We focus on the research and development of novel biologic drugs. Through the past decade, we have built up a robust pipeline and the drug modality including monoclonal antibody, bispecific antibody, single-domain antibody and other modalities. Our therapeutics areas mainly focus on GI cancers and autoimmune diseases. Currently, our drug candidate targets include EGFR, CD47, CSF-1R, CLDN18.2 and other undisclosed immune checkpoints covering various aspects of the tumor microenvironment (TME). As of today, our pipeline has 9 drug candidates, 4 of which are in the clinical development stage, accumulatively receiving 7 open INDs.
Code
Target
Modality
Indication
Discovery
Pre-clinical
IND
Phase I
Phase II
Phase III
Fully Human IgG1 anti-PD-L1 monoclonal antibody containing wild-type Fc with ADCC
Phase II study ongoing: monotherapy for the treatment of non-clear cell renal cell carcinoma (nccRCC)
Phase I study ongoing: monotherapy for the treatment of advanced nasopharyngeal carcinoma,
preliminary data showed an excellent safety profile with promising efficacy of ORR = 26.7% (4/15)
Phase Ia combination study ongoing: dose-escalation study of BC003 in combination with BC001 for advanced solid tumor
Multiple combo clinical trials are under planning
Chimeric IgG1 anti-EGFR monoclonal antibody, identical CDR sequence with Cetuximab
Phase Ia study completed: three dose cohorts of 400, 500 and 750 mg/m2 tested in a "3+3" approach and the results showed the drug to be safe and tolerable
Phase Ib (combination therapy with TIP for the treatment of advanced penile cancer) study ongoing: good safety (no new safety risk), excellent efficacy (ORR=94.1%, 16/17)
Pivotal phase II clinical study is in planning
Phase Ia combination study ongoing: dose-escalation study of BC001 in combination with BC003 for advanced solid tumor
Humanized anti-IL4R monoclonal antibody
Phase I clinical trial demonstrated a safety profile, and Phase II clinical development is in progress for moderate to severe atopic dermatitis and asthma
Fc sequence optimized with extended half-life
Optimized the formula to high concentration, 150ml/ml
Stable process development with high titers
First-in-class anti-CSF-1R mAb in China, fully human IgG1 mAb with ADCC
Exploratory phase I clinical trial is ongoing
Targeted indications:
TGCT (Orphan indication), IPF (Orphan indication), solid tumor, etc.
Novel bi-specific antibody targeting CD47 X CLDN 18.2 with excellent developability, safety and efficacy
NMPA IND expecting Q1 2022, FDA IND expecting Q2 2022
CLDN18.2/single domain Fc fusion protein antibody
With enhanced ADCC effect, BC008 showed good anti-tumor efficacy in multiple animal models
IND submitted in Jan 2021
Innovative humanized monoclonal antibody, targeting new immune checkpoints, with certain curative effects on multiple tumor types
Showing synergistic effects when combined with other IO drugs
Fc engineered optimization improving the safety
Fully Human IgG1 anti-PD-L1 monoclonal antibody containing wild-type Fc with ADCC
Phase II study ongoing: monotherapy for the treatment of non-clear cell renal cell carcinoma (nccRCC)
Phase I study ongoing: monotherapy for the treatment of advanced nasopharyngeal carcinoma,
preliminary data showed an excellent safety profile with promising efficacy of ORR = 26.7% (4/15)
Phase Ia combination study ongoing: dose-escalation study of BC003 in combination with BC001 for advanced solid tumor
Multiple combo clinical trials are under planning
Chimeric IgG1 anti-EGFR monoclonal antibody, identical CDR sequence with Cetuximab
Phase Ia study completed: three dose cohorts of 400, 500 and 750 mg/m2 tested in a "3+3" approach and the results showed the drug to be safe and tolerable
Phase Ib (combination therapy with TIP for the treatment of advanced penile cancer) study ongoing: good safety (no new safety risk), excellent efficacy (ORR=94.1%, 16/17)
Pivotal phase II clinical study is in planning
Phase Ia combination study ongoing: dose-escalation study of BC001 in combination with BC003 for advanced solid tumor
Humanized anti-IL4R monoclonal antibody
Phase I clinical trial demonstrated a safety profile, and Phase II clinical development is in progress for moderate to severe atopic dermatitis and asthma
Fc sequence optimized with extended half-life
Optimized the formula to high concentration, 150ml/ml
Stable process development with high titers
First-in-class anti-CSF-1R mAb in China, fully human IgG1 mAb with ADCC
Exploratory phase I clinical trial is ongoing
Targeted indications:
TGCT (Orphan indication), IPF (Orphan indication), solid tumor, etc.
Novel bi-specific antibody targeting CD47 X CLDN 18.2 with excellent developability, safety and efficacy
NMPA IND expecting Q1 2022, FDA IND expecting Q2 2022
CLDN18.2/single domain Fc fusion protein antibody
With enhanced ADCC effect, BC008 showed good anti-tumor efficacy in multiple animal models
IND submitted in Jan 2021
Innovative humanized monoclonal antibody, targeting new immune checkpoints, with certain curative effects on multiple tumor types
Showing synergistic effects when combined with other IO drugs
Fc engineered optimization improving the safety