HENGRUI PHARMA (01276.HK): SHR-4685 Injection Obtains Clinical Trial Approval for Advanced Solid Tumours
NewTimeSpace News: Jiangsu Hengrui Pharmaceuticals Co.,Ltd (01276.HK) announced that its subsidiary Suzhou Shengdiya Biopharmaceuticals has received the Drug Clinical Trial Approval Letter for SHR-4685 Injection issued and approved by the National Medical Products Administration (NMPA), authorising monotherapy clinical trials of the product in patients with advanced solid tumours. This innovative anti-tumour drug is independently developed by the Group, and no similar drugs have been approved for marketing at home or abroad to date.
NewTimeSpace News: Jiangsu Hengrui Pharmaceuticals Co.,Ltd issued an overseas regulatory announcement dated 7 July 2026. Suzhou Shengdiya Biopharmaceuticals, the Company’s subsidiary, obtained the Drug Clinical Trial Approval Letter for SHR-4685 Injection approved by NMPA, permitting clinical trials of the product as monotherapy for advanced solid tumours.
SHR-4685 Injection is an innovative anti-cancer drug self-developed by the Group, intended for the treatment of advanced solid tumours. Public inquiries confirm that no analogous drugs have been approved for launch globally as of the announcement date. Up to the date of the announcement, the total accumulated R&D expenditure on relevant projects of this product stood at approximately unaudited RMB19.4 million.
Following receipt of the clinical trial approval letter, the product still needs to complete clinical trials and pass NMPA’s review and approval procedures before it can be manufactured and marketed.
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