Jiachen Xihai broad-spectrum mRNA novel coronavirus seedlings were approved for phase I/II registration clinical trial by the US Food and Drug Administration

On November 19, 2022, Jiachen Xihai Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jiachen Xihai"), a fast-growing innovative drug R&D biotechnology company, announced that its self-developed broad-spectrum protective mRNA novel coronavirus vaccine JCXH-221 has been approved by the US Food and Drug Administration (FDA) New Drug Clinical Trial Application (IND) and will conduct phase I/II multicenter clinical trials
in the United States 。 JCXH-221 is a widely protective mRNA new coronavirus vaccine designed based on the unique polyantigen structure of Jiachen Xihai, which can be used to prevent infections and diseases
caused by a variety of new coronaviruses.
This multicenter Phase I/II clinical trial is designed to evaluate the safety, immunogenicity, and persistence
of the immune response of JCXH-221 in healthy subjects.

"We are excited to receive another FDA IND approval in 2022
.
The clinical approval represents the further enhancement
of Jiachen Xihai's innovative drug and new epidemic pipeline combination based on multi-form RNA technology.
Dr.
NgocDiep Le (MD, PhD), Chief Medical Officer of Jiachen Xihai, said, "Vaccination remains a key means to
reduce SARS-CoV-2 infection and the impact of the disease.
The development of a low-cost, easily stored, transportable, and broad-spectrum protective vaccine remains an urgent task
, given the continued emergence of new variants, the weakening of the immune response after initial vaccination, and the low accessibility of existing mainstream mRNA vaccines to low- and middle-income countries.
We strongly believe that JCXH-221 is an excellent candidate
to address these issues.
"

Jcxh-221 is a monovalent but excellent broad-spectrum protective novel coronavirus vaccine
using conventional non-self-replicating mRNA.
Jcxh-221 is expressed in the receptor and self-assembles into a multimer antigen
containing the main epitopes of multiple novel coronavirus variant strains.
This polymer antigen structure further enhances the immunogenicity of a single antigen without destroying the integrity of all antigen epitopes, and obtains the effect of 1+1 much greater than 2 (PCT international patent examination process).

In multiple preclinical animal models, JCXH-221 demonstrated strong neutralizing antibody titer
against the original strains of the new coronavirus, beta, delta, Omicron BA.
1, BA.
2.
12.
1, BA.
4/5 and other strains.
In terms of delivery carriers, JCXH-221 uses Jiachen Xihai's Ready-To-Use (RTU) delivery system (PCT international patent examination process), which can achieve a validity period
of at least 18 months under the condition of storage at 2-8 degrees Celsius.
At the same time, in terms of delivery efficiency, this new carrier is not inferior to conventional LNPs
that require cryopreservation or ultra-low temperature preservation.

Dr.
Wang Zihao (PhD), co-founder and CEO of Jiachen Xihai, added, "Epidemiologists can almost certainly survive and evolve in human society for a long time, and emerging new variants may have the ability to break through pre-existing immune protection barriers, so the new coronavirus vaccine is likely to become a standing vaccine
that susceptible people need to be revaccinated every year.
And from a virological point of view, the evolution of viruses is never a one-way street, and those that seem to have receded but more deadly variants can also make a comeback and cause great damage
.
One lesson that the pandemic has taught to developers over the past three years is that if we simply chase new variants, the development of the pandemic will always be one step
behind the virus.
Under these premises, Jiachen Xihai believes that widespread protection (potential versatility) is the development direction
of the next generation of new crown epidemic seedlings.
The JCXH-221 is designed
for these requirements.
Through novel antigen design, JCXH-221 has the potential to achieve broad-spectrum protection of monovalent epidemic seedlings (single mRNA strands) while avoiding the disruption of the integrity of a single antigen by chimeric design
.
Compared with multivalent epidemic seedlings, monovalent epidemic seedlings have advantages
in production, testing and release, and dose control.
In addition, the mild storage, transportation and distribution conditions of JCXH-221 can also improve the accessibility of mRNA epidemic in underdeveloped countries and regions
.
Finally, JCXH-221 achieves Freedom To Operate (FTO) on an international scale and has the moat protection
of two PCT basic patents.
Together, we believe JCXH-221 will be an excellent next-generation standing COVID seedling
.
"

The Phase I clinical trial of JCXH-221 will be a randomized, double-blind, dose-escalation study to evaluate the safety and immunogenicity of JCXH-221 and determine the recommended dose (RP2D)
for the Phase II clinical trial.
The Phase II clinical trial will be a randomized, double-blind study to further validate the safety and immunogenicity
of JCXH-221 under RP2D.
In the clinical trial, JCXH-221 will be compared
with the current mainstream bivalent mRNA epidemic in the US market.