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On January 4, 2022, Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) and CSPC (stock code: 1093.
HK) jointly announced a registered clinical trial of HER2 bispecific antibody KN026 combined with chemotherapy ( KN026-CSP-001) application was approved by the Center for Drug Evaluation (CDE) of the State Drug Administration
.
KN026-CSP-001 is a randomized, multicenter, phase II/III clinical study to evaluate the effectiveness and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastric-esophageal junction adenocarcinoma) who have failed first-line treatment , Professor Xu Jianming from the General Hospital of the Chinese People’s Liberation Army served as the principal investigator
.
Gastric cancer and adenocarcinoma of the gastroesophageal junction are one of the common malignant tumors.
There are more than 1 million new cases of gastric cancer each year in the world.
China is a country with a high incidence of gastric cancer, with about 410,000 new cases and 294,000 deaths each year.
Death cases account for more than 40% of gastric cancer cases worldwide
.
The characteristics of gastric cancer in China are the low detection rate of early gastric cancer, the high proportion of advanced stage (greater than 80%), and the low 5-year survival rate (about 35.
1%), which seriously threatens the lives and health of Chinese people
.
HER2 is overexpressed in many tumors, among which gastric cancer is about 15-20%.
HER2 overexpression is related to tumor aggressiveness and poor prognosis.
With the development of targeted therapy, HER2-positive advanced gastric cancer is being treated with targeted drugs in combination Later, it achieved better curative effect than traditional chemotherapy
.
However, for patients with HER2-positive gastric cancer who have progressed or relapsed after first-line treatment in China, there is no effective drug targeting HER2, and there is a huge unmet clinical need
.
KN026 is a HER2 bispecific antibody independently developed by Corning Jereh.
The Phase II study data released at the ASCO annual meeting in 2021 showed that KN026 has a good effect in the treatment of patients with advanced HER2-positive gastric and gastroesophageal junction adenocarcinoma, regardless of whether the patient has been in the past or not.
Received trastuzumab treatment: Among patients with high HER2 expression, the objective response rate (ORR) was 55.
6%, the disease control rate (DCR) was 72.
2%, and the 9-month progression-free survival rate was 60.
4%; previously received trastoma The objective response rate (ORR) of the bead-treated patients was 44.
4%, and the disease control rate (DCR) was 66.
7%
.
The approval of the clinical trial application is a touchstone for the sincere cooperation between Corning Jereh and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China.
It is hoped that more excellent data can be seen through the progress of the research, which will serve the domestic urgent needs.
Patients with advanced gastric cancer who need new treatment options bring hope
.
About KN026KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can bind two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than Qu Use tuuzumab or pertuzumab alone to achieve the combined effect of trastuzumab and pertuzumab, such as tumors that exhibit higher affinity and have superior efficacy in HER2-positive tumor cell lines Inhibition
.
At the same time, KN026 also has an inhibitory effect on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.
KN026 has been approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) in 2018, and is currently carrying out multiple phase I/II clinical trials in China, and at the same time advancing phase I clinical trials in the United States
.
Phase I clinical trial results showed that KN026 is well tolerated and safe, and still exhibits significant anti-tumor activity in HER2-positive breast cancer patients who have progressed after multi-line anti-HER2 treatment
.
In August 2021, Corning Jereh and Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Bio"), a wholly-owned subsidiary of CSPC, signed a development and commercialization license agreement for KN026 in Mainland China
.
According to the terms of the agreement, Jinmante Bio will obtain the exclusive development and exclusive commercialization license rights for KN026 in mainland China (excluding Hong Kong, Macau and Taiwan) for breast cancer and gastric cancer indications
.
About Corning Jereh Corning Jereh Biopharmaceuticals focuses 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 Biopharmaceuticals 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 double antibodies, and a Covid-19 multifunctional antibody, four of which are in China, the United States, Japan, and Australia It is in clinical phase I~III
.
In November 2021, Envida® (Envolimab Injection) was officially approved for marketing in China.
It is suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects ( dMMR) in the treatment of adult patients with advanced solid tumors
.
The company has multiple technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that comply with China, the United States and the European Union cGMP standards, and have passed a complete quality system including multiple audits of the European Union QP.
.
The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
.
Welcome to visit the company website
About CSPC CSPC is a national-level innovative company with strong capabilities in the research and development, production and marketing of innovative drugs
.
CSPC is listed on the Hong Kong Stock Exchange (stock code: 1093) and was selected as a constituent stock of the Hang Seng Index in 2018.
It is the first constituent stock of the pharmaceutical industry since the index was launched
.
Currently, it is one of the constituent stocks of the Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland China Healthcare Index, Hang Seng Stock Connect Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng China Enterprise Index
.
At present, CSPC has a total asset value of more than RMB 30 billion and has more than 23,000 employees
.
CSPC has a national top R&D team, with R&D bases in Shijiazhuang, Shanghai, Beijing and the United States, focusing on small molecule targeted drugs, nano drugs, monoclonal antibody drugs, bispecific antibody drugs, antibody conjugate drugs, mRNA Discovery, research and development of vaccines, small nucleic acid drugs and biological drugs in the field of immunity
.
Welcome to visit our website
.
HK) and CSPC (stock code: 1093.
HK) jointly announced a registered clinical trial of HER2 bispecific antibody KN026 combined with chemotherapy ( KN026-CSP-001) application was approved by the Center for Drug Evaluation (CDE) of the State Drug Administration
.
KN026-CSP-001 is a randomized, multicenter, phase II/III clinical study to evaluate the effectiveness and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastric-esophageal junction adenocarcinoma) who have failed first-line treatment , Professor Xu Jianming from the General Hospital of the Chinese People’s Liberation Army served as the principal investigator
.
Gastric cancer and adenocarcinoma of the gastroesophageal junction are one of the common malignant tumors.
There are more than 1 million new cases of gastric cancer each year in the world.
China is a country with a high incidence of gastric cancer, with about 410,000 new cases and 294,000 deaths each year.
Death cases account for more than 40% of gastric cancer cases worldwide
.
The characteristics of gastric cancer in China are the low detection rate of early gastric cancer, the high proportion of advanced stage (greater than 80%), and the low 5-year survival rate (about 35.
1%), which seriously threatens the lives and health of Chinese people
.
HER2 is overexpressed in many tumors, among which gastric cancer is about 15-20%.
HER2 overexpression is related to tumor aggressiveness and poor prognosis.
With the development of targeted therapy, HER2-positive advanced gastric cancer is being treated with targeted drugs in combination Later, it achieved better curative effect than traditional chemotherapy
.
However, for patients with HER2-positive gastric cancer who have progressed or relapsed after first-line treatment in China, there is no effective drug targeting HER2, and there is a huge unmet clinical need
.
KN026 is a HER2 bispecific antibody independently developed by Corning Jereh.
The Phase II study data released at the ASCO annual meeting in 2021 showed that KN026 has a good effect in the treatment of patients with advanced HER2-positive gastric and gastroesophageal junction adenocarcinoma, regardless of whether the patient has been in the past or not.
Received trastuzumab treatment: Among patients with high HER2 expression, the objective response rate (ORR) was 55.
6%, the disease control rate (DCR) was 72.
2%, and the 9-month progression-free survival rate was 60.
4%; previously received trastoma The objective response rate (ORR) of the bead-treated patients was 44.
4%, and the disease control rate (DCR) was 66.
7%
.
The approval of the clinical trial application is a touchstone for the sincere cooperation between Corning Jereh and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China.
It is hoped that more excellent data can be seen through the progress of the research, which will serve the domestic urgent needs.
Patients with advanced gastric cancer who need new treatment options bring hope
.
About KN026KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can bind two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than Qu Use tuuzumab or pertuzumab alone to achieve the combined effect of trastuzumab and pertuzumab, such as tumors that exhibit higher affinity and have superior efficacy in HER2-positive tumor cell lines Inhibition
.
At the same time, KN026 also has an inhibitory effect on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.
KN026 has been approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) in 2018, and is currently carrying out multiple phase I/II clinical trials in China, and at the same time advancing phase I clinical trials in the United States
.
Phase I clinical trial results showed that KN026 is well tolerated and safe, and still exhibits significant anti-tumor activity in HER2-positive breast cancer patients who have progressed after multi-line anti-HER2 treatment
.
In August 2021, Corning Jereh and Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Bio"), a wholly-owned subsidiary of CSPC, signed a development and commercialization license agreement for KN026 in Mainland China
.
According to the terms of the agreement, Jinmante Bio will obtain the exclusive development and exclusive commercialization license rights for KN026 in mainland China (excluding Hong Kong, Macau and Taiwan) for breast cancer and gastric cancer indications
.
About Corning Jereh Corning Jereh Biopharmaceuticals focuses 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 Biopharmaceuticals 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 double antibodies, and a Covid-19 multifunctional antibody, four of which are in China, the United States, Japan, and Australia It is in clinical phase I~III
.
In November 2021, Envida® (Envolimab Injection) was officially approved for marketing in China.
It is suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects ( dMMR) in the treatment of adult patients with advanced solid tumors
.
The company has multiple technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that comply with China, the United States and the European Union cGMP standards, and have passed a complete quality system including multiple audits of the European Union QP.
.
The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
.
Welcome to visit the company website
About CSPC CSPC is a national-level innovative company with strong capabilities in the research and development, production and marketing of innovative drugs
.
CSPC is listed on the Hong Kong Stock Exchange (stock code: 1093) and was selected as a constituent stock of the Hang Seng Index in 2018.
It is the first constituent stock of the pharmaceutical industry since the index was launched
.
Currently, it is one of the constituent stocks of the Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland China Healthcare Index, Hang Seng Stock Connect Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng China Enterprise Index
.
At present, CSPC has a total asset value of more than RMB 30 billion and has more than 23,000 employees
.
CSPC has a national top R&D team, with R&D bases in Shijiazhuang, Shanghai, Beijing and the United States, focusing on small molecule targeted drugs, nano drugs, monoclonal antibody drugs, bispecific antibody drugs, antibody conjugate drugs, mRNA Discovery, research and development of vaccines, small nucleic acid drugs and biological drugs in the field of immunity
.
Welcome to visit our website
.
