{"id":51860,"date":"2025-12-23T20:59:55","date_gmt":"2025-12-23T12:59:55","guid":{"rendered":"https:\/\/flcube.com\/?p=51860"},"modified":"2025-12-23T20:59:58","modified_gmt":"2025-12-23T12:59:58","slug":"3sbios-rhtpo-wins-nmpa-approval-for-liver-disease-thrombocytopenia-before-surgery","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=51860","title":{"rendered":"3SBio\u2019s rhTPO Wins NMPA Approval for Liver Disease Thrombocytopenia Before Surgery"},"content":{"rendered":"\n

3SBio Inc.<\/strong> (HKG: 1530<\/a>) announced that its Recombinant Human Thrombopoietin (rhTPO) injection<\/strong> received National Medical Products Administration (NMPA)<\/strong> approval for a new indication: treatment of chronic liver disease\u2011related thrombocytopenia (CLDT)<\/strong> in adult patients scheduled for surgical procedures (including diagnostic interventions). This expands rhTPO\u2019s use beyond its existing oncology and immune thrombocytopenia approvals.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Approval Date<\/strong><\/td>23\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Recombinant Human Thrombopoietin (rhTPO) injection<\/td><\/tr>
New Indication<\/strong><\/td>CLDT in adults undergoing surgery<\/td><\/tr>
Previous Indications<\/strong><\/td>\u2022 Chemotherapy\u2011induced thrombocytopenia (solid tumors)
\u2022 Primary immune thrombocytopenia (adults)
\u2022 Persistent\/chronic immune thrombocytopenia (children\/adolescents)<\/td><\/tr>
Mechanism<\/strong><\/td>Stimulates bone marrow megakaryocytes to promote platelet formation\/release; shares endogenous TPO amino acid sequence<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Burden & Unmet Need<\/h2>\n\n\n\n
Parameter<\/th>Value<\/th><\/tr><\/thead>
CLDT Prevalence<\/strong><\/td>6% in non\u2011cirrhotic CLD, up to 78% in cirrhosis<\/strong><\/td><\/tr>
Platelet Threshold<\/strong><\/td><100\u00d710\u2079\/L<\/td><\/tr>
Current Strategies<\/strong><\/td>Platelet transfusion, production stimulators, destruction prevention<\/td><\/tr>
Surgical Risk<\/strong><\/td>Thrombocytopenia increases bleeding risk during procedures<\/td><\/tr>
Market Gap<\/strong><\/td>Limited options for pre\u2011operative platelet elevation in CLD<\/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 CLD Population<\/strong><\/td>~30\u201140\u202fmillion patients (2025)<\/td>10\u201115% have severe thrombocytopenia requiring intervention<\/td><\/tr>
China Hematology Market<\/strong><\/td>\u00a58\u201110\u202fbillion<\/strong> (\u2248\u202fUS$1.1\u20111.4\u202fB)<\/td>Growing with aging population<\/td><\/tr>
rhTPO Peak Sales (CLDT)<\/strong><\/td>\u00a51.5\u20112.5\u202fbillion<\/strong> (\u2248\u202fUS$210\u2011350\u202fM)<\/td>20\u201130% share of eligible pre\u2011op CLD patients<\/td><\/tr>
Competitive Advantage<\/strong><\/td>Proprietary rhTPO<\/strong> with proven safety profile across multiple indications<\/td>Cost\u2011effective vs. platelet transfusion<\/td><\/tr>
Launch Timeline<\/strong><\/td>Q2\u202f2026 (hospital formulary placement)<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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