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NextCure Signs a ~$745M Licensing Agreement with Simcere Zaiming for SIM0505

Shots:Simcere has granted NextCure exclusive global rights to develop, manufacture, & commercialize SIM0505 to treat solid tumors, excl. Greater China, where Simcere will retain its rightsAs per the deal, Simcere will receive ~$745M in upfront, development, regulatory & sales milestones, along with net sales-based royalties up to double-digits outside of Greater China. NextCure…

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Insights+ Key Biosimilars Events of June 2024

Insights+ Key Biosimilars Events of June 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…

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The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC) 

Shots: The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3%…

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