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In the past, the speed of domestic drug review and approval was slow.
The review and approval time of a new drug may take 2 to 5 years, or even 8 years longer.
This makes the backlog of applications very large and severely restricts the drug’s listing process.
It also hinders the innovation and development of the pharmaceutical industry
.
In recent years, as the approval of new drugs has accelerated, which has promoted drug R&D and innovation, domestically produced innovative drugs have gradually entered the harvest stage and have moved from domestic to international
.
According to statistics, from 2015 to August 2021, 72 innovative drugs have been approved for marketing by the National Food and Drug Administration, and 4 of them are China-US double-reported
.
It is worth mentioning that the number of innovative drugs approved for marketing has increased rapidly in recent years.
Since 2021, the number of innovative drugs approved for marketing by the National Medical Products Administration has reached 25, surpassing the total number of last year
.
In addition, the number of domestically produced varieties from domestic to international is also increasing
.
It is reported that since 2021, at least 4 innovative drugs (new indications) developed or co-developed by domestic pharmaceutical companies have submitted marketing applications in the United States, including Cinda Bio’s Sintilimab and Wanchun Pharmaceutical’s Purna Brin E5 medicine Ryzneuta, as well as the real king of Terry Plymouth monoclonal antibody and other biological
.
On May 18, 2021, Cinda Bio announced that Sintilimab, jointly developed by the company and Eli Lilly, has been formally accepted by the U.
S.
FDA.
The indication for this application is the combination of pemetrexed and platinum.
Class is used for the first-line treatment of non-squamous NSCLC
.
It is reported that this is also Sintilimab's first new drug listing application in the United States
.
In China, Sintilimab has been approved for two indications, including: for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line chemotherapy, combined with pemetrexed and platinum-based chemotherapy For the first-line treatment of EGFR or ALK-negative advanced non-squamous NSCLC, three other marketing applications have been accepted and reviewed by the China National Medical Products Administration (NMPA)
.
In April 2021, Wanchun Pharmaceutical announced that its pranabulin has submitted a new drug application for CIN to CDE and FDA
.
This is also the first innovative drug to submit a new drug marketing application since the establishment of Wanchun Pharmaceutical
.
According to the data, the indication for this application is for severe neutropenia (CIN) caused by chemotherapy
.
Pranabrin is currently in the priority review (Priority revivew) stage, and the FDA will complete the review before November 30, 2021
.
In China, on May 12, 2021, Pranabrin was included in the proposed priority review, and the indication is "combined application with PEGylated recombinant human granulocyte stimulating factor, which is suitable for chemotherapy in adult patients with non-myeloid malignant tumors.
" Caused by neutropenia
.
” In addition, in August 2021, Hengrui Pharmaceuticals signed a strategic cooperation agreement with Dalian Wanchun, a subsidiary of Wanchun Pharmaceuticals, and Hengrui Pharmaceuticals obtained the joint development rights of Pranabrin in Greater China.
And exclusive commercialization rights
.
In March 2021, Efan Pharmaceuticals announced that its controlled subsidiary Yiyi Biologics has submitted a Biological Products License (BLA) application (BLA) for Ryzneuta to the FDA for the treatment of chemotherapy-induced neutropenia
.
It is understood that Ryzneuta's global development plan covers 10 clinical trials.
So far, more than 1,200 patients have been recruited in many countries and regions including the United States, the European Union, Australia and China.
All trials have reached all major and secondary trials.
To the end
.
In March 2021, Junshi Biotech announced that it had submitted a rolling application to the FDA for the approval of a biological product of Teriplizumab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)
.
This is the first domestic anti-PD-1 monoclonal antibody to submit a marketing application to the US FDA
.
On September 1, Junshi Bio announced that it has completed a rolling submission to the US FDA regarding teriprizumab combined with gemcitabine/cisplatin as the first-line treatment and monotherapy for patients with advanced recurrence or metastatic nasopharyngeal carcinoma and single agent for recurrence or metastasis BLA for second-line and above treatment after platinum-containing chemotherapy for sexual nasopharyngeal carcinoma
.
It is understood that in February 2021, Junshi Biotech has reached a cooperation with Coherus on the development and commercialization of teriprizumab in the United States and Canada, and Coherus is responsible for all commercial activities in the United States and Canada.
.
According to the company's plan, it will actively promote the commercialization of tereprizumab in China, the United States and other countries to benefit more patients with nasopharyngeal cancer
.
The review and approval time of a new drug may take 2 to 5 years, or even 8 years longer.
This makes the backlog of applications very large and severely restricts the drug’s listing process.
It also hinders the innovation and development of the pharmaceutical industry
.
In recent years, as the approval of new drugs has accelerated, which has promoted drug R&D and innovation, domestically produced innovative drugs have gradually entered the harvest stage and have moved from domestic to international
.
According to statistics, from 2015 to August 2021, 72 innovative drugs have been approved for marketing by the National Food and Drug Administration, and 4 of them are China-US double-reported
.
It is worth mentioning that the number of innovative drugs approved for marketing has increased rapidly in recent years.
Since 2021, the number of innovative drugs approved for marketing by the National Medical Products Administration has reached 25, surpassing the total number of last year
.
In addition, the number of domestically produced varieties from domestic to international is also increasing
.
It is reported that since 2021, at least 4 innovative drugs (new indications) developed or co-developed by domestic pharmaceutical companies have submitted marketing applications in the United States, including Cinda Bio’s Sintilimab and Wanchun Pharmaceutical’s Purna Brin E5 medicine Ryzneuta, as well as the real king of Terry Plymouth monoclonal antibody and other biological
.
On May 18, 2021, Cinda Bio announced that Sintilimab, jointly developed by the company and Eli Lilly, has been formally accepted by the U.
S.
FDA.
The indication for this application is the combination of pemetrexed and platinum.
Class is used for the first-line treatment of non-squamous NSCLC
.
It is reported that this is also Sintilimab's first new drug listing application in the United States
.
In China, Sintilimab has been approved for two indications, including: for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line chemotherapy, combined with pemetrexed and platinum-based chemotherapy For the first-line treatment of EGFR or ALK-negative advanced non-squamous NSCLC, three other marketing applications have been accepted and reviewed by the China National Medical Products Administration (NMPA)
.
In April 2021, Wanchun Pharmaceutical announced that its pranabulin has submitted a new drug application for CIN to CDE and FDA
.
This is also the first innovative drug to submit a new drug marketing application since the establishment of Wanchun Pharmaceutical
.
According to the data, the indication for this application is for severe neutropenia (CIN) caused by chemotherapy
.
Pranabrin is currently in the priority review (Priority revivew) stage, and the FDA will complete the review before November 30, 2021
.
In China, on May 12, 2021, Pranabrin was included in the proposed priority review, and the indication is "combined application with PEGylated recombinant human granulocyte stimulating factor, which is suitable for chemotherapy in adult patients with non-myeloid malignant tumors.
" Caused by neutropenia
.
” In addition, in August 2021, Hengrui Pharmaceuticals signed a strategic cooperation agreement with Dalian Wanchun, a subsidiary of Wanchun Pharmaceuticals, and Hengrui Pharmaceuticals obtained the joint development rights of Pranabrin in Greater China.
And exclusive commercialization rights
.
In March 2021, Efan Pharmaceuticals announced that its controlled subsidiary Yiyi Biologics has submitted a Biological Products License (BLA) application (BLA) for Ryzneuta to the FDA for the treatment of chemotherapy-induced neutropenia
.
It is understood that Ryzneuta's global development plan covers 10 clinical trials.
So far, more than 1,200 patients have been recruited in many countries and regions including the United States, the European Union, Australia and China.
All trials have reached all major and secondary trials.
To the end
.
In March 2021, Junshi Biotech announced that it had submitted a rolling application to the FDA for the approval of a biological product of Teriplizumab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)
.
This is the first domestic anti-PD-1 monoclonal antibody to submit a marketing application to the US FDA
.
On September 1, Junshi Bio announced that it has completed a rolling submission to the US FDA regarding teriprizumab combined with gemcitabine/cisplatin as the first-line treatment and monotherapy for patients with advanced recurrence or metastatic nasopharyngeal carcinoma and single agent for recurrence or metastasis BLA for second-line and above treatment after platinum-containing chemotherapy for sexual nasopharyngeal carcinoma
.
It is understood that in February 2021, Junshi Biotech has reached a cooperation with Coherus on the development and commercialization of teriprizumab in the United States and Canada, and Coherus is responsible for all commercial activities in the United States and Canada.
.
According to the company's plan, it will actively promote the commercialization of tereprizumab in China, the United States and other countries to benefit more patients with nasopharyngeal cancer
.
