The domestic pharmaceutical innovation industry is in full swing, especially with the acceleration of new drug review and approval, and the good news of new drug research and development in the domestic drug market is continuous
.
It is reported that in the last week of 2022, 42 Class 1 new drugs/biological products were approved for clinical trials, including Connexin 43 inhibitors of CSPC Group, GLP-1 and GIP receptor double agonists of Ruibo Pharmaceutical, and TIGIT/PVRIG bispecific antibodies of Simcere Pharmaceutical
.
Now, the time has come to 2023
.
In the past week, a large number of new drugs of pharmaceutical companies have been approved clinically, including Salubris SAL0133 tablets, Zhongqi Pharmaceutical's meloxiconajing injection, Kangtai Bio's numb and mumpy combined live attenuated vaccine, etc
.
Zhongqi Pharmaceutical's meloxiconacrystal injection was approved for clinical practice
On January 5, CSPC Pharmaceutical Group announced on the Hong Kong Stock Exchange that the meloxic-conajing injection developed by its subsidiary CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Food and Drug Administration for clinical trials
in China.
The drug is mainly used in the treatment
of chronic pain such as osteoarthritis and rheumatoid arthritis.
It is understood that opioids are the most common drugs for the treatment of moderate to severe pain, but can cause serious adverse reactions
such as respiratory depression, excessive nausea and vomiting, and addiction.
As a non-opioid that requires only one dosing per day, the product is expected to be a better choice
for the treatment of moderate to severe pain in adults.
Kangtai Bio Mepsi combined with live attenuated vaccine was approved for clinical practice
Kangtai Biotech announced on the evening of January 5 that the mumps and cheek combined live attenuated vaccine developed by Minhai Biotechnology, a wholly-owned subsidiary of the company, recently obtained the "Drug Clinical Trial Approval Notice" issued by the State Medical Products Administration, and after review, the drug met the relevant requirements of drug registration and agreed to conduct clinical trials
.
The combination of live attenuated mumps vaccine is used to prevent measles, mumps and rubella
.
The vaccine is intended for people over 8 months of age who are susceptible to measles, mumps and rubella, and stimulates immunity against measles, mumps and rubella viruses to prevent measles, mumps and rubella
.
Jimin Credible New Drug received clinical trial approval from FDA
On January 4, Jimin Trust Group announced that the clinical trial application (IND) for JYB1907 new drug for injection independently developed by its subsidiary, Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
(hereinafter referred to as "Shanghai Jiyu"), has obtained clinical trial approval
from the US FDA.
JYB1907 is an innovative drug targeting GARP/TGF-β1 recombinant humanized monoclonal antibody independently developed by Shanghai Jiyu Macromolecular Innovation Institute, with independent intellectual property rights, it is a new drug of biological products class 1, intended for the treatment of locally advanced or metastatic solid tumors, which is the first GARP/TGF-β1 monoclonal antibody drug in China to be declared and approved for clinical approval in the United States, and the clinical trial application was accepted by the FDA on November 17, 2022.
It obtained FDA clinical trial approval
on December 17.
Salubris SAL0133 tablets were approved for clinical trials
On January 4, Salubris issued an announcement that the State Food and Drug Administration approved the issuance of the "Clinical Trial Approval Notice", agreeing to SAL0133 tablets to carry out phase I clinical trials
for the treatment of adult mild/common novel coronavirus pneumonia (COVID-19).
Preclinical research data showed that SAL0133 showed strong inhibitory activity against 3CLpro at the enzyme level, strong antiviral activity against wild-type new coronavirus and five new crown variants Alpha (B.
1), Beta, Delta, Omicron (BA.
2, BA.
5), and the EC90 value of antiviral activity against the current epidemic strain OmicronBA.
5 strain was 10 times
that of nematevir.
.
.
.
.
.
.
It is worth noting that due to the particularity of drug research and development, the cycle from clinical trial to production and marketing is long, there are many links, and it is easily affected by many unpredictable factors, and there are many uncertainties in the progress and results of clinical trials and the future product market competition, so the clinical approval of these new drugs is only the first step, and it will take time to verify
whether these drugs can be successfully launched in the future.
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