Hengrui Pharma (01276) Secures NMPA Approval to Add New Indication for Hetrombopag Olamine Tablets

Bulletin Express03-13 19:42

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma,” 01276.HK) announced that China’s National Medical Products Administration has cleared a new indication for the company’s self-developed Class 1 innovative drug, Hetrombopag Olamine Tablets.

The oral thrombopoietin-receptor agonist can now be used, in combination with immunosuppressive therapy, to treat patients aged 15 years or older with treatment-naive severe aplastic anemia (SAA). The product is available in 2.5 mg and 5 mg tablet strengths and remains a prescription-only medicine.

Hetrombopag Olamine Tablets were first launched in 2021 with two approved indications: (1) adult chronic primary immune thrombocytopenia with insufficient response to standard therapies, and (2) adult SAA with inadequate response to immunosuppressive therapy.

Severe aplastic anemia is an acute bone-marrow failure syndrome with rapid progression and high mortality from infection or bleeding. Hetrombopag activates STAT and MAPK signalling pathways to stimulate platelet production. Comparable products on the market include Eltrombopag (Promacta), Avatrombopag (Doptelet) and Lusutrombopag (Mulpleta). EvaluatePharma estimates that aggregate global sales for these peers reached approximately USD 2.59 billion in 2024.

Hengrui Pharma has invested about RMB 632.50 million to date in the Hetrombopag development programme (unaudited). Management cautions that post-approval manufacturing and commercial uptake remain subject to uncertainty and advises investors to consider associated risks.

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(“Hengrui Pharma,” 01276.HK) announced that China’s National Medical Products Administration has cleared a new indication for the company’s self-developed Class 1 innovative drug, Hetrombopag Olamine Tablets.</p>\n<p>The oral thrombopoietin-receptor agonist can now be used, in combination with immunosuppressive therapy, to treat patients aged 15 years or older with treatment-naive severe aplastic anemia (SAA). The product is available in 2.5 mg and 5 mg tablet strengths and remains a prescription-only medicine.</p>\n<p>Hetrombopag Olamine Tablets were first launched in 2021 with two approved indications: (1) adult chronic primary immune thrombocytopenia with insufficient response to standard therapies, and (2) adult SAA with inadequate response to immunosuppressive therapy.</p>\n<p>Severe aplastic anemia is an acute bone-marrow failure syndrome with rapid progression and high mortality from infection or bleeding. 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