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Recent popular reports from Yimaike ★ [Lecture Preview] Gene Editing: CRISPR Experiment Optimization and sgRNA Design ★Actively deploy ADC! Qilu Pharma introduces MUC1 ADC drugMedClub broke the news on April 20, 2021/eMedClub News/--On April 19, Rongchang Bio announced: “China’s first self-developed antibody-conjugated drug (ADC) new drug won The batch countdown will open a new era of targeted tumor therapy.
"
Querying the reporting progress of the Insight database shows that on April 11, the drug has completed the on-site inspection of the production.
Rongchang Biotech also stated in the press release that it has established a 2000L-scale cell culture production line, small molecule synthesis, coupling, and ADC preparation canning production line for vedicutumab (RC48, disitamab vedotin), which is a commercial production line.
Well prepared fully.
Looking forward to this “Chinese New” original ADC drug to “Global New”, Rongchang Bio will also create more accurate and efficient “magic bullets” to lighten the way for cancer patients to fight cancer.
According to the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, the priority review announcement form shows that the drug is intended to treat HER2 overexpression locally advanced or metastatic gastric cancer (including gastric cancer) that has received at least 2 systemic chemotherapy after recurrence/metastasis.
The marketing application of esophageal junction cancer) has been included in the priority review, which means that the drug is about to be approved for gastric cancer.
According to the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, the priority review announcement form shows that the drug is intended to treat HER2 overexpression locally advanced or metastatic gastric cancer (including gastric cancer) that has received at least 2 systemic chemotherapy after recurrence/metastasis.
The marketing application of esophageal junction cancer) has been included in the priority review, which means that the drug is about to be approved for gastric cancer.At the 2020 American Society of Clinical Oncology (ASCO) annual meeting, the results of the "RC48 treatment of HER2 overexpression of locally advanced or metastatic gastric cancer phase 2 clinical study" led by Professor Lin Shen from Peking University Cancer Hospital were announced.
Studies have shown that the drug has an objective response rate (ORR) of 23.
6% in third-line and above HER2 overexpression locally advanced or metastatic gastric cancer.
Moreover, the study also included patients with low HER2 expression, broadening the scope of traditional HER2-positive patients and expanding the target patient population.
The results of this study have been submitted to the National Medical Products Administration, and have obtained fast-track approval channels, and are expected to be approved for marketing in June.
At the same time, the U.
S.
Food and Drug Administration (FDA) also granted vedicitumumab rapid approval channel qualification.
At the 2019 American Cancer Conference, the results of the study on the treatment of metastatic and recurrent urothelial carcinoma (bladder cancer) led by Professor Guo Jun, Deputy Dean of Peking University Cancer Hospital, was released.
Studies have shown that the drug has an overall disease control rate of 90% and a confirmed objective response rate (cORR) of 51%.
The trial has achieved the world's best clinical data in the treatment of recurrent urothelial cancer (mainly bladder cancer).
Guo Jun said that the powerful "weapon" of vedicitumumab can provide patients with metastatic urothelial cancer with disease control for a long time and prolong the overall survival of patients.
This is of great significance.
Therefore, The U.
S.
FDA granted Vidicuzumab "Breakthrough Therapy Designation" and quickly approved it for clinical trials in the United States.
In addition, vedicitumumab can benefit patients with HER2-expressing breast cancer, biliary tract cancer, and other patients with HER2-expressing solid tumors after the failure of conventional treatment.
In the future, patients with HER2-expressing may be trans-tumorous.
The possibility of use.
Congratulations to Rongchang Biologics for completing the on-site inspection of the production site of Weidixituzumab for injection, and hope that the drug will be approved as soon as possible and benefit patients.
Sources of the article: 1.
Immediate Drug News "China's first self-developed antibody conjugate drug is expected to be approved soon to treat gastric cancer" Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, industry insights, etc.
of innovative biological drugs, all media There are 160,000+ high-end matrix users, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutional users exceed 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
"
Querying the reporting progress of the Insight database shows that on April 11, the drug has completed the on-site inspection of the production.
Rongchang Biotech also stated in the press release that it has established a 2000L-scale cell culture production line, small molecule synthesis, coupling, and ADC preparation canning production line for vedicutumab (RC48, disitamab vedotin), which is a commercial production line.
Well prepared fully.
Looking forward to this “Chinese New” original ADC drug to “Global New”, Rongchang Bio will also create more accurate and efficient “magic bullets” to lighten the way for cancer patients to fight cancer.
According to the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, the priority review announcement form shows that the drug is intended to treat HER2 overexpression locally advanced or metastatic gastric cancer (including gastric cancer) that has received at least 2 systemic chemotherapy after recurrence/metastasis.
The marketing application of esophageal junction cancer) has been included in the priority review, which means that the drug is about to be approved for gastric cancer.
According to the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, the priority review announcement form shows that the drug is intended to treat HER2 overexpression locally advanced or metastatic gastric cancer (including gastric cancer) that has received at least 2 systemic chemotherapy after recurrence/metastasis.
The marketing application of esophageal junction cancer) has been included in the priority review, which means that the drug is about to be approved for gastric cancer.At the 2020 American Society of Clinical Oncology (ASCO) annual meeting, the results of the "RC48 treatment of HER2 overexpression of locally advanced or metastatic gastric cancer phase 2 clinical study" led by Professor Lin Shen from Peking University Cancer Hospital were announced.
Studies have shown that the drug has an objective response rate (ORR) of 23.
6% in third-line and above HER2 overexpression locally advanced or metastatic gastric cancer.
Moreover, the study also included patients with low HER2 expression, broadening the scope of traditional HER2-positive patients and expanding the target patient population.
The results of this study have been submitted to the National Medical Products Administration, and have obtained fast-track approval channels, and are expected to be approved for marketing in June.
At the same time, the U.
S.
Food and Drug Administration (FDA) also granted vedicitumumab rapid approval channel qualification.
At the 2019 American Cancer Conference, the results of the study on the treatment of metastatic and recurrent urothelial carcinoma (bladder cancer) led by Professor Guo Jun, Deputy Dean of Peking University Cancer Hospital, was released.
Studies have shown that the drug has an overall disease control rate of 90% and a confirmed objective response rate (cORR) of 51%.
The trial has achieved the world's best clinical data in the treatment of recurrent urothelial cancer (mainly bladder cancer).
Guo Jun said that the powerful "weapon" of vedicitumumab can provide patients with metastatic urothelial cancer with disease control for a long time and prolong the overall survival of patients.
This is of great significance.
Therefore, The U.
S.
FDA granted Vidicuzumab "Breakthrough Therapy Designation" and quickly approved it for clinical trials in the United States.
In addition, vedicitumumab can benefit patients with HER2-expressing breast cancer, biliary tract cancer, and other patients with HER2-expressing solid tumors after the failure of conventional treatment.
In the future, patients with HER2-expressing may be trans-tumorous.
The possibility of use.
Congratulations to Rongchang Biologics for completing the on-site inspection of the production site of Weidixituzumab for injection, and hope that the drug will be approved as soon as possible and benefit patients.
Sources of the article: 1.
Immediate Drug News "China's first self-developed antibody conjugate drug is expected to be approved soon to treat gastric cancer" Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, industry insights, etc.
of innovative biological drugs, all media There are 160,000+ high-end matrix users, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutional users exceed 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
