Recently, Ascentage Pharma announced that its application for a new drug clinical trial (IND) for the treatment of anemia-related diseases has been accepted
by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration.
APG-5918 is the first Chinese original EED inhibitor to enter the clinical stage, and is advancing clinical research
in China and the United States for the treatment of advanced solid tumors or hematologic malignancies.
The accepted clinical trial is a randomized, double-blind, placebo-controlled Phase I clinical trial designed to evaluate the safety and tolerability of APG-5918 in adult healthy subjects and anemia subjects, as well as the initial efficacy
against anemia.
Domestic new drug research and development is hot, this problem has become the focus of pharmaceutical companies (Image source: Pharmaceutical Network)
On November 16, Hengrui Pharmaceutical also announced that 3 drugs have obtained clinical trial approval notices and will carry out clinical trials in the near future
.
Among them, Shandong Shengdi Pharmaceutical Co.
, Ltd.
, a subsidiary, received the approval and issuance of the "Drug Clinical Trial Approval Notice" for HRS-1358 tablets and HRS-1780 tablets by the State Food and Drug Administration, and will carry out clinical trials
in the near future.
In addition, Shanghai Hengrui Pharmaceutical Co.
, Ltd.
, a subsidiary, received the approval of the National Medical Products Administration for the issuance of the "Drug Clinical Trial Approval Notice"
for SHR-7367 injection.
It is reported that SHR-7367 injection is a humanized antibody independently developed by Hengrui Pharmaceutical, which is intended to be used for the treatment of advanced malignant tumors
.
Clinical trial is a very important part of new drug research and development, and it is also an indispensable link
for every new drug before it is approved for production and put on the market.
In recent years, in fact, the number of clinical trials in China has been continuously growing, and the Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2021) (hereinafter referred to as the Report) shows that the total number of annual registrations of the drug clinical trial registration and information disclosure platform exceeded 3,000 for the first time in 2021, a total of 3,358.
In addition, according to the Report, in 2021, the total number of clinical trials registered on the drug clinical trial registration and information disclosure platform increased by 29.
1%
compared with the total annual registration in 2020.
Among them, the number of new drug clinical trials (exploratory and confirmatory clinical trials registered with acceptance numbers) was 2033, an increase of 38.
0%
compared with the number of registrations in 2020.
How to break through the bottleneck of new drug research and development
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 number of failures is also rising
.
Since the beginning of this year, there have been many cases
of failed drug clinical trials.
For example, Harbour Biopharma announced the end of its phase III clinical trial of tenacercept and will not enroll new subjects; Green Valley Pharmaceutical's Alzheimer's disease (AD) drug GV-971 (mannite sodium capsules, trade name: Phase IX I) international phase III clinical trials have been stopped.
.
.
In this regard, the industry expects that in the future, with the continuous advancement of new drug research and development of pharmaceutical companies, problems such as low success rate of drug clinical trials, low efficiency of clinical use of drugs, and rising development costs will also become increasingly apparent
.
So how should pharmaceutical companies respond to these problems? Analysts believe that we should pay attention to the development and clinical application of new drugs in basic research, do a good job in the transformation from "science" to "technology", and attach importance to production, education and research to accelerate the transformation
of scientific research results from samples to products to commodities.
Among them, in the preclinical stage, many people in the industry have mentioned that reliable biomarkers related to disease prevention, diagnosis and treatment can be mined with the help of high-quality big data and artificial intelligence
.
In fact, the artificial intelligence + new drug research and development model has long been used by pharmaceutical companies in innovative research and development
.
In May this year, ISM001-055, the world's first new drug candidate discovered and designed by Insilico through an artificial intelligence platform, entered phase I clinical trials in China, and completed the dosing
of the first healthy subjects in July.
In September, with the assistance of HUAWEI CLOUD Pangu Drug Molecular Model, Professor Liu Bing's team from the First Affiliated Hospital of Xi'an Jiaotong University also broke through the development of a super antibacterial drug Drug X, which is expected to become the world's first new target and new class of antibiotics
in the past 40 years.
epilogue
In general, the current trend of innovation in the pharmaceutical industry
.
In this context, pharmaceutical companies will also encounter more bottlenecks and challenges
in research and development, including clinical trials.
For pharmaceutical companies, they can only face difficulties, take patients as the center, and use high-quality big data, artificial intelligence and other high-tech means to improve R&D efficiency
.
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