REC610 – Recombinant Shingles Vaccine Candidate under Phase I Clinical Stage

In December 2022, we obtained a clinical trial approval in the Philippines for novel adjuvanted recombinant shingles vaccine, REC610, and the first batch of subject enrollment was completed

in February 2023. This clinical study is a randomized, observerblinded, GSK Shingrix® active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above. As of the Latest Practicable Date, the phase I clinical trial in the Philippines has been progressing smoothly, and a follow-up on all subjects has been completed 30 days after they received two doses of vaccine, showing favorable safety profile and tolerability. The application for conducting clinical trials for REC610 in China has been accepted. If no adverse opinions or doubts have been received from the CDE of the NMPA within 60 days from the date of acceptance, the Company may conduct clinical trials according to the submitted plan..

• Shingles Vaccine
  

Herpes zoster (HZ) is a disease caused by reactivation of the varicella-zoster virus (VZV) of the dorsal sensory ganglion or cranial ganglion. This reactivation occurs when immunity to VZV declines due to aging or immunosuppression. Shingles can occur at any age, but is most common in older people. Symptoms of shingles usually include general malaise, fever, chills, myalgia, headache, itching, numbness and a rash. Chickenpox - The shingles virus can spread from a person with active shingles to another person who has never had chickenpox or been vaccinated. After recovery from shingles, the virus can remain dormant in the dorsal sensory and cranial ganglia for decades.

About 2.5 million adults in China develop shingles each year, and almost all Chinese adults over the age of 50 carry dormant herpes zoster virus. Based on existing clinical studies, GSK's adjuvant recombinant protein vaccine Shingrix®, the only approved shingles vaccine in China, has outperformed Merck's Zostavax® in its prophylactic efficacy. Phase III clinical data from Shingrix® demonstrated a prophylaxis efficacy of 96.6% in people aged 50 to 59 years, 97.4% in people aged 60 to 69 years, and 91.3% in people older than 70 years.

REC610 -- Recombinant herpes zoster vaccine

• Using recombinant protein technology similar to Shingrix® and showing immunogenicity not inferior to Shingrix® in animal studies
• Like GSK, technical pain points have been addressed and a complex adjuvant system has been developed to enhance immunogenicity
• Simultaneously evaluate the possibility of using new adjuvants developed internally
• Plans to use COVID-19 vaccine manufacturing expertise to achieve co-production at the commercial stage