About GENOR-B Company

Our mission Our mission is to be a biopharmaceutical engine for the discovery, research, development, manufacture and commercialization of innovative therapies to benefit patients in China and around the world. Overview Established in 2007, the Group has continued to develop for over 15 years. The Group continues to have the mission of “serving patients in China and around the world and providing them with innovative therapies”. Since our establishment in 2007, our strategic focus has been on several major treatment areas for oncology, autoimmunity, and other chronic diseases, and there are many medical needs that have yet to be met in related fields. In 2023, the Group will continue to implement the development strategy of “focus, optimization, acceleration and expansion” to operate efficiently, create opportunities, and seek development in a complex and challenging economy and environment. During the reporting period, the Group's core products, Rosil (GB491, Lerociclib), GB261 (CD20/CD3, bispecific antibody) and GB263T (eGFR/cMET/cMET, three specific antibodies), and early development pipeline products were also showcased at many global industry conferences and received high international recognition; they also showed the Group's full progress in pipeline products and early development. At ASCO 2023, the results of the GB491, Lerociclib (Lerociclib) LEONARDA-1 study were presented in the form of a poster discussion session (Poster Discussion Session) during the metastatic breast cancer session. The relevant data was selected by the ASCO Conference as an ASCO Daily News report, fully demonstrating the differentiated advantages of Lerosil (GB491, Lerociclib) in terms of efficacy and safety. At the 65th American Hematology Annual Meeting (ASH) from December 9 to 12, 2023, the group presented the preliminary clinical safety and efficacy results of the GB261 (CD20/CD3, bispecific antibody) phase I/II study led by Peking University Cancer Hospital in the form of a poster. On December 1, 2023, the Group published the preliminary dose climbing results of the world's first phase I/II study of the EGFR/cMET/cMET tri-specific antibody GB263T in the AACR journal Molecular Cancer Therapeutics. From November 1 to 5, 2023, the company presented research data on two innovative drug molecules in the form of posters at the 38th annual meeting of SITC in 2023. The Group's core product, GB491, Lerociclib (, Lerociclib) was officially accepted by the NMPA on March 28, 2023 for a new drug marketing application for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with fluvir groups to treat disease progression after previous endocrine treatment. As of the date of this annual report, the work related to clinical site inspection has been successfully completed. Furthermore, data analysis of efficacy data from advanced first-line phase III clinical studies of lerocilide (GB491, Lerociclib) reached the intended end point. The company officially submitted an NDA to the NMPA on February 28, 2024. It was officially accepted on March 13, 2024. In terms of height difference optimization dual polyantibody products, phase I/II clinical trials of GB261 (CD20/CD3, bispecific antibody) and GB263T (eGFR/cMET/cMET, tri-specific antibody) under the Group have completed dose climbing. While achieving rapid progress higher than the speed of the industry, they have also verified the highly differentiated advantages of these two products. The Group further optimized and suspended production and operation at the Yuxi Plant in Yunnan during the reporting period. In terms of early research and development, the Group focuses on molecular research that has the potential to become FIC and BIC products and has the greatest potential to produce clinical effects and commercially viable drugs. Five PCC molecules have now been developed, all of which are the world's first/ best-in-class bis/multispecific antibody projects. The abstracts of 2 of these trispecific antibody molecules were accepted for publication by AACR in 2024, and one project has already entered the IND development stage. Source innovation and strategic cooperation go hand in hand. The company is focusing on expanding global innovation and actively expanding external cooperation at various levels such as early R&D and commercialization. Recently, the Group signed a technology transfer agreement with the China-US Huadong Pharmaceutical Company (“China-US Huadong”). Based on this, the Group transferred one of its antibody drugs and related IP rights to East China. Shareholders have rich resources and industry expertise, including global and Chinese biotechnology-focused professional funds, and biopharmaceutical platforms with extensive experience in supporting and developing biopharmaceutical companies. The Group's core management team members have an average of more than 20 years of industry experience, an excellent track record, and a balanced mix of expertise, covering fields such as research and discovery, clinical development, manufacturing, registration services and financing. The company has clear goals, clear strategy, passion and deep accumulated professional ability without fear of difficulties. It has achieved rapid progress in key projects during the reporting period, not only achieving leadership in many industries, but will also lay a solid foundation for achieving achievements.