On January 27, it was reported that Tianyu Pharmaceutical (300702) announced that its avatrombopag maleate bulk drug substance has recently passed the review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This bulk drug substance belongs to chemical drug category 4, with the registration number Y20230000333, and the review result, jointly evaluated with the preparation, is A.

The company submitted the registration application for avatrombopag maleate bulk drug substance to CDE in June 2023 and was accepted. Although this bulk drug substance has passed the CDE review, it still needs to obtain a "meeting requirements" result from the GMP compliance inspection by the Zhejiang Provincial Medical Products Administration before it can be launched and sold in China. Currently, 14 manufacturers in China have passed the CDE technical review. The company is preparing to apply for the GMP compliance inspection, and the time for market launch and sales remains uncertain. Investors are reminded to make decisions cautiously and pay attention to investment risks.

In the first three quarters of 2024, Tianyu Pharmaceutical achieved revenue of 1.932 billion yuan and a net profit attributable to the parent company of 85.11 million yuan.

Source: https://finance.eastmoney.com/a/202501273309356569.html