On September 2, the CDE website showed that SHR-A1811 (Recombinant Trastuzumab for Injection), developed by Suzhou Shengdiya Biopharmaceuticals, a subsidiary of Hengrui Pharma, is proposed to be included in the priority review for the treatment of adult patients with locally advanced or metastatic HER2-mutated non-small cell lung cancer who have previously received at least one systemic therapy.On September 2, Simcere announced that a new cardiovascular and cerebrovascular treatment drug product, which it co-developed, received the Breakthrough Therapy Designation from the U.S. FDA. This designation is primarily applicable to breakthrough innovative drugs for treating serious or life-threatening diseases.On September 2, the CDE website announced that Sinocelltech's Class 1 new drug, SCT520FF Injection, has been approved for clinical trials for the indication of neovascular age-related macular degeneration. Public information shows that SCT520FF Injection is an anti-angiogenic biologic developed independently by Sinocelltech.On September 2, the latest announcement on the CDE official website revealed that XNW5004 Tablets, submitted by Suzhou Xennovate Pharma Tech Co., Ltd., are proposed to be included in the breakthrough therapy designation for the treatment of relapsed or refractory peripheral T-cell lymphoma. Public information indicates that XNW5004 is a new generation of EZH2 small molecule inhibitor.Investment and Financing in PharmaceuticalsOn September 3, CGeneTech announced the first close of its over CNY 100 million Series C financing round. The investment was made by Tongren Boda, and the funds raised will be used for the commercial production and sales of the company's soon-to-be-launched Class 1 innovative drug product, Sengliptin (formerly known as Shengliptin), as well as the clinical development of its subsequent innovative product pipeline.Technology-Driven Drug Research
On September 2, Professor Wang Ting's team (Zhang Xiaoxian, Nakul Shah, Meng Zhuxian, and Liang Yonghao as co-first authors of the paper) published the "fourth opus" in the journal *Nature Genetics*. The title of the paper is: **Epigenetic therapy potentiates transposable element transcription to create tumor-enriched antigens in glioblastoma cells**. This study provides an in-depth description of the potential for epigenetic therapies to activate more tumor-specific transposon-gene chimeric transcripts, offering a strong theoretical foundation for the future combined application of epigenetic therapies and immunotherapies.[1]Jang, H.J., Shah, N.M., Maeng, J.H. et al. Epigenetic therapy potentiates transposable element transcription to create tumor-enriched antigens in glioblastoma cells. Nat Genet (2024). https://doi.org/10.1038/s41588-024-01880-x
