SIM-0505

On January 13, Xiansheng Pharmaceutical Group, through its subsidiary Xiansheng Zaiming, announced a collaboration agreement with AbbVie. According to the agreement, AbbVie will obtain licensing options for SIM0500 and will make an upfront payment as well as potential milestone payments of up to $1.055 billion. Additionally, AbbVie will enjoy sales revenue sharing outside of the Greater China region. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody developed by Xiansheng Zaiming using its proprietary T-cell engager multispecific antibody technology platform. This drug is currently undergoing Phase I clinical trials for relapsed or refractory multiple myeloma (MM) in both the U.S. and China. As a long-established domestic biopharmaceutical company, Xiansheng Pharmaceutical has cash flow products including Xianbixin, Endu, and Elamod. In the first half of 2024, the company reported an adjusted profit attributable to shareholders of approximately 538 million RMB, an increase of about 144 million RMB compared to approximately 394 million RMB in the same period of 2023, representing a growth rate of about 36.5%. The company's annual net profit target is 1 billion RMB, a 40% increase compared to 2023. Looking back at 2024, several of Xiansheng Pharmaceutical's products have encountered key catalysts, likely ensuring performance in 2025. The sequential therapy composed of Xianbixin sublingual tablets and Xianbixin is expected to peak at 2.5 billion RMB in sales. On December 2, 2024, Xianbixin sublingual tablets were approved for market by the National Medical Products Administration, intended to improve neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke. The main results of the Phase III clinical study of Xianbixin sublingual tablets were published in the Journal of the American Medical Association Neurology, demonstrating safety and efficacy in treating acute ischemic stroke. Given that Xianbixin injection sales have exceeded 2 billion RMB, the future potential for Xianbixin sublingual tablets is vast. Enlitone (Situximab β) and Kexaira (Trilaciclib) have successfully entered the National Medical Insurance catalog and are expected to see growth in 2025. Enlitone, as the first domestically produced EGFR-targeted drug, fills the gap for domestically produced EGFR-targeted antibody drugs for colorectal cancer. Kexaira, as the first-of-its-kind short-acting, reversible cyclin-dependent kinase CDK4/6 inhibitor, can temporarily block hematopoietic stem/progenitor cells in G1 phase before chemotherapy, protecting them from the cytotoxic effects of chemotherapeutic agents, thereby enhancing the efficacy of chemotherapy. Established in 2020, Xiansheng Zaiming focuses on the research, development, production, and commercialization of innovative anti-tumor drugs. On February 24, 2024, Xiansheng Pharmaceutical announced that its subsidiary Xiansheng Zaiming completed a 970 million RMB financing round, achieving a post-investment valuation of 8.47 billion RMB. CITIC Investment led the round with 800 million RMB, while Zhongshen New Venture invested 100 million RMB, Xingze Capital contributed 50 million RMB, and Zhonghe Capital invested 20 million RMB. In Xiansheng Zaiming's product pipeline, SIM0500 (CD3/BCMA/GPRC5D) and SIM0505 (CDH6-ADC) are particularly noteworthy. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody developed using Xiansheng Zaiming's proprietary T-cell engager multispecific antibody technology platform. This molecule combines a low-affinity high-target-activation CD3 antibody with anti-tumor-associated antibodies to create a T-cell activating drug specifically targeting tumors, exhibiting synergistic effects from multiple antibodies. BCMA and GPRC5D are closely related to the pathogenesis of multiple myeloma, with many CAR-T and TCE therapies associated with this target. Pharmaceutical giant Johnson & Johnson has also shown strong interest in this target combination, developing several CD3 bispecific antibodies and exploring the effects of combination therapy. SIM0500, as one of the top three candidates globally in clinical progress for GPRC5D-BCMA-CD3, completed its first patient enrollment (FPI) in May 2024. Additionally, SIM0500 has obtained FDA fast track designation, significantly enhancing its speed of clinical advancement. SIM0505 (CDH6-ADC) is a CDH6 ADC that is currently still in the preclinical stage. The interest in the CDH6 target has gradually increased in recent years. In 2023, MSD introduced the first ADC targeting CDH6, raludotatug deruxtecan (R-DXd; DS-6000). At the 2023 ESMO, the first ADC updated its Phase I results, showing significant efficacy. In January 2025, Xiansheng Zaiming announced that the CDH6 ADC has been approved for clinical trials in both the U.S. and China. Xiansheng Pharmaceutical's traditional business has shown stable growth, with an adjusted net profit growth rate expected to exceed 40% in 2024. The innovative drug business — Xiansheng Zaiming, having accumulated over several years, is nearing a harvest period. With strong innovation in SIM0500 (CD3/BCMA/GPRC5D) and SIM0505 (CDH6-ADC), this collaboration with AbbVie further validates its innovative strength. We look forward to this well-established pharmaceutical company rejuvenating itself and achieving new heights, leading the way in the industry.