(People’s Daily Health Client Kong Tianjiao) On March 18, the People’s Daily Health Client issued a clinical trial indication from the Center for Drug Evaluation (CDE) of the State Food and Drug Administration on the 17th. The license column and the announcement on the company’s official website found that as many as 7 drugs have been approved for clinical use. Among them, Beiheng Bio’s CTA101UCAR-T cell injection was approved for clinical use, Chia Tai Tianqing TQB3820 tablets obtained the implied license for clinical trials, and AstraZeneca injection Approved with Monalizumab, Oleclumab Injection, etc.
Among these clinically approved related drugs, five of them are anti-tumor drugs, and the other two are related to the treatment of pneumoconiosis and kidney disease.
5 oncology drugs approved for clinical use
On March 17, the official website of the Center for Drug Evaluation of the State Food and Drug Administration showed that Chia Tai Tianqing TQB3820 tablets obtained an implied license for clinical trials. The application indications are single drug or combined with dexamethasone, and combined with proteasome inhibitor and dexamethasone for the treatment of malignant hematological tumors such as multiple myeloma and lymphoma.
CDE shows that Henlius’ self-developed recombinant human anti-PD-L1 and anti-TIGIT bispecific antibody injection HLX301 has been approved by the State Food and Drug Administration to conduct Phase 1 clinical research in China , intended for the treatment of advanced tumors. At present, no bispecific antibody targeting PD-1/L1 and TIGIT has been approved for marketing globally. In addition, the CTA101 UCAR-T cell injection product independently developed by Beiheng Bio has officially obtained the implied license for clinical trials from the State Food and Drug Administration. CTA101 is the first “off-the-shelf” UCAR-T cell therapy product approved by CDE in China for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
CDE shows that AstraZeneca’s Monalizumab and Oleclumab Injection have been approved for clinical use, both of which are indicated for combination therapy with durvalumab in the treatment of radical platinum-containing drugs Patients with locally advanced (stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed after concurrent chemoradiotherapy. Tianyan Pharmaceutical announced that the FDA approved Tianyan to conduct a Phase Ib/II new drug clinical trial of the combination therapy of its anti-CTLA-4 monoclonal antibody ADG126 and anti-PD-1 antibody pembrolizumab. The global trial will evaluate patients with advanced/metastatic solid tumors at multiple clinical centers in the U.S. and Asia Pacific (APAC).
Drugs for pulmonary tuberculosis, pneumoconiosis and nephropathy approved for clinical use
In addition, CDE’s official website shows that Wanbangde Pharmaceutical’s bromhexine hydrochloride solution for inhalation has been approved for clinical use. The drug is suitable for the expectorant treatment of acute bronchitis, chronic bronchitis, pulmonary tuberculosis, pneumoconiosis and post-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 patients with primary IgA nephropathy in China.
