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Shanghai and Hong Kong November 1, 2021/PRNewswire/ - Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as a leading biopharmaceutical company dedicated to the development and commercialization of the world’s first and/or best-in-class blood and innovative tumor therapies "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) today announced that the US Food and Drug Administration (FDA) has approved its ATG-101 New Drug Research Application (IND)
.
ATG-101 is a bispecific monoclonal antibody being developed by Deqi Pharmaceuticals for the treatment of metastatic or advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL)
ATG-101 is the first innovative drug developed by Deqi Pharmaceutical's R&D team that has entered the clinic and has global rights and interests
.
This approval is the second clinical trial application approved by ATG-101 worldwide after the approval of Australia and the initiation of phase I clinical trials.
As a new PD-L1/4-1BB bispecific antibody, ATG-101 can block the immunosuppressive PD-L1/PD-1 binding and conditionally activate the 4-1BB costimulatory signal, thereby activating anti-tumor Immune effector cells enhance safety while enhancing drug efficacy
.
ATG-101 has shown significant anti-tumor efficacy in animal models of immune checkpoint inhibitor resistance or recurrence, and has shown excellent safety in GLP toxicology studies
"ATG-101 is expected to provide newer and more effective treatments for solid tumors and NHL patients who have received anti-PD-1 or anti-PD-L1 treatments that have relapsed or are drug-resistant.
It is expected to meet a huge and ongoing Unmet medical needs,” said Dr.
Mei Jianming, founder, chairman and CEO of Deqi Pharmaceuticals, “The approval of the clinical trial application for ATG-101 in the United States is an important milestone for Deqi Pharmaceuticals.
ATG-101 The phase I dose-escalation clinical trial
of Chemie is also underway in Australia, and it is expected that IND applications will be submitted in China this year .
These fully demonstrate the strong execution of our team in different countries around the world, and further promote Deqi Pharmaceutical’s "Doctors have no boundaries, and innovation is forever.
" Continue's vision
About ATG-101
ATG-101 is a new PD-L1/4-1BB bispecific antibody that is being developed for the treatment of metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL)
.
ATG-101 can simultaneously block PD-L1/PD-1 binding and activate 4-1BB costimulatory signals, thereby activating anti-tumor immune effector cells
About Deqi Pharmaceutical
Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company dedicated to providing the most advanced therapies and treatments for patients in Asia Pacific and even the world Tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
Forward-looking statements
The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
Source: Deqi Pharmaceutical Co.
