Qilu Pharmaceutical Breaks Through Key Industrialization Technologies in Cell Culture for Biologics Manufacturing

　　【Pharmaceutical Network Pharmaceutical EngineeringRecently, Jinan City held a field observation activity for major projects promoting green, low-carbon, and high-quality development through the deepening of the conversion of old and new growth drivers. Among them, the Qilu Pharmaceutical biological drug project was one of the projects under inspection.
 

The total investment of the project is 2.599 billion yuan, covering an area of 92.7 mu. It commenced construction in January 2023 and has completed the main construction. Located in Suncun Subdistrict, Jinan High-tech Zone, the project is a major industrial breakthrough project for the province's new and old kinetic energy conversion in 2022, a key provincial project in 2023, a provincial high-quality green and low-carbon development project in 2024, and a key municipal project in 2024.
 

It is reported that the project has broken through the key industrialization technology of cell culture. After production, it will be used to undertake the commercial production of multiple products such as innovative macromolecular combination antibody drugs, new Class I drugs, and biosimilars, which will drive the coordinated development of equipment, raw materials, excipients, and packaging materials enterprises.
 

In recent years, Qilu Pharmaceutical has continuously increased its investment in innovation and R&D, with R&D investment exceeding 4 billion yuan in 2023. After more than a decade of strategic planning, Qilu Pharmaceutical has established a comprehensive pipeline of innovative drugs in major disease areas such as cancer, infectious diseases, liver diseases, autoimmune diseases, and metabolic disorders. Currently, Qilu Pharmaceutical has over 80 Class I innovative drugs in the research and development stage. During the "14th Five-Year Plan" period, multiple innovative drugs will be successively launched, providing more new options for the treatment of major diseases.
 

It was reported that in September this year, Qilu Pharmaceutical's self-developed Class 1 new drug, Eparlolib Tosorali Monoclonal Antibody Injection (Qibean®), received marketing approval from the National Medical Products Administration for the treatment of recurrent or metastatic cervical cancer.
 

Data shows that this drug is an approved PD-1/CTLA-4 dual-function combination antibody, consisting of an IgG4-type PD-1 antibody and an IgG1-type CTLA-4 antibody in a specific ratio. Both the CTLA-4 and PD-1 pathways negatively regulate T-cell immune function, and the Aito combination antibody can simultaneously target and block these two immune checkpoint signaling pathways, activating an anti-tumor immune response.
 

In addition, Qilu Pharmaceutical's Class 1 new drug for ALK-positive non-small cell lung cancer, Iruplakib (Qixinke®), was approved for marketing in 2023. It is suitable for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression after previous treatment with crizotinib or are intolerant to crizotinib. In February 2024, the drug received approval for a new indication, covering all ALK-positive advanced non-small cell lung cancer patients. Iruplakib marks the beginning of Qilu Pharmaceutical’s innovation drug development entering its harvest period.
 

It is reported that Qilu Pharmaceutical Co., Ltd. is also keeping up with the development trend of international innovative drugs, establishing five major R&D platforms linked between China and the United States, integrating high-quality global resources, targeting unmet clinical needs, and will continue to develop "global new" and "global good" drugs.
 

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