{"id":17,"date":"2015-09-23T20:12:20","date_gmt":"2015-09-23T20:12:20","guid":{"rendered":"http:\/\/advenchen.com\/blog\/?page_id=17"},"modified":"2026-04-24T01:59:44","modified_gmt":"2026-04-24T01:59:44","slug":"news","status":"publish","type":"page","link":"https:\/\/advenchen.com\/?page_id=17","title":{"rendered":"News"},"content":{"rendered":"

JCA-HTA submission on April 9, 2026<\/strong><\/p>\n

June 30, 2025<\/strong>
\nCatequentinib Hydrochloride (AL3818) EMA Market Authorization Application (MAA) has been successfully submitted.<\/p>\n

June 1, 2025<\/strong>
\nDr. Robin Jones of Royal Marsden Hospital, London has oral presentation at 2025 annual ASCO meeting titled ” Randomized Phase III Trial of Catequentinib Hydrochloride (AL3818) versus Placebo in Advanced or Metastatic Leiomyosarcoma\u201d<\/p>\n

November 20, 2024<\/strong>
\nAL3818-US-004 (APROMISS) double blind, placebo controlled Leiomyosarcoma (LMS) phase 3 trial has been completed with the database lock date on November 17, 2024.<\/p>\n

February 16, 2024
\n<\/strong>AL3818-US-002 Japan run-in cohort with three patients of AL3818-US-002 global platinum resistant ovarian cancer phase 3 study has completed DLT evaluation within 6 months and started close out process.<\/p>\n

November 7, 2023
\n<\/strong>\u201cAL3818-US-002 global platinum resistant ovarian cancer phase 3 study has completed enrollment for the last patient at Seoul National University Hospital of South Korea and entered 12 months follow up stage.<\/p>\n

June 6, 2023
\n<\/strong>\u201cPhase Ib\/ IIa study assessing the safety and efficacy of AL8326 monotherapy in patients with \u22652nd line small cell lung cancer (SCLC) treatment\u201d has been published at ASCO 2023 annual meeting.<\/p>\n

October 22, 2022
\n<\/strong>\u201cPhase 2 study assessing the efficacy of adding AL3818 (Catequentinib Dihydrochloride, Anlotinib Hydrochloride) to chemotherapies in subjects with platinum resistant ovarian carcinoma\u201d has been published at 23rd ESGO annual meeting.<\/p>\n

September 7, 2021
\n<\/strong>The first patient of phase 3 platinum resistant ovarian cancer clinical study (AL3818-US-002) has been enrolled for the treatment.<\/p>\n

June 6, 2021
\n<\/strong>\u201cA phase III study (APROMISS) of AL3818 (Catequentinib, Anlotinib) hydrochloride monotherapy in subjects with metastatic or advanced synovial sarcoma\u201d was presented by Dr. Van Tine at ASCO 2021 annual meeting.<\/p>\n

June 15, 2020
\n<\/strong>APROMISS trial amendment has been approved by the Italian Ethical Committee.<\/p>\n

March 16, 2018<\/strong>
\nAdvenchen is excited to announce the European Medicines Agency (EMA) granted AL3818 orphan designation for the treatment of soft tissue sarcomas on February 22, 2018. To qualify for orphan designation, a medicine must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that is prevalent in less than 5 in 10,000 people in the EU and must be of significant benefit to those affected by the condition. AL3818 is being evaluated for the treatment of alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma in a global phase 3 trial. The trial is now open for recruitment at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy.<\/p>\n

December 6, 2017<\/strong>
\nAdvenchen is preparing for regulatory submission to open APROMISS (NCT03016819), the global phase 3 evaluation of AL3818 in soft tissue sarcoma, in Japan. The consultation meeting with the PMDA has been scheduled for the end of December 2017.<\/p>\n

July 12, 2017<\/strong>
\nAdvenchen is pleased to announce the FDA has granted AL3818 orphan drug designation for the potential treatment of soft tissue sarcomas. Soft tissue sarcomas are considered an orphan disease in the U.S. and there are still limited treatment options available. This is an exciting accomplishment supporting Advenchen’s efforts pursuing AL3818 in patients with alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma. The FDA Orphan Drug Designation program grants orphan designation for drugs intended for diseases or conditions that affect fewer than 200,000 people in the United States.<\/p>\n

January 11, 2017<\/strong>
\nHappy New Year! Advenchen is excited to announce the initiation of APROMISS, a global phase 3 trial evaluating our novel small molecule tyrosine kinase inhibitor, AL3818, in recurrent or metastatic, advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS).<\/p>\n","protected":false},"excerpt":{"rendered":"

JCA-HTA submission on April 9, 2026 June 30, 2025 Catequentinib Hydrochloride (AL3818) EMA Market Authorization Application (MAA) has been successfully submitted. June 1, 2025 Dr. Robin Jones of Royal Marsden Hospital, London has oral presentation at 2025 annual ASCO meeting titled ” Randomized Phase III Trial of Catequentinib Hydrochloride (AL3818) versus Placebo in Advanced or […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-17","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/pages\/17","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/advenchen.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17"}],"version-history":[{"count":23,"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/pages\/17\/revisions"}],"predecessor-version":[{"id":354,"href":"https:\/\/advenchen.com\/index.php?rest_route=\/wp\/v2\/pages\/17\/revisions\/354"}],"wp:attachment":[{"href":"https:\/\/advenchen.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}