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On June 9th, the National Medical Products Administration (NMPA) issued an announcement to pass the priority review and approval procedure with conditional approval of China’s self-developed innovative antibody-conjugated drug (ADC) for injection vedicitumumab, which is suitable for at least Treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received two kinds of systemic chemotherapy
.
NMPA also approved the first category of innovative drug Donafenib tosylate tablets through the priority review and approval process for the market for unresectable hepatocellular carcinoma patients who have not received systemic treatment in the past
.
Vermicutuzumab is an ADC that contains the HER2 antibody part, a linker, and the cytotoxic drug monomethyl auristatin E (MMAE), which can target the HER2 protein on the tumor surface.
Accurately identify cancer cells, penetrate cell membranes, and then use small molecule cytotoxic drugs to kill them
.
This approval is based on the data of a single-arm, open, multi-center pivotal II clinical trial of vedicitumumab in patients with HER2-positive locally advanced or metastatic gastric cancer
.
The study enrolled 127 patients with HER2 overexpression (including ICH3+, IHC2+/FISH+ and IHC2+/FISH- patients) who had previously received 2-line or above-line system chemotherapy for advanced gastric cancer (including gastroesophageal junction adenocarcinoma)
.
Data released at the 2020 American Society of Clinical Oncology (ASCO) annual meeting showed that the objective response rate (ORR) of the main efficacy index evaluated by the Independent Efficacy Evaluation Committee (IRC) was 23.
6%, and the median progression-free survival (PFS) was 4.
1 months, the median overall survival (OS) was 7.
5 months
.
In terms of safety, the common adverse events of vedicitumumab include decreased white blood cell count, hair loss, and decreased neutrophil count, which are mainly mild to moderate and are basically clinically controllable
.
In addition, the clinical research of Vidicuzumab in HER2-expressing urothelial carcinoma, breast cancer, biliary tract cancer and non-small cell lung cancer is ongoing
.
Among them, the application of vedicitumumab for patients with locally advanced or metastatic urothelial cancer overexpressing HER2 has been included in the breakthrough treatment category by CDE in December 2020
.
Donafenib Donafenib is an oral multi-target, multi-kinase inhibitor class of small molecule anti-tumor drugs, and its essence is "deuterated sorafenib"
.
This approval is mainly based on data from an open, randomized, parallel-controlled, multi-center phase II/III clinical study (trial code ZGDH3) of Donafinil for the first-line treatment of advanced hepatocellular carcinoma
.
ZGDH3 is a pivotal phase II/III clinical trial conducted in 37 research centers in China.
The enrolled population is patients with inoperable or metastatic hepatocellular carcinoma
.
A total of 668 patients were included in the study
.
The results of the study showed that: in terms of effectiveness, the overall survival of the main research endpoint of the experimental group was significantly better than that of the control group
.
There was no significant difference in the median progression-free survival, objective remission rate, and disease control rate of the secondary study endpoints between the two groups.
In terms of safety, adverse events (AE) of grade ≥3, important AEs, and drug suspensions occurred in the experimental group The AEs were significantly lower than the sorafenib group.
The above results suggest that the survival benefit and safety of the experimental group are better than those of the control group
.
Donafenib is the world's first large-scale phase III clinical trial with a single-agent head-to-head comparison in the treatment of advanced hepatocellular carcinoma since 2007, and its survival benefit and safety are superior to those of sorafenib.
New tumor drugs
.
Based on the excellent results of the ZGDH3 study, the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" included Donafenib as a Class I expert recommended drug for the first-line treatment of advanced liver cancer
.
.
NMPA also approved the first category of innovative drug Donafenib tosylate tablets through the priority review and approval process for the market for unresectable hepatocellular carcinoma patients who have not received systemic treatment in the past
.
Vermicutuzumab is an ADC that contains the HER2 antibody part, a linker, and the cytotoxic drug monomethyl auristatin E (MMAE), which can target the HER2 protein on the tumor surface.
Accurately identify cancer cells, penetrate cell membranes, and then use small molecule cytotoxic drugs to kill them
.
This approval is based on the data of a single-arm, open, multi-center pivotal II clinical trial of vedicitumumab in patients with HER2-positive locally advanced or metastatic gastric cancer
.
The study enrolled 127 patients with HER2 overexpression (including ICH3+, IHC2+/FISH+ and IHC2+/FISH- patients) who had previously received 2-line or above-line system chemotherapy for advanced gastric cancer (including gastroesophageal junction adenocarcinoma)
.
Data released at the 2020 American Society of Clinical Oncology (ASCO) annual meeting showed that the objective response rate (ORR) of the main efficacy index evaluated by the Independent Efficacy Evaluation Committee (IRC) was 23.
6%, and the median progression-free survival (PFS) was 4.
1 months, the median overall survival (OS) was 7.
5 months
.
In terms of safety, the common adverse events of vedicitumumab include decreased white blood cell count, hair loss, and decreased neutrophil count, which are mainly mild to moderate and are basically clinically controllable
.
In addition, the clinical research of Vidicuzumab in HER2-expressing urothelial carcinoma, breast cancer, biliary tract cancer and non-small cell lung cancer is ongoing
.
Among them, the application of vedicitumumab for patients with locally advanced or metastatic urothelial cancer overexpressing HER2 has been included in the breakthrough treatment category by CDE in December 2020
.
Donafenib Donafenib is an oral multi-target, multi-kinase inhibitor class of small molecule anti-tumor drugs, and its essence is "deuterated sorafenib"
.
This approval is mainly based on data from an open, randomized, parallel-controlled, multi-center phase II/III clinical study (trial code ZGDH3) of Donafinil for the first-line treatment of advanced hepatocellular carcinoma
.
ZGDH3 is a pivotal phase II/III clinical trial conducted in 37 research centers in China.
The enrolled population is patients with inoperable or metastatic hepatocellular carcinoma
.
A total of 668 patients were included in the study
.
The results of the study showed that: in terms of effectiveness, the overall survival of the main research endpoint of the experimental group was significantly better than that of the control group
.
There was no significant difference in the median progression-free survival, objective remission rate, and disease control rate of the secondary study endpoints between the two groups.
In terms of safety, adverse events (AE) of grade ≥3, important AEs, and drug suspensions occurred in the experimental group The AEs were significantly lower than the sorafenib group.
The above results suggest that the survival benefit and safety of the experimental group are better than those of the control group
.
Donafenib is the world's first large-scale phase III clinical trial with a single-agent head-to-head comparison in the treatment of advanced hepatocellular carcinoma since 2007, and its survival benefit and safety are superior to those of sorafenib.
New tumor drugs
.
Based on the excellent results of the ZGDH3 study, the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" included Donafenib as a Class I expert recommended drug for the first-line treatment of advanced liver cancer
.
