Recently, Saisheng Pharmaceutical issued an announcement that the company received the notice of approval of the supplementary application for clinical trial of humanized anti-VEGF monoclonal antibody injection issued by the National Medical Products Administration
.
It is reported that as early as September 2022, Saisheng Pharmaceutical issued an announcement and received a notice of acceptance of the application for supplementation of humanized anti-VEGF monoclonal antibody injection issued by the National Medical Products Administration
.
The indications of this drug are: metastatic colorectal cancer.
For the approval of the supplementary application for this clinical trial, Saisheng Pharmaceutical said that it marks that the variety can continue to carry out clinical trials, and the company will actively promote follow-up related work
.
Coincidentally, on January 12, Kelun Pharmaceutical announced that the phase II clinical study of innovative TROP2-ADC (Kelun project code SKB264) developed by Sichuan Kelunbotai and osimertinib in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) patients with EGFR mutation was issued by the State Food and Drug Administration (NMPA
).
SKB264 (MK2870) is an antibody-conjugate drug (TROP2-ADC) composed of a humanized monoclonal antibody targeting TROP2 with independent intellectual property rights and a linker that can be enzymatically cleaved and connected to a novel topoisomerase I inhibitor, and is conducting phase II clinical trials for multiple tumors in China and the United States, and phased clinical data
have been obtained.
On the same day, Kangchen Pharmaceutical also announced that it recently received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration, and its declaration of "Evaluation of the Efficacy and Safety of KC1036 Combined with Docetaxel in the Treatment of Advanced Driverless Gene Lung Adenocarcinoma Treated with Platinum-containing Chemotherapy and PD-1/PD-L1 Antibody Therapy Failure" has been approved by NMPA
.
KC1036 tablets are Class 1 innovative chemical drugs independently developed by Kangchen Pharmaceutical, which are not marketed at home and abroad, and are intended for the treatment
of solid tumors.
In fact, with the rapid development of China's innovative drug industry and the acceleration of new drug review and review, the research and development of domestic innovative drugs is becoming more and more hot, and since the beginning of this year, a large number of new drugs have been approved for clinical trials
in China.
It is worth mentioning that many domestic new drugs have recently received clinical trial approval notices from the FDA
.
For example, on January 12, Harbour Biopharma announced that it has obtained New Drug Application Authorization (IND) from the US Food and Drug Administration (FDA) to initiate clinical trials
of the monoclonal antibody HBM1020 (also the world's first similar product targeting B7H7) in the United States.
According to the data, HBM1020 is the world's first fully human monoclonal antibody
targeting B7H7 produced by the H2L2 transgenic mouse platform.
This antibody enhances anti-tumor immunity
by blocking the binding of immune checkpoint targets and ligands.
Preclinical data confirm its immunoactivation and antitumor functional activity
.
On January 6, the Singapore subsidiary of Dongcheng Nuclear Drug Innovation R&D Platform Lannacheng received the drug clinical trial approval notice for 177Lu-LNC1004 injection approved by the US Food and Drug Administration (FDA), and will soon start phase I clinical trial
.
177Lu-LNC1004 injection is a kind of in vivo therapeutic drug targeting fibroblast activation protein (FAP), which is a new target drug intended to be used to treat adult patients with FAP-positive expression of advanced solid tumors.
Industry analysts believe that from the increasing number of new drug clinical trials, it can be seen that the domestic innovative drug industry has gradually begun to enter the harvest period
.
In the future, a large number of new drugs and good drugs will emerge in the domestic drug market to benefit the majority of patients
.
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