Kelun Pharmaceutical's Generic Mulpleta Gains NMPA Approval in China

Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China

China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the company’s generic drug development.

Drug Profile and Indications
Lusutrombopag is an oral small molecule human thrombopoietin receptor agonist (TPO-RA). It was approved for import in China in 2023 and is used for adult patients with chronic liver disease and thrombocytopenia who are preparing for surgery, including diagnostic procedures. The approval of Kelun’s generic version expands the treatment options for patients in need of this medication.

Significance of the Approval
The NMPA approval of Kelun Pharmaceutical’s generic Mulpleta highlights the company’s commitment to providing affordable and accessible treatment options for patients with chronic liver disease and thrombocytopenia. This development underscores Kelun’s role in advancing generic drug solutions and enhancing the overall healthcare landscape in China.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry