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Ascletis Pharma Inc

Ascletis Pharma Inc. is a biotechnology company engaged in the research and development, manufacture, marketing, and sale of pharmaceutical products in Mainland China. Its commercial products include Ritonavir tablets and ASCLEVIR and GANOVO for the treatment of Hepatitis C virus. The company is also developing therapies such as ASC22 for CHB and HIV functional cure, ASC10 for respiratory syncytial virus, ASC10 and ASC11 for COVID-19, ASC40, ASC41, and ASC43F FDC for non-alcoholic steatohepatitis, and ASC42 for primary biliary cholangitis. Additional pipeline candidates include ASC40 for recurrent glioblastoma, ASC61 for advanced solid tumors, ASC40 as an oral small molecule for acne, ASC30 for obesity, ASC47 for muscle-preserving weight loss, and ASC39, an amylin-selective oral small molecule amylin receptor agonist. Founded in 2013, Ascletis Pharma Inc. is based in Wan Chai, Hong Kong.

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1672.HK

Sagimet Closes Down 5% After Acne Drug Data and $115M Offering

Sagimet Biosciences closed Thursday down about 5%, a day after its partner Ascletis Pharma released 52-week results from a phase 3 open-label extension trial conducted in China of denifanstat in patients with acne vulgaris. On Thursday, Sagimet separately announced it closed a common stock offering with gross proceeds of approximately $115.0M before commissions, discounts, and expenses, with the proceeds earmarked for denifanstat pre-launch activities, a phase 3 trial in the US, and other pipeline programs. In the trial, patients were first treated in the 12-week randomized, double-blind, placebo-controlled ASC40-304 study, and those selected to roll into the open-label extension all received denifanstat for another 40 weeks. Results showed that patients who received denifanstat for the entire 52 weeks had a treatment success rate of 57.8%, compared to 55.6% for those who started on placebo, while mean percentage change in total lesion count was -73% in the deni/deni cohort and -70.7% in the deni/placebo group. Denifanstat, a fatty acid synthase inhibitor, is also under development for metabolic dysfunction-associated steatohepatitis, or MASH.
SGMT · Capital · Negative Sagimet closed a ~$115M common stock offering, diluting shareholders.
SGMT · Technology · Neutral Partner Ascletis reported 52-week phase 3 acne data for denifanstat, with modest incremental benefit over placebo.
1672.HK · Technology · Neutral Ascletis released 52-week phase 3 open-label extension results for denifanstat in acne vulgaris in China.
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Biotech & Genomic Medicine▲

Ascletis Pharma Submits Two IND Applications to FDA for Obesity Treatments ASC36 and ASC36_35 FDC

Ascletis Pharma has submitted two Investigational New Drug applications to the U.S. FDA for its obesity treatment candidates ASC36 and ASC36_35 FDC. ASC36 is a once-monthly to once-quarterly peptide amylin receptor agonist, while ASC36_35 FDC is a once-monthly injection co-formulation of ASC36 plus the peptide GLP-1R/GIPR agonist ASC35. In preclinical diet-induced obesity rat studies, ASC36 monotherapy showed approximately 91% and 32% greater relative body weight reduction than petrelintide and eloralintide monotherapies, respectively, and ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared with co-administration of eloralintide and tirzepatide. The company's lead program, ASC30, is being evaluated for chronic weight management. Ascletis' stock was up 1.99% at HK$11.77.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
1672.HK · Regulation · Positive IND submissions to FDA for obesity treatments ASC36 and ASC36_35 FDC, a regulatory step toward clinical trials.
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