The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating adeno-associated virus (AAV) gene replacement therapy AT-845 in adults with late-onset Pompe disease.
Just in time for the Chinese New Year, Mabwell Bioscience Co. Ltd. announced that its U.S. subsidiary, Mabwell Therapeutics Ltd., closed a licensing deal with Disc Medicine Inc. worth up to $412 million for preclinical candidate 9MW-3011, a humanized monoclonal antibody (MAb) that regulates iron metabolism.
The discovery of two new sarcoma-specific pathways and 14 new genes that predispose people to heritable sarcomas could pave the way to managing cancer risk early via detection of these mutations for this rare type of cancer. Sarcomas are rare connective tissue malignancies mostly derived from embryonic mesoderm and affect younger people.
Proposed mergers with Chinese companies will likely be subject to increased scrutiny from the Committee on Foreign Investment in the United States (CFIUS) as evidenced by the temporary hold placed on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd. that was announced in June 2022.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
CAR T specialist Carsgen Therapeutics Holdings Ltd. out-licensed commercial rights for its B-cell maturation antigen (BCMA) CAR T therapy, CT-053, in mainland China to Huadong Medicine Co Ltd. in a deal worth up to $152 million.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Proposed mergers with Chinese companies will likely be subject to increased scrutiny from the Committee on Foreign Investment in the United States (CFIUS) as evidenced by the temporary hold placed on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd. that was announced in June 2022.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
