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On February 22, Rongchang Bio-Pharmaceutical (Yantai) Co.
, Ltd.
(Rongchang Bio-B, 09995.
HK) announced that vedicitumab for injection (Aidexi®) combined with toripalimab injection ( Tuoyi®) for the treatment of perioperative muscle-invasive bladder cancer (MIBC) for the new drug clinical research application, obtained the implied approval for the clinical trial of the Center for Drug Evaluation (CDE) of the State Drug Administration
.
Vidicitumab is the first new ADC drug independently developed by a Chinese company and approved for marketing.
Its first indication was approved by the State Food and Drug Administration on June 8, 2021.
Treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, treated with systemic chemotherapy
.
On December 31 of the same year, the second indication of the drug was approved for marketing, for the treatment of locally advanced or metastatic urinary tract patients who had previously received platinum-containing chemotherapy and had HER2 overexpression, that is, immunohistochemical test results were 2+ or 3+.
It has become the first ADC drug in China to target HER2 for the treatment of urothelial carcinoma
.
Bladder cancer is one of the most common malignant tumors of the urinary system as a malignant tumor originating from the bladder urothelium
.
According to the staging criteria of the International Union Against Cancer, bladder cancer can be divided into non-muscle invasive bladder cancer and muscle invasive bladder cancer, among which muscle invasive bladder cancer (MIBC) occurs in nearly 50% of patients within 2 years after surgery.
Recurrence or metastasis has a poor prognosis, so perioperative systemic therapy is very important to improve the prognosis of MIBC patients
.
There is a huge unmet clinical need in this field
.
It is reported that Rongchang Bio has obtained the implied permission of the clinical trial for a single-arm, open, multi-center phase II clinical study, with Professor Guo Jun of Peking University Cancer Hospital as the principal investigator
.
Based on data from the study of vedicitumab in locally advanced or metastatic urothelial carcinoma, to explore the efficacy of the drug in combination with toripalimab in the perioperative treatment of MIBC patients planning to undergo radical surgery and security
.
Rongchang Bio is one of the few domestic biopharmaceutical companies with a fully integrated ADC platform
.
Based on this platform, the company has continuously improved and optimized the ADC product pipeline.
So far, 7 products have entered clinical research or have been approved for marketing
.
In addition to vedicitumab targeting HER2, RC88 targeting mesothelin, RC108 targeting c-Met, and RC118 targeting Claudin18.
2 have entered clinical phase I, and RC168, RC178 and RC188 have already entered clinical phase I.
Enter the IND preparation stage
.
About Vidicitumab (Aidexi®) Vidicitumab is the first domestic ADC (antibody-conjugated) new drug independently developed by Rongchang Biotech in China that has been approved for marketing.
It is used in the treatment of HER2-expressing advanced gastric cancer.
It has achieved world-leading data in clinical trials of multiple tumors such as urothelial carcinoma, urothelial carcinoma and breast cancer
.
As the clinical efficacy is significantly better than the existing treatment methods, the indication of urothelial cancer has been granted the double breakthrough therapy designation by the US FDA and the China Food and Drug Administration, and the breast cancer indication has been granted the breakthrough therapy designation by the China Food and Drug Administration
.
At present, the two major indications of gastric cancer and urothelial cancer have been approved for marketing, and phase II/III clinical studies of other indications such as breast cancer, lung cancer and bile duct cancer are in progress
.
In August 2021, Seattle Gene, a well-known international biopharmaceutical company, received a global ( The Asia-Pacific region only includes Singapore and Japan) exclusive license agreements, and the transaction volume once set a new record for the overseas authorization of a single product of a Chinese pharmaceutical company
.
About Rongchang Bio-Rongchang Bio-Pharmaceutical (Yantai) Co.
, Ltd.
was founded in 2008 and is headquartered in Yantai Economic and Technological Development Zone, China (Shandong) Pilot Free Trade Zone, with R&D centers in Beijing, Shanghai, San Francisco and Washington, D.
C.
and branches
.
On November 9, 2020, Rongchang Bio was listed on the Hong Kong Stock Exchange, raising a total of US$590 million, setting a record for the world's largest biotech IPO that year
.
, Ltd.
(Rongchang Bio-B, 09995.
HK) announced that vedicitumab for injection (Aidexi®) combined with toripalimab injection ( Tuoyi®) for the treatment of perioperative muscle-invasive bladder cancer (MIBC) for the new drug clinical research application, obtained the implied approval for the clinical trial of the Center for Drug Evaluation (CDE) of the State Drug Administration
.
Vidicitumab is the first new ADC drug independently developed by a Chinese company and approved for marketing.
Its first indication was approved by the State Food and Drug Administration on June 8, 2021.
Treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, treated with systemic chemotherapy
.
On December 31 of the same year, the second indication of the drug was approved for marketing, for the treatment of locally advanced or metastatic urinary tract patients who had previously received platinum-containing chemotherapy and had HER2 overexpression, that is, immunohistochemical test results were 2+ or 3+.
It has become the first ADC drug in China to target HER2 for the treatment of urothelial carcinoma
.
Bladder cancer is one of the most common malignant tumors of the urinary system as a malignant tumor originating from the bladder urothelium
.
According to the staging criteria of the International Union Against Cancer, bladder cancer can be divided into non-muscle invasive bladder cancer and muscle invasive bladder cancer, among which muscle invasive bladder cancer (MIBC) occurs in nearly 50% of patients within 2 years after surgery.
Recurrence or metastasis has a poor prognosis, so perioperative systemic therapy is very important to improve the prognosis of MIBC patients
.
There is a huge unmet clinical need in this field
.
It is reported that Rongchang Bio has obtained the implied permission of the clinical trial for a single-arm, open, multi-center phase II clinical study, with Professor Guo Jun of Peking University Cancer Hospital as the principal investigator
.
Based on data from the study of vedicitumab in locally advanced or metastatic urothelial carcinoma, to explore the efficacy of the drug in combination with toripalimab in the perioperative treatment of MIBC patients planning to undergo radical surgery and security
.
Rongchang Bio is one of the few domestic biopharmaceutical companies with a fully integrated ADC platform
.
Based on this platform, the company has continuously improved and optimized the ADC product pipeline.
So far, 7 products have entered clinical research or have been approved for marketing
.
In addition to vedicitumab targeting HER2, RC88 targeting mesothelin, RC108 targeting c-Met, and RC118 targeting Claudin18.
2 have entered clinical phase I, and RC168, RC178 and RC188 have already entered clinical phase I.
Enter the IND preparation stage
.
About Vidicitumab (Aidexi®) Vidicitumab is the first domestic ADC (antibody-conjugated) new drug independently developed by Rongchang Biotech in China that has been approved for marketing.
It is used in the treatment of HER2-expressing advanced gastric cancer.
It has achieved world-leading data in clinical trials of multiple tumors such as urothelial carcinoma, urothelial carcinoma and breast cancer
.
As the clinical efficacy is significantly better than the existing treatment methods, the indication of urothelial cancer has been granted the double breakthrough therapy designation by the US FDA and the China Food and Drug Administration, and the breast cancer indication has been granted the breakthrough therapy designation by the China Food and Drug Administration
.
At present, the two major indications of gastric cancer and urothelial cancer have been approved for marketing, and phase II/III clinical studies of other indications such as breast cancer, lung cancer and bile duct cancer are in progress
.
In August 2021, Seattle Gene, a well-known international biopharmaceutical company, received a global ( The Asia-Pacific region only includes Singapore and Japan) exclusive license agreements, and the transaction volume once set a new record for the overseas authorization of a single product of a Chinese pharmaceutical company
.
About Rongchang Bio-Rongchang Bio-Pharmaceutical (Yantai) Co.
, Ltd.
was founded in 2008 and is headquartered in Yantai Economic and Technological Development Zone, China (Shandong) Pilot Free Trade Zone, with R&D centers in Beijing, Shanghai, San Francisco and Washington, D.
C.
and branches
.
On November 9, 2020, Rongchang Bio was listed on the Hong Kong Stock Exchange, raising a total of US$590 million, setting a record for the world's largest biotech IPO that year
.
