ABOUT LUZHU

Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Biotech) was established in November 2001, located at No. 3 Guangtong Street, Zhangjiawan Tongzhou District, Beijing,which occupies approximately 27 acres of land. Since inception in 2001, Luzhu Biotech had successfully developed 3 polysaccharide protein conjugate vaccines, 2 polysaccharide vaccines and 1 virus inactivated vaccine, all of which have been transferred to Beijing Zhifei Luzhu Biopharmaceuticals Co., Ltd. In 2009, Luzhu Biotech initiated Phase I clinical trials for K193 of bispecific antibody injection product for the treatment of B cell leukemia and lymphoma in China. Luzhu Biotech began the research on human monoclonal antibodies, bispecific antibodies, and recombinant virus vaccines. Luzhu Biotech obtained clinical approvals for two monoclonal antibody biological analogues in 2017, and a CD19-CD3 bispecific K193 antibody in 2019 for the treatment of B-cell leukemia and lymphoma. Its Recombinant Herpes Zoster Vaccine was approved for clinical study in August 2021.


Luzhu Biotech will use well-established targeted antigen presentation technologies to develop a variety of viral vaccines, and will utilize bispecific antibody development technology platform (Registered trademarks Fabite®, Fabsca®) of which company owns intellectual property rights, has competitive advantages in the development of bispecific antibody products for the treatment of hematological malignancies.


At the end of 2018, Luzhu Biopharmaceuticals (Zhuhai) Co., Ltd. a wholly-owned subsidiary, was established in Jinwan District, Zhuhai City with a registered capital of RMB200.0 million, occupying approximately 69,366 sq.m. The subsidiary is principally engaged in research, development and production of vaccines and therapeutic biologics.


Luzhu Biotech will continue to focus on the research and development (R&D) of vaccine and therapeutic bispecific antibody for human disease prevention, control and treatment, and remain committed to providing high-quality and affordable human vaccines and therapeutic biologics. After two decades of independent research and development and active introduction of innovative technologies, Luzhu Biotech has established multiple innovative technology platforms empowering the full cycle of drug development, which provides a solid foundation for the development of human vaccines candidates, monoclonal antibody product candidates and bispecific antibody product candidates.

Since inception in 2001, Luzhu Biotech had successfully developed five commercialized vaccine products, namely Meningococcal Group A and C Conjugate Vaccine, Meningococcal Groups A and C and Haemophilus Influenzae Type b Conjugate Vaccine, Haemophilus Influenzae Type b Conjugate Vaccine, Group A/C/Y/W135 Meningococcal Polysaccharide Vaccine and Group A and C Meningococcal Polysaccharide Vaccine. All of them had been transferred to Zhifei Luzhu Biopharma. Inactivated EV71 Vaccine, a vaccine candidate Luzhu Biotech independently developed. In December 2018, Luzhu Biotech obtained NMPA clinical trial approval for Inactivated Enterovirus Type 71 vaccine. Inactivated EV71 Vaccine has been transferred to Zhifei Biopharma.

Luzhu Biotech initiated the study of recombinant human monoclonal antibody and received clinical trial approvals for 2 biosimilar drugs in 2017 and a bispecific antibody in 2019.

Luzhu Biotech makes use of bispecific antibody development technology platform, (Registered trademarks Fabite®, Fabsca®), and has developed several types of bispecific antibodies for the treatment of human leukemia. The K193 antibody injection is currently in Phase Ⅰ clinical study.

Luzhu Biotech received clinical trial application approval for Recombinant Herpes Zoster Vaccine from the NMPA in August 2021, and has completed a Phase Ⅰ clinical trial and are currently conducting a Phase Ⅱ clinical trial in China. In addition, Luzhu Biotech has submitted an IND application to the FDA.

Luzhu Biotech had three invention patents granted and four registered trademarks in the PRC. Luzhu Biotech had filed 10 patent applications worldwide, of which one invention patent application is about to be granted in Russia, and another invention patent application is about to be granted in the PRC.

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