{"id":51767,"date":"2025-12-22T18:49:48","date_gmt":"2025-12-22T10:49:48","guid":{"rendered":"https:\/\/flcube.com\/?p=51767"},"modified":"2025-12-22T18:49:49","modified_gmt":"2025-12-22T10:49:49","slug":"mercks-pimicotinib-wins-china-approval-as-first-class-1-therapy-for-tgct","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=51767","title":{"rendered":"Merck\u2019s Pimicotinib Wins China Approval as First Class\u202f1 Therapy for TGCT"},"content":{"rendered":"\n

Merck KGaA<\/strong> (ETR:\u202fMRK<\/a>) announced that China\u2019s National Medical Products Administration (NMPA)<\/strong> granted priority review approval<\/strong> for Pimicotinib hydrochloride capsules<\/strong>, the first Class\u202f1 innovative drug<\/strong> approved in China for Tenosynovial Giant Cell Tumor (TGCT)<\/strong> in adult patients where surgery could cause functional limitations or severe complications. The approval is based on the global Phase\u202fIII MANEUVER study<\/strong>, which showed the highest Objective Response Rate (ORR)<\/strong> among systemic TGCT treatments per RECIST\u202fv1.1.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Approval Date<\/strong><\/td>22\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Pimicotinib hydrochloride capsules<\/td><\/tr>
Drug Class<\/strong><\/td>Class\u202f1 innovative drug<\/td><\/tr>
Indication<\/strong><\/td>Symptomatic TGCT in adults (surgery\u2011risk)<\/td><\/tr>
Review Pathway<\/strong><\/td>Priority review<\/td><\/tr>
Clinical Basis<\/strong><\/td>Global Phase\u202fIII MANEUVER study<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 MANEUVER Study<\/h2>\n\n\n\n
Endpoint<\/th>Pimicotinib<\/th>Significance<\/th><\/tr><\/thead>
Objective Response Rate (ORR)<\/strong><\/td>Highest among systemic TGCT therapies (RECIST\u202fv1.1)<\/td>Demonstrates superior efficacy<\/td><\/tr>
Clinical Outcomes<\/strong><\/td>Significant improvement in symptoms and function<\/td>Addresses high\u2011unmet\u2011need population<\/td><\/tr>
Safety Profile<\/strong><\/td>Manageable adverse events<\/td>Supports favorable risk\u2011benefit ratio<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Deal Structure & Development Chain<\/h2>\n\n\n\n
Timeline<\/th>Event<\/th><\/tr><\/thead>
December\u202f2023<\/strong><\/td>Abbisko Therapeutics grants Merck exclusive China rights for Pimicotinib<\/td><\/tr>
April\u202f2025<\/strong><\/td>Merck exercises global commercialization option for Pimicotinib (ABSK021)<\/td><\/tr>
December\u202f2025<\/strong><\/td>NMPA approves Pimicotinib for TGCT in China (global first)<\/td><\/tr>
Global Status<\/strong><\/td>Merck holds worldwide rights (ex\u2011China option exercised)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Opportunity<\/h2>\n\n\n\n
Metric<\/th>Value<\/th>Context<\/th><\/tr><\/thead>
China TGCT Prevalence<\/strong><\/td>~10,000\u201115,000 adult patients (2025)<\/td>Rare disease with limited treatment options<\/td><\/tr>
Global TGCT Market<\/strong><\/td>$300\u2011500\u202fmillion<\/strong> (2025)<\/td>Dominated by surgical resection; no approved systemic therapy<\/td><\/tr>
Pimicotinib Peak Sales<\/strong><\/td>\u00a5800\u202fmillion\u20111.2\u202fbillion<\/strong> (\u2248\u202fUS$112\u2011170\u202fM) by 2030<\/td>60\u201170% share of China TGCT market<\/td><\/tr>
Pricing Strategy<\/strong><\/td>Premium orphan drug pricing<\/td>Eligible for NRDL fast\u2011track inclusion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n