Luzhu Biotech-B (2480.HK) announces full-year 2025 performance

Core product LZ901 demonstrates excellent safety and immunogenicity, expected to be commercialized in the second half of 2026

Business Highlights

For the 12 months ended December 31, 2025:

During the reporting period, significant progress was made in the clinical development and commercialization of Greentree Biotech's product pipeline. In January 2025, the company submitted a BLA for its core product LZ901 to the National Medical Products Administration (NMPA), which was subsequently accepted in February 2025. By the third quarter of 2025, the NMPA completed on-site inspections for clinical trials and production facilities. As of the announcement date, the NMPA is still reviewing the BLA for LZ901, with the company expecting commercial launch in the second half of 2026.

Additionally, head-to-head comparative studies demonstrated superior advantages. The company successfully completed the head-to-head comparative study for LZ901 in the first half of 2025. The results showed that compared to the recombinant glycoprotein E subunit vaccine HZ/su (Shingrix®), LZ901 induced stronger cellular immunogenicity and exhibited better safety in adults aged 50 years or older.

The US clinical trial concluded successfully. In September 2025, the company successfully completed the Phase I clinical trial of LZ901 in the United States. According to the clinical trial results, both the high-dose and low-dose groups of the LZ901 vaccine demonstrated good safety and immunogenicity compared to the placebo group.

Other pipelines are proceeding steadily. In the fourth quarter of 2025, the company’s recombinant Respiratory Syncytial Virus (RSV) vaccine entered the pre-IND application stage. Additionally, the company has multiple preclinical products in its pipeline, including a recombinant varicella vaccine, recombinant HSV-1/2 vaccine, and bispecific antibodies K333 and K1932.

(March 19, 2026, Hong Kong, China) Beijing Greentree Biotechnology Co., Ltd. (Company") Director ("Director」）会（「Board of DirectorsThe group and its subsidiaries (collectively referred to as "announced on March 18, 2026.Group) for the year ended December 31, 2025 ("Reporting Period") along with comparative figures for the year ended December 31, 2024.

During the reporting period, the company managed to narrow its losses due to improved research and development efficiency and the completion of phased investments. Other income of the group decreased by approximately 48.4% from about RMB 21.4 million for the year ended December 31, 2024, to approximately RMB 11.0 million for the year ended December 31, 2025, primarily due to a reduction in government subsidies and interest income on bank balances. Research and development expenses decreased by approximately 28.6% from about RMB 135.1 million for the year ended December 31, 2024, to approximately RMB 96.5 million for the year ended December 31, 2025, mainly because of reduced clinical trial expenses for LZ901 and the full recognition of employee costs related to share-based payments under the existing share award plan in 2024, with no such costs recognized in 2025. The pre-tax loss decreased by approximately 10.6% from around RMB 168.2 million for the year ended December 31, 2024, to approximately RMB 150.4 million for the year ended December 31, 2025.

As of December 31, 2025, the company had bank balances of approximately RMB 95.9 million, financial assets at fair value through profit or loss of approximately RMB 323.5 million, total cash and financial assets amounting to approximately RMB 419.4 million, and unused credit lines from banking facilities totaling approximately RMB 400.3 million. The company’s cash reserves and financing sources were relatively sufficient, indicating an overall improvement in financial health.

Multiple vaccines in clinical trial stages establish a diversified and advanced product pipeline

As of December 31, 2025, the group's product pipeline included three investigational products in clinical stages and six investigational products in pre-clinical stages.

The three investigational products in clinical stages include:

LZ901

LZ901 is a recombinant shingles vaccine independently developed by the group, featuring a tetrameric molecular structure for preventing shingles caused by the varicella-zoster virus. In January 2025, Green Bamboo Biotech submitted the BLA for its core product LZ901 to the National Medical Products Administration, which was accepted in February. In the third quarter of 2025, the NMPA completed on-site inspections of LZ901's clinical trials and production processes. As of this announcement date, the NMPA is still reviewing the BLA for LZ901. The group currently anticipates commercializing LZ901 in mainland China in the second half of 2026.

During the reporting period, the group successfully completed the head-to-head comparative study of LZ901. The results showed that compared to the recombinant glycoprotein E subunit vaccine HZ/su (Shingrix®), LZ901 demonstrated superior cellular immunogenicity and better safety in adults aged 50 years or older. Additionally, in September 2025, the group successfully completed the Phase I clinical trial of LZ901 in the United States. The trial results indicated that both the high-dose and low-dose groups of the LZ901 vaccine showed good safety and immunogenicity compared to the placebo group, laying a foundation for subsequent clinical studies.

K3 is a research-stage product independently developed by the group, being a biosimilar of Humira® (adalimumab), a recombinant human anti-tumor necrosis factor (TNF)-α monoclonal antibody injection. It is primarily used to treat various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. The Phase III clinical trial of K3 in mainland China is expected to begin no earlier than 2027.

K193

K193 is a bispecific antibody injection independently developed by the group for the treatment of B-cell leukemia and lymphoma, targeting B-lymphocyte antigen CD19 (CD19) and cluster of differentiation 3 (CD3). K193 is the world's first bispecific antibody with an asymmetric structure targeting CD19/CD3. In December 2019, the group initiated the Phase I clinical trial of K193 in mainland China, which is expected to be completed no earlier than 2027.

The group also has six other preclinical research-stage products: recombinant varicella vaccine, recombinant RSV vaccine, recombinant HSV-1 vaccine, recombinant HSV-2 vaccine, K333 bispecific antibody for treating myeloid leukemia, and K1932 bispecific antibody for treating lymphoma. As of the fourth quarter of 2025, the recombinant RSV vaccine has entered the pre-IND application stage.

At the same time, the group places great emphasis on ensuring production and quality. The group owns research and production facilities in Beijing and Zhuhai. The new research facility located in Yizhuang, Beijing, began operations in August 2025. Meanwhile, the production facility in Beijing is expected to commence trial operations in the second half of 2026. The group provides training to its production team to ensure that every team member possesses the necessary skills and techniques required for the relevant product processes while adhering to quality control requirements and applicable laws and regulations. As of December 31, 2025, the group’s production team consists of 48 personnel.

In preparation for the commercialization of its core product LZ901, the group began forming a commercialization team in the second half of 2025. As of December 31, 2025, the group’s commercialization team includes 11 personnel.

Future and Outlook

The group plans to actively promote the clinical development of drugs in its pipeline, particularly the clinical development of its core product LZ901. It will also rapidly advance the development of other preclinical products in the pipeline, formulate strategic plans to facilitate domestic and international commercialization efforts, and expand the group’s product pipeline through independent development and/or collaboration. While fully advancing the commercialization of LZ901, the group will continue to invest resources to accelerate the development of subsequent pipeline projects: the recombinant RSV vaccine entered the pre-IND stage in the fourth quarter of 2025; the recombinant HSV-2 and HSV-1 vaccines are expected to enter the pre-IND stages in the second half of 2026 and 2027, respectively; bispecific antibody products such as K333 for treating myeloid leukemia and K1932 for treating B-cell lymphoma are also in the preclinical stage, and the group will simultaneously push forward their research and development.

About Beijing Green Bamboo Biotechnology Co., Ltd.

Beijing Luzhu Biotechnology Co., Ltd. is a biotech company dedicated to developing innovative human vaccines and therapeutic biologics to prevent and control infectious diseases, as well as treat cancer and autoimmune disorders. Since its establishment in 2001, the group has focused on human medicine, leveraging its understanding of immunology and protein engineering to build a technology platform that enables the development of recombinant vaccines and antibody candidates with improved efficiency, high purity, and enhanced stability.

As of the date of this report, the group's product pipeline includes three clinical-stage candidates, one of which is the core product LZ901, along with six preclinical-stage candidates. The group holds seven patents related to the core product across Russia, mainland China, Japan, Australia, the United States, Canada, and South Korea, as well as two pending applications in Europe and the UK. All registered patents and patent applications for the core product are associated with the same set of patent claims filed in nine different jurisdictions to protect the core product, reflecting the fact that apart from mainland China and the US, other jurisdictions are also considered future target or potential markets for LZ901.

The company's H shares were listed on the Stock Exchange on May 8, 2023.

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