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China's State Drug Administration (NMPA) Drug Review Center (CDE) recently announced that Youzhiyou Biological research and development of "injection recombinant anti-CD38 and CD3 dual specific antibodies" (research and development code: Y150) to obtain a clinical trial implied license, the adaptive disease is multiple myeloma (MM).
the first clinically approved CD38xCD3 dual-specific antibody in China, according to a press release from Yuzhiyou Bio.
screenshot source: CDE official website CD38 antigen is a size 46 kDa type II transfilm glycoprotein, CD38 and the mating body CD31 interaction, in regulating cell migration, subject-mediated adhesion and signal conduction plays an important role.
study found that CD38 was highly expressed in a large number of malignant blood cancers, especially in cancers such as multiple myeloma, making CD38 a target for the development of therapeutic antibody drugs for multiple myeloma.
public information shows that Y150 is based on the unique YBODY® dual anti-technology platform developed by youzhiyou bio, an injection recombinant anti-CD38 and CD3 humanized dual-specific antibody products, one end of which targets highly expressed CD38 antigens of tumor cells, the other end targets CD3 antigens on the surface of immune T cells.
by targeting CD38 antigens and CD3 antigens, T cells are recruited to tumor cells and T cells are activated to immune killer tumor cells, thereby inhibiting tumor cell growth.
Y150 is suitable for clinical treatment in patients with multiple myeloma who are still progressing after routine chemotherapy or CD38 mono-anti-treatment, according to the Yoshiyou Biosysthetic Press Release.
clinical studies show that Y150 has the advantages of good efficacy, difficult resistance and small dose of drug use compared to CD38 monoantial drugs.
2020, the Y150 program was approved by the FDA for clinical trials in the United States.
this clinical approval in China means that Y150 will also start clinical research in patients with multiple myeloma in China.
note that the Y150 program is also the third CD3 class dual-specific antibody project approved by NMPA for clinical studies.
According to the official website of Youzhiyou Bio, the company developed two other dual-resistance projects targeting CD3: M802: an injection recombinant anti-HER2 and CD3 humanized dual-specific antibody products, one end of which targets highly expressed HER2 antigens of tumor cells, the other end of which targets CD3 antigens on the surface of immune T cells, which can play an anti-tumor effect through a variety of mechanisms; 1: An injection with recombinant anti-EpCAM and CD3 human mice embedded with dual-specific antibody products, by targeting EpCAM antigens and CD3 antigens, T cells recruited to tumor cells, and activated T cells to immune killing tumor cells, thereby inhibiting tumor cell growth, relieve or eliminate tumor cells on the lymphatic tube blocking and peritina damage, and thus make the patient's malignant abdominal symptoms controlled, alleviated and eliminated.
, multiple myeloma is the second most common malignant tumor of the blood system, with more than 130,000 newly diagnosed multiple myeloma cases worldwide each year, according to public data released by the Government.
despite the available treatments, multiple myeloma remains an incurable malignancies, and most patients relapse after treatment or remission.
the arrival of CD38 monoantial, so that patients with multiple myeloma, especially relapsed and incurable patients saw the dawn.
congratulations to Youzhiyou BioCD38/CD3 double antibody approved clinically, look forward to the drug follow-up research smoothly, as soon as possible to benefit patients.
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