January: New Imported Drug Approvals by the NMPA - December 2024

• □　Beclometasone/Formoterol for Inhalation (FOSTAIR) – marketed by Chiesi Farmaceutici S.p.A.
• □　Donanemab Injection (KISUNLA) – marketed by Eli Lilly and Company
• □　Dotinurad Tablets (URECE) – marketed by FUJI YAKUHIN CO., LTD.
• □　Imipenem, Cilastatin and Relebactam for Injection (RECARBRIO) – marketed by MSD B.V.
• □　Lenacapavir Sodium Injection and Tablets (SUNLENCA) – marketed by Gilead Sciences Ireland UC
• □　Loncastuximab Tesirine For Injection (ZYNLONTA) – marketed by ADC Therapeutics SA
• □　Lurbinectedin for Injection (ZEPZELCA) – marketed by PharmaMar AG
• □　Mepolizumab Injection (NUCALA) – marketed by GlaxoSmithKline Trading Services Limited
• □　Mosunetuzumab Injection (LUNSUMIO) – marketed by Roche Pharma (Schweiz) AG
• □　Odevixibat Capsules (BYLVAY) – marketed by Ipsen Pharma
• □　Olaparib Tablets (Brand: N/A) – marketed by M/s Natco Pharma Limited
• □　Osimertinib Mesylate Tablets (TAGRISSO) – marketed by AstraZeneca AB – new indication
• □　Pembrolizumab Injection (KEYTRUDA) – marketed by MSD LLC – new indication
• □　Pretomanid Tablets (DOVPRELA) – marketed by Mylan Ireland Limited
• □　Rilonacept for injection (ARCALYST) – marketed by Kiniksa Pharmaceuticals (UK), Ltd.
• □　Safinamide Mesylate Tablets (XADAGO) – marketed by Zambon S.p.A.
• □　Vamorolone Oral Suspension (AGAMREE) – marketed by Santhera Pharmaceuticals GmbH
• □　Zolbetuximab for Injection (VYLOY) – marketed by Astellas Pharma Europe B.V.
• (Source: BaiPharm)