Ascletis Pharma Inc. presented subgroup data from a phase II trial showing its subcutaneous PD-L1 antibody envafolimab (ASC-22) was able to functionally cure chronic hepatitis B, according to hepatitis B surface antigen decline following 24-week treatment.
The U.S. FDA granted Nanjing Iaso Biotherapeutics Co. Ltd. both regenerative medicine advanced therapy and fast track designations for its new drug, BCMA CAR T-cell therapy CT-103A (equecabtagene autoleucel), allowing it to speed up development and commercialization in the U.S. for the treatment of relapsed/refractory multiple myeloma.
Harbour Biomed Holdings Ltd. licensed exclusive U.S. rights to B7H4 x 4-1BB bispecific immune activator HBM-7008 to Cullinan Oncology Inc. in a deal worth up to $625 million. China-based Harbour will obtain a $25 million up-front payment and is eligible to receive up to $600 million in development, regulatory and sales-based milestones, as well as tiered royalties of up to 20% on U.S. commercial sales.
Hengrui Pharmaceuticals Co. Ltd. licensed its EZH2 inhibitor, SHR-2554, to Treeline Biosciences Inc. in a deal worth more than $700 million. Treeline will be granted worldwide exclusive rights to the lymphoma drug, except for greater China, in exchange for an up-front payment of $11 million, development milestone payments of up to $45 million, and milestone payments of up to $650 million based on annual net sales once commercialization begins.
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.
Shukun Technology Inc.’s recently approved AI-based system to assess coronary arteries can get results in minutes, significantly speeding up diagnostics.
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