PharmaSources/CaicaiJuly 29, 2020
Tag: Inhibitor , leukemia , clinical
The hottest event of the week was the official kick-off of the centralized procurement of the third batch of pharmaceutical products organized in China, with 86 specifications started to be acquired the basic information. Regarding other aspects, no new drugs other than Humanwell’s Class 1 new drug remimazolam besylate were approved for marketing. Now, let’s review the hot events of the pharmaceutical industry this week. The news involved 6 sections: approval, R&D, performance, centralized procurement, listing, and transactions that happened during July 20-24, including 24 pieces.
R&D
12. AbbVie announced on July 21 that its JAK1 inhibitor: upadacitinib (15 mg and 30 mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis. As the most common form of eczema, atopic dermatitis is a chronic inflammatory condition that generally occurs in the form of a rash.
13. Ascentage announced on July 22 that the Phase Ib clinical study of its MDM2 inhibitor: APG-115 for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML), or relapsed/progressed high/very high risk myelodysplastic syndrome (MDS) dosed its first patient in China. AML is a clonal proliferative disease of the bone marrow and is the most common type of leukemia in China, with an incidence rate of 1.62-2.32 cases per 100,000.
14. According to the CDE website on July 22, Genor Biopharma’s marketing application for “Geptanolimab Injection” was accepted for the treatment of peripheral T-cell lymphoma (PTCL). Geptanolimab is an innovative anti-PD-1 monoclonal antibody with a brand-new sequence, in which Genor Biopharma has the core independent intellectual property right.
15. TOT BIOPHARM announced on July 23 that TAA013, an HER2 targeted ADC independently developed by it, had recently reached a key clinical-stage milestone. TAA013 is the ADC owned by TOT BIOPHARM which has shown the fastest progress. It is an ADC conjugated from trastuzumab and the high activity substance DM1 through the linker. The first patient has been successfully dosed in a pivotal Phase III registrational clinical trial.
16. N.B. Quadriga announced on July 23 that the first patient was dosed in a Phase 1 study of its new drug NBQ72S in development in patients with advanced malignancies. NBQ72S is a novel, first-in-class, bifunctional small molecule drug that targets human L-type amino acid transporter 1 (LAT1).
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Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.
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