Domestic innovative drugs ushered in a bright moment! CAR-T therapy is proposed to be included in the list of breakthrough therapeutic drugs.

On August 5th, the National Drug Administration(NMPA) Drug Review Center (CDE) announced that cilta-cel, LCAR-B38MCAR-T cell self-re-transfusion agent, a new class of biologics owned by Legendary Biologics, is expected to be included in the list of breakthrough therapeutic drugs, and that China's first "breakthrough therapy" is expected to cost legendary organisms.
This is the first time that the "Breakthrough Treatment Publicity" column has been published since the National Drug Administration recently released the Breakthrough Treatment Drug Review Procedure (Trial) document, which also means that this special review channel has been officially launched in China.
"Breakthrough Treatment Publicity" column for the first time announced this inclusion of the list is not only of great significance to legendary organisms, this is also the CDE "Breakthrough Treatment Publicity" column of the first update, in China's drug regulatory process has important historical significance.
breakthrough therapeutic drugs are drugs used to prevent and treat diseases that seriously affect quality of life or are seriously life-threatening and have no effective means of prevention, or that have sufficient evidence to show a clear clinical advantage over existing treatments.
November 2019, CDE issued a notice for comments on the Breakthrough Therapeutic Drug Work Procedure and the Priority Review Approval Process.
senior industry expert Liu Mingrui said that the opening of the two drafts, both clearly issued the program is to encourage research and creation of new drugs, speed up the drug research and development process with obvious clinical advantages and registration and listing, reflecting the state to encourage innovation and meet clinical needs, early intervention in communication, guide new drug developers, between enterprises and the government to build a bridge to promote clinical value of innovative drugs to market as soon as possible to serve the vast number of patients desire and determination.
china's breakthrough therapies will be an important label for the future, representing china's level of innovation," a source in charge of the country's legendary biology told the health community.
breakthrough therapy in China is to further accelerate the process of marketing drugs with clinical advantages in China and further meet the clinical treatment needs of major diseases in China.
, the State Drug Administration launched the Breakthrough Drug Procedure Application System and the new version of the Priority Review and Approval Application System on July 9 this year, opening an electronic submission channel.
the first publicity of this "Breakthrough Treatment Announcement" column, which also means that this special review channel was officially launched in China today.
In addition to the approved Legendary Bio's Class 1 new drug, Sidakiolensa, the breakthrough drug MAX-40279 for the treatment of FRT3 wild acute myeloid leukemia (AML) and the breakthrough treatment of PD-L1 monoantigenic ZKAB001 cervical cancer adaptive therapy are to be filed.
new model to stimulate domestic innovative pharmaceutical companies it is worth mentioning that LCAR-B38M (JNJ-4528) is a car-T therapy developed by Legendary Biology that targets B-cell mature antigens (BCMA).
the product was approved by the FDA in December 2019 for the treatment of patients with multiple myeloma (MM).
FDA is the world's first official drug regulator to conduct breakthrough therapies.
according to FDA regulations, two conditions can be considered breakthrough therapeutic drugs: first, adaptation is considered life-threatening or serious disease, and second, there is evidence that a significant clinical endpoint is significantly superior to existing drugs.
Jinxi, associate dean of the International Medical Business School at China Pharmaceutical University, said china's breakthrough therapy recognition model is also modeled on FDA rules because of the earlier and more mature system for the special review of new drugs in the United States.
fda determines that breakthrough therapy approval requires more evidence of effectiveness than other traditional rapid development programs, but in return, applicants receive more substantial FDA involvement and support during the clinical development phase.
i.e., once identified as a breakthrough therapy, the drug in progress will receive in-depth guidance from the FDA (the Effective Drug Development Program), an organizational commitment to accelerate FDA development and review, and potential eligibility for rolling new drug applications and listing applications for priority review based on supportive clinical data.
model has been used for reference by the State Drug Administration.
documents issued by china's Drug Administration, it is now clear that applicants can apply for breakthrough treatment drug procedures at the stage of Phase 1 and Phase 2 clinical trials, usually no later than Phase 3 clinical trials.
Drug Review Center communicates and prioritizes resources for drugs included in breakthrough therapeutic drug programs, strengthens guidance and promotes drug development.
application for communication with the Drug E. Research Center after the applicant is ready for work.
Communication during drug clinical trials includes first communication, meetings due to major safety/major technical issues, meetings on key phases of drug clinical trials, and general technical consultations, which are given priority by the IDRIC.
that is, from the phase I clinical trial phase, the NMPA will receive efficient and robust guidance and, when submitting an application for drug marketing, a priority review approval process will be included.
but Ding Jinxi also believes that even if the United States technical standards are increasingly consistent, but in terms of quantity, China's drug regulatory agencies and the FDA gap is also obvious.
nearly a year after the relevant documents were officially issued, the first varieties in China were identified, and only two varieties were to be declared.
, the FDA has approved 11 varieties in the same period since it began implementing breakthrough therapies in 2013, far higher than in China.
, Ding Jinxi believes that this is related to the innovative strength of China's pharmaceutical industry.
" a big reason is that the overall innovation ability of China's pharmaceutical enterprises compared with developed countries is still relatively weak, which also leads to china's breakthrough therapy identified products are not many, but compared with the introduction of breakthrough therapy model, but also to the domestic innovative pharmaceutical companies a great incentive, the future through the identification of the relevant varieties will certainly be more and more.
," Mr Ding said.
new policies introduced by the State Drug Administration, including the implementation of breakthrough therapy, will strongly promote the further development of China's innovative pharmaceutical companies, according to Ding Jinxi, who is once again being courted by hot money.
the above points are confirmed in a little bit.
As early as August 2015, the state launched a new round of drug registration system innovation, aimed at speeding up review and approval, improve the review and approval scale, improve clinical trial approval, and has introduced the listing license holder system pilot and other policies.
In fact, in addition to the Priority Review Approval Procedure (Draft for Comments) issued by the State Drug Administration in November 2019, the newly revised Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production were also formally implemented on 1 July this year.
The new policy, while fully implementing the system of drug listing license holders and clarifying the subject and corresponding responsibilities of drug listing license, emphasizes optimizing the review and approval workflow, clarifying the time limit for review, and improving the efficiency of drug registration.
the three pilot documents, the specific scope and conditions of application of the four special approval channels have been more clearly elaborated.
For example, the document defines the conditions for priority review and approval, including innovative and improved new drugs, as well as the time frame for review and approval, such as 70 days for clinically urgently needed and overseas-listed rare disease drugs, and administrative approval decisions should be made within 10 days for the inclusion of 'green channel' drugs.
'multi-pronged' special approval channels for these columns, the greatest benefit is to increase the speed and efficiency of the development and approval of innovative drugs.
the relevant person in charge of pharmaceutical companies told the health community: 'For the development of new drugs, the previous must be reviewed step by step, can now be synchronized in all aspects of the trial.
' policy support document, the new drug market path will become more simplified, domestic innovative enterprises have been encouraged, so they began to invest in research and development.
sensitive capital quickly smelled the moment, and hot money poured in to invest in innovative biotech companies.
capital inflows have also led to the rapid growth of innovative drugs and pharmaceutical companies.
is now listed in Hong Kong, the code with the "B" suffix of pharmaceutical companies, mostly around 2014 set up, one after another to get multiple rounds of financing, the final listing;
cancer drugs, which are the focus and focus of research and development of these innovative drug companies.
, a professor at the National Health Service, told the health community.
" policy will also allow investors to see opportunities to make money in the field of innovative drugs, thereby putting a lot of money into the industry, pharmaceutical companies will be able to further produce results, thus forming a virtuous circle.
" but Liu Mingrui also stressed that although the policy and market environment is constantly getting better, for innovative pharmaceutical companies, new drug research and development has a high investment, high risk and long cycle characteristics, a new drug from the beginning of research and development to be approved for the market, after 10 to 15 years is a normal time, the cost is also very large, how to weigh the future of early investment and late returns, but also China's innovative drug companies must face challenges.
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