On the evening of January 21, 2026, Hualan Vaccine announced that it recently received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) for its Recombinant Zoster Vaccine (CHO Cell).
Following a review conducted under the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, and other relevant regulations, the vaccine (accepted on October 30, 2025) has met the requirements for drug registration. Clinical trials for the prevention of herpes zoster (shingles) are now authorized to proceed.
The announcement explains that Herpes Zoster (Shingles) is an acute cutaneous and neurological disease caused by the reactivation of the varicella-zoster virus (VZV) after years of dormancy. It primarily affects adults and the elderly with declining immune function. Characterized by clusters of vesicles along nerves and significant pain, it can severely impact quality of life. Its primary complication, postherpetic neuralgia (PHN), may persist for months or longer after the rash subsides. According to the July 2025 article "Prevalence and Risk Factors of Herpes Zoster in the Chinese Population" in the Chinese Journal of Epidemiology, a survey of approximately 28,000 adults across 25 provinces showed an overall prevalence of 6.15% in China, rising to 12.95% among those aged 70 and above. Vaccination is considered a crucial preventive measure, and with China's accelerating aging population and rising health awareness, the domestic market for shingles vaccines holds significant growth potential.
The Recombinant Zoster Vaccine (CHO Cell) developed by Hualan Vaccine utilizes Chinese Hamster Ovary (CHO) cells to express key VZV proteins, aiming to reduce the risk of shingles and complications by inducing an immune response. As a mature and safe biopharmaceutical platform, CHO cells facilitate stable and reliable production. This product represents a key strategic move for the company in the field of shingles prevention, potentially offering a new option for susceptible populations.
This clinical trial approval marks the official transition of the vaccine's development into the clinical testing phase, which will further verify its safety and efficacy. This milestone lays the foundation for future registration and marketing, enriches the company’s R&D pipeline, and carries positive significance for Hualan Vaccine's long-term development.
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