Beijing Luzhu Biotechnology Co., Ltd. announced that the recombinant herpes zoster vaccine, a core product independently developed by the Group -- LZ901, its phase II clinical trial in China has been completed successfully in May 2023. The Company is in the course of advancing the multi-center, randomized, double-blinded, and placebo-controlled phase III clinical trial of LZ901 in the PRC, and targets to commence the same as early as possible. The phase II clinical trial of LZ901 was designed as a randomized, double-blinded and placebo-controlled clinical trial.

The primary objectives of this clinical trial are to evaluate the immunogenicity and safety of different doses of LZ901 in healthy people aged between 50 to 70 years old. The secondary objective of this clinical trial is to evaluate the immune persistence of different doses of LZ9901 in healthy people aged between50 to 70 years old. A total of 450 subjects aged between 50 to 70 yearsold were enrolled in the phase IIclinical trial of LZ901.

Highlights of the phase II clinical trial results in the PRC are set out below: in terms of immunogenicity studies, the geometric mean concentration ("GMC"), geometric mean titer ("GMT") and the positive conversion rate of antibody in the high-dose LZ901 group were significantly higher than those in the low-dose cohorts. On the other hand, the GMC, GMT and the positive conversion rate of antibodies in the high-dose and low-dose LZ901 group was significantly higher than those in the placebo group; and in terms of safety studies, adverse events ("AEs") in the trial mainly occurred within 0-7 days, and the incidence rate of Grade I, Grade II and Grade III AEs of the trial vaccines were approximately 23.74%, 6.02% and 1.00%, respectively. No Grade IV AEs and no serious AEs had been observed during the phase II clinical trial of L Z901 in the PRC.

The phase II clinical trial data provide the definitive basis for the phase III clinical trial of L Z901.