Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in securing US marketing rights for this crucial drug.
Abraxane, initially approved in the US in 2005 and registered in the EU, Japan, and other regions, is a lifeline for patients with metastatic breast cancer who have failed chemotherapy or relapsed within six months post-adjuvant chemotherapy. Hengrui Med’s generic version, approved in China in August 2018, offers an affordable alternative for these patients. Furthermore, in August this year, the drug received a second indication in China for first-line metastatic pancreatic cancer, expanding its potential patient base.
This ANDA approval not only enhances Hengrui Med’s global footprint but also underscores the company’s commitment to improving patient access to essential oncology drugs. With the Phase III trials for felzartamab expected to commence in 2025, the future looks promising for advancements in cancer treatment .- Flcube.com
