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The treatment of urothelial carcinoma in China has entered the ADC era
.
On January 5, Rongchang Bio-Pharmaceutical (Yantai) Co.
, Ltd.
(09995.
HK) announced that the new indication of vedicetumab for injection (trade name: Aidexi®) has been approved by the National Medical Products Administration (NMPA).
is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-containing chemotherapy and have HER2 overexpression (2+ or 3+ immunohistochemical results)
.
This indication was submitted for approval on July 14 last year, and was quickly approved in less than half a year.
It became the first ADC drug targeting HER2 in the treatment of urothelial cancer in China, and opened a new way for precision treatment of urothelial cancer in China.
The era marks that urothelial cancer patients officially ushered in the first ADC drug that has been double-certified as a breakthrough therapy in China and the United States, which is a major milestone
.
Urothelial carcinoma is its second approved indication
.
As China's first self-developed antibody-drug conjugate (ADC) new drug, on June 8 last year, the first indication of vedicitumab for injection was approved for marketing, and it is suitable for at least two systems Chemotherapy in patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma
.
Urothelial carcinoma is one of the common malignant tumors, and its morbidity and mortality are the first among male genitourinary tumors
.
According to the Frost & Sullivan report, the number of new cases of urothelial cancer in the world will reach about 662,000 in 2030, with a compound annual growth rate of 2.
5% from 2025 to 2030; in China, the incidence of urothelial cancer is The growth rate is higher than the global level, and it is expected to reach about 106,000 cases in 2030
.
Statistics show that the recurrence and metastasis rates of the disease are relatively high.
About 20% of patients have already metastasized or progressed to an unresectable stage at the time of diagnosis.
The existing treatment methods are far from meeting the huge clinical needs
.
A clinical study led by Professor Guo Jun from Peking University Cancer Hospital showed that vedicitumab for injection had outstanding efficacy and survival in patients with previously treated platinum-containing chemotherapy and HER2-overexpressing locally advanced or metastatic urothelial carcinoma Benefit, the objective response rate by independent imaging assessment was 50.
5%, the median progression-free survival time was 5.
9 months, and the median survival time was 14.
2 months
.
In particular, the combined PD-1 clinical study has achieved amazing clinical trial results
.
Because the clinical efficacy is significantly better than the existing treatment methods, the indication of vedicetumab for injection in urothelial carcinoma has successively obtained the breakthrough therapy designation granted by the US FDA and the China State Food and Drug Administration, becoming the first to receive the US and China It is a domestic ADC drug with dual certification of breakthrough therapy in China
.
"The approval and marketing of vedicetumab for urothelial carcinoma for injection is a milestone event, which means that the treatment pattern of HER2-positive urothelial carcinoma has undergone a major subversion, and the treatment of such patients is officially moving towards precision therapy.
The times
.
" Professor Guo Jun of Peking University Cancer Hospital said: "It is coupled with a highly efficient cytotoxic molecule MMAE on the monoclonal antibody against HER2, so it has three major advantages: first, it has a stronger affinity with the HER2 receptor; Second, it can not only accurately kill tumor cells with HER2 receptors, but also produce a para-killing effect to kill tumor cells with low HER2 expression; Potential synergy with immunotherapy drugs
.
These advantageous properties made Vidicitumab for injection appear in the field of urothelial cancer treatment as soon as it debuted, and it was included in the Chinese Clinical Oncology (CSCO) guidelines in 2021, thus establishing its role in the HER2-positive urinary tract.
The therapeutic status of skin cancer also marks that Chinese scholars are at the forefront of the world in the anti-HER2 treatment of urothelial cancer
.
"Professor Guo Jun said: "Veldicitumab for injection will bring hope to the majority of urothelial cancer patients who are in the dilemma of treatment
.
"
In the future, with the in-depth exploration and accumulation of first-line, neoadjuvant and adjuvant therapy, it is believed that it will definitely bring more amazing treatment experience to urothelial cancer patients and other solid tumor patients in China, benefiting more tumor patients
.
"Rongchang Bio is one of the few biopharmaceutical companies in China that has a fully integrated ADC platform
.
Based on this platform, the company has continuously improved and optimized its ADC product pipeline.
So far, it has HER2-targeting vedicitumab for injection, inter-targeting Four products, including RC88 of Cortexin, RC108 of c-Met, and RC118 of Claudin18.
2, have entered clinical research or been approved for marketing
.
The two indications for skin cancer have been approved for marketing and included in the new National Medical Insurance Drug List (2021 version).
Currently, the first "medical insurance prescription" for the treatment of advanced gastric cancer has been issued; its treatment of breast cancer, lung cancer, bile duct cancer and other The phase II/III clinical study of the indication is in progress
.
About Veldicitumab for Injection Veldicitumab for injection (Aidexi®) is the first original antibody conjugated (ADC) in China developed by Rongchang Biotech.
) drugs, targeting the HER2 protein on the surface of tumors, can accurately identify and kill tumor cells, and have achieved world-leading clinical data in clinical trials for the treatment of gastric cancer, urothelial cancer, breast cancer and other tumors.
It is an ADC drug that has been double-recognized as a breakthrough therapy by the US FDA and the China National Medical Products Administration
.
On June 8, 2021, Vidicitumumab for injection was approved for sale by the State Food and Drug Administration for gastric cancer indications, and was included in the new National Medical Insurance Catalogue on December 3 of the same year; on January 5 this year, urothelial carcinoma was approved for sale.
Approved for sale
.
Phase II/III clinical studies of the drug in the treatment of other indications such as breast cancer, lung cancer, and bile duct cancer are in progress, and the indication for breast cancer is officially included in the breakthrough therapy category
.
In August 2021, Seattle Gene, a well-known international biopharmaceutical company, acquired Vidicitumab for injection with up to $2.
6 billion in down payment and milestone payments, and a gradient of sales commissions ranging from high single digits to more than 15 percent.
The global exclusive license agreement (excluding the Asia-Pacific region), and the transaction volume once set the highest record for the overseas authorization of a single product of a Chinese pharmaceutical company
.
About Breakthrough Therapy Breakthrough therapy (BTD) designation, initiated by the US Food and Drug Administration in 2012, aims to accelerate the development and review of serious life-threatening diseases, and the preliminary clinical results have shown that the efficacy of the drug is significantly improved compared to existing treatments of new drugs
.
In July 2020, the Chinese version of "Breakthrough Therapy" was implemented, and CDE began to communicate and exchange resources on the priority allocation of drugs included in the breakthrough therapy drug program, which greatly shortened the time to market for related new drugs
.
Since breakthrough therapy certification emphasizes the breakthrough compared to existing therapies, the applied drug must produce clinical data with obvious advantages and achieve a "true breakthrough" in clinical efficacy.
There are very few domestic new drugs with dual certification in China
.
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.
.
.
On January 5, Rongchang Bio-Pharmaceutical (Yantai) Co.
, Ltd.
(09995.
HK) announced that the new indication of vedicetumab for injection (trade name: Aidexi®) has been approved by the National Medical Products Administration (NMPA).
is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-containing chemotherapy and have HER2 overexpression (2+ or 3+ immunohistochemical results)
.
This indication was submitted for approval on July 14 last year, and was quickly approved in less than half a year.
It became the first ADC drug targeting HER2 in the treatment of urothelial cancer in China, and opened a new way for precision treatment of urothelial cancer in China.
The era marks that urothelial cancer patients officially ushered in the first ADC drug that has been double-certified as a breakthrough therapy in China and the United States, which is a major milestone
.
Urothelial carcinoma is its second approved indication
.
As China's first self-developed antibody-drug conjugate (ADC) new drug, on June 8 last year, the first indication of vedicitumab for injection was approved for marketing, and it is suitable for at least two systems Chemotherapy in patients with HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma
.
Urothelial carcinoma is one of the common malignant tumors, and its morbidity and mortality are the first among male genitourinary tumors
.
According to the Frost & Sullivan report, the number of new cases of urothelial cancer in the world will reach about 662,000 in 2030, with a compound annual growth rate of 2.
5% from 2025 to 2030; in China, the incidence of urothelial cancer is The growth rate is higher than the global level, and it is expected to reach about 106,000 cases in 2030
.
Statistics show that the recurrence and metastasis rates of the disease are relatively high.
About 20% of patients have already metastasized or progressed to an unresectable stage at the time of diagnosis.
The existing treatment methods are far from meeting the huge clinical needs
.
A clinical study led by Professor Guo Jun from Peking University Cancer Hospital showed that vedicitumab for injection had outstanding efficacy and survival in patients with previously treated platinum-containing chemotherapy and HER2-overexpressing locally advanced or metastatic urothelial carcinoma Benefit, the objective response rate by independent imaging assessment was 50.
5%, the median progression-free survival time was 5.
9 months, and the median survival time was 14.
2 months
.
In particular, the combined PD-1 clinical study has achieved amazing clinical trial results
.
Because the clinical efficacy is significantly better than the existing treatment methods, the indication of vedicetumab for injection in urothelial carcinoma has successively obtained the breakthrough therapy designation granted by the US FDA and the China State Food and Drug Administration, becoming the first to receive the US and China It is a domestic ADC drug with dual certification of breakthrough therapy in China
.
"The approval and marketing of vedicetumab for urothelial carcinoma for injection is a milestone event, which means that the treatment pattern of HER2-positive urothelial carcinoma has undergone a major subversion, and the treatment of such patients is officially moving towards precision therapy.
The times
.
" Professor Guo Jun of Peking University Cancer Hospital said: "It is coupled with a highly efficient cytotoxic molecule MMAE on the monoclonal antibody against HER2, so it has three major advantages: first, it has a stronger affinity with the HER2 receptor; Second, it can not only accurately kill tumor cells with HER2 receptors, but also produce a para-killing effect to kill tumor cells with low HER2 expression; Potential synergy with immunotherapy drugs
.
These advantageous properties made Vidicitumab for injection appear in the field of urothelial cancer treatment as soon as it debuted, and it was included in the Chinese Clinical Oncology (CSCO) guidelines in 2021, thus establishing its role in the HER2-positive urinary tract.
The therapeutic status of skin cancer also marks that Chinese scholars are at the forefront of the world in the anti-HER2 treatment of urothelial cancer
.
"Professor Guo Jun said: "Veldicitumab for injection will bring hope to the majority of urothelial cancer patients who are in the dilemma of treatment
.
"
In the future, with the in-depth exploration and accumulation of first-line, neoadjuvant and adjuvant therapy, it is believed that it will definitely bring more amazing treatment experience to urothelial cancer patients and other solid tumor patients in China, benefiting more tumor patients
.
"Rongchang Bio is one of the few biopharmaceutical companies in China that has a fully integrated ADC platform
.
Based on this platform, the company has continuously improved and optimized its ADC product pipeline.
So far, it has HER2-targeting vedicitumab for injection, inter-targeting Four products, including RC88 of Cortexin, RC108 of c-Met, and RC118 of Claudin18.
2, have entered clinical research or been approved for marketing
.
The two indications for skin cancer have been approved for marketing and included in the new National Medical Insurance Drug List (2021 version).
Currently, the first "medical insurance prescription" for the treatment of advanced gastric cancer has been issued; its treatment of breast cancer, lung cancer, bile duct cancer and other The phase II/III clinical study of the indication is in progress
.
About Veldicitumab for Injection Veldicitumab for injection (Aidexi®) is the first original antibody conjugated (ADC) in China developed by Rongchang Biotech.
) drugs, targeting the HER2 protein on the surface of tumors, can accurately identify and kill tumor cells, and have achieved world-leading clinical data in clinical trials for the treatment of gastric cancer, urothelial cancer, breast cancer and other tumors.
It is an ADC drug that has been double-recognized as a breakthrough therapy by the US FDA and the China National Medical Products Administration
.
On June 8, 2021, Vidicitumumab for injection was approved for sale by the State Food and Drug Administration for gastric cancer indications, and was included in the new National Medical Insurance Catalogue on December 3 of the same year; on January 5 this year, urothelial carcinoma was approved for sale.
Approved for sale
.
Phase II/III clinical studies of the drug in the treatment of other indications such as breast cancer, lung cancer, and bile duct cancer are in progress, and the indication for breast cancer is officially included in the breakthrough therapy category
.
In August 2021, Seattle Gene, a well-known international biopharmaceutical company, acquired Vidicitumab for injection with up to $2.
6 billion in down payment and milestone payments, and a gradient of sales commissions ranging from high single digits to more than 15 percent.
The global exclusive license agreement (excluding the Asia-Pacific region), and the transaction volume once set the highest record for the overseas authorization of a single product of a Chinese pharmaceutical company
.
About Breakthrough Therapy Breakthrough therapy (BTD) designation, initiated by the US Food and Drug Administration in 2012, aims to accelerate the development and review of serious life-threatening diseases, and the preliminary clinical results have shown that the efficacy of the drug is significantly improved compared to existing treatments of new drugs
.
In July 2020, the Chinese version of "Breakthrough Therapy" was implemented, and CDE began to communicate and exchange resources on the priority allocation of drugs included in the breakthrough therapy drug program, which greatly shortened the time to market for related new drugs
.
Since breakthrough therapy certification emphasizes the breakthrough compared to existing therapies, the applied drug must produce clinical data with obvious advantages and achieve a "true breakthrough" in clinical efficacy.
There are very few domestic new drugs with dual certification in China
.
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.
.
