On August 12, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Idecabtagene Vicleucel Injection) has received the FDA's tacit approval. It is intended for the treatment of non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN). This marks the fifth clinical approval the product has received in the field of autoimmune diseases in both China and the United States.On August 12, the CDE website showed that the marketing application of WANTAI BioPharm's 9-valent human papillomavirus (HPV) vaccine is proposed to be included in the priority review, applicable for the prevention of cervical cancer caused by HPV types 16 and 18, grade 2 and 3 cervical intraepithelial neoplasia (CIN2/3) and adenocarcinoma in situ (AIS), grade 1 cervical intraepithelial neoplasia (CIN1) and persistent infection, as well as persistent infections caused by HPV types 6, 11, 31, 33, 45, 52, and 58.On August 13, the CDE website announced that marstacimab injection, a Class 1 therapeutic biological product applied for by Pfizer, had been submitted for marketing authorization in China and accepted. Marstacimab (PF-06741086), developed by Pfizer, is a novel hemophilia therapy that requires only once-weekly subcutaneous injection.On August 12, the CDE website announced that AstraZeneca's Class 1 new drug, AZD7798 Injection, has been approved for clinical trials, aiming to develop a treatment for moderate to severe Crohn's disease. According to AstraZeneca's official website and public information, AZD7798 is a humanized monoclonal antibody targeting T cell subsets.Investment and Financing in the Pharmaceutical IndustryAugust 12, Ocumension Therapeutics announced that it has reached an agreement with Alcon. Ocumension will acquire the rights related to a portfolio of eight ophthalmic products for dry eye treatment and surgical use from Alcon in China, including seven marketed products and one product currently in clinical development. The scope of the agreement will also cover research and development, manufacturing, and commercialization in China. According to the press release, Ocumension will issue 139,159,664 shares to Alcon, representing 16.71% of the total share capital (post-issuance). As a result, Alcon will become one of the largest shareholders of Ocumension. Under the terms of the arrangement, each company grants the other the right of first negotiation for future products.Technology-Driven Drug Research
On July 31, a team led by Kim Lewis from the Center for Antimicrobial Discovery at Northeastern University in the United States and Richard E. Lee from the Department of Chemical Biology and Therapeutics at St. Jude Children's Research Hospital published a review article titled "Sophisticated natural products as antibiotics" in Nature. By conducting a retrospective analysis of the characteristics of natural product antibiotics and their complex mechanisms for effectively targeting bacteria, the article provides inspiration for designing novel antibiotics.
[1]Kim Lewis, et al. Sophisticated natural products as antibiotics. Nature. 2024 Jul 31.
