Zhimeng Biopharma Inc. found a global partner for its hepatitis B virus (HBV) program, licensing rights to GSK plc for CB-06, an oral small-molecule Toll-like receptor 8 agonist. Pending positive data from an ongoing phase I study, GSK will gain rights to develop, manufacture and commercialize the drug for chronic HBV infection, either for use in combination or as a sequential treatment with bepirovirsen.
New drug technology may soon deliver a breakthrough to eliminate internal bleeding caused by drug overuse. Shaanxi Micot Technology Co. Ltd.’s MT-1011 is a synthetic water-soluble small-molecule anticoagulant antagonist. After a single intravenous dose, it can bind directly to other anticoagulants to stop anticoagulant effects and restore the clotting function. Data from clinical trials support its mechanism.
In its first worldwide licensing deal in the cardiovascular space, Ji Xing Pharmaceuticals Ltd. acquired rights to preclinical-stage PB-6440, in development for diseases including hypertension, from Phasebio Pharmaceuticals Inc.
The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
With China taking steps to enact or propose amendments to more than 60 intellectual property (IP)-related laws and regulations over the past few years, drug and device companies doing business in the country need to keep abreast of the changes. Despite China’s efforts, most of the participants in the Feb. 9 U.S. Patent and Trademark Office’s quarterly China IP webinar indicated in a pre-webinar survey that they have yet to see much of an improvement in China’s enforcement and regulation of IP rights.
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine.
Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance.
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
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