Shanghai Pharma's Dihydroxypropyl Theophylline Injection gets generic approval

Shanghai Pharmaceuticals Holding Co., Ltd. announced that its subsidiary, Shanghai Sine Pharmaceutical Co., Ltd., received approval for its Dihydroxypropyl Theophylline Injection (2ml:0.3g) through the generic drug consistency evaluation. This approval, granted by the National Medical Products Administration, signifies that the product meets quality and efficacy standards equivalent to its reference listed drug.

The Dihydroxypropyl Theophylline Injection, used for conditions like bronchial asthma and chronic obstructive pulmonary disease, was originally developed by Eisai Co., Ltd. and launched in Japan in 1952. Sine Pharmaceutical submitted the supplementary application for the new specification and consistency evaluation in August 2024. Shanghai Pharma has invested approximately RMB3.05 million in research and development for this drug.

According to IQVIA data, the hospital procurement value for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in mainland China reached RMB9.737 million in 2024. This approval is expected to boost the product's market share and competitiveness, benefiting Shanghai Pharma's future market standing.