Pharmaceutical companies are laying out shingles vaccines, and how is the current research and development progress

On October 21, multinational pharmaceutical company GlaxoSmithKline (GSK) announced positive interim results
in the expansion of its recombinant herpes zoster vaccine "Xin'anlishi".
The results showed that the vaccine provided at least 10 years of protection
against shingles after the initial vaccination.

These results come from an extended study ZOSTER-049 (ZOE-LTFU), two phase III clinical trials, Zoster-006 (ZOE-50) and Zoster-022 (ZOE-70), which is designed to continue to
follow participants in the Zoster-006 and Zoster-022 clinical trials for six years.
Currently, this expanded study is ongoing and will continue to evaluate the long-term efficacy, immunogenicity and safety
of the vaccine.

GSK said that in terms of the primary endpoint, data from this interim study showed that the overall protective efficacy of Xin'anlix against shingles exceeded 80%
during a follow-up period of about 6 to 10 years after the initial vaccination.
The interim analysis will be presented
on October 22, 2022 at IDWeek in Washington, D.
C.

Shingles is caused by the reactivation of the varicella-zoster virus, and as we age, the immune system loses its ability to generate a strong and effective immune response, increasing the risk of shingles, a disease that causes unbearable pain that some patients still experience severe pain after the rash has faded, this nerve pain is called postherpetic neuralgia and can last for months or even years
.

Vaccination against herpes zoster is an effective measure to prevent the onset of
shingles.

Currently, there are three shingles vaccines on the market, in addition to GSK's Shinan Lishi, Merck's Zostavax and SK Chemical's SkyZoster
.
Among them, SkyZoster is only sold
in South Korea.
Zostavax has been discontinued due to low prevention effectiveness and weak market competitiveness
.
Both Zostavax and SkyZoster are live attenuated vaccines that are treated to achieve structural changes, reduced toxicity, but retain immunogenicity, thereby establishing an immune response; Xin'anlishi belongs to the recombinant vaccine that generates and enhances the immune response
in vivo through varicella-zoster glycoprotein E antigen and AS01B adjuvant.

In the Chinese market, GSK's Xin'an Lishi was approved for marketing in 2019, which is also the only shingles vaccine in China that has been marketed, and is aimed at people
aged 50 and above.

Since 2018, GSK's Xin'an Lishi has long occupied the top ten of the global vaccine variety, but in the Chinese market, due to high pricing, self-payment and insufficient awareness of shingles disease in middle-aged and elderly people, sales performance is relatively average
.

However, a number of local Chinese companies are developing shingles
vaccines.
There are three types of herpes zoster vaccines, namely live attenuated vaccines, recombinant vaccines and messenger RNA (mRNA) vaccines, all of which are covered by
companies.

From the perspective of the type of live attenuated vaccine, the company with the fastest development progress is Baig Biotech (688276.
SH), which obtained the clinical trial approval of live attenuated herpes zoster vaccine as early as June 26, 2014, and has completed the relevant work of clinical trials, which has been declared for marketing
.

At the end of September this year, Baig Biotech said in an investor survey that the company's clinical trial and production site verification of live attenuated herpes zoster vaccine have been completed, and the company is currently waiting for a reply
from the Drug Evaluation Center of the State Food and Drug Administration.

From the perspective of recombinant vaccine type, Luzhu Bio's recombinant shingles vaccine has entered the second phase of clinical research and development
.

From the perspective of (mRNA) vaccine types, it is still in the preclinical research stage
.

With the aging of the population and the increase in the number of new cases of shingles, the future growth space of China's shingles vaccine market is still optimistic
.
According to Frost & Sullivan data, China's shingles vaccine market increased from 0 in 2015 to 600 million yuan in 202 by sales revenue, and is expected to grow at a CAGR of 103.
8% from 2021 to 2025 to RMB10.
8 billion in 2025, and further grow at a CAGR of 21.
1% from 2025 to 2030 to RMB28.
1 billion
in 2030.