The new engine of macromolecular drug research, Xuanzhu biomacromolecule research and development platform developed rapidly.

　　Drugs are generally divided into chemical small molecule drugs and biological large molecule drugs. Small molecule drugs can enter the human body by oral administration or injection, which is convenient for administration. Macromolecule drugs, also known as biological products, refer to drugs used for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood and blood components, somatic cells, gene therapy and recombinant therapeutic proteins, which are prepared from ordinary microorganisms, cells, various animal and human tissues and liquids obtained by biotechnology such as genetic engineering, cell engineering, protein engineering and fermentation engineering.

　　Compared with chemically synthesized drugs, biomacromolecule drugs have the characteristics of large relative molecular weight, complex structure, low dosage and easy degradation in vivo. With the rapid development of biotechnology and the growing prosperity of biomedical industry, the focus of global research and development is shifting from small molecules to large molecules, and biomacromolecule drugs are widely used to treat tumors, autoimmune diseases and metabolic diseases. At present, the advanced treatment methods for major diseases in the world are all related to biomacromolecule drugs.

　　As one of the most promising and fiercely competitive fields of drug research and development in the 21st century, developed countries such as Europe, the United States, and Japan all put biomacromolecule drugs as the focus of drug research and development. The biopharmaceutical market in China is also developing rapidly, and it is estimated that the compound annual growth rate will reach 14.4% from 2021 to 2030. The outline of China's medium-and long-term scientific and technological development plan has listed "protein drugs" as a major scientific problem to be solved urgently in the country, and it has been included in the key development field of "population and health".

　　Broad prospects of drugs based on biological macromolecules. Xuanzhu Bio has advanced layout, built two potential antibody technology platforms "Mab-Edit" and "Mebs-Ig" (bispecific antibody edited by antibody), established a macromolecular R&D center, laid out two innovative fields of double antibody and double antibody ADC, and built a mature macromolecular R&D system in the whole process.

　　In the past two years, based on the continuous progress of independent research and development capabilities, Xuanzhu Bio has been getting good news in the development of macromolecular drugs. In March, 2022, XZP-KM257, a class I innovative drug independently developed, was applied for clinical trials for the treatment of advanced solid tumors with moderate and high expression of HER2+, which was successfully approved by National Medical Products Administration. KM257 is a HER2/HER2 bispecific antibody born by Xuanzhu Bio-based on Mebs-lg platform and Mab-Edit technology platform with independent intellectual property rights. The mechanism is innovative and it targets two different domains (domain II and domain IV) of HER2, which is highly innovative. The approval of KM257 for clinical trial indicates that the first macromolecular drug of Xuanzhu has entered the clinical development stage.

　　In March, 2023, KM501 and KM602 were also approved for clinical trials in National Medical Products Administration, China. KM501, also designed through Mebs-Ig platform, is the first dual-antibody ADC at home and abroad that completely knocks out fucose and targets two different domains of HER2. It is suitable for the treatment of locally advanced/metastatic solid tumors with positive/expression, amplification or mutation of HER2, including related advanced tumors with low expression of HER2. As one of the few domestic enterprises that develop dual-antibody ADC products, Xuanzhu Bio has stood at the same starting line with Zymeworks, Regeneron, AstraZeneca and Zhengda Tianqing in this field.

　　KM602 is a fusion protein product of CD80 Fc. At present, only one similar product in the world is in the clinical phase I research stage, and there is no domestic manufacturer to declare it. It is expected to become the First-in-Class product with the same target in the world. The two drugs have been successfully administered to the first patient in Phase I clinical trials, respectively, and they are in the climbing stage of single drug in Phase I. The research is progressing smoothly and the research and development progress is leading at home and abroad.

　　With the rapid development of macromolecular drugs, bispecific antibodies and antibody-coupled drugs (ADC), as hot frontier technologies in biomedical research and development, are an important battlefield for innovative pharmaceutical companies in the future. Xuanzhu Bio will continue to strengthen the research and development and layout in the field of macromolecular new drugs, aiming at strengthening and expanding the depth and breadth of existing research and development pipelines, enhancing the comprehensive research and development strength, vigorously promoting the research and development progress of macromolecular drugs, realizing the whole process from concept to commercial production, and laying a foundation for promoting the research and development level and drug-making of macromolecular drugs in China.

　　After nearly ten years of biological innovation and development, Xuanzhu has formed a complete new drug research and development system, and has two major research and development systems, namely, small-molecule chemical drugs and macromolecular biological drugs, and has established a team with rich industrialization and commercialization experience. The company's products cover small molecules, monoclonal antibodies, bispecific antibodies, antibody-coupled drugs, fusion proteins and other types. The layout of long, medium and short pipelines is perfect and balanced, and it has the ability of continuous innovation and continuous output: it is estimated that 2-3 varieties will be listed next year, and profits will be realized in three years, which will provide a good boost for the sustainable development of innovative products from the source.

　　It is this spirit of courage to explore and innovate that in recent years, Xuanzhu Biology has been recognized and affirmed by the industry and won many honors. In 2020, it was introduced by the key investment of Shijiazhuang High-tech Industrial Development Zone and obtained the strategic investment of national funds. In 2021, it was recognized by potential unicorn enterprises and awarded as "China Digital Medical New Species Enterprise", becoming the only new species enterprise (potential unicorn) in Hebei Province that has been stationed in innovative drug research and development. In 2022, it obtained the certification of intellectual property management system. This year, it was also rated as Forbes China Unicorn Enterprise, Innovative Small and Medium-sized Enterprises in Hebei Province, High-tech Small and Medium-sized Enterprises in Hebei Province, and Top 100 Enterprises with Comprehensive Strength in Drug R&D in China in 2023.

　　"Innovation-driven, boosting the development of new drugs in China and serving human health". It is believed that Xuanzhu Bio-Society has been actively promoting the development of representative biomacromolecule drugs with independent intellectual property rights and transforming them into clinical applications, improving the research and development level and collaborative innovation ability of biomacromolecule drugs in China, accelerating the global research and development process of biopharmaceuticals and benefiting patients.

　　(Source: Financial Information)