Shang Jian biological CD38 single anti-declaration clinical and accepted.

Today, China's State Drug Administration (NMPA) Drug Review Center recently announced that Shang Jian biological class 1 new drug CD38 monoanti-resistation declaration clinical and accepted.
this is the company's second product to submit a clinical trial to NMPA, the first of which, PD-1 antibodies, was approved for clinical use in November 2018.
, two CD38 antibodies have been approved worldwide, including Johnson and Johnson's Janssen's Daretouzumab, which was approved in China last year and isatuximab, developed by Sanofi, which was recently approved for clinical purposes in China.
, THE CD38 antibody introduced by Tianyi is undergoing phase 2 clinical trials Chinese mainland multi-center registration.
screenshot source: CDE official website ShangJian Bio focuses on the field of cancer and other major diseases of innovative antibody drug development, led by Dr. Lu Ming founded, and has set up advanced research and development centers in Beijing, Hangzhou, Guangzhou and other places.
currently, the company is working on more than 10 innovative drugs, focusing on the field of oncology layout.
this Shangjian biorecombinant anti-CD38 human-derived monoclonal antibody injection in China declared clinical, is the company's second in NMPA to submit clinical trials of the product.
, the first product recombinant anti-PD-1 all-human monoclonal antibody injection was approved for clinical treatment in November 2018, it is the company's independent research and development of the first national class 1 new drug with independent intellectual property rights.
Shangjian biological key product progress (screenshot source: Shangjian biological website) CD38 molecule is a single-chain type II trans-membrane glycoprotein, widely expressed in hematopoietic cells and non-hematopoietic cell lines, with many complex and unique biological characteristics and functions.
studies show that CD38, as the target of blood tumors, may have application prospects in the treatment of recurrent refractive refractive T-cell tumors.
in recent years, CD38 antibody in adult multiple myeloma (MM) treatment has been significantly effective and good safety.
2015, jansen Pharmaceuticals' first CD38 monoclonal antibody-targeted drug, daratumab, has received FDA approval to extend the scope of treatment for MM patients.
the drug was approved in China in July last year for the treatment of relapsed and refractable MM adult patients.
March 2020, monoclonal antibody isatuximab, developed by Sanofi to target cd38 receptors on the surface of plasma cells, was also approved by the U.S. FDA for the treatment of adult multiple myeloma patients with pomadomine and dexamethasone.
just recently, the product was implicitly licensed in two clinical trials in China, the combination of dynamine and dexamethasone for the treatment of high-risk smoke-type multiple myeloma (SMM).
in addition to the above two products, CD38 antibodies are currently being developed in China and Tianyi bio-innovative human source CD38 antibody TJ202/MOR202.
the exclusive development of human-source monoclonal antibodies by MorphoSys using HuCAL technology, and Skylife has exclusive development and commercialization interests in Chinese mainland, Hong Kong, Macau and Taiwan.
, the product has completed the first patient administration of a phase 2 clinical trial registered with Chinese mainland multi-center, and two clinical trials of TJ202/MOR202 in recurrent or refractive MM in Taiwan, China.
this Time Shangjian BioCD38 Antibody was declared clinical in China, meaning that the product will soon enter the clinical stage.
References , the first class I drug for Shangjian Bio was approved for clinical trials. Retrieved Oct 8, 2018, from.