Recently, East Sunshine Pharmaceutical initiated a Phase III clinical trial to evaluate the efficacy and safety
of creftinib besylate tablets in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations.
Crifacitinib is a new generation of highly specific FLT3 inhibitors, and the main drugs approved for the same target in China are gemitinib, which was approved for import in February 2021 and will have sales of more than 50 million yuan
in physical pharmacies in Chinese cities in 2021.
East Sunshine Pharmaceutical has newly initiated a randomized, open-label, salvage chemotherapy controlled, multicenter phase III clinical trial to evaluate the efficacy and safety
of clefatinib besylate tablets in patients with relapsed/refractory AML with FLT3-ITD mutations.
Industry insiders believe that with the launch of this phase III clinical trial of East Sunshine Pharmaceutical, its Class 1 new drugs are expected to usher in new progress
.
It is understood that since the beginning of this year, in addition to crefatinib besylate tablets, East Sunshine Medicine has three Class 1 new drugs approved for clinical trials for the first time, including NASH new drug HEC138671 tablets, migraine new drug HEC137076MsOH tablets and antitumor new drug HEC169096 tablets, of which HEC137076MsOH tablets and HEC169096 tablets have started clinical trials
.
At present, on the whole, domestic Class 1 new drugs have gradually begun to break out, and a large number of pharmaceutical companies have entered the harvest period
.
In addition to continuous clinical practice, Class 1 new drugs have been successfully marketed, and there are many
pharmaceutical companies that have entered commercialization.
For example, Remegen currently has two new drugs of class 1 of tetacept and vedicitumab entering the commercialization stage
.
According to data from Intranet, the terminal sales of the above products in China's public medical institutions in the first half of 2022 exceeded 30 million yuan and 60 million yuan respectively, and the sales performance far exceeded market expectations
.
Among them, tatacept was recently granted orphan drug designation by the FDA for myasthenia gravis (MG) indications
.
Analysts believe that the continuous breakthrough in Class 1 new drugs is mainly due to the continuous increase
in research and development of Remegen.
It is understood that in the past four years, Remegen's cumulative R&D expenses have exceeded 1.
745 billion yuan, completed the commercialization of 2 blockbuster drugs, and achieved a drug authorization
with a total transaction amount of more than 2.
6 billion US dollars.
If this efficiency of R&D input and output can be continued, Remegen may bring greater surprises
to the market in the future.
It is worth mentioning that at present, Remegen is not satisfied with the status quo, but adheres to clinical value-oriented, committed to the discovery, development and commercialization of original and differentiated biological drugs, focusing on major diseases such as autoimmunity, oncology and ophthalmology, and a number of potential products under research are expected to achieve first-in-class or best-in-class
.
In addition, Haosen Pharmaceutical currently has 5 Class 1 new drugs approved, of which ametinib has domestic sales of more than 1.
5 billion yuan
in 2021.
In addition, the imported class 3.
1 new drug inherizumab (CD19 monoclonal antibody) was also approved for import in 2022, which is the company's first biological drug
.
At present, Hausen Pharmaceutical has built a research and development pipeline covering more than 100 drugs under development, among the 1 new drugs under development in China, Peihua West Hippocampide (long-acting EPO drug) has been reported for production, and polyethylene glycol thymosin α1 (thymus immunomodulator) has entered phase III clinical trials
.
In general, driven by a series of favorable policies, domestic innovative drugs are ushering in an intensive harvest period, and a large number of pharmaceutical companies are expected to enter the achievement exchange period
in the future.
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