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On March 14, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration showed that Novartis' LNP023 capsules are planned to be included in the breakthrough therapy program for C3 glomerulopathy (C3G)
.
On March 1, Innovent Biopharmaceutical Group and Baoyuan Pharmaceutical jointly announced that Taletrectinib (Innovent R&D code: IBI-344, Baoyuan R&D code: AB-106) has been approved by the State Drug Administration of China.
(NMPA) Center for Drug Evaluation (CDE) included in the list of breakthrough therapy drugs, and the proposed indications are ROS1 fusion-positive non-small cell lung cancer patients who have not received ROS1 tyrosine kinase inhibitor (TKI) therapy and who have received ROS1 TKI therapy.
.
It is understood that breakthrough therapy drugs refer to drugs that are used to prevent and treat diseases that seriously affect the quality of life or are seriously life-threatening and have no effective prevention and treatment methods, or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods
.
In August 2020, this special review channel was opened to speed up the launch of innovative drugs
.
Recently, CDE released the "Working Procedures of the Center for Drug Evaluation to Accelerate the Review of Innovative Drug Marketing Applications (Trial) (Draft for Comment)" (hereinafter referred to as the "Working Procedures"), which aims to encourage the research and creation of new drugs to meet clinical drug needs, Timely summarize and transform the work experience of anti-epidemic emergency review, and speed up the review of innovative drugs
.
The industry said that with the announcement and clarification of the "Working Procedures", breakthrough therapies will usher in major benefits
.
It is reported that the policy has increased support for breakthrough therapy drugs, and they can directly go through the priority review process, which will accelerate their approval for marketing
.
The "Working Procedures" are applicable to applicants who have completed the exploratory clinical trials and have the conditions for conducting pivotal clinical trials until they are approved for marketing
.
This procedure does not require applicants to apply, and the innovative drug varieties included in the breakthrough therapy drug procedure can automatically carry out follow-up communication and review and approval according to this procedure
.
The time limit for communication is 30 days, and the time limit for variety review and priority review is 130 days
.
For example, the previous priority review arranged class I meetings for communication according to queuing sequence.
The new work procedure is based on specific varieties.
After completing the preliminary exploratory clinical trial, the applicant can submit an application for communication before and during the key clinical trial, and clearly propose Key technical issues and related supporting materials affecting drug application, submit phased research materials that meet the requirements of the registration application data format; and an expert group helps to plan clinical plans
.
In addition, pre-NDA communication has been formulated as a separate work procedure; plus a series of registration support, it has undoubtedly become a model for teachers to draw key points in advance before the exam
.
It is understood that a number of products were included in the innovative drugs intended for breakthrough therapy during the year.
For example, in addition to the aforementioned Novartis' LNP023 capsules intended to be included in the breakthrough therapy program, CDE also announced the introduction of CK-3773274 tablets and combination tablets from Keixing Pharmaceuticals.
The two products of Mavacamten Capsules of Tuobi Biotech have entered the innovative drugs that are intended to be breakthrough therapeutic varieties
.
Among them, CK-3773274 tablets are suitable for diseases with excessive myocardial contraction such as hypertrophic cardiomyopathy, and Mavacamten capsules are suitable for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
.
Breakthrough therapy drugs can directly go through the priority review process.
According to the new "Working Procedures", breakthrough therapy will usher in good news, and the spring of China's innovative drugs will also come
.
However, insiders also said that by carefully reading the document, it can be known that the scope of application of the "Working Procedures" is only for "innovative drugs included in the breakthrough treatment drug program".
If you want to take this shortcut, you need to first identify it as a breakthrough therapy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
On March 1, Innovent Biopharmaceutical Group and Baoyuan Pharmaceutical jointly announced that Taletrectinib (Innovent R&D code: IBI-344, Baoyuan R&D code: AB-106) has been approved by the State Drug Administration of China.
(NMPA) Center for Drug Evaluation (CDE) included in the list of breakthrough therapy drugs, and the proposed indications are ROS1 fusion-positive non-small cell lung cancer patients who have not received ROS1 tyrosine kinase inhibitor (TKI) therapy and who have received ROS1 TKI therapy.
.
It is understood that breakthrough therapy drugs refer to drugs that are used to prevent and treat diseases that seriously affect the quality of life or are seriously life-threatening and have no effective prevention and treatment methods, or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods
.
In August 2020, this special review channel was opened to speed up the launch of innovative drugs
.
Recently, CDE released the "Working Procedures of the Center for Drug Evaluation to Accelerate the Review of Innovative Drug Marketing Applications (Trial) (Draft for Comment)" (hereinafter referred to as the "Working Procedures"), which aims to encourage the research and creation of new drugs to meet clinical drug needs, Timely summarize and transform the work experience of anti-epidemic emergency review, and speed up the review of innovative drugs
.
The industry said that with the announcement and clarification of the "Working Procedures", breakthrough therapies will usher in major benefits
.
It is reported that the policy has increased support for breakthrough therapy drugs, and they can directly go through the priority review process, which will accelerate their approval for marketing
.
The "Working Procedures" are applicable to applicants who have completed the exploratory clinical trials and have the conditions for conducting pivotal clinical trials until they are approved for marketing
.
This procedure does not require applicants to apply, and the innovative drug varieties included in the breakthrough therapy drug procedure can automatically carry out follow-up communication and review and approval according to this procedure
.
The time limit for communication is 30 days, and the time limit for variety review and priority review is 130 days
.
For example, the previous priority review arranged class I meetings for communication according to queuing sequence.
The new work procedure is based on specific varieties.
After completing the preliminary exploratory clinical trial, the applicant can submit an application for communication before and during the key clinical trial, and clearly propose Key technical issues and related supporting materials affecting drug application, submit phased research materials that meet the requirements of the registration application data format; and an expert group helps to plan clinical plans
.
In addition, pre-NDA communication has been formulated as a separate work procedure; plus a series of registration support, it has undoubtedly become a model for teachers to draw key points in advance before the exam
.
It is understood that a number of products were included in the innovative drugs intended for breakthrough therapy during the year.
For example, in addition to the aforementioned Novartis' LNP023 capsules intended to be included in the breakthrough therapy program, CDE also announced the introduction of CK-3773274 tablets and combination tablets from Keixing Pharmaceuticals.
The two products of Mavacamten Capsules of Tuobi Biotech have entered the innovative drugs that are intended to be breakthrough therapeutic varieties
.
Among them, CK-3773274 tablets are suitable for diseases with excessive myocardial contraction such as hypertrophic cardiomyopathy, and Mavacamten capsules are suitable for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
.
Breakthrough therapy drugs can directly go through the priority review process.
According to the new "Working Procedures", breakthrough therapy will usher in good news, and the spring of China's innovative drugs will also come
.
However, insiders also said that by carefully reading the document, it can be known that the scope of application of the "Working Procedures" is only for "innovative drugs included in the breakthrough treatment drug program".
If you want to take this shortcut, you need to first identify it as a breakthrough therapy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
