The FDA's breakthrough therapy has determined that the listing of Regency BioTerripri single resistance in the United States will significantly speed up.

Recently, the local company Junshi Bio's independent research and development of anti-PD-1 monoanti-terripri monoanti-anti-announcement exciting good news: the U.S. Food and Drug Administration (FDA) approved the "breakthrough therapy" for the treatment of Terripri mono-anti-nasopharyngeal cancer.
this is China's domestic listed and in the study of anti-PD-1 single resistance, the first FDA breakthrough therapy identified products, to achieve a breakthrough in domestic PD-1 zero.
This year, Tripply monoantigen has obtained three FDA "orphan drug" qualifications in the fields of mucosal melanoma, nasopharyngeal cancer, and soft tissue sarcoma, plus this breakthrough therapy recognition, which means that Tripply monoantigen in the United States clinical research and approval of the market progress will be greatly accelerated.
The fastest "green channel" FDA's "breakthrough therapy" was identified primarily for drugs that treat serious or life-threatening diseases and that have shown significant advantages over existing therapies in early studies, and to get them to market as quickly as possible by accelerating their time to market.
The U.S. is one of the most scrutinyed drugs in the world, and the FDA's new drug market is a long process, often taking more than a decade from laboratory results to a real shelf.
, however, there are ways for some special effects drugs to speed up approval.
the FDA has given four "green channels": Fast Track, Accelerated Approval, Priority Review and Breakthrough Therapy.
four "green channels", "breakthrough therapy" identified as the fastest way for drugs to be marketed in the United States.
FDA said in its official note that access to breakthrough therapies will enjoy all the conveniences of "fast track" and will be guided by the FDA's focus starting with Phase I clinical practice.
fast-track mechanism itself contains "priority approval" and "accelerated approval".
as long as the relevant standards are met, once the drug is included in the "fast track" approval, it has the right to speed up the approval and priority approval.
, access to "breakthrough therapy" is granted all fda policy facilities for accelerated drug reviews.
is undoubtedly the most anticipated policy for a new drug and the FDA's most difficult qualification.
the FDA's first "breakthrough therapy" in 2012, 173 drugs have qualified for this qualification in eight years, the vast majority of which are from foreign pharmaceutical giants.
chinese companies have been identified as breakthrough therapies.
U.S. expects China-made anti-PD-1 single-resistance "breakthrough therapy" to determine the extent to which new drugs can be accelerated in the U.S. market? A new drug after the "breakthrough therapy" identified, generally in the phase II clinical stage to obtain preliminary clinical evidence, you can submit a listing application, the listing application can be submitted 6 to 10 months after approval.
, the FDA will be more active in communicating with companies during the application period, guiding them in research and development programs, clinical trial design, and so on, so that companies take fewer detours.
is a big attraction for pharmaceutical companies, especially since China's self-developed new drugs can enter the U.S. market through this channel, but also a recognition of the strength of corporate research and development.
, however, expecting China-made anti-PD-1 single-resistance to shorten the time-to-market and enter the U.S. market as soon as possible does not seem to be a real creature, but more like the objective needs of the U.S. side.
, six PD-1/PD-L1 inhibitors are currently on the market in the United States, but at high prices.
K medicine, for example, the 100mg/4ml size sells for about $10,000.
prices for several other PD-1 drugs are similar.
's Trepley Single Resistance (240mg/6ml) sells for 7,200 yuan in China, which clearly has a huge price advantage over the existing PD-1 products listed in the United States.
richard Pazdur, director of the FDA's Center of Excellence in Oncology, said at the 2019 annual meeting of the American Association for Cancer Research that Chinese pharmaceutical companies are welcome to bring high-quality and low-cost PD-1/PD-L1 inhibitors to the U.S. market.
many domestic enterprises are actively responding to this call.
January 9, 2018, Regency Bio obtained FDA approval to conduct clinical trials of Ripley monoantigens in the United States.
POLARIS-02 Phase II clinical study published at this year's ANNUAL MEETING of ASCO, Thetripri single anti-treatment of patients with advanced nasopharyngeal cancer achieved good results.
study included 190 patients with resusctic/metastatic nasopharyngeal cancer, of whom 20.5% had objective remission (ORR), 41.6% had disease control (DCR), the medium duration of remission (DOR) was 12.8 months, and the total survival of OS was 17.4 months, with significant survival benefits.
According to the 2020 Semi-Annual Report published by Regency Bio, the Phase III International Multi-Center Clinical Study JUPITER-02 study of the first-line treatment plan for patients with Trryply's single-anti-combination chemotherapy treatment of relapsed or metastatic nasopharyngeal cancer has also been completed.
FDA awarded Terripri single anti-"breakthrough therapy" recognition, no doubt for the domestic excellent anti-PD-1 single anti-resistance products to the global market opened a door.
fact, not only in the PD-1/PD-L1 field, the FDA breakthrough therapy of Ripley monoantigen is also the first in the field of large molecule antibody drugs in China.
From January 2019, the FDA breakthrough therapy for the first time spent local small molecule innovation drugs, so far less than two years, China's large molecule antibodies, CAR-T cell therapy field to achieve a "0" breakthrough, and constantly prove to the world the innovative power of Chinese medicine.
we look forward to the future more and more local innovative drugs out of the country, in order to serve patients on the broader international stage.
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