On the evening of January 31, BCHT Biotechnology announced that its zoster vaccine live had been approved for marketing, intending to prevent the herpes zoster infection in people over 40 years old, which is also the first approved herpes zoster vaccine made in China. The announcement notes that after obtaining the drug registration certificate, the zoster vaccine live also need to obtain the lot release certification and complete procedures such as the local access, making the time for marketing is not sure. Thus, the price of the vaccine has not been determined, and the clinical data has not yet been disclosed. Nevertheless, BCHT Biotechnology still kicks off the domestic substitution of the herpes zoster vaccine.
What is the herpes zoster? What are the technical routes for vaccine R&D? What's the current progress of R&D?
The market demand of the herpes zoster vaccine is huge
Herpes zoster (HZ) is an acute infectious skin disease caused by the reactivation of varicella-zoster virus (VZV) lurking in the body. When VZV is infected for the first time in childhood, it causes varicella. Then the virus enters the skin sensory nerve ending, moves to the center via the nerve fiber of the posterior root of the spinal cord or the trigeminal ganglion, and exists in the sensory ganglion of spinal nerve or cranial nerve for a long time in a persistent and latent form.
When the body has a low immunity or a nonspecific stimulation, the virus will be re-active, grow and propagate, causing the invaded ganglion inflammation or necrosis. Before the outbreak, the patients are characterized by low fever, discomfort, pain in the site where the rash will occur, and paresthesia; During the acute attack stage, the patients are characterized by rash and pain, blister on the unilateral skin surface, erythema, etc; During the chronic stage, the patients are characterized by persistent postherpetic neuralgia. According to the patients' description, the pain of postherpetic neuralgia is comparable to the labor pain and chronic cancer pain, which will last for weeks to years. The morbidity and severity of herpes zoster show a growth trend with the increase in age. About 70% cases of herpes zoster occur in the people over 50 years old.
At present, herpes zoster can not be treated by any specific medicine, and vaccine is the most effective prevention way. According to the consulting organizations, the herpes zoster vaccine market is forecast to reach RMB 56 billion in China in 2030, with a huge clinical need.
When Shingrix monopolizes the market with its excellent efficacy, how can BCHT Biotechnology stand out?
At present, only 3 kind herpes zoster vaccines are approved for marketing, that is MSD's Zostavax, GSK's Shingrix and SK's SkyZoster. Among them, SkyZoster is only sold in Korea.
Shingrix monopolizes the market with its excellent efficacy for its technical route and its self-developed new adjuvant AS01B, then how can BCHT Biotechnology's herpes zoster vaccine stand out?
According to the BCHT Biotechnology, its herpes zoster vaccine has the following advantages: (1) Applicable age is younger: People over 40 years old (it is over 50 years old for Shingrix); (2) One injection in the whole vaccination process, with high compliance (two injections for Shingrix); (3) Adverse reaction is low, with a better safety.
It is predicted that the revenue peak of BCHT Biotechnology's herpes zoster vaccine will reach about RMB 3.5-4.5 billion according to the current data of the active population of middle-aged and elderly people vaccinated with the flu vaccine.
The R&D status of herpes zoster vaccine in China
At present, in China, the enterprises with the herpes zoster vaccine can be mainly divided into two categories: One is the enterprises with live attenuation vaccine, including BCHT Biotechnology, Wantai BioPharm, Shanghai Biotechnology, etc, among which BCHT Biotechnology is in the fastest progress of this technical route. The other one is the enterprises with recombinant protein vaccine, including RECBIO, Immune-Path Biotechnology, Luzhu Biotech, Ab&B Bio-Tech, etc.
Among them, the Immune-Path Biotechnology is in the fastest progress. In 2020, the clinical trial ...
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