Huahai Pharmaceutical gets naloxone approval, advances oncology drug to phase 3

Zhejiang Huahai Pharmaceutical Co., Ltd. announced a drug registration certificate from the National Medical Products Administration for its Naloxone Hydrochloride Injection (2ml:2mg). The injection is approved for indications including opioid overdose and anesthetic-induced respiratory depression. This Type 3 chemical drug is approved for domestic production and is projected to tap into a domestic market valued at approximately yuan 478 million in 2024. The company has invested approximately yuan 48.1 million in its research and development.

In a related development, the company's subsidiary, Shanghai Huaaotai Biopharmaceutical Co., Ltd., will commence Phase III clinical trials for HB0025 Injection. This innovative PD-L1/VEGF bispecific fusion protein targets non-small cell lung cancer in combination with chemotherapy, following successful communication with the CDE. The company has invested approximately yuan 325.97 million in the HB0025 project to date.

The approval of Naloxone Hydrochloride Injection is expected to enhance Huahai Pharmaceutical's market competitiveness. Concurrently, HB0025 aims to become a significant treatment option for various tumor types, advancing the company’s oncology pipeline.