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On February 10, 2022, Suzhou, China - Corning Jerry Biopharmaceuticals (stock code: 9966.
HK) announced that PD-L1/CTLA-4 dual anti-KN046 combined with nab-paclitaxel and gemcitabine in the first-line treatment of advanced pancreatic cancer Phase III Registered clinical study (study number: KN046-303, ENREACH-PANCREATIC-01) completed the first patient dosing
.
In recent years, the incidence and mortality of pancreatic cancer have been increasing globally
.
According to the 2020 global cancer burden data released by the World Health Organization, China will have more than 120,000 new cases and deaths from pancreatic cancer in 2020, ranking 8th and 6th among all cancer types in China, respectively
.
About 80% of pancreatic cancers are found at an advanced stage
.
Currently, locally advanced or metastatic pancreatic cancer has an extremely poor prognosis, with a 5-year survival rate of only 3% to 5%.
Patients with inoperable treatment have very limited options for drugs
.
Due to the characteristics of pancreatic cancer, immunotherapy represented by PD-1 antibody has not shown definite clinical efficacy
.
Patients urgently need innovative drugs with significant curative effects
.
ENREACH-PANCREATIC-01 is a multi-center, randomized, double-blind, phase III clinical study in patients with unresectable locally advanced or metastatic pancreatic cancer without systemic treatment.
It plans to enroll 408 subjects.
The randomized 1:1 ratio was designed to compare the efficacy and safety of KN046 in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine in these populations
.
The primary endpoint of the study was overall survival (OS)
.
The principal investigator, Professor Jin Gang of Shanghai Changhai Hospital, said: Pancreatic cancer is a malignant tumor of the digestive system that is difficult to detect, progresses rapidly, and has a very high mortality rate.
The current clinical treatment options are quite limited, and the prognosis for patients is extremely poor
.
Corning Jereh KN046 is a new PD-L1/CTLA-4 dual-immune drug.
In a phase II clinical study, the objective response rate and disease control rate of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma reached 50.
0% and 50.
0%, respectively.
95.
5%, with excellent therapeutic potential
.
We look forward to positive results from this phase III study
.
Co-principal investigator Professor Xu Jianming of the General Hospital of the Chinese People's Liberation Army said: Pancreatic cancer is one of the most difficult solid tumors to treat clinically
.
The objective response rate obtained by the KN046 combined with AG regimen in the preliminary clinical study is better than the historical data, which is a very encouraging result
.
We look forward to bringing this innovative therapy to more patients through this Phase III registrational clinical study
.
Dr.
Xu Ting, Chairman and President of Corning & Jeremy, said: Immunotherapy represented by PD-(L)1 antibody has brought great progress to the treatment of advanced tumors, but it still has no significant effect on advanced pancreatic cancer
.
Due to its unique multiple immunomodulatory mechanisms, KN046 demonstrated excellent efficacy in early clinical trials of pancreatic cancer
.
Through this clinical registration, we look forward to confirming the efficacy and safety of KN046 in patients with advanced pancreatic cancer, so that patients have better treatment options and can obtain long-term survival benefits
.
In the future, we will also cooperate with industry experts to continue to explore the application of KN046 in neoadjuvant, adjuvant and downstaging operations in pancreatic cancer, making pancreatic cancer a controllable and treatable disease in the near future.
.
About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes: the fusion of CTLA-4 and PD-L1 single-domain antibody with different mechanisms; it can be targeted and enriched in PD - Tumor microenvironment with high L1 expression and clearance of Treg that inhibit tumor immunity
.
KN046 has carried out nearly 20 clinical trials at different stages covering more than 10 types of tumors, including non-small cell lung cancer, thymic cancer, pancreatic cancer, liver cancer, esophageal squamous cell carcinoma, and triple-negative breast cancer in Australia, the United States and China.
Survival benefit advantage
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter Phase II clinical trials in the United States, and granted orphan drug designation for KN046 for the treatment of thymic epithelial tumors in September 2020
.
Four registrational clinical trials of KN046 are currently underway
.
About Corning Jereh Corning Jereh Biopharma is focused on the research and development, production and commercialization of innovative anti-tumor drugs
.
On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange, stock code: 9966
.
Corning Jereh Biopharmaceutical has a discovery, R&D and manufacturing platform for the entire industry chain in bispecific antibody and protein engineering
.
The company's product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly based on double antibodies, and a multifunctional antibody for Covid-19, of which four products are in China, the United States, Japan, and Australia.
It is in phase I to III clinical trials
.
In November 2021, Envida® (envolimab injection) was officially approved for marketing in China, which is suitable for unresectable or metastatic microsatellite instability (MSI-H) or mismatch repair gene deficiency ( dMMR) for the treatment of adult patients with advanced solid tumors
.
The company has multiple technology platforms with independent intellectual property rights such as heterodimers and mixed antibodies, as well as large-scale production capacity in line with China, the United States and EU cGMP standards, and has passed multiple audits including EU QP.
Complete quality system
.
The company is committed to building a world-leading, multi-dimensional drug development and industrialization platform, focusing on new multifunctional biomacromolecules, benefiting patients in China and around the world
.
Welcome to the company website
.
HK) announced that PD-L1/CTLA-4 dual anti-KN046 combined with nab-paclitaxel and gemcitabine in the first-line treatment of advanced pancreatic cancer Phase III Registered clinical study (study number: KN046-303, ENREACH-PANCREATIC-01) completed the first patient dosing
.
In recent years, the incidence and mortality of pancreatic cancer have been increasing globally
.
According to the 2020 global cancer burden data released by the World Health Organization, China will have more than 120,000 new cases and deaths from pancreatic cancer in 2020, ranking 8th and 6th among all cancer types in China, respectively
.
About 80% of pancreatic cancers are found at an advanced stage
.
Currently, locally advanced or metastatic pancreatic cancer has an extremely poor prognosis, with a 5-year survival rate of only 3% to 5%.
Patients with inoperable treatment have very limited options for drugs
.
Due to the characteristics of pancreatic cancer, immunotherapy represented by PD-1 antibody has not shown definite clinical efficacy
.
Patients urgently need innovative drugs with significant curative effects
.
ENREACH-PANCREATIC-01 is a multi-center, randomized, double-blind, phase III clinical study in patients with unresectable locally advanced or metastatic pancreatic cancer without systemic treatment.
It plans to enroll 408 subjects.
The randomized 1:1 ratio was designed to compare the efficacy and safety of KN046 in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine in these populations
.
The primary endpoint of the study was overall survival (OS)
.
The principal investigator, Professor Jin Gang of Shanghai Changhai Hospital, said: Pancreatic cancer is a malignant tumor of the digestive system that is difficult to detect, progresses rapidly, and has a very high mortality rate.
The current clinical treatment options are quite limited, and the prognosis for patients is extremely poor
.
Corning Jereh KN046 is a new PD-L1/CTLA-4 dual-immune drug.
In a phase II clinical study, the objective response rate and disease control rate of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma reached 50.
0% and 50.
0%, respectively.
95.
5%, with excellent therapeutic potential
.
We look forward to positive results from this phase III study
.
Co-principal investigator Professor Xu Jianming of the General Hospital of the Chinese People's Liberation Army said: Pancreatic cancer is one of the most difficult solid tumors to treat clinically
.
The objective response rate obtained by the KN046 combined with AG regimen in the preliminary clinical study is better than the historical data, which is a very encouraging result
.
We look forward to bringing this innovative therapy to more patients through this Phase III registrational clinical study
.
Dr.
Xu Ting, Chairman and President of Corning & Jeremy, said: Immunotherapy represented by PD-(L)1 antibody has brought great progress to the treatment of advanced tumors, but it still has no significant effect on advanced pancreatic cancer
.
Due to its unique multiple immunomodulatory mechanisms, KN046 demonstrated excellent efficacy in early clinical trials of pancreatic cancer
.
Through this clinical registration, we look forward to confirming the efficacy and safety of KN046 in patients with advanced pancreatic cancer, so that patients have better treatment options and can obtain long-term survival benefits
.
In the future, we will also cooperate with industry experts to continue to explore the application of KN046 in neoadjuvant, adjuvant and downstaging operations in pancreatic cancer, making pancreatic cancer a controllable and treatable disease in the near future.
.
About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes: the fusion of CTLA-4 and PD-L1 single-domain antibody with different mechanisms; it can be targeted and enriched in PD - Tumor microenvironment with high L1 expression and clearance of Treg that inhibit tumor immunity
.
KN046 has carried out nearly 20 clinical trials at different stages covering more than 10 types of tumors, including non-small cell lung cancer, thymic cancer, pancreatic cancer, liver cancer, esophageal squamous cell carcinoma, and triple-negative breast cancer in Australia, the United States and China.
Survival benefit advantage
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter Phase II clinical trials in the United States, and granted orphan drug designation for KN046 for the treatment of thymic epithelial tumors in September 2020
.
Four registrational clinical trials of KN046 are currently underway
.
About Corning Jereh Corning Jereh Biopharma is focused on the research and development, production and commercialization of innovative anti-tumor drugs
.
On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange, stock code: 9966
.
Corning Jereh Biopharmaceutical has a discovery, R&D and manufacturing platform for the entire industry chain in bispecific antibody and protein engineering
.
The company's product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly based on double antibodies, and a multifunctional antibody for Covid-19, of which four products are in China, the United States, Japan, and Australia.
It is in phase I to III clinical trials
.
In November 2021, Envida® (envolimab injection) was officially approved for marketing in China, which is suitable for unresectable or metastatic microsatellite instability (MSI-H) or mismatch repair gene deficiency ( dMMR) for the treatment of adult patients with advanced solid tumors
.
The company has multiple technology platforms with independent intellectual property rights such as heterodimers and mixed antibodies, as well as large-scale production capacity in line with China, the United States and EU cGMP standards, and has passed multiple audits including EU QP.
Complete quality system
.
The company is committed to building a world-leading, multi-dimensional drug development and industrialization platform, focusing on new multifunctional biomacromolecules, benefiting patients in China and around the world
.
Welcome to the company website
.
