Shots:
Simcere Zaiming has entered into an exclusive global licensing agreement with Roche for the development & commercialization of SIM0660, a potential treatment of B-cell-mediated diseases
As per the deal, Roche will acquire exclusive global rights to develop, manufacture, & commercialize SIM0660 in exchange for ~$1.53B in total, incl. $75M in upfront, as well as…
Shots:
Ipsen has entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613 to treat solid tumors with the highest unmet needs
Ipsen will secure global rights to SIM0613 outside Greater China, gain manufacturing rights after technology transfer, & assume responsibility for all development activities beyond Greater China, incl. P-I preparation & IND/CTA submissions
As…
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 rights
As 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…
Shots:
AbbVie & Simcere Zaiming (subsidiary Simcere Pharma) have signed an option to license agreement for developing SIM0500, being assessed in P-I for r/r multiple myeloma (MM) in the US & China
As per the terms, Simcere will get an upfront, up to $1.055B option fees & milestones plus net-sales-based tiered royalties outside Greater China…
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%…
Shots:
Fermion & Simcere Pharma have entered into an exclusive license and collaboration agreement to develop FZ002-037 for pain management
As per the agreement, Simcere secures exclusive rights to develop & commercialize FZ002-037 across Greater China (Mainland China, Hong Kong, Macau & Taiwan) in exchange for an undisclosed upfront, milestones and sales-based tiered royalties…
Shots:
The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML)
The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:
Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma
Read More: J&J
Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
Shots:
The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trials
Interim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…
Shots:
AbbVie & Neomorph have partnered in a collaboration & option-to-license deal to develop molecular glue degraders for oncology & immunology, using Neomorph's molecular glue discovery
As per the terms, Neomorph will receive upfront & is eligible for ~$1.64B in future option fee & milestones, plus net sales-based royalties
Molecular glue degraders are…

