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Laekna, Inc. Initiates IND-Enabling Study for Monoclonal Antibody LAE123 in Severe Diseases
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe…
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Laekna and Eli Lilly & Co. Enter Clinical Cooperation to Advance Obesity Treatment LAE102
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced a significant clinical cooperation agreement with US pharmaceutical major Eli Lilly & Co., (NYSE: LLY), aimed at accelerating the global clinical development of Laekna’s obesity treatment candidate, LAE102. Under the terms of the agreement, Lilly will take on the responsibility for…
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Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
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Laekna, a Sino-US biotech firm, has announced the commencement of a subcutaneous dosing cohort within its Phase I single ascending dose (SAD) study for the monoclonal antibody drug candidate LAE102, which is under investigation for the treatment of obesity. The study, which is randomized, double-blinded, and placebo-controlled, aims to evaluate…
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Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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Laekna’s ActRIIA Monoclonal Antibody LAE102 Gets Green Light from China’s CDE for Obesity Treatment
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Sino-US biotech firm Laekna has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its monoclonal antibody drug candidate, LAE102, intended for the treatment of obesity. This development follows the drug’s previous clinical trial approval in the US last month. In-house developed, LAE102…
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Laekna’s Anti-ActRIIA Antibody LAE102 Clears FDA Hurdle for Obesity Treatment Trial
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Sino-American biotech firm Laekna has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary monoclonal antibody, LAE102. The molecule is set to be evaluated as a potential treatment for obesity, a condition that affects a significant portion of the global…
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Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
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Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody targeting adult obesity and metabolic disorders, has been accepted for review by the Center for Drug Evaluation (CDE). LAE102 is a potent and selective monoclonal antibody against ActRIIA, known for its regulatory roles in tumor…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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Laekna Raises £791 Million in Hong Kong IPO for Pipeline Expansion
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Sino-US Laekna (HKG: 2105) has successfully raised £791 million through an initial public offering (IPO) of 63,728,000 shares on the Hong Kong Stock Exchange, with each share priced at HKD12.41. Company Background and Core ProductsFounded in 2016, Laekna has established itself with two core products, both in-licensed from Swiss pharmaceutical…
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Sino-US Laekna Receives FDA Clearance for LAE102 Clinical Trial in NSCLC
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Sino-US Laekna has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its LAE102 antibody. The drug is set to be assessed as a potential treatment for non-small cell lung cancer (NSCLC). This achievement marks LAE102 as Laekna’s first internally-discovered drug candidate…
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Laekna Therapeutics Files for IPO on Hong Kong Stock Exchange, Aims to Expand Cancer and Hepatic Fibrosis Therapies
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China’s Laekna Therapeutics Shanghai Co., Ltd has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange (HKSE), according to the exchange. The offering will be sponsored by CICC. This move marks a significant step in Laekna’s growth strategy as it seeks to raise capital to further…
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Laekna Therapeutics Doses First Patient in LAE001/LAE002 Study for Prostate Cancer
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China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea. Study DetailsLAE201INT2101 is a multi-center,…
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Innovent and Laekna Dose First Patient in Afuresertib and Tyvyt Study for PD-1 Resistant Tumors
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China’s Innovent Biologics Inc. (HKG: 1801) and partner Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in a Phase I/II clinical study (NCT05383482) evaluating afuresertib combined with Tyvyt (sintilimab) plus chemotherapy in solid tumors resistant to PD-1/PD-L1 inhibitors. Study DetailsThe multi-center, single-arm, open-label, dose-escalation study…
