HONG KONG – China-based Hua Medicine (Shanghai) Ltd.’s phase III trial of a potentially first-in-class dual-acting glucokinase activator, dorzagliatin, met its primary efficacy endpoint.

HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).

SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.

BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.

HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN).

HONG KONG – Hutchison China Meditech Ltd.'s (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents on Sept. 12, and further since, after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.

HONG KONG – In one of the latest combination efforts against cancer, Kahr Medical Ltd. is teaming up with Switzerland's Basel-based Roche Holding AG to study the use of the former's lead program, DSP-10, in combination with the latter's PD-L1-blocking checkpoint inhibitor, Tecentriq (atezolizumab), in patients with advanced non-small-cell lung carcinoma refractory to checkpoint inhibitors.

PERTH, Australia – Stem cell therapy has failed to deliver on its promises, according to Exopharm Ltd. founder and CEO Ian Dixon, who said he believes that exosomes, or the extracellular vesicles released by stem cells, could be a disrupter in the regenerative medicine space.