About GENOR-B Company

Our mission Continuing with the mission of “serving patients in China and the world and providing them with innovative therapeutics”, the company is committed to becoming an engine for the discovery, research, and development of innovative biopharmaceuticals for innovative therapies. Overview Since its establishment in 2007, the Group has focused on becoming an innovative company with innovative drug research and development, pre-clinical research, clinical development, registration and CMC development. Since the successful launch of the “Focus, Optimization, Acceleration and Expansion” development strategy in 2022, and after achieving initial results in 2023, the Group will continue to implement this strategy in 2024, with a view to stable development, efficient operation, and creating opportunities in a challenging economic and industry environment. The Group further optimized its structure during the reporting period, and through various flexible forms of external cooperation, successfully implemented the enterprise's asset-light model and drastically reduced operating costs. While reducing costs and increasing efficiency, we actively carry out strategic cooperation, sign merger agreements, and reach BD cooperation on multiple pipelines, focusing on promoting core pipeline development and approval of new drugs. In terms of expanding external cooperation, the Group and Yiteng Pharmaceutical Group Co., Ltd. (“Yiteng Pharmaceutical”) entered into a merger agreement on September 13, 2024. The Company will acquire Yiteng Pharmaceutical through a merger (“proposed merger”). As a cost, the Company will allocate and issue shares (“cost shares”) to shareholders of Yiteng Pharmaceutical. Following the completion of the proposed merger, the former shareholders of Yiteng Pharmaceutical will hold about 77% of the Company's issued shares expanded through allotment and issuance, while the Company's shareholders (“shareholders”) will hold about 23% (the final issue size depends on the number of relevant shares at the time of the proposed merger and delivery). The proposed merger will bring about multi-dimensional complementarity of advantages to form significant synergy effects, including complementarity between R&D capabilities and commercialization platforms, collaboration between product pipelines and market expansion, and optimization of financial resources. The proposed merger is expected to achieve two-way empowerment of “R&D driven” and “product commercialization”, deep integration in R&D, sales, production, and finance, and is expected to enhance the Group's market competitiveness. The proposed merger constitutes a very significant acquisition and reverse acquisition for the Company; therefore, the proposed merger requires shareholders' approval, and the group (“Expanded Group”) expanded by Yiteng Pharmaceutical and its subsidiaries after the proposed merger and settlement must also meet the basic listing eligibility requirements of the Hong Kong Stock Exchange Limited (“Exchange”) securities listing rules (“listing rules”). In addition to signing a merger agreement with Yiteng Pharmaceutical, the Group entered into a licensing agreement and equity agreement with TRC2004, Inc. on August 2, 2024. Under the license agreement, the Group agreed (among others) to grant TRC2004, Inc. an exclusive global license (excluding mainland China, Hong Kong, Macau and Taiwan) to develop, use, manufacture, commercialize and otherwise utilize GB261 (CD20/CD3, bispecific antibody) (“GB261”). The collaboration with TRC2004, Inc. will focus mainly on exploring the potential of GB261 in autoimmune diseases. This is a recognition of the company's independent research and development capabilities, and it is hoped that this potential BICCD20/CD3 bispecific antibody can be verified by more clinical trial data as soon as possible, and ultimately verify its promising efficacy and good safety. The company expects GB261 to become an “innovative therapy for patients in China and around the world” and supports the company in carrying out its mission. In September 2024, CandidTherapeutics merged with TRC2004, Inc. Furthermore, in January 2024, the Group signed a technology transfer agreement with the China-US Huadong Pharmaceutical Company (“China-US Huadong”), according to which the Group's anti-FGFR2b molecular sequence, technical data and related intellectual property (“IP”) rights were transferred to the latter. On January 2, 2025, Jiahe Biopharmaceutical Co., Ltd. (“Jiahe Biopharmaceutical”), a wholly-owned subsidiary of the Company, and Yiteng Pharmaceutical signed a cooperative development agreement (“Cooperative Development Agreement”) for two triple-antibodies: GBD218 is the lead molecule for three specific antibodies targeting CD3/BCMA/GPRC5D, and the GBD220 project aims to produce CD3/CD19/BCMA tri-specific antibodies. Both of the above three antibodies are in the early detection stage (pre-PCC stage). In terms of focusing on core pipeline development and new drug approval, lerosil (GB491, Lerociclib) combined with letrozole reached the main end point. On February 28, 2024, it was officially submitted to the China National Drug Administration (“NMPA”) on February 28, 2024 for use in combination with letrozole for hormone receptor (HR) positive and partial or advanced human epidermal growth factor receptor 2 negative (“HR+/HER2”) Metastatic breast cancer (advanced first-line breast cancer) The New Drug Marketing Application (“NDA”) was officially accepted on March 13, 2024, the clinical site inspection was completed in September 2024, and the submission of NDA supplementary materials was completed in December 2024. The advanced second-line breast cancer NDAs of GB491, Lerociclib (, Lerociclib) combined with fluvirizil also made good progress in 2024. The submission of NDA supplements was completed in March 2024, the drug inspection by the Central Inspection Institute was completed in May 2024, overseas production site inspections before approval of the new drug marketing application in September and October 2024, and the production inspection follow-up report was submitted to CFDI in December 2024. On February 24, 2025, CDE officially accepted overseas production verification before approval of the new drug marketing application Follow up the matter report to restart the NDA review for advanced second-line breast cancer. GB268 (anti-PD-1/VEGF/CTLA-4) is another highly innovative tri-specific antibody independently developed by the Group, which specifically targets PD-1, VEGF, and CTLA-4. Preclinical results showed that compared with the combination of PD-1, CTLA-4, and VEGF, and anti-PD-1/VEGF double antibodies or anti-PD-1/CTLA-4 double antibodies, GB268 can significantly enhance anti-tumor effects, is safer, and has the potential to become an upgraded version of an immune checkpoint inhibitor. GB268 entered the preclinical development phase (preinDosing) in 2024. In March 2025, a four-week repeated administration of good laboratory practice (“GLP”) toxicology studies for crab-eating monkeys were completed. There were no serious drug-related adverse reactions in animals after multiple doses. Preliminary CMC findings suggest that the triantibody molecule has good pharmacogenicity and stability, and has completed pilot scale Pharmaceutical Production Quality Management Specification (GMP) production. The good safety and pharmacokinetic characteristics obtained in phase I/II lymphoma clinical trials of GB261 (CD20/CD3, bispecific antibody) and clinical anti-tumor activity are consistent with the molecular design mechanism of GB261, showing promising efficacy and good safety. The GB261I/II phase lymphoma clinical trial was completed in 2024, and the clinical study report was completed in July 2024. GB263T, the world's first tri-specific antibody developed in-house by the Group, showed promising efficacy in therapeutic doses (1,260-1,680 mg), and also showed superior safety characteristics. The updated clinical trial results were accepted by the 2024 European Society of Oncology (ESMO) Assembly and published on September 14, 2024. In terms of early research, our R&D focuses on developing targets and projects with first-of-its-in-class (FIC) /best-in-class (BIC) potential. As of December 31, 2024, the development of multiple PCC molecules has been completed, all of which are highly innovative and have the potential to become the best-in-class bis/multispecific antibody projects; research summaries of 2 tri-specific antibody molecules (GB268 anti-PD-1/VEGF/CTLA-4 and GBD218CD3/BCMA/GPRC5D) have been accepted for publication at the 2024 American Association for Cancer Research (AACR). Our Group's Drug Candidates As of the date of this annual report, the Group has relied on the high level of expertise and close collaboration of various departments, and active expansion of external cooperation to continue to advance the clinical process of pipeline innovative drugs on a global scale.