China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.
Developed in-house, RC88 is engineered to target tissues with over-expressed MSLN, delivering the microtubule inhibitor monomethyl auristatin E (MMAE) as its therapeutic payload. High levels of MSLN expression are associated with more aggressive and advanced stages of ovarian cancer. Currently in Phase II trials in China, RC88 received FDA approval in December 2023 to initiate a global Phase II study in gynecological cancers. This development comes amid significant industry activity, as Pfizer-owned Seagen recently partnered with China’s Nona Biosciences and Medilink Therapeutics for global rights to their co-developed MSLN-targeted ADC, HBM9033 (YL215), in a deal exceeding USD 1 billion.- Flcube.com
