30th Mar 2026 09:05
(Alliance News) - GSK PLC on Monday reported regulatory momentum in China for its drugs Exdensur and bepirovirsen.
The pharmaceutical firm's shares were up 0.5% to 2,060.00 pence on Monday morning in London.
Its medication Exdensur, whose generic name is depemokimab, has clearance from China's National Medical Products Administration for the treatment of severe asthma.
Approval is specifically as add-on maintenance treatment in patients aged 12 and up, whose asthma is characterised by an eosinophilic phenotype.
According to GSK, the drug "is the first and only ultra-long-acting biologic in China" approved for this indication. The green light follows phase-three trials which linked Exdensur to "sustained exacerbation reduction with two doses per year versus placebo", when both Exdensur and placebo patients also received standard care.
Kaivan Khavandi, global head of GSK's Respiratory, Immunology & Inflammation R&D unit, hailed the approval as "an important advance for patients" which could help reshape asthma treatment.
"By providing sustained suppression of type 2 inflammation, an underlying driver of exacerbations and disease progression, Exdensur could redefine care in just two doses a year," Khavandi noted.
In parallel, Chinese regulators are reviewing Exdensur as an add-on therapy with intranasal corticosteroids for adults with severe chronic rhinosinusitis featuring nasal polyps, for whom corticosteroid therapy and/or surgery has proved insufficient.
The drug already has clearance in the US for severe asthma, as well as in Japan, the EU, and UK for the treatment of severe asthma and rhinosinusitis with nasal polyps.
Also on Monday, GSK said that China's NMPA had accepted its medication bepirovirsen for review as a new drug to treat adults with chronic hepatitis B.
Bepirovirsen is an investigational antisense oligonucleotide with "a statistically significant and clinically meaningful functional cure rate" in GSK's phase-three testing.
The medication was designated a breakthrough therapy in China back in 2021. It is yet to be approved in any jurisdiction, but has fast-track status in the US and Senku designation in Japan. GSK on Friday said the drug had been accepted for review by the European Medicine Agency as a novel hepatitis B therapy.
It is also under assessment "as a potential backbone therapy for future sequential treatment strategies aimed at expanding functional cure to broader patient populations," GSK noted.
The company licensed bepirovirsen from Ionis Pharmaceuticals Inc and has been co-developing it with the Carlsbad, California-based firm.
By Holly Munks, Alliance News reporter
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