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[Pharmaceutical Network Market Analysis] In the innovative research and development track of PD-1, a new drug for the treatment of tumors, the domestic PD-1 market competition has become increasingly fierce
.
According to the research report of Essence Securities, it is expected that by the end of 2022, 16 PD-1/PD-L1 monoclonal antibodies and 1 PD-1/CTLA-4 double antibody will be launched in China, of which domestic PD-1/PD-1/PD -L1 has a total of 13 models (including double antibodies)
.
With the continuous development and launch of PD-1 products, the market is constantly facing more and more challenges for domestic innovative pharmaceutical companies
.
Among them, the continuous reduction of prices has increasingly become the primary problem faced by innovative pharmaceutical companies
.
It is reported that after the implementation of the new version of the medical insurance catalogue this year, the medical insurance price of domestic PD-1 has been reduced again
.
For example, Sintilimab (10ml:100mg) under Innovent Bio has been reduced from 2843 yuan/bottle to 1080 yuan/bottle, a decrease of 62%; Junshi Bio’s Toripalimab (2ml:80mg) has been reduced from 906.
08 Yuan/branch was reduced to 825.
00 yuan/bar, another specification (6ml: 240mg) was reduced from 2100.
97 yuan/bar to 1912.
96 yuan/bar; BeiGene's Tislelizumab (10ml: 100mg) was reduced from 2180 yuan/bar It was reduced to 1450 yuan/piece, a price reduction of 33%
.
It should be noted that the decline in the price of PD-1 products has begun to affect the performance of domestic innovative pharmaceutical companies
.
According to the 2021 financial report, the sales of Junshi Bio’s toripalimab in 2021 will be 412 million yuan, down nearly 60% year-on-year
.
In addition, other businesses have seen some volatility
.
In this context, in order to avoid homogenization and low-price competition and obtain more development opportunities, domestic innovative pharmaceutical companies have begun to set their sights on overseas markets
.
At present, a large number of enterprises are applying for listing related products in overseas markets one after another
.
It is understood that as early as 2021, Innovent Bio, Junshi Bio, Kangfang Bio, and BeiGene have successively submitted BLA (biological product license application) for PD-1 antibody drugs to the FDA (US Food and Drug Administration).
.
For example, in May 2021, Apricot Biopharmaceuticals submitted a BLA application to the U.
S.
FDA for the third-line treatment of metastatic nasopharyngeal carcinoma
.
According to the data, pembrolizumab is China's PD-1 drug for BLA under the FDA's RTOR (Real-Time Oncology Review) project
.
In September 2021, the U.
S.
FDA also accepted BeiGene’s New Drug Application (BLA) for tislelizumab for the treatment of unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy (ESCC) patients
.
The PDUFA target date is July 12, 2022
.
It is worth noting that on April 13 this year, Junshi Bio announced that toripalimab, an anti-PD-1 monoclonal antibody independently developed by the company for the treatment of small cell lung cancer (SCLC), has been approved by the US Food and Drug Administration.
orphan drug designation granted by the FDA
.
The industry believes that this means that Junshi Bio's PD-1 products are expected to stand out among the many domestic PD-1 manufacturers queuing to go overseas
.
However, it should be noted that some industry insiders have revealed that overseas markets have realized the serious problem of homogenization and competition of PD-1 products
.
At the same time, the entry of domestic PD-1 into overseas markets cannot meet the needs of supplementing new indications, nor can it reduce the cost of medication for patients
.
Therefore, in the future, if domestic PD-1 wants to go overseas, enterprises may spend more time, energy and investment
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to the research report of Essence Securities, it is expected that by the end of 2022, 16 PD-1/PD-L1 monoclonal antibodies and 1 PD-1/CTLA-4 double antibody will be launched in China, of which domestic PD-1/PD-1/PD -L1 has a total of 13 models (including double antibodies)
.
With the continuous development and launch of PD-1 products, the market is constantly facing more and more challenges for domestic innovative pharmaceutical companies
.
Among them, the continuous reduction of prices has increasingly become the primary problem faced by innovative pharmaceutical companies
.
It is reported that after the implementation of the new version of the medical insurance catalogue this year, the medical insurance price of domestic PD-1 has been reduced again
.
For example, Sintilimab (10ml:100mg) under Innovent Bio has been reduced from 2843 yuan/bottle to 1080 yuan/bottle, a decrease of 62%; Junshi Bio’s Toripalimab (2ml:80mg) has been reduced from 906.
08 Yuan/branch was reduced to 825.
00 yuan/bar, another specification (6ml: 240mg) was reduced from 2100.
97 yuan/bar to 1912.
96 yuan/bar; BeiGene's Tislelizumab (10ml: 100mg) was reduced from 2180 yuan/bar It was reduced to 1450 yuan/piece, a price reduction of 33%
.
It should be noted that the decline in the price of PD-1 products has begun to affect the performance of domestic innovative pharmaceutical companies
.
According to the 2021 financial report, the sales of Junshi Bio’s toripalimab in 2021 will be 412 million yuan, down nearly 60% year-on-year
.
In addition, other businesses have seen some volatility
.
In this context, in order to avoid homogenization and low-price competition and obtain more development opportunities, domestic innovative pharmaceutical companies have begun to set their sights on overseas markets
.
At present, a large number of enterprises are applying for listing related products in overseas markets one after another
.
It is understood that as early as 2021, Innovent Bio, Junshi Bio, Kangfang Bio, and BeiGene have successively submitted BLA (biological product license application) for PD-1 antibody drugs to the FDA (US Food and Drug Administration).
.
For example, in May 2021, Apricot Biopharmaceuticals submitted a BLA application to the U.
S.
FDA for the third-line treatment of metastatic nasopharyngeal carcinoma
.
According to the data, pembrolizumab is China's PD-1 drug for BLA under the FDA's RTOR (Real-Time Oncology Review) project
.
In September 2021, the U.
S.
FDA also accepted BeiGene’s New Drug Application (BLA) for tislelizumab for the treatment of unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy (ESCC) patients
.
The PDUFA target date is July 12, 2022
.
It is worth noting that on April 13 this year, Junshi Bio announced that toripalimab, an anti-PD-1 monoclonal antibody independently developed by the company for the treatment of small cell lung cancer (SCLC), has been approved by the US Food and Drug Administration.
orphan drug designation granted by the FDA
.
The industry believes that this means that Junshi Bio's PD-1 products are expected to stand out among the many domestic PD-1 manufacturers queuing to go overseas
.
However, it should be noted that some industry insiders have revealed that overseas markets have realized the serious problem of homogenization and competition of PD-1 products
.
At the same time, the entry of domestic PD-1 into overseas markets cannot meet the needs of supplementing new indications, nor can it reduce the cost of medication for patients
.
Therefore, in the future, if domestic PD-1 wants to go overseas, enterprises may spend more time, energy and investment
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
