T-cell lymphoma new drug! Cinda BioPD-1 inhibitor Dabershu ® (Sindili mono-resistance) was granted the U.S. FDA's certification of orphan drugs!

March 30, 2020 /
Biovalley BIOON/ -- Innovent Biologic is a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as tumor , autoimmune , and metabolic diseases recently, the company's self-developed innovative PD-1 inhibitor Tyvyt (Daberschu®, generic name: intilimab, Sindilli mono-resistant injection) was awarded by the U.S Food and Drug Administration (
The FDA ) grants the orphan drug (ODD) for the treatment of T-cell lymphoma Orphan Drug is a drug used to prevent, treat, diagnose sashimi rare diseases, which are a category of very low incidence of diseases, also known as "orphan diseases" In the U.S., rare diseases are the type of disease that affects fewer than 200,000 people, and incentives for the development of rare disease drugs include various clinical development incentives, such as tax credits related to clinical trial costs, FDA user fee deductions, assistance the design of clinical trials FDA , and a seven-year market-exclusive period for approved indications after the drug is marketed Dabershu ® (Recombinant Whole Human Source Anti-PD-1 Monoclonal Antibody, International Trademark: Tyvyt ®, Chemical Common Name: Sindyli Monoantigen) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thus blocking PD-1/procedural death receptor lig-1, which causes tumor immunity tolerance PD-L1) pathway, re-activating the anti-tumor activity of lymphocytes, thus achieving the goal of treating tumor Dabershu ® (Sindili monoire) is an international-quality innovative biopharmaceutical developed by Cinda Biopharmaceuticals and Lilly Pharmaceuticals in China Its listing application has been formally approved by the State Drug Administration, the first indication approved is recurrent/incurable classic Hodgkin's lymphoma, and was selected in the 2019 edition of the Chinese Society for Clinical Oncology (CSCO) lymphoma treatment guidelines In the 2019 Health Care Nation, The ® Of Dabershu (Sindili Mono-injection) is the only international-quality PD-1 inhibitor to enter the national health insurance , more than 20 clinical studies( eight of which are registered clinical trials ) are currently under way to explore the of sindili monotonous anti-
tumors on other solid tumors Cinda Bio is also conducting clinical research on Sindy Li monoantigen injections in the United States (biovalleybioon.com) original origin: FDA ODD database