Mabwell Biologics Licenses Next-Gen Long-Acting G-CSF Drug to Qilu Pharmaceutical for Up to RMB 500 Million

Jun 26, 2025 22:15 CST Updated 22:15

Mabwell

Innovative Biopharmaceutical Company

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

On June 26, Mabwell, Taikang Bio, and Qilu Pharmaceutical signed a licensing agreement through friendly negotiations, granting Qilu Pharmaceutical exclusive rights to develop, manufacture, improve, utilize, and commercialize the licensed products within Greater China (including mainland China, Hong Kong, Macao, and Taiwan). Taikang Bio is entitled to receive an upfront payment and sales milestone payments totaling up to RMB 500 million. Additionally, Taikang Bio will receive royalties of up to double-digit percentages of the net sales of the licensed products. Qilu Pharmaceutical will pay Taikang Bio a one-time, non-refundable upfront payment of RMB 380 million.

Arginase α for Injection (8MW0511) is a recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection. It is indicated for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs that are likely to cause febrile neutropenia, to reduce the incidence of infection manifested as febrile neutropenia.

8MW0511 is a new-generation long-acting G-CSF (high-activity modified cytokine) independently developed by the company. It utilizes gene fusion technology to combine high-activity modified G-CSF with human serum albumin (HSA), making it the first drug in China approved for marketing that uses albumin long-acting fusion technology. By fusing G-CSF with HSA, the molecular weight is increased, significantly inhibiting the G-CSF receptor-mediated clearance pathway, which can substantially prolong the drug's half-life in the body. This allows for reduced dosing frequency in clinical use and improved treatment compliance. Additionally, HSA is a natural component of human blood, and its use as a carrier protein ensures higher safety. 8MW0511 is produced using the Pichia pastoris expression system. Compared with chemically modified long-acting products, the preparation process avoids complex chemical modification reactions, resulting in simpler production technology and better product uniformity.

Qilu Pharmaceutical, one of China's leading vertically integrated pharmaceutical companies, develops, manufactures, and distributes finished dosage forms and active pharmaceutical ingredients. Qilu currently has 12 subsidiaries worldwide, 11 manufacturing bases in China, and more than 36,000 employees. In 2024, Qilu ranked among the top 3 in China’s pharmaceutical industry. Committed to providing high-quality and trustworthy medicines to the world to improve people’s well-being, Qilu is actively exporting its products to over 100 countries and regions globally. To date, Qilu has launched more than 300 products, with over 55 being "first-to-market" in China. The company has also established a robust pipeline, including more than 200 generic drugs, over 20 biosimilars, and more than 80 innovative products. Qilu Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Qilu Pharmaceutical Group.

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