Shanghai Fosun Pharmaceutical (02196): Xingsheng Xinhui has received approval from the National Medical Products Administration for clinical trials of XS-03 tablets.

Shanghai Fosun Pharmaceutical (02196) announces that its holding subsidiary Jiangsu Xingsheng Xinhui Pharmaceutical Co., Ltd. (hereinafter referred to as "Xingsheng Xinhui") recently received approval from the National Medical Products Administration to conduct clinical trials for the use of XS-03 tablets (classified as Class 1 chemical drugs; hereinafter referred to as "XS-03") in combination with FOLFOX or FOLFIRI and Bevacizumab for the treatment of RAS-mutated metastatic colorectal cancer (hereinafter referred to as "the treatment regimen"). Xingsheng Xinhui plans to conduct Phase Ib/II clinical trials for the treatment regimen in China (excluding the Hong Kong, Macau, and Taiwan regions) once the conditions are met. In this clinical study, XS-03 will be used in combination with FOLFOX or FOLFIRI and Bevacizumab for the treatment of RAS-mutated metastatic colorectal cancer. Currently, the combination of FOLFOX or FOLFIRI with Bevacizumab is the first-line standard treatment for advanced metastatic colorectal cancer. XS-03 involved in the treatment regimen is a small molecule oral PLK1 inhibitor independently developed by the group (including the company and its subsidiaries/units). XS-03 mainly works by inhibiting cell cycle regulatory factors, inducing mitotic arrest, inhibiting tumor cell proliferation, and promoting tumor cell apoptosis. In addition, XS-03 has a synthetic lethality with KRAS mutations and shows good inhibitory effects on colorectal cells carrying KRAS mutations. Studies so far have shown that XS-03 has significant anti-tumor effects in various tumor models with good clinical safety. As of the date of this announcement (February 27, 2025), XS-03 is in Phase I clinical trials for the treatment of RAS-mutated advanced solid tumors in China. As of January 2025, the group's cumulative research and development investment for this treatment regimen is approximately RMB 200,000 (excluding monotherapy, unaudited). As of the date of this announcement, there are no small molecule inhibitors with the same target approved for monotherapy or combination therapy globally.