can inhibit tumor angiogenesis and growth, and can be used in the treatment of many kinds of cancer. Vorolanib has a significant anti-angiogenic effect on VEGFR, PDGFR, c-Kit, Flt-3, CSF1R and other multiple targets, and the special PK/PD of vorolanib can preserve activity and reduce toxicity. A phase II/III clinical trial (CONCEPT) is evaluating vorolanib in combination with everolimus in the treatment of patients with advanced renal cell carcinoma.

  • Balstilimab
    PD-1
    Monoclonal Antibody
    Cervicai Cancer,Single Agent
    Cervical Cancer, Combo with Zalifrelimab
  • BalstilimabProject Description

    Balstilimab is a human monoclonal antibody targeting programmed cell death protein 1 (PD-1), and is an immune checkpoint inhibitor. Balstilimab potently antagonizes PD-1 binding to PD-L1 and PD-L2, relieves T cell suppression, and enhances T cell effector function, therefore activating the immune system to attack tumor. Balstilimab as a single agent and in combination with Zalifrelimab, an anti-CTLA-4 antibody, is planned for clinical investigation for the treatment of advanced cervical cancer as well as other advanced solid tumors. The IND applications for Balstilimab have been accepted by NMPA CDE and are currently in technical review.


  • Zalifrelimab
    CTLA-4
    Monoclonal Antibody
    Cervical Cancer,Combo with Balstilimab
  • ZalifrelimabProject Description

    Zalifrelimab is a human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4), and is an immune checkpoint inhibitor. By blockade of CTLA-4 binding to its ligands, CD80 and CD86, Zalifrelimab antagonizes the negative regulation of T cells by CTLA-4, therefore enhancing tumor immune surveillance and anti-tumor response. Zalifrelimab is planned for clinical investigation in combination with Balstilimab, an anti-PD-1 antibody, for the treatment of advanced cervical cancer as well as other advanced solid tumors. The IND applications for Zalifrelimab have been accepted by NMPA CDE and are currently in technical review.


  • BPI-16350
    CDK 4/6
    Small Molecule
    Solid Tumor
  • BPI-16350Project Description

    BPI-16350 is a novel antitumor drug independently developed by Betta. It is a cyclin dependent kinase CDK4 and CDK6 inhibitor with new structure. CDK4/6 are the key factors to regulate cell cycle, which can trigger cell cycle transition from G1 phase to S phase. BPI-16350 can specifically combine with CDK4/6 to inhibit the kinase activity, inhibit the proliferation, metastasis and other related signal transduction of cancer cells, block the cell cycle in G1 phase, thus inhibiting the proliferation of tumor cells. The clinical trial of BPI-16350 in breast cancer has been approved and is now ongoing.


  • BPI-27336
    ERK 1/2
    Small Molecule
    Solid Tumor
  • BPI-27336Project Description

    BPI-27336 is a potent and selective inhibitor of ERK1/2 protein in the RAS-MAPK pathway. It is a new molecular entity developed by Betta Pharmaceutical Co., Ltd. with independent intellectual property. In preclinical studies, BPI-27336 showed excellent antitumor effect, especially in KRAS-mutant animal models, with good safety and pharmacokinetic features. BPI-27336 is expected to be a breakthrough therapy for cancers carrying the traditionally undruggable KRAS mutations, a huge unmet medical need. It may also be used to treat cancers that are resistance or refractory to other RAS-MAPK pathway inhibitors. BPI-27336 is currently in Phase I clinical study, with first-in-human dosing completed on October 21, 2020.

  • BPI-17509
    FGFR 1/2/3
    Small Molecule
    Solid Tumor
  • BPI-17509Project Description

    BPI-17509 is a novel, potent and highly selective small molecule oral inhibitor of fibroblast growth factor receptor (FGFR1/2/3) independently developed by Betta. It is intended to be used in various tumor therapies with FGFR gene. FGFR plays an important role in tumor proliferation, angiogenesis, migration and survival. BPI-17509 can specifically inhibit the activity of FGFR1/2/3, block the related signal transduction pathway, and then affect several physiological processes such as cell proliferation, apoptosis, migration, neovascularization in vivo, thus inhibiting tumor growth. The clinical trial application of BPI-17509 has been approved and is now ongoing.

  • BPI-23314
    BET
    Small Molecule
    AML
    Solid Tumor
  • BPI-23314Project Description

    BPI-23314 is a novel molecular compound independently developed by Betta with completely independent intellectual property rights. It is a potent and highly selective bromodomain and extra-terminal domain (BET) oral small molecule inhibitor. BPI-23314 can specifically inhibit the function of BET family proteins, regulate the transcription and expression of cancer-related genes, and then affect cell growth, proliferation, apoptosis and other physiological processes, thus inhibiting tumor growth. The clinical trial of BPI-23314 has been approved and is now ongoing.

  • MRX2843
    MerTK/FLT3
    Bi-specific Antibody
    Solid Tumor
  • MRX2843Project Description

    MRX2843 is a novel, potent,  and bioavailable small-molecule oral inhibitor, which is a dual inhibitor of MERTK and FLT3. MERTK and FLT3 are overexpressed or mutated in a variety of tumors. MRX2843 can affect tumor growth by inhibiting MERTK and FLT3 in tumor cells and innate immune cells in tumor microenvironment, thereby affecting the key signal transduction pathways or immunomodulation to inhibit tumors. The clinical trial of MRX2843 for advanced solid tumor has been approved, and it is ongoing.

  • BPI-28592
    TRK
    Small Molecule
    Solid Tumor?
  • BPI-28592Project Description

    BPI-28592 is a potent and selective inhibitor of the tropomyosin receptor kinase (TRK, also known as NTRK). It is a new molecular entity developed by Betta Pharmaceutical Co., Ltd. with independent intellectual property. BPI-28592 is a second-generation TRK inhibitor, which, in preclinical animal models, not only inhibits the growth of tumors with TRK fusion mutations, but also is effective against mutations that are resistant or refractory to the first-generation TRK inhibitors such as larotrectinib or entrectinib. BPI-28592 is expected to bring a new therapy to patients with TRK mutations. The investigational new drug (IND) application for BPI-28592 tablets has been approved by NMPA. The Phase I clinical study is planned to start soon.

  • BPI-43487
    FGFR4
    Small Molecule
    Solid Tumor?
  • BPI-43487Project Description
  • BPI-361175
    EGFR
    Small Molecule
    Solid Tumor
  • BPI-361175Project Description

    BPI-361175 is a novel, oral, highly potent and selective 4th generation EGFR inhibitor developed by Betta Pharmaceutical Co., Ltd. The new chemical entity targets EGFR C797S mutation and other EGFR related mutations that are resistant to 3rd generation EGFR TKI in non-small cell lung cancer (NSCLC) and other solid tumors. It shows excellent inhibitory effect and selectivity in vitro assay and exhibits significant anti-tumor activity in a variety of xenograft models harboring EGFR C797S or other related mutations. The IND application of BPI-361175 has been approved by NMPA, and Phase 1 clinical trial is being initiated.

  • BPI-21668
    PIK3CA
    Small Molecule
    Solid Tumor
  • BPI-21668Project Description

    BPI-21668 is a novel, potent and selective small molecule inhibitor of Phosphatidylinositol 3-kinase α (PI3Kα) developed by Betta Pharma. It is intended to be used for the treatment of advanced solid tumor with PIK3CA mutations. BPI-21668 shows consistent biological activities in vitro and in vivo. It can potently and selectively inhibit proliferation of PIK3CA-mutant cells. Used as a single agent or in combination, BPI-21668 shows good anti-tumor effect in multiple solid tumor models. BPI-21668 also exhibits excellent physicochemical and pharmacokinetic properties. The IND application of BPI-21668 has been approved by NMPA, and Phase 1 clinical trial is starting.

  • MCLA-129
    EGFR/c-MET
    Solid Tumor
  • MCLA-129Project Description

    MCLA-129 is a bispecific antibody targeting both EGFR and c-Met. MCLA-129 can simultaneously block the signal transductions of EGFR and c-MET, therefore inhibiting tumor growth and survival. Through enhanced ADCC and ADCP activities, MCLA-129’s tumor cell killing potential is further increased. MCLA-129 is planned for clinical investigation for the treatment of advanced solid tumors with EGFR or MET abnormalities. The clinical trial for MCLA-129 has been approved and is currently under development.


  • BPI-421286
    KRASG12C
    Small Molecule
    Solid Tumor
  • BPI-421286Project Description
  • China
  • US
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