Shanghai Haihe Biopharma Co., Ltd. announced that its oral paclitaxel solution (brand name: Bairuisu; R&D code: RMX3001/DHP107), co-developed with South Korea's Dae Hwa Pharmaceutical, has been approved by China's National Medical Products Administration (NMPA) for a new indication: recurrent or metastatic HER2-negative breast cancer. The product was first approved in September 2024 for advanced gastric cancer patients whose disease progressed during or after first-line fluoropyrimidine-based therapy.
3SBio Inc. (01530.HK) holds the exclusive commercialization rights to the product in Chinese mainland and Hong Kong. In September 2017, Haihe in-licensed the rights to develop, manufacture and sell the product in Chinese mainland, Taiwan, Hong Kong and Thailand from Dae Hwa Pharmaceutical.
Paclitaxel is one of the most widely used chemotherapy drugs, with substantial market demand. Until now, all paclitaxel products marketed in China were intravenous formulations that had to be prepared in hospital and given by infusion, requiring frequent hospital visits and causing injection-site reactions. Built on Dae Hwa's innovative lipid-based self-emulsifying drug delivery technology, the product is the world's first orally administered paclitaxel to be successfully developed and approved.
The breast cancer approval is based on the global pivotal Phase III 107CS-5 study (OPTIMAL, NCT03315364), an international, open-label, randomized, controlled non-inferiority trial. It showed that oral paclitaxel was non-inferior to intravenous paclitaxel in progression-free survival (PFS), while offering advantages in peripheral neuropathy and hypersensitivity reactions; the oral form also markedly improves convenience for patients.
The product was previously approved for advanced gastric cancer by South Korea's Ministry of Food and Drug Safety (MFDS) in September 2016 and by China's NMPA in September 2024. The new breast cancer indication further expands the market potential of this first-in-class oral chemotherapy.

Source: https://finance.sina.com.cn/roll/2026-10-09/doc-iniuquqp7083982.shtml