(Yicai) April 1 -- China's top drugs regulator has given the green light to a next-generation influenza antiviral medication developed by Chinese drugmaker Kerui Pharmaceutical, providing a new option on the domestic market dominated by imported influenza treatments.

The National Medical Products Administration approved Kerui Pharma's Masulansavir tablets to treat uncomplicated influenza A and B in people aged 12 and older who are otherwise healthy, the regulator announced on its website on March 27.

The tablets can quickly block the influenza virus messenger ribonucleic acid synthesis, rapidly inhibiting viral replication, according to the company’s description of the treatment mechanism. Patients only need one dose to eliminate the virus within 22 hours.

The influenza antiviral market in China is dominated by Baloxavir marboxil, developed by Japanese pharma giant Shionogi. Its mechanism of action is similar to that of Masulansavir, as it also requires just a single dose for treatment. 

However, despite its outstanding efficacy, many patients have been deterred from Baloxavir marboxil due to its price of more than CNY200 (USD27.55) per tablet. The cost of Masulansavir has not been disclosed yet.

Masulansavir will likely benefit many influenza patients in China after its launch, Professor Cao Bin, head of the Phase III clinical research team for the drug at the China-Japan Friendship Hospital, told Yicai.

Due to Qingfeng Pharmaceutical Group, the controlling shareholder of Kerui Pharma and owner of the factory making Masulansavir, having an annual production capacity of over 4.5 billion tablets, the drug will remove the risk of patients being left without treatment in case of supply shortages of imported products and will likely be cheaper, Cao noted.

Masulansavir operates on the same mechanism as Baloxavir marboxil, so it can be considered an innovative generic drug, a pharma expert said to Yicai. However, due to the differences in their chemical structures, Masulansavir remains a new drug with independent intellectual property rights owned by Ganzhou-based Kerui Pharma, the person noted.

The Chinese market for antiviral influenza drugs may soon see new entries, with another antiviral influenza drug, ZX-7101A, developed by Zenshine Pharmaceuticals, expected to be approved within this month, industry insiders told Yicai. The action mechanism of ZX-7101A is similar to that of Masulansavir, they pointed out.

Editors: Tang Shihua, Martin Kadiev