CSPC Pharma's Pertuzumab Application Accepted On November 11, the CDE website showed that CSPC Pharma's pertuzumab injection application for HER2-positive breast cancer treatment was accepted. Notably, this marks the fifth biosimilar pertuzumab application in China. Pertuzumab, originally developed by Roche, targets HER2's extracellular dimerization domain (subdomain II), blocking HER2 from forming ligand-dependent heterodimers with other HER family members (including EGFR, HER3, and HER4), thereby inhibiting tumor growth. Approved by the U.S. FDA in 2012 and in China in 2018, Roche's pertuzumab achieved global sales of $4.097 billion in 2024 despite biosimilar competition. Currently, biosimilars from Zhengda Tianqing and Qilu Pharma are approved in China, while CSPC Pharma, Fosun Pharma, and Borui Bioscience have also submitted applications.

CR Sanjiu Gains Exclusive Rights to Narcolepsy Drug On November 10, China Resources Sanjiu Medical & Pharmaceutical announced an agreement with Langyu Group and Bioprojet, securing exclusive rights in mainland China for the innovative drug pitolisant (brand name: Wakix) for narcolepsy treatment. Narcolepsy is a rare chronic neurological disorder impairing wake-sleep regulation, often causing daytime sleep attacks, cataplexy, hallucinations, and sleep paralysis. With an estimated 300,000–700,000 patients in China, pitolisant is the first non-controlled medication approved for narcolepsy’s "tetrad" symptoms, backed by top-tier clinical evidence and global guidelines. Its obstructive sleep apnea indication, approved in Europe, aligns with CR Sanjiu’s respiratory strategy.

Immunotech-B’s CAR-T Exceeds $860M in Global Deal On November 10, Lyell Immunopharma acquired global rights (ex-Greater China) to Immunotech-B’s LYL273 (formerly GCC19CART), a novel autologous CAR-T targeting guanylate cyclase-C (GCC) for metastatic colorectal cancer (mCRC) and other GCC-expressing solid tumors. Immunotech-B received $40M upfront plus 1.9M Lyell shares, with potential additional payments: $30M clinical milestones, up to $115M regulatory milestones, $675M commercial milestones, and up to 1.85M Lyell shares. LYL273, optimized for solid tumor microenvironments via CD19-CAR and cytokine control, holds FDA Fast Track designation for mCRC.