Humanwell Pharmaceutical’s Class 1 innovative drug, HWS116 Injection, has been approved for clinical trials.

Release time:

2025-05-19 14:31

Source:

Recently, Wuhan Renfu Innovative Drug R&D Center Co., Ltd., a subsidiary of Renfu Pharmaceutical Group, received approval and was issued a license by the National Medical Products Administration. HW S 116 Injection solution the “Notice of Approval for Clinical Trials of Drugs,” Approval granted to conduct clinical trials for advanced solid tumors. This product... is by Renfu Pharmaceutical Therapeutic biological products developed through independent research and development 1 The successful approval of the novel drug for clinical trials marks an important breakthrough for the company in the field of innovative biopharmaceutical R&D.

HWS 116 It is a targeted... FGFR2b The humanized monoclonal antibody inhibits tumor growth by blocking the signaling pathway mediated by fibroblast growth factor receptors, and through its... Fc Antibody-dependent cell-mediated cytotoxicity (ADCC) mediated by... ADCC ) and phagocytosis ( A DCP ) Kill tumor cells. FGFR2b Its overexpression is closely associated with highly aggressive tumors such as gastric cancer, breast cancer, and intrahepatic cholangiocarcinoma, approximately... 30% of the HER2 It is present in patients with advanced-stage gastric cancer who are negative. FGFR2b Overexpression Targeted development FGFR2b the therapy, which helps to achieve FGFR2b Overexpression Precision treatment for cancer patients.

Group Pharmaceutical Research Institute Complete We conducted pharmaceutical, pharmacological and toxicological studies, clinical trial design, and registration submissions for HWS116 injection. In February 2025, we submitted a clinical trial application to the Drug Review Center of the National Medical Products Administration and received acceptance of the application. Preclinical data indicate that, HW S 116 Can significantly inhibit F GFR2b Highly expressed Various Subcutaneous tumor growth in mice Its anti-tumor effect is superior to that of drugs targeting the same target. Bemarituzumab Toxicological studies have shown that this product... Good safety performance 。

HWS116 Injection Clinical trial Application The approval will further enrich the company's... Tumor The company will accelerate the advancement of its innovative product pipeline in this field. This variety clinical research-related work, Achieve it at an early date F GFR2b Precision medicine for patients with malignant tumors.