The company is a biotechnology company dedicated to developing innovative human vaccines and therapeutic biologics to prevent and control infectious diseases and treat cancer and autoimmune diseases. Since its establishment in 2001, the Group has focused on the field of human medicine, and has established a technical platform based on its understanding of immunology and protein engineering, so that the Group can develop recombinant vaccines and antibody products with improved efficiency, high purity and stability. As of June 30, 2024, the Group's product pipeline includes three clinical-stage products under development, one of which is the core product LZ901, and four pre-clinical products under development. As of June 30, 2024, the Group has five R&D patents related to core products and four pending approval applications. All registered patents and patent applications for core products relate to the same set of patent claims filed in nine different jurisdictions to protect the core product. This is because in addition to China and the US, other jurisdictions are also future target markets or potential markets for LZ901. The Company's H shares were listed on the Stock Exchange on May 8, 2023. The total net proceeds of the Company's global offering of H shares (“Global Offering”) (net of underwriting commissions and other expenses payable by the Company in connection with the global offering) is approximately HK$241.6 million.
相关临床试验
5
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2001
招募中
2
40.0%
Unknown
3
60.0%
暂无批准数据
- LZ901, a recombinant gE-Fc fusion protein subunit vaccine, achieved 91.6% overall efficacy against herpes zoster in a Phase III trial of 26,018 adults aged ≥40 years. - Vaccine efficacy was 93.9% in participants aged 40–69 but declined to 66.9% in those aged ≥70, with 95.5% efficacy against post-herpetic neuralgia. - LZ901 uses an aluminum hydroxide adjuvant, differentiating it from GSK's Shingrix, and demonstrated a favorable safety profile with low grade 3 reactions. - Beijing Luzhu Biotechnology has submitted a BLA to China's NMPA, with the publication providing peer-reviewed support for potential first domestic recombinant zoster vaccine approval.
- Luzhu Biotechnology's recombinant herpes zoster vaccine LZ901 successfully completed Phase II clinical trials in China with 450 subjects aged 50-70, demonstrating superior immunogenicity compared to placebo groups. - The vaccine showed a favorable safety profile with adverse events primarily occurring within 0-7 days and no Grade IV adverse events or serious adverse events observed during the Phase II trial. - LZ901 completed Phase I clinical trials in the United States in September 2025, with both high-dose and low-dose groups showing good safety and immunogenicity compared to placebo. - The company has received Biologics License Application acceptance from China's National Medical Products Administration and is advancing toward Phase III clinical trials with a competitive pricing strategy.
- Beijing Luzhu Biotechnology has achieved a significant regulatory milestone as China's NMPA accepts the biologics license application for its recombinant herpes zoster vaccine LZ901. - The vaccine, targeting adults aged 40 and above, has successfully met its Phase III clinical trial endpoints, positioning it as a potential new preventive option for shingles. - While the acceptance enables further regulatory evaluation, the company maintains cautious outlook regarding the ultimate development and commercialization success.
