On July 2, Biostar announced that the U.S. FDA has approved its Phase 2 clinical trial (BG01-2402) for utidelone injection in treating HER2-negative breast cancer brain metastases (BCBM). The study aims to evaluate the intracranial and systemic efficacy and safety of utidelone injection combined with capecitabine in patients with HER2-negative BCBM.
On July 1, SPH (601607) announced that its wholly-owned subsidiary, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd., had recently received the "Drug Clinical Trial Approval Notice" for WST03 formulation (capsules) issued by the National Medical Products Administration, and will soon initiate Phase I clinical trials in China. The announcement stated that WST03 is a vaginal microbiota live biotherapeutic product intended for the treatment of bacterial vaginosis (BV).On June 29, the CDE official website showed that ZVS101e Injection from Beijing Zhongyin Technology Co., Ltd. has been included in the list of breakthrough therapies for the treatment of Bietti's Crystalline Dystrophy (BCD). Data shows that ZVS101e is a gene replacement therapy candidate drug developed by Zhongyin Technology.On June 28, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human GPRC5D-targeted CAR-T product RD118 received tacit approval from the National Medical Products Administration (NMPA) of China, intended for the treatment of relapsed/refractory multiple myeloma (RRMM).Investment and Financing Pharmaceutical AffairsRecently, Suzhou Antishengshi Pharmaceutical Technology Co., Ltd. announced the completion of a nearly 100-million-yuan Series A round of financing. This round was led by SDIC Venture Capital, with follow-on investments from existing shareholders and Ruihe Venture SCA3 Industry Fund, supporting Antishengshi in promoting new technology research and development, commercial production implementation, and international business strategic layout. The funds raised will be used to accelerate the advancement of products targeting indications such as Duchenne Muscular Dystrophy, Spinocerebellar Ataxia, and Huntington's Disease, and apply for registration clinical trials, promote the product development of multiple subsequent innovative pipelines, and facilitate international cooperation.On July 1, Merck & Co. and Orion Corporation jointly announced that they had exercised their options to convert the co-development and commercialization rights of the CYP11A1 inhibitor opevesostat (MK-5684/ODM-208), as well as other CYP11A1 inhibitor candidates under development, into an exclusive global license for Merck.Technology-Driven Drug Research
On June 25, a study published in the journal Nature Biotechnology revealed that a team of scientists from Yale University discovered a method to make NK cells more effective in fighting cancer. The researchers claimed that this discovery is expected to bring a breakthrough in the treatment of solid tumors.[1]Peng, L., Renauer, P.A., Sferruzza, G. et al. In vivo AAV–SB-CRISPR screens of tumor-infiltrating primary NK cells identify genetic checkpoints of CAR-NK therapy. Nat Biotechnol (2024). https://doi.org/10.1038/s41587-024-02282-4
