Fosun Pharma’s Generic Remodulin Gains NMPA Approval for Pulmonary Arterial Hypertension

Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its generic version of Remodulin (treprostinil) has been approved by the National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH). The drug is marketed to alleviate symptoms caused by exercise.

Understanding PAH and Treatment
PAH is a malignant progressive disease characterized by lesions in the pulmonary arteries, primarily in the pulmonary arterioles. This condition is accompanied by increased pulmonary vascular resistance and arterial pressure, which can lead to right heart failure and death. Treprostinil, an extraintestinal prostacyclin analog, is recommended by clinical guidelines worldwide. It functions by directly relaxing the pulmonary and systemic arterial blood vessel beds and inhibiting platelet aggregation.

Partnership and Market Context
Fosun Pharma partnered with compatriot firm ForeFront Pharma in 2021, securing exclusive marketing and agent rights to the drug in mainland China. This approval adds to the existing market presence of the originator United Therapeutics and Zhaoke Ophthalmology, which previously had their versions approved for marketing. The availability of a generic version is expected to enhance accessibility and affordability for patients suffering from PAH.-Fineline Info & Tech

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