On November 2, Acro Biotech announced that the clinical trial application of the new PD-L1/4-1BB bispecific antibody "HK010 injection" with independent intellectual property rights has been approved by the State Food and Drug Administration and is intended to be used for the treatment of advanced malignant tumors
.
It is understood that up to now, no PD-L1/4-1BB bispecific antibody has been listed at home and abroad, and related products are in the clinical research stage
at home and abroad.
Anko Biotech said that it will accelerate the clinical trial
of HK010 injection as soon as possible under the leadership of the Affiliated Cancer Hospital of Fudan University.
On November 2, Shanghai Pharmaceutical announced that the "sublingual membrane of rasagiline mesylate" developed by Shanghai Shanghai Shangyang Zhongxi Pharmaceutical Co.
, Ltd.
, a holding subsidiary of the company, recently received the "Drug Clinical Trial Approval Notice" (notification number: 2022LP01749) approved and issued by the State Food and Drug Administration, and clinical trials
will be started in the near future.
Data show that rasagiline mesylate, as a new type B monoamine oxidase (MAO-B) inhibitor, effectively improves the symptoms
of various Parkinson's diseases by inhibiting MAO-B activity, preventing the decomposition of endogenous dopamine in the brain and increasing the level of dopamine in the synaptic cleft.
On November 1, the website of the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration announced that two Class 1 new drugs declared by Eli Lilly have obtained implicit approval for clinical trials, namely: 1) PD-1 agonist peresolimab injection, which is intended to be developed for moderate to severe active rheumatoid arthritis; 2) PI3Kα H1047R inhibitor LOXO-783 tablets, intended to be developed for the treatment of advanced breast cancer and other solid tumors
with PIK3CA H1047R mutation.
Clinical trials are a very important part of new drug research and development, and it is also an indispensable link
for each new drug before it is approved for production and put on the market.
At present, under the background of innovation and upgrading at the core of building product competitiveness and the continuous standardization of the clinical development of innovative drugs, the clinical trials of new drugs of major pharmaceutical companies are accelerating
.
However, it should be noted that in terms of drug clinical trials, with the continuous increase in R&D investment of domestic and foreign pharmaceutical companies, although there are many candidates entering clinical trials, the proportion of candidates that can survive to successful approval for marketing is not large
.
It is understood that since the beginning of this year, there have been many cases
of drug clinical trial failure.
For example, Harbour Biomed announced the end of its phase III clinical trial of tenarcept and will no longer enroll new subjects; The international phase III clinical trial of Green Valley Pharmaceutical's Alzheimer's Disease (AD) drug GV-971 (mannut sodium capsule, trade name: Phase IX I) has been discontinued.
.
.
The industry believes that under the background of accelerated innovation of pharmaceutical companies but difficult research and development, clinical resources will be relatively tight in the future, and the cost of new drug development may become a trend
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.
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