China Approves Hengrui's Oral TPO-RA Hetrombopag for Thrombocytopenia
核心洞察
China's NMPA has approved Jiangsu Hengrui Pharma (搜索)'s oral TPO receptor agonist hetrombopag for thrombocytopenia (搜索) caused by chemotherapy in solid tumours.
Hengrui says the clearance makes hetrombopag the first oral TPO agonist approved anywhere in the world for chemotherapy-induced thrombocytopenia (搜索).
The NMPA also approved hetrombopag for second-line use in paediatric patients aged six and over with immune thrombocytopenia (搜索), extending its existing indications.
Jiangsu Hengrui Pharma (搜索)'s oral thrombopoietin (TPO) receptor agonist hetrombopag has been approved in China for low platelet counts (thrombocytopenia (搜索)) caused by chemotherapy for solid tumours. According to Hengrui, the National Medical Products Administration (搜索) (NMPA) decision makes hetrombopag the first oral TPO agonist approved for chemotherapy-induced thrombocytopenia (搜索) (CIT) anywhere in the world.
The NMPA has also approved hetrombopag for second-line use in paediatric patients aged six and over with immune thrombocytopenia (搜索) (ITP), adding to its existing use in adults with the rare autoimmune blood disorder and in adolescents and adults with severe aplastic anaemia (搜索) (SAA).
Thrombocytopenia (搜索) is a common chemotherapy complication in solid tumours, raising bleeding risk and, in severe cases, requiring dose reductions that can compromise anti-tumour efficacy and burden health systems through platelet transfusions and supportive care. Injectable TPO products already used for CIT in China — 3SBio (搜索)'s Tpiao (rhTPO), approved for the indication, and off-label romiplostim biosimilars — require multiple clinic visits. The CIT approval gives hetrombopag a field free of oral TPO competition from Novartis' Revolade (eltrombopag) and generics, Fosun Pharma and Sobi (搜索)'s Doptelet (avatrombopag), and Shionogi/Eddingpharm (搜索)'s Mulpleta (lusutrombopag); Doptelet and Revolade produced mixed CIT trial results, while Mulpleta's developers focus on chronic liver disease-associated thrombocytopenia. Hengrui cited EvaluatePharma data putting global oral TPO drug sales at approximately $2.2 billion last year.
Source: pharmaphorum