The first in China! Junshi Bio-Anti-PD-1 Therapy Ripley Monoanti (Toyi ®) has been recognized by the FDA Breakthrough Therapy: Treatment of Nasopharyngeal Cancer!

12, 2020 /PRY/ -- TopAlliance Biosciences has announced that the U.S. Food and Drug Administration (FDA) has awarded its self-developed anti-PD-1 monoantigen (Toripalimab®) breakthrough therapy for nasopharyngeal cancer (BTD).
will significantly support and accelerate Theprint's commercial development program in the United States.
It's worth noting that Ripley monoantigen is the first home-grown anti-PD-1 monoantigen to be recognized by the FDA's breakthrough therapy, another important regulatory milestone following the FDA's fda-granted orphan drug eligibility for Terripley monotherapy nasopharyngeal cancer in May 2020.
, Therapuri's monoantigeno-anti-acetinine treatment for mucosal melanoma was also approved by the FDA as an orphan drug.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases and to have preliminary clinical evidence that they can substantially improve the condition compared to existing treatments.
access to BTD drugs, and closer guidance, including from senior FDA officials, in the development process to ensure that new treatment options are available to patients in the shortest possible time.
In China, in April 2020, Junshi Bio's application to the State Drug Administration (NMPA) for the listing of a new adaptation of Ripley monoantigen for the treatment of relapsed and metastatic nasopharyngeal cancer that had previously failed to receive second-line and above system treatment was accepted and was included in the priority review process by NMPA in July.
is also the world's first anti-PD-1 single anti-treatment relapse/metastatic nasopharyngeal cancer new drug application.
addition, the JuPITER-02 study (NCT03581786) of phase 3 clinical studies (NCT03581786) of the first-line treatment plan for patients with relapsed or metastatic nasopharyngeal cancer was completed.
nasopharyngeal cancer (Photo: Baidu Encyclodedia) Nasopharyngeal cancer is a malignant tumor that occurs in the epithelitis of the mucous membranes of the nasopharyngeal system, mostly in the top and side walls of the nasopharyngeal, especially the pharynx.
2018, there will be 129,000 new cases worldwide.
In China, nasopharyngeal cancer is one of the most common malignant tumors, the incidence of nasopharyngeal cancer in groups Chinese is significantly higher than the world average, and there is a clear regional high incidence, of which the annual incidence of nasopharyngeal cancer in Guangdong is (20-40) / 100,000.
Early nasopharyngeal cancer patients treated well, 90% can be cured or long-term tumor-free survival, but early nasopharyngeal cancer lacks specific clinical symptoms, clinical diagnosis of about 80% of patients have mostly entered the middle and late stage, lymph node metastasis or distant metastasis.
a distant shift, the five-year survival rate is less than 50 per cent.
, more than 10 PD-(L)1 therapies have been approved worldwide, eight of which have been approved in China.
's Ripley monoantigen (Toyi) was approved for sale by NMPA in December 2018, becoming china's first self-developed PD-1 monoantigen, a drug adaptive to the treatment of non-excisive or metastasis melanoma that has failed to receive systemic treatment in the past.
May 2020, a new adaptation application for the treatment of patients with local progressive or metastatic urethrial skin cancer (UC) who had been treated in the past was accepted by NMPA.
has been clinically developed since the beginning of 2016 and has conducted more than 30 clinical studies worldwide involving more than 10 adaptive disorders.
() Original source: Junshi Biosciences Receives FDA Research Therapy Designation for Toripalimab for The Treatment of Nasopharyngeal Carcinoma.