(People's Daily Health Client Kong Tianjiao) On March 18, the People's Daily Health Client found from the clinical clinical trial implied license column released by the Drug Evaluation Center (CDE) of the State Food and Drug Administration (CDE) on the 17th and the announcement of the company's official website that as many as 7 drugs were clinically approved, of which Beiheng BioCTA101UCAR-T cell injection was approved for clinical trials, Chia Tai Tianqing TQB3820 tablets were approved for clinical trials, and Monalizumab for AstraZeneca injection was approved for clinical trials. Oleclumab Injection was approved, etc.
Among these approved clinical related drugs, 5 are anti-tumor drugs, and the other two drugs involve pneumoconiosis and kidney disease-related treatments.
5 oncology drugs were approved for clinical trials
On March 17, the official website of the Drug Evaluation Center of the State Food and Drug Administration showed that Chia Tai Tianqing's TBB3820 tablets were implicitly approved for clinical trials. The indications for application are monotherapy or combination with dexamethasone, and combination treatment with proteasome inhibitors and dexamethasone for the treatment of multiple myeloma, lymphoma and other malignant hematological tumors.
CDE shows that Henlius' self-developed recombinant human anti-PD-L1 and anti-TIGIT bispecific antibody injection HLX301 was approved by the State Food and Drug Administration to carry out a Phase 1 clinical study in China, which is intended for the treatment of advanced tumors. At present, no bispecific antibodies targeting PD-1/L1 and TIGIT have been approved worldwide. In addition, the CTA101 UCAR-T cell injection product independently developed by Beiheng Bio has officially obtained the implied license for clinical trials of the State Food and Drug Administration. CTA101 is the first "spot" UCAR-T cell therapy product approved by cde for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
According to the CDE, Monalizumab and Oleclumab Injection for AstraZeneca injection were approved for clinical trials, both of which were indications for locally advanced (stage III) and inexcisable small cell lung cancer (NSCLC) patients who had not progressed after radical platinum-containing concurrent chemoradiotherapy with dovalizumab. Tianyan Pharmaceutical announced that the FDA approved Tianyan to conduct Phase Ib/II new drug clinical trials of its anti-CTLA-4 monoclonal antibody ADG126 and anti-PD-1 antibody pembrolizumab combination therapy. The global trial will evaluate patients with advanced/metastatic solid tumors at clinical centers in the UNITED STATES and Asia Pacific (APAC).
Drugs for the treatment of tuberculosis, pneumoconiosis and kidney disease were approved for clinical treatment
In addition, the CDE official website shows that Wanbond Pharmaceutical inhaled bromohexine hydrochloride solution was approved for clinical trials. The drug is suitable for acute bronchitis, chronic bronchitis, tuberculosis, pneumoconiosis, expectorant treatment after surgery. According to the China Drug Clinical Trial Registration and Information Publicity Platform, Genting Xinyao has launched a Phase 3 clinical trial of Nefecon in China for the treatment of patients with primary IgA nephropathy.
