Tecentriq(atezolizumab)
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国家医保局发文严查回流药;诚益生物递表港交所
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-09 00:29
Policy Developments - The National Healthcare Security Administration (NHSA) has initiated a crackdown on "returning drugs" through a "100-day action" plan, emphasizing comprehensive regulation across all stages of the drug supply chain [2] - The NHSA aims to enhance intelligent regulatory systems to preemptively manage healthcare fund oversight [2] Drug and Device Approvals - The FDA has approved Boehringer Ingelheim's small molecule tablet Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first new therapy for IPF in over a decade [5] - Roche and Jazz Pharmaceuticals received FDA approval for the PD-L1 inhibitor Tecentriq (atezolizumab) in combination with Zepzelca (lurbinectedin) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) [6] - Northeast Pharmaceutical announced that its DCTY0801 injection has received clinical trial approval for treating EGFRvIII positive recurrent or progressive high-grade glioma [7] - BaiLi Tianheng has received clinical trial approval for its innovative drug BL-ARC001 for advanced solid tumors, which is a first-in-class antibody-drug conjugate [9] Capital Markets - Chengyi Biotechnology has submitted a listing application to the Hong Kong Stock Exchange, with Jefferies, BofA Securities, and CICC as joint sponsors [11] - Changfeng Pharmaceutical's IPO on the Hong Kong Stock Exchange saw a significant opening increase of over 218%, trading at HKD 47 per share [12] Industry Developments - Innovent Biologics has entered into a licensing agreement with Zenas BioPharma for three autoimmune pipeline products, including a USD 100 million upfront payment and potential milestone payments exceeding USD 2 billion [14] - AstraZeneca has signed a USD 555 million collaboration agreement with Algen Biotechnologies to leverage AI for discovering new therapeutic targets in immunology [16][17]