Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China.
Hutchmed Ltd. has received a $15 million milestone payment from Astrazeneca plc for initiating a phase III trial testing the Hutchmed c-Met inhibitor Orpathys (savolitinib) in combination with Astrazeneca’s Tagrisso (osimertinib) in EGFR-mutated non-small-cell lung cancer.
PERTH, Australia – Prota Therapeutics Ltd.’s lead candidate PRT-120 induced clinical remission of peanut allergy in 51% of children in a phase IIb clinical trial. There are currently no curative therapies to treat food allergies, Prota Therapeutics CEO Mimi Tang told BioWorld. Peanut allergy in children can be particularly problematic because the only treatment is avoidance.
Livzon Pharmaceutical Group Inc.’s key interim data from the phase III trials of its recombinant SARS-CoV-2 fusion protein vaccine, V-01, has shown efficacy against the omicron variant. The phase III trial aims to evaluate the efficacy, safety and immunogenicity of V-01 as a booster in adults older than 18 after they have received two doses of inactivated vaccines.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
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