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Summary
We are a biotechnology company committed to developing innovative human vaccines and therapeutic biologics to prevent and control infectious diseases and treat cancer and autoimmune diseases. Since our inception in 2001, we have focused on human medicine and have established technology platforms with our understanding of immunology and protein engineering, which empowers us to develop our recombinant vaccine and antibody product candidates with favorable efficiency, high purity and improved stability. As of the Latest Practicable Date, our product pipeline consisted of three clinical-stage product candidates, including our Core Product LZ901, and four pre-clinical-stage product candidates. As of the same date, we had two invention patents and seven pending applications relating to our Core Product. All of the registered patents and patent applications for our Core Product are related to the same set of patent claims filed to nine different jurisdictions to protect our intellectual property, given that in addition to China and the U.S., the other jurisdictions are also the target markets or potential markets in the future for LZ901.

WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OUR CORE PRODUCT, OR ANY OF OUR PIPELINE PRODUCTS.

Since our inception, we have strategically focused on internally developing innovative human vaccines, including bacterial-based vaccines and recombinant vaccines, and therapeutic biologics, such as monoclonal antibodies and bispecific antibodies, targeting a broad spectrum of infectious diseases, cancer, and autoimmune diseases. Leveraging our technology platforms and strong research and development capabilities, we established a diversified and advanced product pipeline. During the Track Record Period and up to the Latest Practicable Date, we did not generate any revenue as we had out-licensed most of our historically developed candidates before the Track Record Period, and by the Latest Practicable Date we had not commercialized any of our product candidates.

OUR BUSINESS MODEL

We operate a business model focused on in-house discovery, research and development and commercialization, and out-licensing of high-quality and affordable human vaccines and therapeutic biologics. We are led by an experienced management team that manages our research and development, manufacturing and commercialization. Our co-founder, executive Director, general manager and chief scientist, Mr. KONG Jian, has over 33 years of biopharmaceutical experience leading scientific research of biological products and has developed five bacteria vaccines (the “Bacteria Vaccines”). For details, please see “— Our Products and Product Candidates — Our Other Historically Developed Products” and “Business — Our Products and Product Candidates — Our Commercialized Vaccine Products” in this document. Led by our management team and supported by our research and development team with strong execution capabilities, we have adopted an efficient approach to identify proven targets, such as antigens, that have produced effects during treatment to optimize, transform and develop into product candidates that enhance our portfolio for the treatment of cancer and autoimmune diseases. We have built a diversified and advanced product pipeline. We expect to continue to advance our pipeline of clinical-stage and pre-clinical stage product candidates and discover new product candidates over time.

Since our inception in 2001 and prior to the Series A Financing in 2019, we primarily relied on (i) capital injections from our shareholders, primarily due to which our registered capital increased from RMB0.5 million in 2001 to RMB78.6 million in 2019, (ii) one-off or milestone payments of RMB34.8 million in total received from our historically developed products that had been transferred or out-licensed to third-parties prior to the Track Record Period, and (iii) revenue generated from the sales of the Immunoreagent Testing Kits to support our business operations, which amounted to RMB9.1 million from 2004 to 2018. For details of the our registered capital and subsequent capital injections by our shareholders since our inception and prior to the Series A Financing, please see the section headed “History, Development and Corporate Structure” in this document. For details of the revenue generated from the sales of the Immunoreagent Testing Kits, please see “— Our Products and Product Candidates — Our Other Historically Developed Products” in this section.

In the future, we plan to prioritize the development of innovative recombinant protein vaccines, followed by innovative biological products to meet the unmet needs of disease prevention and treatment. Other than K3, a biosimilar of adalimumab, we do not plan to develop or commercialize any other biosimilars as biosimilars have low profit margins due to fierce competition from originator drugs and other competing biosimilars and the development and commercialization of K3 requires strict cost controls to maintain profit margin. As a result, we plan to focus on innovative recombinant protein vaccines and innovative biological products that have higher profit margins. K3 is the only biosimilar we plan to develop and commercialize as adalimumab holds the largest market share of anti-TNF-α biologics globally and has large market opportunity.

Going forward, we will actively explore collaboration opportunities in the development, manufacturing and sales of our products, including out-licensing of our product candidates. We currently do not have any plan to out-license LZ901 and our other product candidates in China. We plan to collaborate with multinational pharmaceutical companies who have a robust sales and marketing network to rapidly commercialize LZ901 globally in overseas markets, including in the U.S. and Southeast Asian countries. As of the Latest Practicable Date, we had only initiated preliminary discussions with third parties to explore opportunities to out-license LZ901 in markets outside of China, and had not identified any collaboration partners. For details, please see “Business — Commercialization” in this document. Before deciding whether to out-license a product candidate, we identify collaboration partners who may be better positioned to accelerate or further research and development or successful commercialization of the product candidate. We communicate with our collaboration partners, approximately once a quarter and on an irregular basis for related technologies for Beijing Science Sun and from time to time for Zhifei Biopharma, to monitor the progress of product development or achievement of commercialization performance targets.



Source: Luzhu Biotech-B (02480) Prospectus (IPO Date : 2023/04/25)
Listing Market MAIN
Industry Biotechnology - Pharmaceuticals
Background H Shares
Major Business Area N/A
Corporate Information
Substantial Shareholders KONG Jian & Associates (Total share: 45.90%); (H share: 45.90%)
Beijing E-town Sun Fund Management Co., Ltd. (Total share: 18.89%); (H share: 18.89%)
Beijing Yizhuang II Biological Medical Industry Investment Fund (Total share: 9.12%); (H share: 9.12%)
Beijing Science Sun Pharmaceutical Co., Ltd. (Total share: 6.84%); (H share: 6.84%)
[00939] China Construction Bank Corporation (Total share: 5.79%); (H share: 5.79%)
Directors KONG Jian (Chairman and General Manager and Chief Scientific Officer and Executive Director)
JIANG Xianmin (Vice Chairlady and Deputy General Manager and Chief Medical Officer and Executive Director)
ZHANG Yanping (Deputy General Manager and Executive Director)
KONG Shuangquan (Non-Executive Director)
MA Biao (Non-Executive Director)
HOU Aijun (Independent Non-Executive Director)
LEUNG Wai Yip (Independent Non-Executive Director)
LIANG Yeshi (Independent Non-Executive Director)
Company Secretary LIU Siyu
YUEN Wing Yan, Winnie
Principal Bankers Agricultural Bank of China Limited
China Construction Bank
Solicitors Eric Chow & Co. in Association with Commerce & Finance Law Offices
Commerce & Finance Law Offices
Auditors Deloitte Touche Tohmatsu
Registered Office 5th Floor, Manulife Place, 348 Kwun Tong Road, Kowloon, Hong Kong
Share Registrars Tricor Investor Services Ltd. [Tel: (852) 2980-1333]
Share Registrars Tel No (852) 2980-1333
Internet Address http://www.luzhubiotech.com
Email Address IR@luzhubiotech.com
Tel No (86 010) 6156-8561
Fax No (86 010) 6156-7093
 
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