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Luzhu Biotechnology Announces 2023 Interim Results
The R&D Pipeline Continues to Advance
Commercial Deployment Has Entered into The Agenda
HONG KONG, Aug 23, 2023 - (ACN Newswire) - Beijing Luzhu Biotechnology Co., Ltd. ("Luzhu Biotechnology" or the "Company", together with its subsidiaries, the "Group", stock code: 02480.HK), announced its interim results for the six months ended June 30, 2023 (" the period ").
Luzhu Biotechnology is a biotechnology company dedicated to developing innovative human vaccines and therapeutic biologics, with products for the prevention and control of infectious diseases, as well as the treatment of cancer and autoimmune diseases. As of June 30, 2023, the company's product pipeline includes three ongoing clinical products, one of which is the core product LZ901 (recombinant herpes zoster vaccine), and four ongoing pre-clinical products. There are also two intention patents and seven pending applications relating to the core product.
During the period, the Company completed its listing on the Main Board of the Hong Kong Stock Exchange, and the net proceeds from the listing were approximately HK$241.6 million. As of June 30, 2023, as a biotechnology company that has not yet achieved commercialization, the Company has achieved other income of approximately RMB5.3 million and the R&D expenses amounted to approximately RMB33.2 million. Loss and total comprehensive expense for the period decreased by approximately 88% period-on-period, from a loss of approximately RMB652 million to a loss of approximately RMB79.4 million, mainly because there was no fair value loss of financial liabilities at fair value through profit or loss during the period as the shares involved had been reclassified from financial liabilities to equity at their fair value in June 2022.
Mr. KONG Jian, Executive Director, General Manager and Chief Scientist of Luzhu Biotechnology, said: "Since our inception in 2001, we have strategically focused on the field of human medicine. With our understanding of immunology and protein engineering, we have established an innovative precision protein engineering platform for developing our recombinant vaccine and antibody product candidates with excellent efficiency, high purity, and improved stability. After years of effort, three of our product candidates have entered into the clinical stage, including our core product LZ901, which is expected to commence phase III clinical trial in China in the third quarter of 2023, and achieve commercialization in the fourth quarter of 2025. As commercial deployment of our product candidates has entered into our agenda, we believe that the company's capabilities and commercial value will be presented more directly going forward."
Strong Technical Platform Supporting Multi Product Pipeline Research and Development
After 20 years of research and development, Luzhu Biotechnology has established an innovative precision protein engineering platform, which empowers the entire cycle of drug development and provides a solid foundation for the development of the Group's human vaccines candidates, monoclonal antibody product candidates and bispecific antibody product candidates.
The innovative antigen presentation technology used by the Group for vaccine development starts from the concept of improving the immunogenicity of a target antigen, then streamlines the design of a recombinant viral antigen while retaining the primary structure of the natural antigen to improve immunogenicity, safety, and patient vaccination experience. By using the internally developed next-generation bispecific antibody development platform, Fabite, and with the help of production-house biologics manufacturing infrastructure and capabilities, the Group established a diversified and advanced product pipeline, covering human vaccine candidates, monoclonal antibody product candidates, and bispecific antibody product candidates.
LZ901 is the Company's independently developed recombinant herpes zoster vaccine candidate and core product. It has a tetramer molecular structure to prevent shingles, and has initiated clinical trials in both China and the United States. LZ901 has demonstrated high immunogenicity, efficacy, and safety in pre-clinical studies and phase I/II clinical trials in China, while inducing specific humoral and cellular immunity. The Company plans to conduct the Phase III clinical trial of LZ901 in China in the third quarter of 2023, expanding the enrollment scope to adults aged 40 and above, and submitting a Biological Product License Application ("BLA") in the second half of 2024, and achieving product commercialization in the fourth quarter of 2025.
Future Outlook
Going forward, the Group plans to implement the following strategies and vision of the Group:
-- actively promote the clinical development of the Group's pipeline candidates including LZ901, K3 and K193;
-- rapidly advance the development of the other pre-clinical product candidates of the Group, including recombinant varicella vaccine, recombinant rabies vaccine, K333 and K1932;
-- expand the production capacity of the Group to meet growing market demand;
-- lay out strategic plans to promote commercialization in China and abroad; and
-- expand the product pipeline of the Group through independent development and/or collaboration.
The results announcement shows that Luzhu Biotechnology is orderly advancing the research and development of its product candidates.
In particular, for K3, the independently developed recombinant human anti-TNF-a monoclonal antibody injection product candidate of the Group, which is a biosimilar of adalimumab, the Group plans to initiate a phase III clinical trial in China in the first quarter of 2024 and complete the same in the fourth quarter of 2024. The Group further plans to submit a BLA for K3 in the fourth quarter of 2024 or first quarter of 2025. The Group expects K3 to receive BLA approval in the second half of 2025 and achieve commercialization in the fourth quarter of 2025, thereby expanding the market in China for adalimumab biosimilars.
For K193, the independently developed bispecific antibody injection (B-lymphocyte antigen CD19-cluster of differentiation 3) product candidate of the Group for the treatment of B cell leukemia and lymphoma, the Group expects to complete the phase I clinical trial in China in the first quarter of 2024 and plans to initiate a phase II clinical trial in China in the second quarter of 2024.
The series of layouts means that Luzhu Biotechnology will further strengthen the business expansion and development of pipelines, accelerate the commercialization process of pipelines, and rapidly enhance the social and commercial value of Luzhu Biotechnology.
Source: Beijing Luzhu Biotechnology Co., Ltd.
Sectors: BioTech, Healthcare & Pharm
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