SHANDONG XINHUA (00719.HK): Ketorolac Injection Wins Registration
On 6 November 2026, SHANDONG XINHUA said it obtained China's drug registration certificate for ketorolac tromethamine injection, a Class 3 chemical drug.
Key Highlights:
- The ketorolac tromethamine injection, 1ml:30mg, obtained the drug registration certificate as a Class 3 chemical drug.
- It is a Class B item in the 2025 medical insurance catalogue; 2025 sales reached about RMB230 million.
NewTimeSpace News: On 6 November 2026, Shandong Xinhua Pharmaceutical Company Limited (Stock Code: 719) published an overseas regulatory announcement.
The announcement shows that the injection, 1ml:30mg, is a Class 3 prescription chemical drug with approval number H20266508, filed with the CDE in February 2025 and cleared in November 2026. It is indicated for short-term treatment, no more than five days, of moderate to severe acute pain requiring opioid-level analgesia in adults, usually post-operative pain, and is a Class B item in the 2025 national medical insurance catalogue; sales at Chinese public medical institutions reached about RMB230 million in 2025. The approval enriches the analgesic portfolio and enhances competitiveness.
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