On February 11, Tasly Pharmaceutical Group Co.Ltd(600535) announced that its holding subsidiary Tasly Pharmaceutical Group Co.Ltd(600535) biomedicine Co., Ltd. (hereinafter referred to as ” Tasly Pharmaceutical Group Co.Ltd(600535) biology”) had received the notification of on-site inspection results of drug production issued by Shanghai Drug Administration. At the same time, Tasly Pharmaceutical Group Co.Ltd(600535) bio received the notice of approval for supplementary application for drugs of recombinant human urokinase for injection issued by the State Drug Administration.
Recombinant human urokinase for injection is the only commercial recombinant human urokinase product in China. It is a specific thrombolytic drug. At present, the approved indication is acute ST segment elevation myocardial infarction. The application for marketing license of the product for the indications of acute ischemic stroke and acute pulmonary embolism has been submitted and accepted. The sales revenue of the drug in 2020 was 216 million yuan, accounting for 1.59% of the operating revenue in Tasly Pharmaceutical Group Co.Ltd(600535) 2020; From January to September 2021, the sales revenue was 178 million yuan, accounting for 3.09% of the company’s operating revenue in the first three quarters of 2021. In China’s thrombolytic drug market, in addition to recombinant human urokinase for injection, three fibrin specific plasminogen activators have been approved for listing, namely recombinant tissue plasminogen activator for injection (ateplase), recombinant plasminogen activator for injection (Reteplase) and recombinant human tissue plasminogen activator TNK mutant for injection (teneplase).
This Tasly Pharmaceutical Group Co.Ltd(600535) bio has passed the compliance inspection of drug production quality management norms and obtained the notice of approval of drug supplementary application, which shows that the recombinant human urokinase protocell culture production line for injection (300L fermentation scale) meets the requirements of drug production quality management norms and has met the production conditions, which is conducive to further expanding the production capacity.
