CStone Pharmaceuticals Announces Completion of Subject Enrollment in Two Phase III Registration Clinical Trials of Zejimet(R) (Sugelimab Injection)

CStone Pharmaceuticals announced that two Phase III registrational clinical trials of its self-developed fully human and full-length anti-PD-L1 monoclonal antibody Zejimet® (sugarimab injection) have completed the enrollment of all subjects, respectively.
is the GEMSTONE-303 study of Zejimet® in combination with chemotherapy in first-line treatment of unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma and Zejimay® in combination with first-line chemotherapy in unresectable locally advanced, recurrent or metastatic esophagus GEMSTONE-304 study in squamous cell carcinoma
.
Dr.
Jianxin Yang, Chief Medical Officer of CStone Pharmaceuticals, said: "We are very pleased to see that two blockbuster studies of Zejimet® in the field of gastrointestinal tumors, the Phase III registration study of first-line chemotherapy in the treatment of gastric and esophageal cancer, have successfully completed all subjects.
Enrollment This is after the approval of Zejimei® in mainland China in December 2021 for the first-line treatment of stage IV non-small cell lung cancer (NSCLC), and the successful submission of the marketing application for stage III NSCLC in September 2021 and January 2022.
After the registrational clinical study for the treatment of relapsed or refractory extranodal natural killer cell/T cell lymphoma reached the primary endpoint, another important development of CStone's product development pipeline We would like to thank all the researchers who participated in the study, Like lung cancer, the morbidity and mortality of gastric cancer and esophageal cancer are among the highest in the world, especially in China, and the majority of patients still face huge unmet treatment needs.
We hope that the results of these two studies can be released soon.
Bringing better treatment options to patients" Gastric and esophageal cancer is one of the most common cancers in the world.
According to GLOBOCAN 2020 data, there will be more than 1 million new gastric cancer cases and 769,000 deaths worldwide in 2020, ranking fifth in the world.
The No.
1 common cancer and the No.
4 cause of cancer death, there were more than 600,000 new cases of esophageal cancer and 544,000 deaths, making it the 8th most common cancer and the 6th cause of cancer death in the world.
The incidence of gastric adenocarcinoma accounted for More than 90% of gastric malignant tumors, and the incidence of gastroesophageal junction adenocarcinoma has also been on the rise in recent years.
According to statistics, about 90% of esophageal cancer patients in China are esophageal squamous cell carcinoma, and most patients with esophageal squamous cell carcinoma have already been diagnosed.
For the advanced stage, the opportunity for radical treatment is lost
.
The GEMSTONE-303 study is a multicenter, placebo-controlled, Phase 3 registrational clinical trial evaluating ZEJME® in combination with CAPOX chemotherapy (oxaliplatin + capecitabine) as first-line treatment for inoperable locally advanced Phase Ib study on the efficacy and safety of metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma showed that the objective response rate of Zejimei® combined with CAPOX chemotherapy regimen as first-line treatment of gastric cancer or gastroesophageal junction cancer reached 62.
1% (18/18).
29), the disease control rate reached 82.
8%, and the remission was sustainable
.
The GEMSTONE-304 study is a multicenter, placebo-controlled, Phase 3 registrational clinical trial evaluating ZEJME® in combination with FP chemotherapy (fluorouracil + cisplatin) as first-line treatment for unresectable locally advanced, recurrent or metastatic disease The Phase Ib study on the efficacy and safety of esophageal squamous cell carcinoma showed that the objective response rate of Zejimei® combined with FP chemotherapy as first-line treatment of advanced esophageal squamous cell carcinoma reached 67.
6% (25/37), the disease control rate reached 89.
2%, and the remission rate reached 89.
2%.
sustainable
.
About Zejimet® (Sugelimab Injection) Zejimet® (Sugelimab Injection) is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals.
The company authorized the introduction of the OmniRat® transgenic animal platform.
This platform can produce fully human antibodies in one stop.
As a fully human full-length anti-PD-L1 monoclonal antibody, Zejimei® is a natural G-type immunoglobulin close to the human body.
The protein 4 (IgG4) monoclonal antibody drug Zejimet® has a lower risk of immunogenicity and associated toxicity in patients, which gives Zejimate® a unique advantage compared to similar drugs
.
At present, the China National Medical Products Administration has approved the new drug marketing application of Zejimei® for the first-line treatment of driver gene-negative squamous, non-squamous stage IV non-small cell lung cancer patients in combination with chemotherapy.
Clinical trials, including a Phase II registrational clinical trial for lymphoma and three Phase III registrational clinical trials for Phase III non-small cell lung cancer, gastric cancer and esophageal cancer
.
CStone and Pfizer enter into a strategic partnership, including CStone and Pfizer Investments on the development and commercialization of Zexima® in mainland China, and CStone and Pfizer Investments to introduce more oncology products into the Greater China region reach strategic cooperation,
etc.