截至2024年6月30日止六个月，作为一家专注于开发、生产及商业化细胞免疫治疗产品的独立的创新型生物科技公司，集团的业务取得重大进展，并实现重要里程碑，运营效率全面提升，例如毛利率维持稳定、销售开支控制良好、组织精简、现金流出净额减少等。集团的领先产品倍诺达在商业化方面持续取得重大进展。此外，凭借卓越的临床开发及运营能力，中国国家药品监督管理局已批准有关倍诺达用于不符合移植条件的r/rLBCL患者的二线治疗的临床研究用新药(IND)申请，且集团已开展相关临床试验的患者入组。国家药监局已分别于2024年8月及2023年4月进一步批准倍诺达治疗r/rMCL患者的补充新药申请;及有关倍诺达用于治疗系统性红斑狼疮(SLE)的IND申请。倍诺达是首个在中国批准用于治疗r/rMCL患者的细胞治疗产品。集团亦启动JWATM214治疗晚期肝细胞癌(HCC)的研究者发起试验(IIT)。此外，集团在研发具有全球商业化潜力的创新产品方面取得了重大进展。WuXi AppTec-B (02126) announced its interim performance for the six months ending June 30, 2024, with the group achieving...
According to the Zhitong Finance APP, WuXi AppTec-B (02126) announced its interim performance for the six months ending June 30, 2024, with the group generating revenue of 86.815 million yuan (RMB, the same below), maintaining relatively stable year-on-year; gross profit of 43.745 million yuan, also maintaining relatively stable year-on-year; and research and development expenses of 0.151 billion yuan.
The announcement stated that the stable sales performance is due to the continued commercialization of the group's targeted CD19 autologous CAR-T cell immunotherapy product, Relmacel (research code: JWCAR029). Relmacel has been approved for the treatment of adult patients with r/rLBCL and r/rFL. With the market continuing to evolve, the group expects the sales revenue of Relmacel to continue increasing. Relmacel has outstanding product characteristics that can bring breakthrough value to patients, and more indications are expected to be approved.
For the six months ending June 30, 2024, as an innovative biotech company focused on developing, producing, and commercializing cell immunotherapy products, the group has made significant progress in its business and achieved important milestones. Overall operating efficiency has improved, with stable gross margin, well-controlled sales expenses, streamlined organization, and reduced net cash outflow. The group's leading product, Relmacel, continues to make significant progress in commercialization. In addition, with excellent clinical development and operational capabilities, the China National Medical Products Administration has approved an Investigational New Drug (IND) application for Relmacel for second-line treatment of r/rLBCL patients not eligible for transplant, and the group has enrolled patients in related clinical trials. The NMPA further approved supplemental new drug applications for Relmacel for the treatment of r/rMCL patients in August 2024 and April 2023, as well as an IND application for the treatment of systemic lupus erythematosus (SLE) with Relmacel. Relmacel is the first cell therapy product approved in China for the treatment of r/rMCL patients. The group has also initiated an investigator-initiated trial (IIT) for JWATM214 to treat advanced hepatocellular carcinoma (HCC). Furthermore, the group has made significant progress in developing innovative products with global commercialization potential.
