{"entity":{"id":"betta","kind":"company","name":"Betta Pharmaceuticals","aka":["贝达药业"],"tldr":"Betta made icotinib, the first cancer drug invented in China, and later ensartinib, the first Chinese ALK inhibitor to win FDA approval.","summary":"Betta Pharmaceuticals, based in Hangzhou, founded in 2003 and listed as 300558.SZ, made icotinib, the first cancer drug invented in China, and later ensartinib, the first Chinese ALK inhibitor to win FDA approval. Icotinib, sold as Conmana, was approved in 2011; ensartinib, sold as Ensacove, was approved in China in 2020 and by the FDA in December 2024 for ALK-positive non-small-cell lung cancer through Xcovery; befotertinib from InventisBio was approved in 2023; and the company holds China rights to the MCLA-129 EGFR by c-MET bispecific from Merus. OnCo links it to icotinib and ensartinib and to InventisBio and Merus. Whether an FDA approval for ensartinib translates into US sales against entrenched ALK drugs is the open question. Ensartinib has its own page. On 3 September 2026 China approved ensartinib as treatment after surgery for stage IB to IIIB ALK-positive non-small-cell lung cancer, on the ELEVATE trial, its third indication; in September 2026 the European Medicines Agency's CHMP recommended approval for ALK-positive advanced non-small-cell lung cancer in an application from Xcovery, a step before the European Commission's decision.","asOf":"2026-10-29","links":[{"label":"Official website","url":"https://www.bettapharma.com/"},{"label":"Ensartinib approved after surgery in China (3 September 2026, Chinese)","url":"https://www.bettapharma.com/News/show/id/2873"},{"label":"CHMP positive opinion for ensartinib (September 2026, Chinese)","url":"https://www.bettapharma.com/News/show/id/2874"}],"tags":["china"],"related":[],"cancers":[],"sections":["targeted-therapy"],"technologies":[],"targets":[],"drugs":["icotinib","ensartinib","mcla-129","befotertinib","vorolanib"],"companies":["inventisbio","merus","xcovery"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06041776","nct04930432","nct07448116"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Checked 29 October 2026 against the Betta company news pages. No acquisition, merger or Hong Kong listing was found on the first page of 2026 news; earlier pages were not read."],"hq":"Hangzhou","country":"CN","companyType":"biotech","website":"https://www.bettapharma.com/","ticker":"300558.SZ","founded":2003,"investors":[],"funding":[]},"route":"/companies/betta/","neighbours":{"section":[{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"drug":[{"id":"befotertinib","kind":"drug","name":"Befotertinib","route":"/drugs/befotertinib/"},{"id":"ensartinib","kind":"drug","name":"Ensartinib","route":"/drugs/ensartinib/"},{"id":"icotinib","kind":"drug","name":"Icotinib","route":"/drugs/icotinib/"},{"id":"mcla-129","kind":"drug","name":"MCLA-129","route":"/drugs/mcla-129/"},{"id":"vorolanib","kind":"drug","name":"Vorolanib","route":"/drugs/vorolanib/"}],"company":[{"id":"inventisbio","kind":"company","name":"InventisBio","route":"/companies/inventisbio/"},{"id":"merus","kind":"company","name":"Merus","route":"/companies/merus/"},{"id":"xcovery","kind":"company","name":"Xcovery","route":"/companies/xcovery/"}],"trial":[{"id":"nct05186506","kind":"trial","name":"A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer","route":"/trials/nct05186506/"},{"id":"nct06041776","kind":"trial","name":"Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations","route":"/trials/nct06041776/"},{"id":"nct06780839","kind":"trial","name":"Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD","route":"/trials/nct06780839/"},{"id":"nct07181499","kind":"trial","name":"Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI","route":"/trials/nct07181499/"},{"id":"nct07435038","kind":"trial","name":"Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","route":"/trials/nct07435038/"},{"id":"nct07448116","kind":"trial","name":"Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.","route":"/trials/nct07448116/"},{"id":"nct06885840","kind":"trial","name":"Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.","route":"/trials/nct06885840/"},{"id":"nct04930432","kind":"trial","name":"Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors","route":"/trials/nct04930432/"}]}}