Company: LGNZZ
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000886163-25-000012
Chunk: 20

Company: LIGAND PHARMACEUTICALS INC
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 20
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 Our partner, Sermonix has a license for the development of oral lasofoxifene, its lead investigational drug, for the United States and additional territories. Lasofoxifene is a selective estrogen receptor modulator in development for the treatment of breast cancer, discovered through the research collaboration between Pfizer and Ligand. Sermonix is currently conducting the Phase 3 ELAINE-3 clinical trial to assess the efficacy of lasofoxifene in combination with Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. In January 2024, Sermonix entered into a strategic collaboration and exclusive license agreement with Henlius for the rights to develop, manufacture and commercialize lasofoxifene in China. Henlius is currently conducting a Phase 3 ELAINE-3 multi-regional clinical trial in China.

Under the terms of our agreement with Sermonix, we are entitled to receive potential regulatory and commercial milestone payments, as well as a tiered royalty of 6% to 10% on potential future net sales. 

Xinshumu (pradefovir) (Xi'an Xintong)

Xi'an Xintong received marketing approval from the Chinese National Medical Products Administration (NMPA) for Xinshumu (pradefovir mesylate tablets) in October 2024. Xinshumu is the first liver-targeted, novel Hepatitis B drug developed based on the HepDirect™ liver-targeting prodrug technology that utilizes a chemically modified prodrug of the active compound which is stable in blood and intestines and is activated by a liver specific CYP subtype enzyme to achieve high liver concentration of the active drug and low systemic exposure, reducing side effects in other organs for improved safety. Under the terms of our agreement with Xi'an Xintong, we are entitled to an annual licensing maintenance fee, milestones and a 9% royalty on potential future sales.

MB07133 (Xi'an Xintong)

Xi'an Xintong is also developing MB07133, a liver specific, HepDirect prodrug of cytarabine monophosphate, for the potential treatment of hepatocellular carcinoma and intrahepatic cholangiocarcinoma. MB07133 is currently in Phase 2 in China.