Xinhua Pharmaceutical gains approvals for prednisolone acetate and epinephrine injection

Shandong Xinhua Pharmaceutical (SZSE:000756) announced it received approval for the marketing application of prednisolone acetate active pharmaceutical ingredient (API) in November 2025. This approval strengthens Xinhua Pharmaceutical's steroid product line and core competitiveness. The API is used for treating various allergic and autoimmune inflammatory diseases, with related preparations having an estimated sales value of approximately RMB 1 billion in China's public medical institutions in 2024.

Additionally, Xinhua Pharmaceutical's epinephrine hydrochloride injection passed the generic drug consistency evaluation in November 2025. This product is listed in China's National Essential Medicines Catalogue and the 2024 National Medical Insurance Drug Catalogue (Category A). The injection is crucial for treating severe respiratory distress due to bronchospasm, allergic shock, and is a primary drug for cardiopulmonary resuscitation. Related epinephrine sales in China's public medical institutions were approximately RMB 2.7 billion in 2024.

Both approvals are expected to boost the company’s market competitiveness. However, the company noted that pharmaceutical sales are subject to policy changes, market conditions, and other factors, advising investors to exercise caution.