Yifan Pharmaceutical (002019.SZ) Subsidiary Signs Exclusive Agreement for an Innovative Drug

Stock News
01/05

Yifan Pharmaceutical Co., Ltd. (002019.SZ) announced that its wholly-owned subsidiary, Yifan Pharmaceutical, has entered into exclusive agreements with Shine Drug Source and Tianjin Shande. The Exclusive Agreements stipulate that Shine Drug Source will grant Yifan Pharmaceutical a sub-licensable, irrevocable, and exclusive right and license for the target product, whose active pharmaceutical ingredient is dimethylaminomicheliolide fumarate monohydrate, within the designated cooperation territory and field. Yifan Pharmaceutical is authorized to independently use the licensed intellectual property to develop, produce, and commercialize the target product within the agreed territory and field, while also being granted an exclusive priority negotiation right for the production and commercialization of the target product for other indications within the cooperation region. Yifan Pharmaceutical is required to pay Shine Drug Source a RMB 100 million upfront payment, a RMB 100 million cornerstone investment or a RMB 50 million milestone payment (to be chosen from one of the two), tiered net sales royalties, and a share of sub-licensing income generated outside of China, if any. Regarding the basic profile of the target product, ACT001, developed by Shine Drug Source, is a Class 1 innovative drug with a novel mechanism of action, which has undergone multiple clinical trials in China, the United States, and Australia over the past eight years targeting various indications including small cell lung cancer brain metastases and glioblastoma. In January 2025, ACT001 received a "Breakthrough Therapy" designation from the National Medical Products Administration (NMPA) for the indication of small cell lung cancer brain metastases and has successfully commenced its Phase III clinical trial. ACT001 achieves localized tumor control and extended survival by inhibiting the NF-κB and STAT3 signaling pathways in relevant cells within the cancer lesion microenvironment, thereby reducing tumor cells' DNA repair capacity and exerting a dual synergistic effect with radiotherapy, chemotherapy, and immunotherapy. The announcement stated that the target product addresses the clinical area of small cell lung cancer brain metastases, which has an urgent unmet need and a scarcity of treatment options. By introducing this innovative anti-tumor drug, which is already in the late clinical stage, the company can effectively supplement its oncology pipeline while avoiding the high investment and time costs associated with de novo independent research and development.

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