The listing application for the core product LZ901 of Green Bamboo Biotechnology has been accepted in China, accelerating the commercialization process.

March 18, 2025,Peking Green Bamboo Biotechnology Co., Ltd.("Green Bamboo Biotechnology" or "the Company") is pleased to announce that the board of directors of the company and its subsidiaries (collectively referred to as "the Group") have released the audited consolidated annual results for the year ended December 31, 2024 (the "Reporting Period") along with comparative figures for the year ended December 31, 2023.

Since its establishment in 2001, Green Bamboo Biotechnology has focused on the field of human medicine, and has developed a technical platform based on an understanding of immunology and protein engineering, allowing the Group to develop efficient, high-purity, and improved stability recombinant vaccines and antibody research products. As of December 31, 2024, the Group's product pipeline includes three investigational products in clinical stages, one of which is the core product LZ901, and six investigational products in preclinical stages. As of December 31, 2024, the Group has a total of six research and development patents related to the core product in Russia, China, Japan, Australia, the USA, and South Korea, and three pending application patents related to the core product in Europe, the United Kingdom, and Canada. All registered patents and patent applications for the core product are related to the same set of patent claims submitted to nine different jurisdictions to protect intellectual property, considering that, apart from China and the USA, other jurisdictions are also target or potential markets for LZ901 in the future.

Research products that are in the clinical trial stage.

LZ901.LZ901 is a recombinant shingles vaccine and core product developed independently by the group. It has become the world's first shingles vaccine with a tetramer molecular structure, used to prevent shingles caused by the varicella-zoster virus ("VZV"). Compared to the naturally occurring VZV antigens, its molecular structure has double the crystallizable fragment (Fc) regions available for antigen-presenting cells ("APC") to bind. LZ901 actively presents VZV antigens to immune cells to trigger immune responses. Additionally, LZ901 has demonstrated high immunogenicity, efficacy, and safety in preclinical studies and Phase I clinical trials conducted in China, while inducing specific humoral and cellular immunity.LZ901.LZ901 is a recombinant shingles vaccine and core product developed independently by the group. It has become the world's first shingles vaccine with a tetramer molecular structure, used to prevent shingles caused by the varicella-zoster virus ("VZV").

In September 2023, the group launched a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial of LZ901 in China, enrolling a total of 26,000 healthy participants aged 40 and above by January 2024. The group also initiated a head-to-head clinical trial comparing LZ901 with Shingrix® in November 2023, enrolling 300 healthy participants aged 50 and above to further compare the immunogenicity and safety of LZ901 with Shingrix®. In June 2024, the group held a mid-term summary meeting of the Phase III clinical trial of LZ901, and based on the mid-term analysis results of the Phase III clinical trial, submitted the BLA for LZ901 to the National Medical Products Administration in January 2025, which was subsequently accepted in February 2025. The National Medical Products Administration will further undertake procedures including technical reviews, clinical trial site inspections, and manufacturing site checks to evaluate the BLA. The group currently expects to commercialize LZ901 in China around the first half of 2026.

K3.K3 is a recombinant human anti-tumor necrosis factor ("TNF")-α monoclonal antibody injection product under research, which is a biosimilar of Humira® (adalimumab), primarily used for the treatment of various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. The group launched a Phase I clinical trial in China in September 2018 (during which K3 showed pharmacokinetics consistent with adalimumab), and the trial was completed in December 2019. The group will further assess the appropriate timing to initiate Phase III clinical trials for K3 in China depending on market conditions, prospects, and the resources available to the group. K3's Phase III clinical trial in China is expected to begin as early as the first half of 2026.

K193This is a bispecific antibody injection developed by the group for the treatment of B-cell leukemia and lymphoma (B-lymphocyte antigen CD19 ("CD19") - cluster of differentiation 3 ("CD3")) currently under development. K193 is the world's first CD19/CD3 bispecific antibody with an asymmetric structure. K193 has an innovative molecular structure developed based on the group's self-researched bispecific antibody development platform Fabite® and the group's mammalian expression technology platform. Compared to other similar products on the market, it is less likely to aggregate and lose activity. In preclinical studies, K193 demonstrated high in vivo and in vitro antitumor activity, with its optimized formulation being stable and user-friendly. The unique mechanism of action of K193 gives it strong therapeutic capabilities against various types of B-cell leukemia and lymphoma. The safe and controllable administration method of K193 also reduces the stress impact on patients caused by medication. In December 2019, the group initiated the Phase I clinical trial of K193 in China, which is expected to be completed in the second half of 2025.

Other highly potential products in the preclinical stage under development.

As of the fiscal year ending December 31, 2024, the Group has begun research and development of two new products, namely a recombinant HSV-1 vaccine for oral or labioscrotal herpes caused by HSV-1 and a recombinant HSV-2 vaccine for genital herpes caused by HSV-2. Currently, both vaccines are in the preclinical stage. According to data published by the World Health Organization in December 2024, it is estimated that globally about 3.8 billion people under 50 (approximately 64%) are infected with HSV-1, and about 0.52 billion people aged 15 to 49 (approximately 13%) are infected with HSV-2. The board believes that if successful in development and commercialization, the recombinant HSV-1 vaccine and recombinant HSV-2 vaccine will be able to address unmet public medical needs, especially since there are currently no approved HSV-1 or HSV-2 vaccines globally. As of December 31, 2024, the Group has a total of six products in the preclinical stage, which are the recombinant varicella vaccine, recombinant RSV vaccine, recombinant HSV-1 vaccine, recombinant HSV-2 vaccine, K333 bispecific antibody for the treatment of myeloid leukemia, and K1932 bispecific antibody for the treatment of lymphoma.

Innovation and research drive the future.

The group's internal R&D team is involved in all stages of new vaccine and biotherapy drug development, from preclinical research and laboratory studies to clinical trials, regulatory filings, and manufacturing process development. Thus, the group has established comprehensive internal product discovery capabilities, including design and optimization of recombinant proteins, amplification, cultivation, and harvesting. As of December 31, 2024, the group's internal R&D team consists of 17 personnel. With its R&D capabilities, the group now has a diverse and advanced product pipeline, covering human vaccines under investigation, monoclonal antibody candidates, and bispecific antibody candidates.

Robust production and quality assurance.

The group has research and production facilities in Peking and Zhuhai, and is currently building a new research and production facility in Peking with a total construction area of approximately 45,072.87 square meters. The group provides training to its production team to ensure that each team member possesses the necessary skills and techniques for the relevant product processes and complies with quality control requirements as well as applicable laws and regulations. As of December 31, 2024, the group's production team includes 43 personnel. The group also has a quality control system aimed at complying with national standards, including GMP standards, covering essentially every aspect of operation, including product design, raw materials, and manufacturing. The group has an experienced quality control team, which consisted of 44 personnel as of December 31, 2024, all of whom have received professional training in regulations, GMP standards, and quality control analytical methods.

Future Outlook

The group plans to achieve its goals and vision through the following strategies: First, actively promote the clinical development of investigational drugs, particularly our core product LZ901; next, quickly initiate the development of other preclinical investigational products, including recombinant varicella vaccine, recombinant RSV vaccine, recombinant HSV-1 vaccine, recombinant HSV-2 vaccine, as well as K333 and K193. In addition, a strategic plan will be developed to promote commercialization both domestically and internationally; finally, through independent development or collaboration, the group will continue to expand its product pipeline, further strengthening our competitiveness in the market.

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