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On March 18, the NMPA website showed that the application status of ramucirumab injection, an innovative anti-VEGFR-2 monoclonal antibody declared by Eli Lilly, has been updated to - approval completed - pending certification, which means The drug is expected to be approved for marketing in China in the near future
.
It is understood that on January 21, 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application of ramucirumab injection
.
According to Lilly's earlier announcement, the indication is expected to be second-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma
.
According to public information, ramucirumab is the first approved second-line therapy for gastric cancer/gastroesophageal junction cancer in the world
.
It is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2 (vascular endothelial growth factor receptor 2)
.
The drug can not only effectively block the binding of VEGF-A and VEGFR-2, but also inhibit the binding of VEGF-C and VEGF-D to VEGFR-2, and achieve anti-tumor effect by inhibiting the angiogenesis of tumor tissue
.
The industry believes that after the approval of ramucirumab in China, it will bring new treatment options for domestic gastric cancer patients
.
In recent years, gastric cancer has been in the forefront of various malignant tumors in China
.
Data show that the mortality rate of gastric cancer in China is about 4-8 times that of developed countries
.
At present, with the continuous expansion of the market demand for gastric cancer, many pharmaceutical companies are increasing their layout in this field
.
Globally, as anti-PD-1 monoclonal antibodies have shown significant clinical benefits in the treatment of gastric cancer, many domestic pharmaceutical companies are also making efforts in this regard
.
As far as the author understands, on February 10, 2022, Junshi Biotechnology announced that toripalimab, an anti-PD-1 monoclonal antibody independently developed by the company, was combined with standard chemotherapy for gastric or esophagogastric junction adenocarcinoma.
Phase III clinical study of adjuvant therapy after radical resection (JUPITER-15 study, NCT05180734), the first patient has been administered
.
It is worth noting that this is the first large-scale international multi-center phase III clinical study of a PD-1 inhibitor independently developed in China for adjuvant therapy in the field of gastric cancer with high incidence in Chinese
.
In addition, on June 9, 2021, the State Food and Drug Administration also issued an announcement to conditionally approve the listing of Rongchang Bio's self-developed vedicitumab for injection (trade name: Aidixi), which is suitable for patients who have received at least 2 Treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, treated with systemic chemotherapy
.
Aidixi is an ADC product independently developed by a local pharmaceutical company after Roche's Kadcyla and Seagen/Takeda's Adcetris, which also brings new treatment options to patients with locally advanced or metastatic gastric cancer
.
In general, with the advancement of medical technology, the treatment options for patients with gastric cancer have also begun to diversify.
In addition to surgery, radiotherapy, chemotherapy, and traditional Chinese medicine, immunotherapy and targeted therapy have also begun to be widely used
.
In the future, under the background of the continuous acceleration of domestic pharmaceutical innovation and development, the industry expects that more gastric cancer treatment drugs will continue to emerge, benefiting more and more patients
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
It is understood that on January 21, 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application of ramucirumab injection
.
According to Lilly's earlier announcement, the indication is expected to be second-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma
.
According to public information, ramucirumab is the first approved second-line therapy for gastric cancer/gastroesophageal junction cancer in the world
.
It is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2 (vascular endothelial growth factor receptor 2)
.
The drug can not only effectively block the binding of VEGF-A and VEGFR-2, but also inhibit the binding of VEGF-C and VEGF-D to VEGFR-2, and achieve anti-tumor effect by inhibiting the angiogenesis of tumor tissue
.
The industry believes that after the approval of ramucirumab in China, it will bring new treatment options for domestic gastric cancer patients
.
In recent years, gastric cancer has been in the forefront of various malignant tumors in China
.
Data show that the mortality rate of gastric cancer in China is about 4-8 times that of developed countries
.
At present, with the continuous expansion of the market demand for gastric cancer, many pharmaceutical companies are increasing their layout in this field
.
Globally, as anti-PD-1 monoclonal antibodies have shown significant clinical benefits in the treatment of gastric cancer, many domestic pharmaceutical companies are also making efforts in this regard
.
As far as the author understands, on February 10, 2022, Junshi Biotechnology announced that toripalimab, an anti-PD-1 monoclonal antibody independently developed by the company, was combined with standard chemotherapy for gastric or esophagogastric junction adenocarcinoma.
Phase III clinical study of adjuvant therapy after radical resection (JUPITER-15 study, NCT05180734), the first patient has been administered
.
It is worth noting that this is the first large-scale international multi-center phase III clinical study of a PD-1 inhibitor independently developed in China for adjuvant therapy in the field of gastric cancer with high incidence in Chinese
.
In addition, on June 9, 2021, the State Food and Drug Administration also issued an announcement to conditionally approve the listing of Rongchang Bio's self-developed vedicitumab for injection (trade name: Aidixi), which is suitable for patients who have received at least 2 Treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, treated with systemic chemotherapy
.
Aidixi is an ADC product independently developed by a local pharmaceutical company after Roche's Kadcyla and Seagen/Takeda's Adcetris, which also brings new treatment options to patients with locally advanced or metastatic gastric cancer
.
In general, with the advancement of medical technology, the treatment options for patients with gastric cancer have also begun to diversify.
In addition to surgery, radiotherapy, chemotherapy, and traditional Chinese medicine, immunotherapy and targeted therapy have also begun to be widely used
.
In the future, under the background of the continuous acceleration of domestic pharmaceutical innovation and development, the industry expects that more gastric cancer treatment drugs will continue to emerge, benefiting more and more patients
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
