CellOrigin and Qilu Pharmaceutical Enter Global Strategic Collaboration to Advance Off-the-Shelf CAR-iMac Cancer Immunotherapy
Recently, Saiyuan Biotechnology (Hangzhou) Co., Ltd. (hereinafter referred to as “Saiyuan Bio”) and Qilu Pharmaceutical Co., Ltd. (hereinafter referred to as “Qilu Pharma”) jointly announced that they have entered into a global strategic collaboration agreement for the development, manufacturing, and commercialization of universal cell therapy products based on chimeric antigen receptor (CAR)-expressing macrophages (CAR-iMac) derived from induced pluripotent stem cells (iPSC).
Under the collaboration agreement, Saiyuan Biotechnology will receive an upfront payment, milestone payments, and future sales royalties from Qilu Pharmaceutical through technology transfer. In return, Qilu Pharmaceutical will utilize Saiyuan Biotechnology’s proprietary technology to develop cell therapy drugs. Both parties will engage in deep cooperation in the research and development, manufacturing, and commercialization of chimeric antigen receptor (CAR) macrophage therapy products based on iPSC differentiation. By optimally integrating their leading technologies, talent teams, and flagship products, the two companies will collaborate in good faith, upholding a strong sense of industry mission and responsibility. Their ultimate goal is to advance the R&D and commercialization of new drugs, thereby benefiting more patients.
Dr. Tong Jiansong, CEO of Saiyuan Biotechstated, “Qilu Pharmaceutical holds a pivotal position in China’s pharmaceutical industry, and we are deeply honored to collaborate with them. Saiyuan Biotechnology will continue to join hands with various sectors of society to jointly explore the research and development of innovative drugs, benefiting more Chinese patients through a series of initiatives.”
Head of Cell Therapy Program, Qilu Pharmaceuticalstated: “In the field of cell therapy, Saiyuan Bio prioritizes foundational original innovation, boasts extensive project experience and robust technological reserves, and places great emphasis on quality systems and regulatory compliance. The company has established a global leading position in the track of CAR-iMac cell therapy based on iPSC differentiation. We are honored to partner with such an outstanding enterprise to accelerate the R&D and market launch of innovative drugs in the cell therapy product sector, thereby bringing greater benefits to patients.”
Saiyuan Bio is dedicated to the R&D and clinical translation of iPSC-derived CAR-engineered innate immune cells, such as CAR-iMac and CAR-iNK cells. The founding team hails from Harvard University, Zhejiang University, the Scripps Research Institute, and leading domestic pharmaceutical companies. By leveraging tools such as single-cell sequencing and gene regulatory network analysis, the company modulates the iPSC differentiation process from a developmental biology perspective to enhance differentiation efficiency. Furthermore, it employs technologies including CRISPR gene editing and synthetic biology to generate engineered immune cells derived from iPSCs, with multiple core patents already granted both domestically and internationally. Through the establishment of an editable, expandable, single-clone-derived iPSC cell bank and the enhancement of its efficient directed differentiation capacity in vitro, Saiyuan Bio aims to ultimately develop universal, effective, and safe cell therapy products.
Saiyuan Biopharma is fully leveraging the inherent advantages of macrophages, specifically their ability to readily infiltrate and survive within the solid tumor microenvironment (TME), to aggressively develop CAR-iMac products primarily targeting various recurrent/refractory solid tumors. The company successfully completed three rounds of financing in 2021, established a clinical-grade iPSC cell bank, and—backed by a robust team with extensive experience in cell therapy CMC—independently developed a scalable manufacturing process for CAR-iMac cells. Furthermore, it has established a comprehensive GMP quality system along with corresponding quality control methods. Saiyuan Biopharma is poised to enroll the first patient in a clinical trial of CAR-Mac cell therapy and submit its Investigational New Drug (IND) application in the near term.
Qilu Pharmaceutical Group upholds the philosophy of “Pharmaceutical Wisdom,” aligning with global scientific frontiers and prioritizing public health. By vigorously implementing an innovation-driven strategy, the Group continuously provides clinical treatments for oncology, cardiovascular and cerebrovascular diseases, infections, psychiatric disorders, neurological conditions, and ophthalmic diseases. In 2021, the Group achieved sales revenue of RMB 34.4 billion, paid taxes amounting to RMB 2.22 billion, and recorded export earnings of RMB 760 million. It has consistently ranked among the top ten enterprises in China’s Top 100 Pharmaceutical Industry List for many consecutive years.
Leveraging its five major R&D centers in China and the United States, the Group is committed to clinical value and patient-centricity, continuously integrating high-quality global resources for innovative drug development. In 2021, the Group’s R&D investment reached RMB 3.32 billion, accounting for approximately 10% of its sales revenue. It has established a rich and competitive or differentiated product pipeline addressing significant unmet needs in major disease areas such as oncology, infectious diseases, liver diseases, autoimmune disorders, and metabolic diseases. This pipeline includes first-in-class, first-wave, and best-in-class drugs, supported by multiple competitive technology platforms. Meanwhile, the Group actively strengthens the introduction of external innovative projects and collaborations with academic institutions, fostering integrated and collaborative innovation. Through compassionate technological innovation, the Group aims to accelerate the market launch of more high-quality medicines, driving a better and healthier future for humanity.