HONG KONG – Tokyo-based Daiichi Sankyo Co. Ltd. has hit its goals in a phase III study testing the use of prasugrel hydrochloride in thrombotic stroke patients.
HONG KONG – Mumbai, India-headquartered Glenmark Pharmaceuticals Ltd. have released statistically significant top-line results from a phase III trial showing that Fabiflu (favipiravir), an antiviral pyrazine RNA polymerase inhibitor, can treat cases of mild to moderate COVID-19 in four days.
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year.
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business. The company is now developing three therapeutic products, one diagnostic and a vaccine.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I. The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results.
LONDON – There were encouraging results from trials of three COVID-19 vaccines on July 20, with Astrazeneca plc, Biontech SE/Pfizer Inc. and Cansino Biologics Inc. all reporting T-cell responses in ongoing phase I/II studies of their respective products.
CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
BEIJING – Androgen receptor (AR) antagonist developer Kintor Pharmaceutical Ltd., of Suzhou, China, is going to provide its proxalutamide (GT-0918) to an ongoing clinical trial in male patients, led by U.S. firm Applied Biology Inc., in Brazil for COVID-19, after preliminary clinical research suggested a potential link between androgenetic alopecia and COVID-19 pathogenesis.