HENGRUI PHARMA (01276.HK): SHR-4595 Gets Clinical Trial Approval in China

NewTimeSpace News: On 21 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that its subsidiary Suzhou Shengdia Biopharmaceutical Co., Ltd. received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration for SHR-4595 for injection, approving clinical trials of the drug in patients with advanced solid tumours. The application, with acceptance number CXSL2600702, was accepted on 6 July 2026.

SHR-4595 for injection is a therapeutic biologic independently developed by the Company that can specifically bind to antigens on the surface of tumour cells and kill tumour cells, and is intended for the treatment of advanced malignant solid tumours. Based on available information, one drug with the same target as this product has been approved for marketing in the PRC and overseas. As at the date of the announcement, cumulative research and development investment in the SHR-4595 project amounted to approximately RMB 16.4 million (unaudited).

The Company noted that, under PRC drug registration laws and regulations, a drug may only be manufactured and launched after clinical trials are conducted and reviewed and approved by the National Medical Products Administration. Drug development from research through clinical trial approval to production involves long cycles and multiple stages, and is subject to uncertainties.

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