Pipeline core
CORE PIPELINE
VRT106 for Injection
VRT106 for Injection, the first product of Veronte, has made many breakthroughs in succession: it has been certified as an orphan drug for liver cancer and malignant glioma issued by the US Food and Drug Administration (FDA) in the United States.
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VRT106 for Injection
Clinical Implied Permit by the Japan Drug and Medical Device Administration (PMDA) in Japan,
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VRT106 for Injection
Clinical trials for advanced solid tumors have been conducted in Japan and China with clinical implied permission from the China Drug Administration (NMPA).
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Product pipeline
PRODUCT PIPELINE
Disease areas
Drug Name
Target
Indications
Progress
View Details
Blood tumor
ICP-248
BCL-2
NHL
,
,
PH I
ICP-248 is a new oral and highly selective BCL2 inhibitor. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the occurrence and development of a variety of malignant hematological tumors. ICP-248 selectively inhibit BCL2 and restore the mechanism of tumor cell death, so as to exert anti-tumor effect. The clinical trial of ICP-248 combined with orbitinib in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has completed the first patient administration in China.
ICP-248 demonstrated good safety and efficacy in a phase I study. All patients achieved an objective response at the 100 mg once daily dose, with a complete response rate (CR) of 50%.
The ICP-248 aims to treat a variety of malignant blood tumors with single drug or combination, and has a broad development space and significant potential in combination with Obutib.
Blood tumor
ICP-B02
CD3xCD20
CD20 B- cell hematologic tumor
,
,
PH I
ICP-B02(CM355) is a CD3xCD20 bispecific antibody developed. ICP-B02 specifically binds to CD20 positive target cells and CD3 positive T cells, recruits immune T cells to the periphery of target cells, activates T cells, and induces T cell-mediated tumor cell killing (TDCC) to kill target cells for the treatment of CD20 + B cell hematoma.
Preliminary data show that ICP-B02 intravenous (IV) and subcutaneous (SC) formulations have demonstrated good efficacy in both follicular lymphoma (FL) and diffuse large B- cell lymphoma (DLBCL) patients. Among the 13 patients who received at least one dose of 6 mg or more, the overall response rate (ORR) was 100 percent.
Non-Hodgkin's lymphoma (NHL) is the main type of CD20 + B- cell hematoma, accounting for 80%-90% of B- cell lymphomas, including diffuse large B- cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), etc.
Blood tumor
Tancituzumab
CD19
R/r DLBCL
,
,
Registered Clinical
Tancituzumab (Tafasitamab), a humanized monoclonal antibody targeting CD19, mediates lysis of B- cell tumors through apoptotic and immune effector mechanisms. The tanxituzumab treatment scheme has been approved for listing in Hong Kong, approved for use in Boao and included in the "Hong Kong and Macao Drug Association" in Dawan District. The registered clinical trial of tanxituzumab combined with lenalidomide for the treatment of relapsed/refractory diffuse large B cell lymphoma (DLBCL) has been completed in China, and BLA listing application is expected to be submitted in 2024. From first-line to second-line and above DLBCL treatment, Nuocheng Jianhua depth layout, the development of a variety of drug combinations, for this aggressive lymphoma to provide more and better treatment options.
Five-year follow-up data showed that tandituzumab in combination with lenalidomide, followed by tandituzumab monotherapy, provided long-term and durable remission in adults with relapsed/refractory DLBCL, with an optimal overall response rate (ORR) of 57.5 percent (primary endpoint).
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for 31% to 34% of NHL cases worldwide. In China, DLBCL accounts for 45.8 percent of all NHLs.
Tancintuzumab combined with lenalidomide for the treatment of relapsed/refractory DLBCL has been recommend by the Chinese CSCO clinical diagnosis and treatment guidelines.
Blood tumor
Obutinib
BTK
R/r MCL
,
,
Registered Clinical (US)
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. The registered clinical trial of Obrutinib for relapsed/refractory mantle cell lymphoma (MCL) has been completed and the NDA listing application is expected to be submitted to FDA in 2024.
MCL is a subtype of B- cell non-Hodgkin lymphoma caused by malignant transformation of B lymphocytes in the follicular mantle region of the lymph node. There is no standard therapy for relapsed/refractory MCL, and the US Food and Drug Administration (FDA)-approved therapies for this patient remain limited, with low rates of complete remission, short duration of remission, and poor safety and tolerability in older patients. Obrutinib for the treatment of relapsed/refractory MCL has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) (Breakthrough Therapy Designation).
Blood tumor
Blood tumor
BTK
1L: MCD DLBCL
,
,
Registered Clinical
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. A registered clinical trial of orbitinib for the first-line treatment of diffuse large B- cell lymphoma (DLBCL) subtype of MCD is ongoing in China. Nuocheng Jianhua has a deep layout of DLBCL disease areas and developed a variety of drug combinations to provide more and better treatment options for this aggressive lymphoma.
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for 31% to 34% of NHL cases worldwide. Diffuse large B- cell lymphoma accounts for 45.8 percent of all NHLs in China.
Obutiinib for the treatment of DLBCL has been included in the 2021 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines.
Blood tumor
Obutinib
BTK
1L: MCL
,
,
Registered Clinical
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. Phase III clinical trials of orbutib for first-line treatment of mantle cell lymphoma (MCL) are ongoing worldwide.
MCL is a subtype of B- cell non-Hodgkin lymphoma caused by malignant transformation of B lymphocytes in the follicular mantle region of the lymph node. MCL is most common in men with a median age of 60 years, and most patients are at an advanced stage of disease at the time of diagnosis.
Blood tumor
Obutinib
BTK
1L: CLL/SLL
,
,
Registered Clinical
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. The registered clinical trial of obutib for the first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) has been completed and the new drug application (NDA) is expected to be submitted in 2024.
CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are 191000 new cases of CLL and 61000 deaths each year.
Blood tumor
Obutinib
BTK
R/r MZL
,
,
Listed
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. Obitinib was approved for the treatment of relapsed/refractory marginal zone lymphoma (MZL) in China in April 2023 and was included in the national health insurance at the end of that year, becoming the first and only BTK inhibitor approved for the treatment of marginal zone lymphoma in China. The Company is initiating a Phase III confirmatory clinical trial of Obitinib against MZL.
The clinical study of orbitinib in relapsed/refractory MZL showed an overall response rate (ORR) of 58.9 percent as assessed by the Independent Review Committee (IRC), and tumor shrinkage was observed in 92.2 percent of patients.
More data can be found in the American Journal of Hematology (American Journal Of Hematology).
Obitinib has been included in the "Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines 2024" and is listed as a level I recommend regimen for second-line treatment of marginal zone lymphoma.
Blood tumor
Obutinib
BTK
R/r MCL
,
,
Listed
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. As a new BTK inhibitor, Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. Obutinib has been approved for the treatment of relapsed/refractory mantle cell lymphoma (MCL) in China in 2020, incorporated into the national health insurance in 2021 and approved for listing in Singapore in 2022.
The latest data showed an ORR of 83% for orbutib in relapsed/refractory MCL, with a complete response rate (CR) of 36.8.
More data can be found in an article published in Blood Advances, a sub-journal of Blood.
MCL is a subtype of B- cell non-Hodgkin lymphoma caused by malignant transformation of B lymphocytes in the follicular mantle region of the lymph node. Despite the high response rate after first-line blood immunotherapy, most patients relapse and require subsequent treatment. There is no standard therapy for relapsed/refractory MCL, and the US Food and Drug Administration (FDA)-approved therapies for this patient remain limited, with low rates of complete remission, short duration of remission, and poor safety and tolerability in older patients.
Obutib has been included in the Chinese Society of Clinical Oncology (CSCO) "2021 Guidelines for the Diagnosis and Treatment of Malignant Lymphoma", has been listed as a first-class recommend regimen for the treatment of relapsed/refractory MCL, and has won many innovative awards.
Blood tumor
Obutinib
BTK
R/r CLL/SLL
,
,
Listed
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. As a new type of irreversible covalent binding BTK inhibitor, orbitinib has an innovative compound structure, which makes it highly selective, reduces off-target effects, and has better efficacy and safety. Obitinib has been approved in China in 2020 for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and will be included in the national health insurance in 2021. How much.
The clinical study of orbitinib in relapsed/refractory CLL/SLL showed an Independent Review Committee (IRC)-assessed overall response rate (ORR) of 92.5 percent and complete response rate (CR) of 21.3 percent. Investigator-assessed ORR and CR were 93.8 and 26.3, respectively. Detailed data can be found in an article published in the American Journal of Hematology (American Journal Of Hematology). How much.
CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. Although CLL/SLL is an indolent tumor, some patients develop disease progression over time. Globally, there are 191000 new cases of CLL and 61000 deaths each year.
Obitinib has been included in the 2021 Guidelines for Diagnosis and Treatment of Malignant Lymphoma of the Chinese Society of Clinical Oncology (CSCO), and has been listed as a first-class recommend plan for the treatment of relapsed/refractory chronic CLL/SLL, and has won a number of innovation awards, Including: the first prize of Beijing Invention Patent Award, Beijing New Technology and New Product (Service) Certificate, 2021 China International Service Trade Fair "Science and Technology Innovation Service Demonstration Case.
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