China's first new crown "special effect medicine" screen?

Recently, Sinopharm Group China Biotech unveiled a total of 9 products with 3 diagnostic reagents in the "diagnosable" field, 2 specific drugs in the "curable" field, and 4 new crown vaccines developed by 3 technical routes in the "preventable" field.
The health and hygiene zone established for the first time by the China International Trade in Services, where intravenous injection of COVID-19 human immunoglobulin (pH4), referred to as "new crown special immunity" and recombinant fully human anti-new crown virus monoclonal antibody injection-two This special medicine and the second-generation vaccine against mutant strains such as Delta are the world's first releases
.

On September 5, CCTV reported this.
Zhu Jingjin, Secretary of the Party Committee of China National Pharmaceutical Group, said in an interview that the "new crown exemption" is based on the plasma of the recovering patients and the special plasma of the plasma donors who have produced antibodies after vaccination.
It is prepared into a specific immunoglobulin that "can neutralize the new coronavirus and have a therapeutic effect on patients with severe and critical illness
.

The news of ## quickly appeared on Weibo and other hot searches on the Internet
.

01 The domestic new crown "special effect medicine" was approved for clinical use

On September 3, Tiantan Biological, a Chinese biological blood product company of Sinopharm Group, issued an announcement stating that its affiliated Sinopharm Wuhan Blood Products Co.
, Ltd.
had obtained the "Drug Clinical Trial Approval" issued by the National Medical Products Administration, and agreed to Wuhan Blood System to carry out "Intravenous COVID Infusion".
-19 Human Immunoglobulin (pH4)" clinical trial
.

Sinopharm Zhongsheng stated that intravenous injection of COVID-19 human immunoglobulin (pH4) is a new class of therapeutic biological products.
It uses healthy human plasma after immunization with the approved Chinese new biological coronavirus inactivated vaccine and uses low-temperature ethanol protein.
Purification and separation method, and virus inactivation and removal method prepared by intravenous injection of specific human immunoglobulin containing high titer SARS-CoV-2 neutralizing antibody
.

On January 30, 2020, China National Biosciences took the lead in undertaking the key special project "Preparation of Specific Plasma and Specific Immune Globulin for Patients in Recovery Period of 2019-nCoV Infection" of the Ministry of Science and Technology National Key Research and Development Program "Public Safety and Risk Prevention and Control and Emergency Technology and Equipment"
.

According to Sinopharm Zhongsheng, the new crown special immunity is the world's first new crown pneumonia-specific treatment drug prepared from plasma after immunization with the new crown inactivated vaccine.
There is no market of the same kind in the world, and there is no other manufacturer in the world based on the plasma after immunization of the listed new crown vaccine.
Carry out the clinical application of intravenous COVID-19 human immunoglobulin
.

According to the Global Times, Chen Kun, secretary of the China National Biological Disciplinary Committee of Sinopharm Group, revealed in an exclusive interview at the Service Trade Fair that "the'new crown exemption' has been applied to patients in recent epidemics in multiple regions across the country, and the test results are good
.

Chen Kun also said that although the new crown virus has mutated, the pathogenic principle has not changed, and it is still within the scope of drug treatment.
The clinical treatment effect of "new crown special immunity" in patients has not been weakened due to the virus mutation.
The cure rate is 100%, and no death has occurred
.

He also said that although the specific time to market for the "new crown exemption" is not yet certain, because under the special circumstances of the epidemic, the new crown vaccine has broken the routine, and special measures have been taken during the special period from research and development to clinical trials to national approval and circulation.
, Greatly reducing the time to market
.

Whether the "New Crown Special Exemption" can be successfully approved for listing still needs to be tested by Phase 3 clinical trials
.

According to the Service and Trade Fair, Sinopharm is accelerating the development of two new-generation vaccines, recombinant protein vaccines and mRNA vaccines.
Among them, the recombinant protein vaccine has completed phase II clinical trials and is expected to be launched by the end of this year; mRNA vaccines with independent property rights are also being developed.
In China, the construction of the mRNA platform and the layout of large-scale production workshops are currently being improved, and it is expected to wait until the listing next year
.

Sinopharm Zhongsheng said that it has recently submitted the third injection of the new coronary pneumonia inactivated vaccine to the relevant departments and is waiting for the approval of the plan
.

02 New crown drug development is still on the way

Although many vaccines are currently on the market around the world, especially the domestic epidemic control has been effective, there is still a lack of effective means or drugs for the treatment of new coronary pneumonia in the world
.

In October 2020, the world's largest clinical trial SOLIDARITY, which was organized by the WHO to screen multiple new crown candidate therapies, failed
.

SOLIDARITY is a global, randomized, controlled, adaptive design clinical trial that has been approved to recruit subjects in 43 countries starting in March 2020
.

On the other hand, trials led by companies have also failed frequently
.

In 2020, multinational giants such as Regeneron, Sanofi, and Roche have already planted some new crown drugs, and several phase III clinical trials for mild and severe new crown antibodies have failed
.

By April 2021, Takeda Pharmaceutical announced the failure of the new crown drug project.
Its alliance with many global blood product giants such as CSL Behring, Biotest, BPL and other global blood product giants has failed to meet the primary endpoint of the clinical phase III trial of plasma-derived therapy developed for new coronary pneumonia
.

In the same month, Merck also announced that it had stopped the research and development of the new crown treatment drug MK-7710 (CD24Fc) obtained by acquiring OncoImmune founded by Chinese scientists for 425 million
.

But it's not just the news of failure
.

In February, the FDA approved Junshi's esvirizumab and Eli Lilly's banivirimab dual antibody therapy for the treatment of patients with mild to moderate new coronary disease who are at risk of progression to severe or hospitalization
.
Although it has not yet been marketed in China, as of the first half of 2021, the diabody therapy has been approved for emergency use in more than 12 countries and regions around the world
.

In China, Tengshengbo Pharmaceutical announced in August that the interim results of a phase 3 clinical study conducted by a global multicenter showed that its monoclonal neutralizing antibody BRII-196/BRII-198 combination therapy is at a high risk for clinical progress compared with placebo.
Among outpatients with COVID-19, the composite endpoint of hospitalization and death was statistically significantly reduced by 78%
.
Tengshengbo Pharmaceutical also disclosed that the combination therapy maintains neutralizing activity against virus variants that require delta
.

On September 7, Tengshengbo Pharmaceutical announced an additional US$100 million to promote the global registration application and commercialization of BRII-196/BRII-198
.

Although vaccination against the new crown is still the first choice for epidemic prevention measures
.
However, as more and more companies such as Sinopharm Zhongsheng and Tengshengbo Pharmaceutical invest in the research and development of therapeutic drugs, it is believed that China's first new crown "special effect medicine" will not be too far away
.