Beijing Luzhu Biotechnology Co., Ltd. ("Luzhu Biotechnology" or the "Company", together with its subsidiaries, the "Group", stock code: 02480.HK), a leading vaccine and antibody drug developer in China, is pleased to announce 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 LZ901 in healthy people aged between 50 to 70 years old. A total of 450 subjects aged between 50 to 70 years old were enrolled in the phase II clinical trial of LZ901.

Highlights of the phase II clinical trial results in the PRC are set out below:

1. 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 antibody in the high-dose and low-dose LZ901 group were significantly higher than those in the placebo group; and
   
   
2. 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 LZ901 in the PRC.
   
   
3. The phase II clinical trial data provide the definitive basis for the phase III clinical trial of LZ901. The dosage for the phase III clinical trial is determined to be 100 μg/0.5mL/vial, and the immunization program shall consist of two doses, with the second dose being administered 30 days after the first dose.

LZ901 is a recombinant herpes zoster vaccine that induces a cellular immune response to confer strong protection against shingles. Unlike live attenuated virus vaccines, recombinant protein vaccine induces an immune response while avoiding risks of residual virulence from vaccinating with live attenuated herpes zoster virus. LZ901 is expected to be priced at a competitive retail price, with a total of two injections per treatment and does not require a third booster shot, which will be more affordable compared to the retail price of the other commercially available herpes zoster vaccines in China. In addition, as demonstrated in Phase I and Phase II clinical trials for LZ901 in China, the side effects from the administration of LZ901 are minimal as its liquid formulation only contains an aluminum hydroxide adjuvant and is free of immune stimulants, which demonstrated a favorable safety profile.

In addition, Luzhu Biotechnology has received IND approval from the United States Food and Drug Administration ("FDA") in July 2022 for LZ901 and initiated a Phase I clinical trial in the U.S. in February 2023. LZ901 is the only domestic vaccine in China that has conducted clinical trials in both the U.S. and China.

Shingles is becoming more prevalent in China due to a growing aging population that is more susceptible to shingles. As part of the continuous efforts of the central government to improve the health of the elderly, the National Health Commission recommends people aged 50 years and older to obtain herpes zoster vaccination to prevent shingles. This, coupled with comparable clinical trial data of LZ901 compared to the imported Shingrix, competitive retail price, high stability of the formulation, ease of storage and transportation, and convenience of use, provide LZ901 with strong market potential and competitive advantages.

Mr. Kong Jian, Chairman, Executive Director, General Manager and Chief Scientist of Luzhu Biotechnology, said, "Since our inception, we have strategically focused on internally developing innovative human vaccines and therapeutic biologics, including vaccines, monoclonal antibodies and bispecific antibodies targeting a broad spectrum of infectious diseases, cancer, and autoimmune diseases. Leveraging our technology platforms and strong research and development capabilities, we established a diversified and advanced product pipeline. LZ901 is the only domestic vaccine in China that has conducted clinical trials in both the U.S. and China, which demonstrates our outstanding R&D and product development capabilities. LZ901 is expected to be the first product of the Company to be commercialized. In the future, we will continue to actively promote the clinical development of our pipeline candidates, lay out strategic plans to promote commercialization at home and abroad, expand production capacity to meet growing market demand to provide the public with more high-quality and affordable vaccines and therapeutic biologics."