Shots:
Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in China
Additionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
Shots:
Recently, Zai Lab presented data from a Phase Ia/Ib study evaluating ZL‑1310, a DLL3 ADC, in patients with extensive‑stage small cell lung cancer, both as a monotherapy and in combination with atezolizumab
ZL‑1310 leverages TMALIN technology, enabling clinicians to deliver more targeted doses of chemotherapy to cancer cells, distinguishing the compound from current standard‑of‑care…
Shots:
The P-III (DeLLphi-304) trial evaluated Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; amrubicin in Japan) in SCLC pts (n=509) who progressed on or after 1L of Pt-based CT
Trial met its 1EP of superior OS & 2EPs of improved PFS & PROs for dyspnea…
Shots:
Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan)
As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…
Shots:
Amgen has reported P-III (DeLLphi-304) trial data evaluating Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; & amrubicin in Japan) in SCLC pts who progressed on or after single line of Pt-based CT
In the interim analysis, trial met its 1EP, with superior OS; full…
Shots:
Innovent & Roche have entered into a collaboration & exclusive license agreement for developing IBI3009 to treat advanced SCLC
As per the terms, Roche secures exclusive worldwide rights to develop, manufacture & commercialize IBI3009 plus will lead full development after early-stage studies, conducted jointly. Innovent will get $80M upfront, up to $1B development…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices
This…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices
Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

