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Since 2021, the research and development enthusiasm of domestic innovative drug companies is still very high.
At the same time, with the accelerated review of new drugs, innovative results have emerged one after another, including the approval of a variety of PD-1 monoclonal antibody indications and two new models during the year.
domestic PD-1 on the market and so on
.
The industry pointed out that the competition among pharmaceutical companies has moved from the R&D stage to the commercialization stage, and a new race will begin
.
At present, innovative drugs are entering the harvest period.
Among them, monoclonal antibody varieties continue to usher in new harvests as domestic pharmaceutical companies are deploying one after another
.
Previously, there were a total of four domestically approved monoclonal antibodies, including Junshi Bio-Treplimumab, Xinda Bio-Sintilizumab, Hengrui Medicine Karelizumab, BeiGene Tilelizumab Monoclonal antibody
.
In the first half of 2021, new indications for tislelizumab and sintilizumab have been approved
.
In August of this year, the recombinant humanized PD-L1 monoclonal antibody Envolimab injection, which was jointly cooperated by Corning Jerry/Sincere Pharmaceuticals/Side Pharmaceuticals, was approved for marketing.
The indication is that the previous standard treatment has failed.
Satellite instability (MSI-H) colorectal cancer, gastric cancer, and advanced solid tumors with defective mismatch repair function (dMMR)
.
Yuheng Bio/WuXi Biologics Sepalizumab injection was also approved for marketing in August for the treatment of relapsed or refractory classic Hodgkin's lymphoma above second-line
.
Sepalizumab injection has also become the sixth domestic PD-1 monoclonal antibody approved by NMPA
.
As of now, China has 10 PD-(L)1 products on the market, including 6 domestic products, as well as imported AstraZeneca’s duvalizumab, Roche’s atelizumab, and BMS’s navolu.
Euumab, Merck’s pembrolizumab
.
In addition, there is a batch of PD-(L)1 waiting in line for approval, and competition on the track is becoming increasingly fierce
.
Under the background that new products have been approved for listing, how to commercialize enterprises has become a major challenge
.
It is understood that since the approval of Sepalizumab injection, the industry has pointed out that at present, including Mingde Biological, American biopharmaceutical company Arcus Biosciences, and Gilead, will promote the future global commercialization of the drug, and more Cancer clinical trials are underway
.
Therefore, domestic pharmaceutical companies that want to seize market share in the market may have a very short time for commercialization
.
Of course, it can be seen that many pharmaceutical companies have already prepared more detailed "strategies".
For example, Corning Jerry, Sidi Medicine, and Simcere Pharmaceutical Co.
, Ltd.
have already provided envolimab injection (KN035) as early as March 2020.
) Reached a strategic cooperation.
Corning Jereh was responsible for production and quality as the original researcher, Sidi Medicine was responsible for the clinical development of the oncology field, and Simcere was responsible for the exclusive commercial promotion of the product in mainland China
.
It is reported that in the first ten days of November, Corning Jerry also authorized KN035 to treat all viral diseases including hepatitis B with exclusive global rights for the development and commercialization of KN035
.
As a consideration, Corning Jereh will be entitled to receive development, registration and commercialization milestone payments and a gradient sales share of approximately 15% to approximately 20% from Golly Pharmaceuticals
.
As the sixth domestic monoclonal antibody to be marketed, the industry pointed out that the road to commercialization of Sepalizumab may be challenging
.
In October of this year, the price of sepalizumab was released: the retail price of 120mg (4ml)/bottle was 3,300 yuan, which is the "floor price" in the domestic PD-1 price
.
The industry believes that national medical insurance is the main medical payer.
This year’s medical insurance catalogue adjustments set the entry line to June 30, 2021.
Sepalizumab therefore missed the opportunity and missed this year’s national medical insurance negotiations and competed in the market.
Under the fierce background, the future commercialization of this product may be difficult
.
At the same time, with the accelerated review of new drugs, innovative results have emerged one after another, including the approval of a variety of PD-1 monoclonal antibody indications and two new models during the year.
domestic PD-1 on the market and so on
.
The industry pointed out that the competition among pharmaceutical companies has moved from the R&D stage to the commercialization stage, and a new race will begin
.
At present, innovative drugs are entering the harvest period.
Among them, monoclonal antibody varieties continue to usher in new harvests as domestic pharmaceutical companies are deploying one after another
.
Previously, there were a total of four domestically approved monoclonal antibodies, including Junshi Bio-Treplimumab, Xinda Bio-Sintilizumab, Hengrui Medicine Karelizumab, BeiGene Tilelizumab Monoclonal antibody
.
In the first half of 2021, new indications for tislelizumab and sintilizumab have been approved
.
In August of this year, the recombinant humanized PD-L1 monoclonal antibody Envolimab injection, which was jointly cooperated by Corning Jerry/Sincere Pharmaceuticals/Side Pharmaceuticals, was approved for marketing.
The indication is that the previous standard treatment has failed.
Satellite instability (MSI-H) colorectal cancer, gastric cancer, and advanced solid tumors with defective mismatch repair function (dMMR)
.
Yuheng Bio/WuXi Biologics Sepalizumab injection was also approved for marketing in August for the treatment of relapsed or refractory classic Hodgkin's lymphoma above second-line
.
Sepalizumab injection has also become the sixth domestic PD-1 monoclonal antibody approved by NMPA
.
As of now, China has 10 PD-(L)1 products on the market, including 6 domestic products, as well as imported AstraZeneca’s duvalizumab, Roche’s atelizumab, and BMS’s navolu.
Euumab, Merck’s pembrolizumab
.
In addition, there is a batch of PD-(L)1 waiting in line for approval, and competition on the track is becoming increasingly fierce
.
Under the background that new products have been approved for listing, how to commercialize enterprises has become a major challenge
.
It is understood that since the approval of Sepalizumab injection, the industry has pointed out that at present, including Mingde Biological, American biopharmaceutical company Arcus Biosciences, and Gilead, will promote the future global commercialization of the drug, and more Cancer clinical trials are underway
.
Therefore, domestic pharmaceutical companies that want to seize market share in the market may have a very short time for commercialization
.
Of course, it can be seen that many pharmaceutical companies have already prepared more detailed "strategies".
For example, Corning Jerry, Sidi Medicine, and Simcere Pharmaceutical Co.
, Ltd.
have already provided envolimab injection (KN035) as early as March 2020.
) Reached a strategic cooperation.
Corning Jereh was responsible for production and quality as the original researcher, Sidi Medicine was responsible for the clinical development of the oncology field, and Simcere was responsible for the exclusive commercial promotion of the product in mainland China
.
It is reported that in the first ten days of November, Corning Jerry also authorized KN035 to treat all viral diseases including hepatitis B with exclusive global rights for the development and commercialization of KN035
.
As a consideration, Corning Jereh will be entitled to receive development, registration and commercialization milestone payments and a gradient sales share of approximately 15% to approximately 20% from Golly Pharmaceuticals
.
As the sixth domestic monoclonal antibody to be marketed, the industry pointed out that the road to commercialization of Sepalizumab may be challenging
.
In October of this year, the price of sepalizumab was released: the retail price of 120mg (4ml)/bottle was 3,300 yuan, which is the "floor price" in the domestic PD-1 price
.
The industry believes that national medical insurance is the main medical payer.
This year’s medical insurance catalogue adjustments set the entry line to June 30, 2021.
Sepalizumab therefore missed the opportunity and missed this year’s national medical insurance negotiations and competed in the market.
Under the fierce background, the future commercialization of this product may be difficult
.
