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On the innovative research and development track of PD-1, a new drug for the treatment of tumors, the competition of domestic innovative pharmaceutical companies has gradually shifted to overseas markets.
Administration) to submit a BLA (Biologics License Application) for PD-1 antibody drugs
.
On April 13, 2022, 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 U.
S.
Food and Drug Administration (FDA).
Orphan-drug Designation granted
.
This is the fifth orphan drug designation for toripalimab.
Previously, toripalimab has been granted orphan drug designation by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma and esophageal cancer
.
Currently, Junshi Biosciences is conducting a registrational clinical study for small cell lung cancer, the JUPITER-08 study (NCT04012606), and has completed the enrollment of subjects
.
JUPITER-08 is a randomized, double-blind, placebo-controlled, multicenter Phase III study evaluating toripalimab plus etoposide and platinum versus placebo plus etoposide and platinum in the first-line setting Efficacy and safety in the treatment of extensive-stage small cell lung cancer
.
Junshi Bio said that toripalimab is a domestic PD-1 that submitted a marketing application to the US FDA, and the FDA has granted toripalimab 2 breakthrough therapy designations, 1 fast track designation, and 1 priority review.
Evaluation and 5 orphan drug qualifications
.
Junshi Biotech and U.
S.
biosimilar drug company Coherus plan to submit more new-indication applications for toripalimab to the FDA in the next three years for the treatment of multiple cancers
.
The industry said that the current domestic PD-1 track competition is fierce, and many companies have set their sights on "going overseas"
.
At present, there are four domestic PD-1s that are planning to go to sea
.
In addition to the products of Junshi Bio, there are also Sintilimab under Innovent Bio, Piamprimab under Aesco Bio, and Tilelizumab under BeiGene
.
However, on March 24, Innovent announced on the Hong Kong Stock Exchange that it had received the U.
S.
Food and Drug Administration (“FDA”) decision on the use of sintilimab combined with pemetrexed and platinum-based chemotherapy for non-squamous Complete Response Letter to New Drug Application (“BLA”) for first-line treatment of patients with non-small cell lung cancer (“NSCLC”)
.
In its reply, the FDA stated that it had completed the review of the BLA, but failed to approve the application, which also meant that it failed to go overseas
.
In addition, in May 2021, Apricot Biopharmaceuticals submitted a BLA application to the U.
S.
FDA for ambrilizumab 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 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 understood that, as early as January 2021, Novartis reached a cooperation and licensing agreement with BeiGene, and Novartis obtained the development, development and licensing of tislelizumab in the United States, Canada, Mexico, the European Union, the United Kingdom, Japan and other countries.
Production and commercialization rights with a total transaction value of $2.
2 billion
.
Statistics show that up to now, 9 models of PD-1 have been approved for marketing in China, 7 of which are domestically produced
.
The total number of global clinical trials targeting PD-1 has reached 4,171, of which China has 1,224, accounting for 29.
35% of the global total
.
With the increase in the number of approved products, more indications will be included in the medical insurance negotiation in 2021, the price competition will be more intense, and the "involution" will be serious
.
With the intensification of "involution", the next round of competition for domestic PD-1 is shifting to overseas markets
.
Click to learn about zyzhan June Medicine Machine Event Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to anyone
.
Administration) to submit a BLA (Biologics License Application) for PD-1 antibody drugs
.
On April 13, 2022, 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 U.
S.
Food and Drug Administration (FDA).
Orphan-drug Designation granted
.
This is the fifth orphan drug designation for toripalimab.
Previously, toripalimab has been granted orphan drug designation by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma and esophageal cancer
.
Currently, Junshi Biosciences is conducting a registrational clinical study for small cell lung cancer, the JUPITER-08 study (NCT04012606), and has completed the enrollment of subjects
.
JUPITER-08 is a randomized, double-blind, placebo-controlled, multicenter Phase III study evaluating toripalimab plus etoposide and platinum versus placebo plus etoposide and platinum in the first-line setting Efficacy and safety in the treatment of extensive-stage small cell lung cancer
.
Junshi Bio said that toripalimab is a domestic PD-1 that submitted a marketing application to the US FDA, and the FDA has granted toripalimab 2 breakthrough therapy designations, 1 fast track designation, and 1 priority review.
Evaluation and 5 orphan drug qualifications
.
Junshi Biotech and U.
S.
biosimilar drug company Coherus plan to submit more new-indication applications for toripalimab to the FDA in the next three years for the treatment of multiple cancers
.
The industry said that the current domestic PD-1 track competition is fierce, and many companies have set their sights on "going overseas"
.
At present, there are four domestic PD-1s that are planning to go to sea
.
In addition to the products of Junshi Bio, there are also Sintilimab under Innovent Bio, Piamprimab under Aesco Bio, and Tilelizumab under BeiGene
.
However, on March 24, Innovent announced on the Hong Kong Stock Exchange that it had received the U.
S.
Food and Drug Administration (“FDA”) decision on the use of sintilimab combined with pemetrexed and platinum-based chemotherapy for non-squamous Complete Response Letter to New Drug Application (“BLA”) for first-line treatment of patients with non-small cell lung cancer (“NSCLC”)
.
In its reply, the FDA stated that it had completed the review of the BLA, but failed to approve the application, which also meant that it failed to go overseas
.
In addition, in May 2021, Apricot Biopharmaceuticals submitted a BLA application to the U.
S.
FDA for ambrilizumab 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 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 understood that, as early as January 2021, Novartis reached a cooperation and licensing agreement with BeiGene, and Novartis obtained the development, development and licensing of tislelizumab in the United States, Canada, Mexico, the European Union, the United Kingdom, Japan and other countries.
Production and commercialization rights with a total transaction value of $2.
2 billion
.
Statistics show that up to now, 9 models of PD-1 have been approved for marketing in China, 7 of which are domestically produced
.
The total number of global clinical trials targeting PD-1 has reached 4,171, of which China has 1,224, accounting for 29.
35% of the global total
.
With the increase in the number of approved products, more indications will be included in the medical insurance negotiation in 2021, the price competition will be more intense, and the "involution" will be serious
.
With the intensification of "involution", the next round of competition for domestic PD-1 is shifting to overseas markets
.
Click to learn about zyzhan June Medicine Machine Event Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to anyone
.
