{"id":302,"date":"2025-09-16T05:19:14","date_gmt":"2025-09-16T05:19:14","guid":{"rendered":"https:\/\/cninmed.com\/en\/?p=302"},"modified":"2025-09-19T13:58:03","modified_gmt":"2025-09-19T13:58:03","slug":"china-nmpa-approved-new-drugs","status":"publish","type":"post","link":"https:\/\/cninmed.com\/en\/2025\/302.html","title":{"rendered":"China NMPA Approved New Drugs \uff08Small Molecule\uff09"},"content":{"rendered":"\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Target<\/td><td>Drug Name<\/td><td>RD Code<\/td><td>Approved(CN)<\/td><td>Company<\/td><td>Partner<\/td><\/tr><tr><td>EGFR-TKI <br>(Gen 1)<\/td><td>Icotinib<\/td><td><\/td><td>2011-06<\/td><td>Betta<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Fruquintinib<\/td><td><\/td><td>2018<\/td><td>HutchMed<\/td><td>LO: Takeda<\/td><\/tr><tr><td>EGFR-TKI<br>(Gen 3)<\/td><td><br>Almonertinib<\/td><td>HS-10296<\/td><td>2020-03<\/td><td>Hansoh<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<br>(Gen 3)<\/td><td>Furmonertinib<\/td><td>AST2818<\/td><td>2021-03<\/td><td>Allist<\/td><td>LO: ArriVent<\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Sunvozertinib<\/td><td><\/td><td>2023-08<\/td><td>Dizal<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Befotertinib<\/td><td>D-0316<\/td><td>2023-05<\/td><td>InventisBio<br>&lt;Betta><\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Rezivertinib<\/td><td>BPI-7711<\/td><td>2024-05<\/td><td>Beta<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Rilertinib<\/td><td>SH-1028<\/td><td>2024-06<\/td><td>Sanhome<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Zorifertinib<\/td><td><\/td><td>2024-11<\/td><td>Alpha Bio<\/td><td><\/td><\/tr><tr><td>EGFR-TKI<\/td><td>Limertinib<\/td><td>ASK120067<\/td><td>2025-01<\/td><td>Osaikang<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>VEGFR<\/td><td>Apatinib<\/td><td><\/td><td><\/td><td>Hengrui<\/td><td><\/td><\/tr><tr><td>EGFR \/ HER2 \/ HER4<\/td><td>Pyrotinib<\/td><td><\/td><td><\/td><td>Hengrui<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>BTK Inhibitor<\/td><td>Zanubrutinib<\/td><td><\/td><td>2020-06<\/td><td>BeOne<\/td><td><\/td><\/tr><tr><td>BTK Inhibitor<\/td><td>Orelabrutinib<\/td><td>ICP-022<\/td><td>2020-12<\/td><td>InnoCare<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>MET<\/td><td>Savolitinib<\/td><td><\/td><td>2021-06<\/td><td><\/td><td><\/td><\/tr><tr><td>MET<\/td><td>Vebreltinib<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>Bcr-Abl TKI<\/td><td>Flumatinib<\/td><td><\/td><td>2019-11<\/td><td>Hansoh<\/td><td><\/td><\/tr><tr><td>Bcr-Abl TKI<\/td><td>Olverembatinib<\/td><td>HQP1351<\/td><td>2021-11<\/td><td>Ascentage<br>&lt;Innovent><\/td><td>LI:GIBH<\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>PARP 1\/2<\/td><td>Pamiparib<\/td><td><\/td><td>2021-05<\/td><td>BeOne<\/td><td><\/td><\/tr><tr><td>PARP 1\/2<\/td><td>Fluzoparib<\/td><td><\/td><td>2021<\/td><td>Hengrui<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>HER2<\/td><td>Neratinib<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>PI3K\u03b4 inhibitor<\/td><td>Linperlisib<\/td><td><\/td><td>2022-11<\/td><td>Yingli<br>&lt;Hengrui><\/td><td><\/td><\/tr><tr><td>MEK<\/td><td>Tunlametinib<\/td><td>HL-085<\/td><td>2024-03<\/td><td>KeChow<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>Bcl-2 inhibitor<\/td><td>Lisaftoclax <\/td><td>APG-2575<\/td><td>2025-07<\/td><td>Ascentage&nbsp;<\/td><td><\/td><\/tr><tr><td>EZH2<\/td><td>Zeprumetostat<\/td><td>SHR2554<\/td><td>2025-08<\/td><td>Hengrui<\/td><td>LO: Treeline<\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>ROS1<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>ALKi (Gen2<\/td><td>Ensartinib<\/td><td><\/td><td>2020-11<\/td><td>Betta<\/td><td>Xcovery<\/td><\/tr><tr><td>ALKi (Gen2<\/td><td>Iruplinalkib<\/td><td>WX-0595<\/td><td>2023-03<\/td><td>Qilu<\/td><td><\/td><\/tr><tr><td>ALKi (Gen2<\/td><td>Envonalkib<\/td><td>TQ-B3139<\/td><td>2024-06<\/td><td>CTTQ<\/td><td><\/td><\/tr><tr><td>ALKi (Gen2<\/td><td>Dirozalkib<\/td><td>XZP-3621<\/td><td>2025-08<\/td><td>Xuanzhu<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>c-Met&nbsp;TKI<\/td><td>Gumarontinib<\/td><td><\/td><td>2023-03<\/td><td>Haihe<\/td><td><\/td><\/tr><tr><td>ROS1\/ALK\/c-Met<\/td><td>Unecritinib<\/td><td>TQ-B3101<\/td><td>2024-04<\/td><td>CTTQ<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>KRAS G12C<\/td><td>Fulzerasib<\/td><td>GFH925<\/td><td>2024-08<\/td><td>GenFleet<br>&lt;Innovent><\/td><td><\/td><\/tr><tr><td>KRAS G12C<\/td><td>Garsorasib<\/td><td>D-1553<\/td><td>2024-11<\/td><td>InventisBio<br>&lt;CTTQ><\/td><td><\/td><\/tr><tr><td>KRAS G12C<\/td><td>Glecirasib<\/td><td>JAB-21822<\/td><td>2025-05<\/td><td>Jacobio<br>&lt;Allist><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>Multi Target<\/td><td>Donafenib<\/td><td><\/td><td>2021-06<\/td><td>Zelgen<\/td><td><\/td><\/tr><tr><td>Multi Target<\/td><td>Vorolanib<\/td><td><\/td><td>2023-06<\/td><td>Betta<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>CDK4\/6 inhibitor<\/td><td>Dalpiciclib<\/td><td><\/td><td>2021-12<\/td><td>Hengrui<\/td><td><\/td><\/tr><tr><td>CDK4\/6<\/td><td><\/td><td>XZP-3287<\/td><td><\/td><td>Xuanzhu<\/td><td><\/td><\/tr><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>AR inhibitor<\/td><td>Rezvilutamide<\/td><td><\/td><td>2022-06<\/td><td>Hengrui<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Target Drug Name RD Code Approved(CN) Company Partner EGFR-TKI (Gen 1) Icotinib 2011-06 Betta EGFR-TKI Fruquintinib &hellip; <a title=\"China NMPA Approved New Drugs \uff08Small Molecule\uff09\" class=\"hm-read-more\" href=\"https:\/\/cninmed.com\/en\/2025\/302.html\"><span class=\"screen-reader-text\">China NMPA Approved New Drugs \uff08Small Molecule\uff09<\/span>Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-302","post","type-post","status-publish","format-standard","hentry","category-china-new-drug"],"_links":{"self":[{"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/posts\/302","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/comments?post=302"}],"version-history":[{"count":19,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/posts\/302\/revisions"}],"predecessor-version":[{"id":367,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/posts\/302\/revisions\/367"}],"wp:attachment":[{"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/media?parent=302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/categories?post=302"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cninmed.com\/en\/wp-json\/wp\/v2\/tags?post=302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}