{"id":55720,"date":"2026-01-28T21:01:04","date_gmt":"2026-01-28T13:01:04","guid":{"rendered":"https:\/\/flcube.com\/?p=55720"},"modified":"2026-01-28T21:01:05","modified_gmt":"2026-01-28T13:01:05","slug":"leqvio-gets-nmpa-nod-for-monotherapy-in-china-hypercholesterolemia","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55720","title":{"rendered":"Leqvio Gets NMPA Nod for Monotherapy in China Hypercholesterolemia"},"content":{"rendered":"\n

Novartis<\/strong> (NYSE:\u202fNVS<\/a>) announced that Leqvio (inclisiran)<\/strong> has received an additional indication approval from the National Medical Products Administration (NMPA)<\/strong> in China, allowing its use as a monotherapy<\/strong> adjunct to diet for adult patients with primary hypercholesterolemia (non\u2011familial) or mixed dyslipidemia to lower LDL\u2011C. The siRNA therapy was previously approved only in combination with statins or other lipid\u2011lowering therapies.<\/p>\n\n\n\n

Regulatory Milestone & Drug Profile<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Novartis AG (NYSE:\u202fNVS)<\/td><\/tr>
Drug<\/strong><\/td>Leqvio (inclisiran)<\/td><\/tr>
Mechanism<\/strong><\/td>Small interfering RNA (siRNA) targeting PCSK9<\/td><\/tr>
New Indication<\/strong><\/td>Monotherapy for primary hypercholesterolemia or mixed dyslipidemia<\/td><\/tr>
Previous Approval<\/strong><\/td>Combination with statins\/LLTs (August\u202f2023)<\/td><\/tr>
Dosing<\/strong><\/td>Twice\u2011yearly injection<\/td><\/tr>
Innovation<\/strong><\/td>World\u2019s first and only approved siRNA cholesterol\u2011lowering therapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Data & Market Context<\/h2>\n\n\n\n