Medical Frontline Drug News
On January 14, Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., had received approval from the U.S. FDA for the clinical trial application of HDM2006 tablets. A Phase I clinical trial can now be conducted in the United States for the indication of advanced malignant tumors. HDM2006 tablets are a novel, potent, highly selective, and orally bioavailable Proteolysis Targeting Chimera (PROTAC) Class 1 chemical drug independently developed by Zhongmei Huadong, targeting HPK1 (Hematopoietic Progenitor Kinase-1).
On January 15, the CDE website announced that the Phase 1 new drug itepekimab injection, submitted by Sanofi, has been approved for clinical trials. It is intended for the treatment of patients with chronic rhinosinusitis without nasal polyps (CRSsNP). This is a monoclonal antibody targeting IL-33, jointly developed by Sanofi and Regeneron.On January 14, Jumpcan announced that its wholly-owned subsidiary, HUBEI JUMPCAN PHARMACEUTICAL CO.,LTD., had received the "Drug Registration Certificate" for Roxadustat Capsules issued by the National Medical Products Administration. The product is classified as Category 4 chemical drug and is mainly used for anemia caused by chronic kidney disease (CKD), including both dialysis and non-dialysis patients.On January 14, TQ05105 (Rovacitinib), a JAK/ROCK inhibitor independently developed by Zhengda Tianqing Pharmaceutical Group under Sino Biopharm, received approval from the U.S. Food and Drug Administration (FDA) for its Phase II New Drug Clinical Trial Application (IND) for the treatment of chronic graft-versus-host disease (cGVHD).Investment and Financing in Pharmaceuticals
On January 13, Shanghai Henlius Biotech, Inc. announced that it had signed a licensing agreement with Abbott, granting the latter exclusive or semi-exclusive rights to develop and commercialize four biosimilars and one innovative biologic independently developed by the company across 69 emerging market countries and regions. The agreement covers Asia, Latin America and the Caribbean, as well as the Middle East and North Africa. This licensing agreement further deepens the existing collaboration between the two parties in the field of oncology biosimilars.Technology-Driven Drug ResearchOn January 14, a research team led by Professor Liu Ting, Professor Fang Dong, and Professor Huang Jun from Zhejiang University (Ph.D. students Xie Haihua and Song Lizhi are the co-first authors) published a research paper titled "Synergistic protection of nascent DNA at stalled forks by MSANTD4 and BRCA1/2-RAD51" in the Nature Chemical Biology, a sub-journal of Nature. The study reveals a new synthetic lethal pathway with BRCA1/2.[1]Xie, H., Song, L., Mao, G. et al. Synergistic protection of nascent DNA at stalled forks by MSANTD4 and BRCA1/2–RAD51. Nat Chem Biol (2025). https://doi.org/10.1038/s41589-024-01833-9
