{"entity":{"id":"laekna-therapeutics","kind":"company","name":"Laekna Therapeutics","aka":["Laekna","Laekna Limited","来凯医药"],"tldr":"Laekna is a Shanghai drug company listed in Hong Kong. Its lead cancer medicine, afuresertib, taken with fulvestrant for a common type of advanced breast cancer, met its main goal in a phase 3 trial and has been submitted for approval in China. It also works on obesity and liver fibrosis.","summary":"Laekna Therapeutics was established in 2016 in Shanghai and listed on the Main Board of the Hong Kong Stock Exchange in June 2023 (stock code 2105). It works in metabolic disease, oncology and liver fibrosis. Its lead oncology asset is afuresertib (LAE002), an AKT inhibitor licensed from Novartis in 2018: the company says the phase 3 AFFIRM-205 trial of afuresertib plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer (NCT04851613) met its primary endpoint, a new drug application was accepted by China's NMPA in August 2026, and China rights for breast cancer were licensed to Qilu Pharma in November 2025. Afuresertib has also been studied with lapiteronel (LAE001, a CYP17A/CYP11B2 inhibitor licensed from Novartis) in metastatic castration-resistant prostate cancer, with LAE005 (anti-PD-L1) and nab-paclitaxel in triple-negative breast cancer, and with paclitaxel in platinum-resistant ovarian cancer. LAE118, a PI3K-alpha mutant-selective inhibitor, entered phase 1 in advanced solid tumours in 2026 and was licensed outside China to Vasque Bio. Preclinical cancer programmes listed include LAE120 (USP1), LAE119 (PARP1), LAE111 (LILRB1/LILRB2), LAE112 (FGFR2b) and LAE113 (TIGIT/PVRIG).","asOf":"2026-11-04","links":[{"label":"Official website","url":"https://www.laekna.com/"},{"label":"R&D and pipeline","url":"https://www.laekna.com/rd"},{"label":"About Laekna and milestones","url":"https://www.laekna.com/aboutus"},{"label":"AFFIRM-205 trial NCT04851613","url":"https://clinicaltrials.gov/study/NCT04851613"},{"label":"OrbiMed portfolio entry","url":"https://www.orbimed.com/portfolio/"}],"tags":[],"related":[],"cancers":["breast-hr-positive","prostate-mcrpc","tnbc","ovarian"],"sections":["targeted-therapy","hormonal"],"technologies":["pi3k-akt-mtor-inhibitors"],"targets":["akt","cyp17a1","pik3ca"],"drugs":["afuresertib","lapiteronel","lae118"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct04851613"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Series Seed to D rounds are listed on the company's milestones without amounts, so no funding rows are given.","Only nct04851613 has an OnCo trial record; the other Laekna oncology trials (NCT04060394, NCT03843918, NCT04374630, NCT05383482, NCT05390710, NCT07787520) do not.","The pipeline lists the lapiteronel combination in mCRPC as US phase III; the sponsor trials found on ClinicalTrials.gov are phase 1/2."],"hq":"Shanghai","country":"CN","companyType":"biotech","website":"https://www.laekna.com/","ticker":"HKEX: 2105","founded":2016,"stage":"public","investors":["orbimed"],"funding":[]},"route":"/companies/laekna-therapeutics/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"section":[{"id":"hormonal","kind":"section","name":"Hormonal Therapy","route":"/fronts/hormonal/"},{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"technology":[{"id":"pi3k-akt-mtor-inhibitors","kind":"technology","name":"PI3K, AKT and mTOR inhibitors","route":"/technologies/pi3k-akt-mtor-inhibitors/"}],"target":[{"id":"akt","kind":"target","name":"AKT","route":"/targets/akt/"},{"id":"cyp17a1","kind":"target","name":"CYP17A1 (17-alpha-hydroxylase/17,20-lyase)","route":"/targets/cyp17a1/"},{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"drug":[{"id":"afuresertib","kind":"drug","name":"Afuresertib","route":"/drugs/afuresertib/"},{"id":"lae118","kind":"drug","name":"LAE118","route":"/drugs/lae118/"},{"id":"lapiteronel","kind":"drug","name":"Lapiteronel","route":"/drugs/lapiteronel/"}],"trial":[{"id":"nct07787520","kind":"trial","name":"A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors","route":"/trials/nct07787520/"},{"id":"nct03843918","kind":"trial","name":"A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer","route":"/trials/nct03843918/"},{"id":"nct05383482","kind":"trial","name":"Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1","route":"/trials/nct05383482/"},{"id":"nct04060394","kind":"trial","name":"Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC","route":"/trials/nct04060394/"},{"id":"nct05390710","kind":"trial","name":"PhI to Solid Tumors and PhII to Locally Advanced or mTNBC","route":"/trials/nct05390710/"},{"id":"nct04851613","kind":"trial","name":"Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer","route":"/trials/nct04851613/"},{"id":"nct04374630","kind":"trial","name":"Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian","route":"/trials/nct04374630/"}],"company":[{"id":"orbimed","kind":"company","name":"OrbiMed","route":"/companies/orbimed/"}]}}