Pharma RSS Digest - 2026-05-14
Overview
May 14, 2026 — The digest is light today, with two substantive company-specific developments carrying through from the morning window. The stories both originated from PR Newswire and span the biotech and medtech subsectors without any clear thematic throughline. Kelun-Biotech's dual regulatory progress in China and the US for a bispecific PD-1/VEGF antibody reflects continued cross-border development activity in oncology, while the NinaMED financing round signals investor appetite for novel neuromodulation approaches targeting overactive bladder. No broader sector catalysts or regulatory announcements moved the tape today.
Key Developments
Kelun-Biotech gains dual regulatory clearance for bispecific antibody candidate. Kelun-Biotech received IND approval from China's CDE for SKB118, a bispecific antibody targeting PD-1 and VEGF, marking the second regulatory milestone for this asset in recent months. The FDA had already cleared the IND in January 2026, enabling the global ASCEND Phase I/II trial (NCT07335497) to proceed with enrollment of up to 290 patients with locally advanced or metastatic solid tumors. A December 2025 collaboration with Crescent Biopharma gave Kelun-Biotech exclusive rights to develop and commercialize SKB118 in Greater China. The company is exploring combining SKB118 with its proprietary ADC assets under an "ADC+IO" strategy, as preclinical data suggests anti-VEGF activity may improve tumor vasculature and enhance ADC delivery. Watch for whether the Chinese trial protocol mirrors the US study and when initial Phase I safety data might emerge.
Kelun-Biotech fda approval update
NinaMED secures $13.75M to advance wearable neuromodulation device for overactive bladder. NinaMED, a newly formed Australian company, closed a financing round led by SPRIM Global Investments to advance the NiNA System, a non-invasive wearable device targeting the saphenous nerve in the upper calf for treatment of overactive bladder. The device is licensed on an exclusive global basis from EBT Medical, a Toronto-based neuromodulation developer. The financing will support preparation of an IDE application and operational buildout in Australia, with the board chaired by Professor Ian Meredith, former EVP and Global Chief Medical Officer at Boston Scientific. The OAB market affects an estimated 550 million patients worldwide, and the saphenous nerve approach offers a potentially more comfortable alternative to existing sacral or tibial stimulation therapies while avoiding systemic drug side effects. Watch for IDE submission timing and whether pivotal trial design yields competitive efficacy and safety profiles against standard pharmacological therapies.
EBT Medical and NinaMED funding update