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Text|Pharmaceutical Mission Hills
Recently, Nuocheng Jianhua released its 2021 interim performance report and company progress.
The company’s revenue increased from RMB 748,000 in the first half of 2020 to RMB 101.
7 million in the first half of 2021, mainly due to the BTK inhibitor Orb Sales revenue of tinib
.
1.
The latest development of the company
The latest development of the company
On July 13, 2021, Nuocheng Jianhua and Bojian reached a license and cooperation agreement for obritinib, which is expected to treat multiple sclerosis (MS)
.
According to the agreement, Nuocheng Jianhua will receive a down payment of US$125 million, and will be eligible to receive up to US$812.
On August 17, 2021, a subsidiary of Nuocheng Jianhua and Incyte signed a cooperation agreement on the development and commercialization of a humanized monoclonal antibody tafasitamab optimized for the Fc domain of CD19 in Greater China.
License agreement
.
According to the agreement, Nuocheng Jianhua will obtain the right to develop and exclusively commercialize tafasitamab in hematoma and solid tumors in Greater China
2.
Key product highlights and important milestones
Key product highlights and important milestones
Abutinib
Obutinib has been included in the Chinese Society of Clinical Oncology (CSCO) "2021 Malignant Lymphoma Diagnosis and Treatment Guidelines", and is listed as the treatment of relapsed and refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (R/R CLL/SLL) And relapsed refractory mantle cell lymphoma (R/R MCL) the first-level recommended program
.
In clinical trials of B-cell malignancies, more than 400 patients have completed the administration of abutinib
.
Clinical data shows that the high selectivity and excellent target occupancy rate of abutinib make it have better safety and effectiveness
The registered clinical trial of Obutinib for relapsed and refractory Waldenstrom's macroglobulinemia (WM) has completed the enrollment of patients, and plans to submit a new drug application (NDA) in the first half of 2022
.
The registered clinical trial of abutinib for relapsed and refractory marginal zone lymphoma (MZL) is scheduled to complete patient recruitment in 2021 and submit an NDA in 2022
.
The Phase 3 clinical trial of obatinib for the first-line treatment of CLL/SLL is proceeding smoothly and is expected to be completed in 2023
.
The phase 3 trial of obritinib combined with R-CHOP regimen for the first-line treatment of MCL has proceeded smoothly
.
Nuocheng Jianhua will announce the clinical data of the combination therapy of abutinib and the next-generation CD20 antibody-MIL-62 at the 2021 European Society of Medical Oncology (ESMO) annual meeting to be held on September 16
.
In the United States, the registered phase 2 trial of obatinib for relapsed and refractory MCL is progressing smoothly and is expected to be completed in 2022
.
Obutinib was granted breakthrough therapy designation by the US FDA in June 2021 for the treatment of R/R MCL
In addition to tumors, Nuocheng Jianhua is exploring the treatment of abutinib for various autoimmune diseases
.
Obutinib for the treatment of multiple sclerosis phase 2 clinical global study completed the first subject administration in the United States, and is currently actively starting to enroll patients in China and Europe
.
The Phase 2 clinical trial of obatinib in China for systemic lupus erythematosus (SLE) is expected to complete the enrollment of 60 patients in October 2021, and the clinical data is planned to be released in the first quarter of 2022
.
Obutinib has been approved for the treatment of primary immune thrombocytopenia (ITP), and the Phase 2 clinical study is actively being started
.
ICP-192 (gunagratinib)
The latest clinical data of gunagratinib announced at the 2021 American Society of Clinical Oncology (ASCO) annual meeting shows that as of February 2021, a total of 30 patients have received gunagratinib treatment
.
The safety and tolerance are good, and the maximum tolerated dose (MTD) has not been reached
Advance the phase 2 clinical study of gunagratinib for cholangiocarcinoma, and continue to conduct dose escalation trials for advanced solid tumors to expand to more indications
.
In the United States, gunagratinib was granted orphan drug designation by the FDA for the treatment of cholangiocarcinoma
.
Phase 1 clinical trials are expected to be completed in the first half of 2022
ICP-723
In the Phase 1 dose escalation (1 mg, 2 mg, 3 mg, and 4 mg) study, two eligible NTRK fusion-positive patients showed efficacy after administration
.
In the first tumor assessment at the end of the first cycle (or on the 28th day), the tumors of the patients in the 3 mg group shrank by more than 20%; the patients in the 4 mg group achieved partial remission (PR) for the first time
In the United States, an IND application for ICP-723 for the treatment of NTRK fusion gene-positive cancers has been submitted
.
ICP-332
In May 2021, the new tyrosine kinase 2 (Tyrosine Kinase 2, TYK2) inhibitor ICP-332 was approved for clinical use in China, and the first subject administration was completed in August 2021
.
ICP-332 will be used to treat immune inflammatory diseases such as psoriasis and atopic dermatitis
ICP-033
In June 2021, the new multi-target receptor tyrosine kinase (RTK) inhibitor ICP-033 was approved for clinical use in China.
It is planned to be used alone or/in combination with immunotherapy and other targeted drugs to treat liver cancer, renal cell carcinoma, Colorectal cancer and other solid tumors
.
In addition to the above-mentioned products, Nuocheng Jianhua also has the following 5-7 new drug candidates at the IND preparation stage, and is currently actively advancing the IND application
.
In the field of autoimmune diseases, ICP-488 is a small molecule inhibitor (JH2) of the pseudokinase domain of TYK2, used to treat diseases such as psoriasis and inflammatory bowel disease (IBD)
.
ICP-490 is an immunomodulator.
By combining with the CRL4CRBN-E3 ligase complex, ICP-490 can induce the ubiquitination and degradation of transcription factors including Ikaros and Aiolos
.
In terms of solid tumors, ICP-189 is an allosteric inhibitor of SHP2, with good selectivity to other phosphatases.
New Drug Research (IND) applications have been accepted by the National Medical Products Administration (NMPA) of China
.
ICP-B03 is a prodrug of interleukin IL-15 that can be targeted for tumor release, which can target and change immune cells in the tumor microenvironment
.
ICP-915 is a highly selective small molecule inhibitor against the G12C mutant form of KRAS
.
By inhibiting the RTK-RAS-MAPK signaling pathway, ICP-915 can be used to treat KRAS-mutated solid tumors and at the same time serve as the cornerstone of combination therapy
.
In terms of hematoma, ICP-248 is a selective inhibitor of B-cell lymphoma 2 (BCL-2)
.
ICP-248 is intended to treat hematological tumors as a single agent and a combination of drugs
.
ICP-B02 is a new CD20xCD3 bispecific antibody drug jointly developed by Nuocheng Jianhua and Connoa Biotechnology for the treatment of lymphoma.
The IND application has been accepted by the NMPA
.
