Jiangsu Hengrui Pharma has secured a landmark regulatory clearance in China for its oral thrombopoietin (TPO) receptor agonist hetrombopag, making it the first oral TPO agonist anywhere in the world to receive approval for chemotherapy-induced thrombocytopenia (CIT). The approval was granted by China’s National Medical Products Administration (NMPA) and positions Hengrui in a category of its own within the competitive oral TPO receptor agonist space.
A Global First in an Underserved Indication
The hetrombopag CIT approval addresses a condition that has long presented a significant clinical challenge. Thrombocytopenia — a reduction in platelet counts — is a common and serious complication of chemotherapy in patients with solid tumours. It raises the risk of bleeding, and in more severe instances, compels oncologists to reduce chemotherapy doses, which can directly compromise treatment outcomes. The condition also places considerable pressure on health systems through the need for platelet transfusions and ongoing supportive care.
Existing treatment options for CIT in China have been limited to injectable TPO products. These include 3SBio’s Tpiao (rhTPO), which holds NMPA approval for this indication, as well as romiplostim biosimilars used off-label. Both approaches require multiple clinic visits, adding to the logistical and physical burden on patients and healthcare facilities alike. The arrival of an oral option addresses a gap that clinicians and patients have long contended with.
Hengrui noted in an official statement: “There is an urgent clinical need for treatment options with both efficacy and convenience of medication, so as to facilitate the progress of anti-tumour treatment as planned.” The company further stated that “the approval of this new indication makes this product the first TPO receptor agonist approved for CIT in the world, which will provide strong support for anti-tumour treatment and promote the standardised management throughout the whole process.”
Expanded Indications Strengthen Hetrombopag’s Profile
Beyond the hetrombopag CIT approval, the NMPA has also cleared the drug for second-line use in paediatric patients aged six and above with immune thrombocytopenia (ITP). This adds to hetrombopag’s already approved use in adults with ITP, as well as in adolescents and adults living with severe aplastic anaemia (SAA), further broadening the drug’s therapeutic reach across multiple platelet-related disorders.
Competitive Landscape in Oral TPO Agonists
The oral TPO receptor agonist market currently features several established players, including Novartis’ Revolade (eltrombopag) and its generics, Fosun Pharma and Sobi’s Doptelet (avatrombopag), and Shionogi/Eddingpharm’s Mulpleta (lusutrombopag). However, the CIT indication sets hetrombopag apart. Both Doptelet and Revolade have been evaluated in clinical trials for CIT but produced mixed results. Mulpleta’s developers, meanwhile, have concentrated their efforts on thrombocytopenia linked to chronic liver disease, leaving CIT without a viable oral competitor for hetrombopag at this stage.
Citing EvaluatePharma data, Hengrui noted that global sales of oral TPO drugs reached approximately $2.2 billion in the most recent reported year, reflecting the scale of commercial opportunity within this therapeutic category.
Addressing an Urgent Clinical Need
The NMPA’s decision to grant approval for the hetrombopag CIT indication reflects the recognised clinical urgency around improving the management of chemotherapy-related platelet complications. The convenience of an oral regimen over injectable alternatives could ease the treatment journey for cancer patients while reducing the frequency of hospital-based interventions. With no other oral TPO receptor agonist currently approved globally for CIT, Hengrui enters this space without direct competition in the category, backed by regulatory validation from one of the world’s most active pharmaceutical approval authorities.
