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Screenshot Source: CDE Official Website PaboliZhu Monoantitor is a heavy-weight PD-1 inhibitor developed by Mercadon to improve the anti-cancer response of human immune cells by blocking the PD-1/PD-L1 signaling path.
, according to CDE publicity, previously, Paboli pearl single anti-injection has six listing application acceptance number has been formally included in the priority review.
Specifically for adaptive disorders as follows: - For the treatment of non-excisible or metastatic melanoma after the failure of first-line treatment; . Local late stage or metastatic NSCLC first-line monotherapy for PD-L1 expression of the skin factor gene mutation negative and mesolytic lymphoma kinase; Second-line treatment of esophageal cancer; first-line single-drug therapy for patients with metastatic or non-removable reoccessive head and neck squamous cell carcinoma (HNSCC) in tumor expression PD-L1 (combined positive score (CPS)≥20).
, the first five adaptations have been approved in China.
addition, Paboli juju monotherapy for specific relapsed head and neck squamous cell carcinoma first-line single-drug treatment of new drug applications are currently being reviewed and approved.
It is worth mentioning that, not long ago (12 November), Paboli Juju's first-line treatment for colorectal cancer was included in the CDE's priority review as a "qualified approved drug", but the acceptance number was not published.
, it is speculated that the product in China submitted a new application for the listing of allergies, corresponding to colorectal cancer first-line treatment.
the United States, Pabliju mono-anti-expansion adaptation for colorectal cancer was approved by the FDA at the end of June.
specifically for patients with colorectal cancer with non-removable or metastatic microsatellitric instability (MSI-H) or misalmetric repair defects (dMMR) in the first-line treatment.
paboliju monotherapy became the first to be approved without the need to be associated with chemotherapy to treat the patient's group of first-line immunotherapy.
advanced colon cancer is a common and high incidence of malignant tumors among the world.
statistics, about 1.36 million new patients and nearly 700,000 deaths each year are a huge challenge for all mankind.
in China, 376,000 new cases occur each year.
currently, there are limited clinically effective treatments for patients who urgently need innovative therapies that are more effective and safe.
according to the China Drug Clinical Trials Registration and Information Disclosure Platform, Paboliju monoantigen has registered more than 40 clinical trials in China, most of which are Phase 3 international multi-center clinical studies.
In addition to the approved adaptations, clinical studies progressing to Phase 3 have been conducted in the field of hepatocellular carcinoma (HCC), stomach cancer, breast cancer, gastroesophageal junction adenocarcinoma, cervical cancer, prostate cancer, urethra cancer, bile tube cancer, endometrial cancer, etc.
: The Drug Review Center of the State Drug Administration of China. Retrieved Nov 23,2020, from # [2] FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer. Retrieved June 29, 2020, from the Chinese drug clinical trial registration and information disclosure platform. Retrieved Nov 23, 2020, from Source: Medical Mission Hills