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On January 1, 2022, the new version of the National Medical Insurance Catalog was officially implemented.
Among them, Rongchang Bio's two blockbuster new drugs, Taitacept (trade name: Taiai) and Vidicitumumab (trade name: Aidixi), were Inclusion will bring good news to over one million patients with systemic lupus erythematosus and gastric cancer in China, reduce the burden of drug costs for patients, and improve the quality of production for patients
.
For Rongchang Bio, after these two new drugs enter the medical insurance, they will be expected to achieve rapid increase in volume and seize market share
.
Vidicitumab is an anti-HER2 antibody conjugated drug (ADC) independently developed in China.
On January 5 this year, the new indication of this product was approved by the State Food and Drug Administration for the treatment of patients who have received platinum-containing chemotherapy in the past.
HER2 overexpression is defined as patients with locally advanced or metastatic urothelial carcinoma with immunohistochemical findings of 2+ or 3+
.
It is understood that this indication was submitted for approval on July 14, 2021, and was successfully approved in less than half a year, becoming the first ADC drug targeting HER2 in the treatment of urothelial carcinoma in China.
The field of precision cancer treatment is of great significance
.
ADC is a popular track in the field of medicine at home and abroad in recent years
.
According to statistics, since the first ADC was approved in 2000, up to now, 13 ADC products have been approved in the world
.
Among them, in the Chinese market, there are many Roche's Kadcyla, Takeda's Adcetris and Pfizer's Besponsa, as well as Rongchang Bio's Vidicitumumab
.
In addition, the Insight database shows that there are more than 50 clinical trials of ADC drugs currently underway in China
.
In general, the competition on the entire ADC track is becoming more and more intense.
In this context, some pharmaceutical companies have already announced their "exit" in advance
.
In March 2021, Bio-Tech announced the termination of the clinical development of BAT8003 (Trop2-ADC for injection), which the company said was based on considerations such as changes in the Trop2-ADC market landscape
.
In February of the same year, the Phase III clinical trial of Bio-Thera’s HER2-ADC drug BAT8001 failed.
.
It can be seen that in the case of fierce market competition, how to break through in the future will be a major challenge for pharmaceutical companies
.
Rongchang Bio has made major moves in the research and development and industrialization of new drugs
.
It is reported that the R&D and industrialization project of Rongchang Biopharmaceuticals is accelerating.
The project is located in Yantai District, Shandong Province, on the south side of Nanjing Street in the Economic and Technological Development Zone.
It covers an area of about 105 acres and has a construction area of about 167,000 square meters
.
At present, the first and second phases of Rongchang Biotech's investment of more than 2 billion yuan have been put into use
.
At the same time, a quality assurance system that meets the requirements of international GMP has been established, and it has passed the audits of domestic and foreign institutions for many times; in addition, the third and fourth phases of the construction with an investment of 4 billion yuan will be put into use successively from 2022, and the construction of the project will reserve sufficient production capacity.
Meet domestic and foreign clinical and market drug supply needs
.
After the project is completed, the annual output value will reach 10 billion yuan, which will speed up the company's new drug industrialization process, and will also help boost the development of Yantai's biopharmaceutical industry
.
The biopharmaceutical industry is a strategic emerging industry that Yantai City focuses on cultivating.
In recent years, the city has taken many measures to support the biopharmaceutical industry and realize the development and growth of the industry
.
In 2020, the total revenue of biopharmaceutical enterprises in the city exceeded 100 billion yuan, reaching 100.
6 billion yuan
.
At present, there are 55 companies with sales revenue exceeding 100 million yuan in the biomedical field of the city, 13 companies with sales revenue exceeding 1 billion yuan, and 5 companies are listed at home and abroad, and 3 industrial parks of 10 billion yuan have begun to take shape
.
According to the plan, by 2023, the main business income of Yantai's biopharmaceutical industry will exceed 200 billion yuan, of which high-end pharmaceutical equipment manufacturing will account for more than 60%
.
The ecological system of the biopharmaceutical industry is basically sound, the overall strength and innovation capability of the industry have jumped significantly, and it has become a life science innovation demonstration city with important international and domestic influence and competitiveness
.
Among them, Rongchang Bio's two blockbuster new drugs, Taitacept (trade name: Taiai) and Vidicitumumab (trade name: Aidixi), were Inclusion will bring good news to over one million patients with systemic lupus erythematosus and gastric cancer in China, reduce the burden of drug costs for patients, and improve the quality of production for patients
.
For Rongchang Bio, after these two new drugs enter the medical insurance, they will be expected to achieve rapid increase in volume and seize market share
.
Vidicitumab is an anti-HER2 antibody conjugated drug (ADC) independently developed in China.
On January 5 this year, the new indication of this product was approved by the State Food and Drug Administration for the treatment of patients who have received platinum-containing chemotherapy in the past.
HER2 overexpression is defined as patients with locally advanced or metastatic urothelial carcinoma with immunohistochemical findings of 2+ or 3+
.
It is understood that this indication was submitted for approval on July 14, 2021, and was successfully approved in less than half a year, becoming the first ADC drug targeting HER2 in the treatment of urothelial carcinoma in China.
The field of precision cancer treatment is of great significance
.
ADC is a popular track in the field of medicine at home and abroad in recent years
.
According to statistics, since the first ADC was approved in 2000, up to now, 13 ADC products have been approved in the world
.
Among them, in the Chinese market, there are many Roche's Kadcyla, Takeda's Adcetris and Pfizer's Besponsa, as well as Rongchang Bio's Vidicitumumab
.
In addition, the Insight database shows that there are more than 50 clinical trials of ADC drugs currently underway in China
.
In general, the competition on the entire ADC track is becoming more and more intense.
In this context, some pharmaceutical companies have already announced their "exit" in advance
.
In March 2021, Bio-Tech announced the termination of the clinical development of BAT8003 (Trop2-ADC for injection), which the company said was based on considerations such as changes in the Trop2-ADC market landscape
.
In February of the same year, the Phase III clinical trial of Bio-Thera’s HER2-ADC drug BAT8001 failed.
.
It can be seen that in the case of fierce market competition, how to break through in the future will be a major challenge for pharmaceutical companies
.
Rongchang Bio has made major moves in the research and development and industrialization of new drugs
.
It is reported that the R&D and industrialization project of Rongchang Biopharmaceuticals is accelerating.
The project is located in Yantai District, Shandong Province, on the south side of Nanjing Street in the Economic and Technological Development Zone.
It covers an area of about 105 acres and has a construction area of about 167,000 square meters
.
At present, the first and second phases of Rongchang Biotech's investment of more than 2 billion yuan have been put into use
.
At the same time, a quality assurance system that meets the requirements of international GMP has been established, and it has passed the audits of domestic and foreign institutions for many times; in addition, the third and fourth phases of the construction with an investment of 4 billion yuan will be put into use successively from 2022, and the construction of the project will reserve sufficient production capacity.
Meet domestic and foreign clinical and market drug supply needs
.
After the project is completed, the annual output value will reach 10 billion yuan, which will speed up the company's new drug industrialization process, and will also help boost the development of Yantai's biopharmaceutical industry
.
The biopharmaceutical industry is a strategic emerging industry that Yantai City focuses on cultivating.
In recent years, the city has taken many measures to support the biopharmaceutical industry and realize the development and growth of the industry
.
In 2020, the total revenue of biopharmaceutical enterprises in the city exceeded 100 billion yuan, reaching 100.
6 billion yuan
.
At present, there are 55 companies with sales revenue exceeding 100 million yuan in the biomedical field of the city, 13 companies with sales revenue exceeding 1 billion yuan, and 5 companies are listed at home and abroad, and 3 industrial parks of 10 billion yuan have begun to take shape
.
According to the plan, by 2023, the main business income of Yantai's biopharmaceutical industry will exceed 200 billion yuan, of which high-end pharmaceutical equipment manufacturing will account for more than 60%
.
The ecological system of the biopharmaceutical industry is basically sound, the overall strength and innovation capability of the industry have jumped significantly, and it has become a life science innovation demonstration city with important international and domestic influence and competitiveness
.
