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The PD-L1 antibody Zejiemei® was approved for the first-line treatment of patients with metastatic non-small cell lung cancer in combination with chemotherapy.
-L1 antibody Zejiemei® is under review for the new drug application for stage III non-small cell lung cancer.
This product is expected to provide a new treatment option for the entire population of stage III and IV non-small cell lung cancer following two first-of-its-kind precision treatments After the drugs Pujihua® and Taijihua® were approved for marketing, Zejiemei® is CStone's third new drug approved for marketing in China in 2021.
Suzhou, China, December 21, 2021-CStone Pharmaceuticals (Hong Kong) Stock Exchange code: 2616), a leading biopharmaceutical company focusing on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs, today announced that the China National Medical Products Administration (NMPA) has approved the PD-L1 antibody drug selection Jiemei® (sugarizumab injection) new drug marketing application for combined pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative metastasis The first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC), and the combination of paclitaxel and carboplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
.
Globally, the incidence of lung cancer continues to increase, which is also the leading cause of cancer-related deaths worldwide, and there is a huge unmet medical demand
.
According to statistics, there will be 2.
21 million new lung cancer patients worldwide in 2020.
1 NSCLC accounts for about 85% of all lung cancer patients, and about 66% of patients are diagnosed with stage III/IV NSCLC
.
2 According to IQVIA's global oncology market report, it is estimated that by 2025, the global oncology drug market will reach 269 billion U.
S.
dollars, of which immuno-oncology drugs will contribute about 20%
.
Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, said: “Zejiemei ® is the third new drug approved by CStone Pharmaceuticals this year.
The approval of Zejiemei ® once again confirms that CStone Pharmaceuticals will create a new drug
.
The ability and strength to bring new high-quality drugs to the market
.
As a major national major science and technology project for new drug creation, Zejiemei® is an international-quality PD-L1 antibody
.
We will work together with Pfizer to utilize the resources and advantages of both parties to accelerate business in an all-round way This innovative treatment will benefit more Chinese patients faster
.
” Peng Zhenke, President of Pfizer Biopharmaceutical Group in China, emphasized: “Thanks to the implementation of the Chinese government’s policy to encourage innovation and the ingenious clinical trial settings of domestic scientists, Jiemei® becomes the first drug approved by Pfizer in its innovative strategic cooperation with a Chinese innovative pharmaceutical company
.
With more than 30 years of commercialization capabilities in China, Pfizer has ensured that it will accelerate the introduction of Zegemei® to Chinese patients
.
The approval of Zejiemei® will further enrich Pfizer With the dual assistance of precision targeted therapy and immuno-oncology therapy, Pfizer will implement the concept of'Science to Win and Fight Cancer', continue to integrate global resource advantages and China's scientific innovation capabilities, and join hands with all parties in the industry.
To help achieve the goal of'Healthy China 2030'
.
" Professor Zhou Caicun, the principal investigator of the ZJM® registered phase III clinical study of GEMSTONE-302 and the director of the Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University, pointed out: "The latest published clinical research data It shows that Zejiemei® combined with chemotherapy can further extend the progression-free survival (PFS) of patients with stage IV newly treated non-small cell lung cancer, and can bring more lasting survival benefits to patients than chemotherapy alone
.
At the same time, the drug's benefits The risk of immunogenicity and related toxicity is lower
.
What's more noteworthy is that Zejiemei®'s unique dual mechanism of action can mobilize the'two forces' of T cells and macrophages in the human body to destroy tumor cells
.
Therefore, Zejiemei® is expected to reshape the landscape of lung cancer treatment
.
Dr.
Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said: "We are very excited to see Zejiemei® being successfully approved in Mainland China
.
From the first phase I clinical trial to the approval of the first major indication for lung cancer, ZJM® only took four years.
This is a comprehensive manifestation of CStone's strong clinical strategy, innovative trial design and rapid execution.
Once again created the'Corner Speed'
.
We will continue to work closely with our partners to launch new drugs for stage III and stage IV non-small cell lung cancer with drug regulatory authorities in many countries and regions, including the U.
S.
Food and Drug Administration (FDA).
Apply for communication and bring this innovative immunotherapy to more lung cancer patients as soon as possible
.
At the same time, we will continue to advance the registered clinical research of Zejiemei® in esophageal squamous cell carcinoma, gastric cancer, relapsed/refractory natural killer T-cell lymphoma, and benefit more cancer patients
.
"The approval of Zejiemei® for this indication is based on a multicenter, randomized, double-blind phase III clinical study called GEMSTONE-302
.
The study aims to evaluate Zejiemei® combined with chemotherapy versus placebo combined with chemotherapy.
Effectiveness and safety in patients with stage IV NSCLC without first-line treatment
.
ZJM® combined with chemotherapy, compared with placebo combined with chemotherapy, significantly prolongs the patient’s progression-free survival (PFS), the patient’s disease progression or The risk of death was reduced by 52%, and showed a trend of obvious benefits in overall survival
.
Patients with different tumor tissue subtypes and PD-L1 expression levels have benefits
.
Zejiemei® has good safety and no new safety signals have been found
.
In addition to the approved indications, in September 2021, NMPA has accepted Zejiemei® as a consolidation therapy for unresectable stage III NSCLC patients who have not progressed after concurrent or sequential radiotherapy and chemotherapy.
, This product is expected to become a PD-(L)1 antibody covering the entire population of stage III and stage IV NSCLC at the same time
.
1.
Globalcan 20202.
doi: 10.
7150/jca.
40267 About Zejiemei® (sugarizumab injection) potential best-in-class PD-L1 antibody Zejiemei® (sugarizumab injection) was developed by CStone Pharmaceuticals Developed research anti-PD-L1 monoclonal antibody
.
The development of Zejiemei® is based on the OmniRat® genetically modified animal platform licensed and introduced by Ligand of the United States
.
The platform can produce fully human antibodies in one stop
.
As a fully human full-length anti-PD-L1 monoclonal antibody, Zejiemei® is a natural G-type immunoglobulin 4 (IgG4) monoclonal antibody closest to the human body
.
Zejiemei® has a lower risk of immunogenicity and related toxicity in patients, which makes Zejiemei® unique advantages compared with similar drugs
.
At present, the China National Medical Products Administration has approved Zejiemei® new drug marketing application for the combination of pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative The first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, and the combination of paclitaxel and carboplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
.
In addition, Zejiemei® has undergone a number of registered clinical trials, including one phase II registered clinical trial for lymphoma, and four phase III registrations for stage III and IV non-small cell lung cancer, gastric cancer and esophageal cancer.
Clinical Trials
.
CStone Pharmaceuticals and Pfizer have reached a strategic cooperation, including CStone and Pfizer Investment on the development and commercialization of Zejiemei® in mainland China, and CStone and Pfizer Investment to introduce more oncology products into the cooperation framework in Greater China reached a strategic cooperation
.
About GEMSTONE-302 Study GEMSTONE-302 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.
gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) designed to evaluate Zejiemei® combined with chemotherapy versus comfort The effectiveness and safety of drug combination chemotherapy in patients with stage IV NSCLC without first-line treatment
.
The primary endpoint of the trial is PFS assessed by the investigator; secondary endpoints include overall survival, PFS assessed by BICR, and safety
.
In August 2020, in the planned interim analysis of the GEMSTONE-302 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint, that is, compared with placebo combined chemotherapy, Zejiemei® combined chemotherapy is significantly The patient's progression-free survival (PFS) was prolonged, and the safety was good, and no new safety signals were found
.
The mid-term analysis of clinical trial data was presented orally in the Proffered Paper session (Late-Breaking Abstract) of the ESMO Asia conference in 2020
.
In July 2021, the final analysis of the PFS of the GEMSTONE-302 study showed that Zejiemei® combined with chemotherapy further enhanced the primary efficacy endpoint progression-free survival benefit, the patient's risk of disease progression or death was reduced by 52%, and overall survival was shown Obvious trend of gains
.
The data will be published as an oral report at the 2021 World Lung Cancer Conference
.
About CStone Pharmaceuticals CStone Pharmaceuticals (HKSE code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
.
Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations
.
With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates
.
At present, CStone Pharmaceuticals has obtained four new drug marketing approvals worldwide, three new drug marketing approvals in Mainland China, and one new drug marketing approval in Taiwan
.
Many late-stage drug candidates are in critical clinical trials or registration stages
.
CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer
.
For more information about CStone Pharmaceuticals, please visit:
.
About Pfizer: Bring breakthrough innovations to patients that change their lives.
At Pfizer, we use science and global resources to provide people with treatment options to extend their lives and significantly improve their lives
.
Pfizer has always been committed to pursuing strict quality, safety and value standards in the exploration, research and development and production of medical and health products
.
Our global product portfolio includes innovative medicines and vaccines
.
Every day, Pfizer's employees in developed and emerging markets are advancing human health, promoting the prevention, treatment and cure of diseases in order to cope with the stubborn diseases that challenge our time
.
Pfizer also cooperates with healthcare providers, governments and communities to support and promote people around the world to obtain more reliable and affordable healthcare services
.
This is consistent with Pfizer's responsibility as a globally outstanding innovative biopharmaceutical company
.
For more than 170 years, Pfizer has been committed to bringing change to everyone who depends on us
.
For more information, please visit
.
Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
.
Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
.
All statements in this article are made on the date of publication of this article and may change due to future developments
.
-L1 antibody Zejiemei® is under review for the new drug application for stage III non-small cell lung cancer.
This product is expected to provide a new treatment option for the entire population of stage III and IV non-small cell lung cancer following two first-of-its-kind precision treatments After the drugs Pujihua® and Taijihua® were approved for marketing, Zejiemei® is CStone's third new drug approved for marketing in China in 2021.
Suzhou, China, December 21, 2021-CStone Pharmaceuticals (Hong Kong) Stock Exchange code: 2616), a leading biopharmaceutical company focusing on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs, today announced that the China National Medical Products Administration (NMPA) has approved the PD-L1 antibody drug selection Jiemei® (sugarizumab injection) new drug marketing application for combined pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative metastasis The first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC), and the combination of paclitaxel and carboplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
.
Globally, the incidence of lung cancer continues to increase, which is also the leading cause of cancer-related deaths worldwide, and there is a huge unmet medical demand
.
According to statistics, there will be 2.
21 million new lung cancer patients worldwide in 2020.
1 NSCLC accounts for about 85% of all lung cancer patients, and about 66% of patients are diagnosed with stage III/IV NSCLC
.
2 According to IQVIA's global oncology market report, it is estimated that by 2025, the global oncology drug market will reach 269 billion U.
S.
dollars, of which immuno-oncology drugs will contribute about 20%
.
Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, said: “Zejiemei ® is the third new drug approved by CStone Pharmaceuticals this year.
The approval of Zejiemei ® once again confirms that CStone Pharmaceuticals will create a new drug
.
The ability and strength to bring new high-quality drugs to the market
.
As a major national major science and technology project for new drug creation, Zejiemei® is an international-quality PD-L1 antibody
.
We will work together with Pfizer to utilize the resources and advantages of both parties to accelerate business in an all-round way This innovative treatment will benefit more Chinese patients faster
.
” Peng Zhenke, President of Pfizer Biopharmaceutical Group in China, emphasized: “Thanks to the implementation of the Chinese government’s policy to encourage innovation and the ingenious clinical trial settings of domestic scientists, Jiemei® becomes the first drug approved by Pfizer in its innovative strategic cooperation with a Chinese innovative pharmaceutical company
.
With more than 30 years of commercialization capabilities in China, Pfizer has ensured that it will accelerate the introduction of Zegemei® to Chinese patients
.
The approval of Zejiemei® will further enrich Pfizer With the dual assistance of precision targeted therapy and immuno-oncology therapy, Pfizer will implement the concept of'Science to Win and Fight Cancer', continue to integrate global resource advantages and China's scientific innovation capabilities, and join hands with all parties in the industry.
To help achieve the goal of'Healthy China 2030'
.
" Professor Zhou Caicun, the principal investigator of the ZJM® registered phase III clinical study of GEMSTONE-302 and the director of the Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University, pointed out: "The latest published clinical research data It shows that Zejiemei® combined with chemotherapy can further extend the progression-free survival (PFS) of patients with stage IV newly treated non-small cell lung cancer, and can bring more lasting survival benefits to patients than chemotherapy alone
.
At the same time, the drug's benefits The risk of immunogenicity and related toxicity is lower
.
What's more noteworthy is that Zejiemei®'s unique dual mechanism of action can mobilize the'two forces' of T cells and macrophages in the human body to destroy tumor cells
.
Therefore, Zejiemei® is expected to reshape the landscape of lung cancer treatment
.
Dr.
Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said: "We are very excited to see Zejiemei® being successfully approved in Mainland China
.
From the first phase I clinical trial to the approval of the first major indication for lung cancer, ZJM® only took four years.
This is a comprehensive manifestation of CStone's strong clinical strategy, innovative trial design and rapid execution.
Once again created the'Corner Speed'
.
We will continue to work closely with our partners to launch new drugs for stage III and stage IV non-small cell lung cancer with drug regulatory authorities in many countries and regions, including the U.
S.
Food and Drug Administration (FDA).
Apply for communication and bring this innovative immunotherapy to more lung cancer patients as soon as possible
.
At the same time, we will continue to advance the registered clinical research of Zejiemei® in esophageal squamous cell carcinoma, gastric cancer, relapsed/refractory natural killer T-cell lymphoma, and benefit more cancer patients
.
"The approval of Zejiemei® for this indication is based on a multicenter, randomized, double-blind phase III clinical study called GEMSTONE-302
.
The study aims to evaluate Zejiemei® combined with chemotherapy versus placebo combined with chemotherapy.
Effectiveness and safety in patients with stage IV NSCLC without first-line treatment
.
ZJM® combined with chemotherapy, compared with placebo combined with chemotherapy, significantly prolongs the patient’s progression-free survival (PFS), the patient’s disease progression or The risk of death was reduced by 52%, and showed a trend of obvious benefits in overall survival
.
Patients with different tumor tissue subtypes and PD-L1 expression levels have benefits
.
Zejiemei® has good safety and no new safety signals have been found
.
In addition to the approved indications, in September 2021, NMPA has accepted Zejiemei® as a consolidation therapy for unresectable stage III NSCLC patients who have not progressed after concurrent or sequential radiotherapy and chemotherapy.
, This product is expected to become a PD-(L)1 antibody covering the entire population of stage III and stage IV NSCLC at the same time
.
1.
Globalcan 20202.
doi: 10.
7150/jca.
40267 About Zejiemei® (sugarizumab injection) potential best-in-class PD-L1 antibody Zejiemei® (sugarizumab injection) was developed by CStone Pharmaceuticals Developed research anti-PD-L1 monoclonal antibody
.
The development of Zejiemei® is based on the OmniRat® genetically modified animal platform licensed and introduced by Ligand of the United States
.
The platform can produce fully human antibodies in one stop
.
As a fully human full-length anti-PD-L1 monoclonal antibody, Zejiemei® is a natural G-type immunoglobulin 4 (IgG4) monoclonal antibody closest to the human body
.
Zejiemei® has a lower risk of immunogenicity and related toxicity in patients, which makes Zejiemei® unique advantages compared with similar drugs
.
At present, the China National Medical Products Administration has approved Zejiemei® new drug marketing application for the combination of pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative The first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, and the combination of paclitaxel and carboplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
.
In addition, Zejiemei® has undergone a number of registered clinical trials, including one phase II registered clinical trial for lymphoma, and four phase III registrations for stage III and IV non-small cell lung cancer, gastric cancer and esophageal cancer.
Clinical Trials
.
CStone Pharmaceuticals and Pfizer have reached a strategic cooperation, including CStone and Pfizer Investment on the development and commercialization of Zejiemei® in mainland China, and CStone and Pfizer Investment to introduce more oncology products into the cooperation framework in Greater China reached a strategic cooperation
.
About GEMSTONE-302 Study GEMSTONE-302 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.
gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) designed to evaluate Zejiemei® combined with chemotherapy versus comfort The effectiveness and safety of drug combination chemotherapy in patients with stage IV NSCLC without first-line treatment
.
The primary endpoint of the trial is PFS assessed by the investigator; secondary endpoints include overall survival, PFS assessed by BICR, and safety
.
In August 2020, in the planned interim analysis of the GEMSTONE-302 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint, that is, compared with placebo combined chemotherapy, Zejiemei® combined chemotherapy is significantly The patient's progression-free survival (PFS) was prolonged, and the safety was good, and no new safety signals were found
.
The mid-term analysis of clinical trial data was presented orally in the Proffered Paper session (Late-Breaking Abstract) of the ESMO Asia conference in 2020
.
In July 2021, the final analysis of the PFS of the GEMSTONE-302 study showed that Zejiemei® combined with chemotherapy further enhanced the primary efficacy endpoint progression-free survival benefit, the patient's risk of disease progression or death was reduced by 52%, and overall survival was shown Obvious trend of gains
.
The data will be published as an oral report at the 2021 World Lung Cancer Conference
.
About CStone Pharmaceuticals CStone Pharmaceuticals (HKSE code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
.
Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations
.
With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates
.
At present, CStone Pharmaceuticals has obtained four new drug marketing approvals worldwide, three new drug marketing approvals in Mainland China, and one new drug marketing approval in Taiwan
.
Many late-stage drug candidates are in critical clinical trials or registration stages
.
CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer
.
For more information about CStone Pharmaceuticals, please visit:
.
About Pfizer: Bring breakthrough innovations to patients that change their lives.
At Pfizer, we use science and global resources to provide people with treatment options to extend their lives and significantly improve their lives
.
Pfizer has always been committed to pursuing strict quality, safety and value standards in the exploration, research and development and production of medical and health products
.
Our global product portfolio includes innovative medicines and vaccines
.
Every day, Pfizer's employees in developed and emerging markets are advancing human health, promoting the prevention, treatment and cure of diseases in order to cope with the stubborn diseases that challenge our time
.
Pfizer also cooperates with healthcare providers, governments and communities to support and promote people around the world to obtain more reliable and affordable healthcare services
.
This is consistent with Pfizer's responsibility as a globally outstanding innovative biopharmaceutical company
.
For more than 170 years, Pfizer has been committed to bringing change to everyone who depends on us
.
For more information, please visit
.
Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
.
Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
.
All statements in this article are made on the date of publication of this article and may change due to future developments
.
