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Pharmaceutical Network February 20, the first domestic PD-1, and then approved new adaptive domestic PD-1 and then approved new adaptive diseases February 19, the State Drug Administration issued an announcement, by Junshi Biological research and development of PD-1 Ripley single anti (to benefit) new adaptive disorders approved.
, it is understood that the approved adaptive disorder is a patient with relapsed/metastatic nasopharyngeal cancer who has previously received failed treatment on the second-line and above systems.
Addition, according to a statement released today by Junshi Bio, a new indication of the use of Ripley monoantiviral chemotherapy for relapsed metastatic nasopharyngeal cancer in advanced first-line non-systematic treatment has been accepted.
Ripley single resistance is the first domestic anti-PD-1 single resistance listed in China, the first approved adaptive disease for melanoma.
approved this time as the second adaptive disorder, the new adaptive drug listing application in July 2020 by the State Drug Administration into the priority review process.
, nasopharyngeal cancer is one of the most common head and neck malignancies.
, according to the World Health Organization, the number of new cases of nasopharyngeal cancer diagnosed worldwide by 2020 has reached 133,000, with nearly half occurring in China.
the incidence of nasopharyngeal cancer in Guangdong Province is 40 times the world average, and Guangxi, Fujian, Hunan and other provinces are also the main endemic areas.
nasopharyngeal cancer has the characteristics of long-distance metastasis in the early stages of the disease, early nasopharyngeal cancer patients after receiving root treatment /chemotherapy for a period of time will still appear metastatic lesions relapse.
December 2020, Mr. Trump was included in the new health-care list after negotiations over the state's health-care plan.
approval of this new adaptation will bring good news to patients with nasopharyngeal cancer, and look forward to more adaptations in the future into the scope of health insurance reimbursement.
data show that, in addition to melanoma and nasopharyngeal cancer two therapeutic areas, Junshi Bio is also actively exploring the efficacy and safety of Ripley monotherapy for urethra cancer, lung cancer, stomach cancer, esophageal cancer, liver cancer, bile tube cancer, breast cancer, kidney cancer and other adaptive disorders.
the expansion of adaptive disorders, major pharmaceutical companies will compete for the track according to the National Cancer Center data, over the past 10 years, the incidence of malignant tumors has maintained an annual increase of about 3.9%, the mortality rate of 2.5% per year growth.
with the increasing aging of the population, the acceleration of industrialization and urbanization, and the addition of unhealthy lifestyles, air pollution and other factors, the number of malignant tumor diseases will continue to increase.
At present, in addition to lung cancer, stomach cancer, colorectal cancer, liver cancer, esophageal cancer are high morbidity, high mortality of the disease, the need for treatment options, but also the main research and development focus of pharmaceutical companies.
addition to approved ADHD, all pharmaceutical companies are in the layout of ADHD.
PD-1/PD-L1 monoantaction as a broad-spectrum anti-cancer products, the approval of new adaptive disorders, can be said to be the core driving force of the expansion of the market size.
O and K drugs were initially approved for the second-line treatment of melanoma, as clinical trials continue to advance, approved adaptations are more and more, from small cancer species to large cancer species flyby, currently bladder cancer, rectal cancer, non-small cell lung cancer, head and neck cancer, liver cancer, breast cancer, etc. have been approved, and a number of cancers are used for first-line treatment.
present, in addition to Junshi Bio, Hengrui's Karelli Zhu single anti-nasopharyngeal cancer after-line treatment and first-line treatment of new adaptive disorders have also been declared on the market, is in the review and approval stage.
In addition, the anti-nasopharyngeal cancer adaptation in Baiji Shenzhou is in Phase III. Phase III clinical trials, and the PaiAnpuri Single Anti-Nasopharyngeal Cancer Adaptation Introsis in Day Qingkangfang (Shanghai) is also in Phase II clinical trials.
the global PD1/PDL1 drug market could reach $78.9 billion by 2030 and $13.1 billion in China, according to frosty Sullivan research.
, with the expansion of PD1/PDL1 single-resistance market scale, the competition of major pharmaceutical companies in the future, especially in adaptive diseases will become more and more intense.