Red Star Capital Bureau reported on August 1 that Tuoxin Pharmaceutical (301089.SZ), a manufacturer of azvudine APIs, recently disclosed in its investor relations activity table that its subsidiary Xinxiang Pharmaceutical Co., Ltd. (hereinafter referred to as “” Xinxiang Pharmaceutical”)’s newly built Azvudine production line is ready for large-scale production, and has a production capacity of 5 tons per year.
On July 25, the State Food and Drug Administration announced that according to the drug Special approval procedures, emergency review and approval, and conditional approval of the registration application of Henan Real Biotechnology Co., Ltd.
According to the disclosure of Tuoxin Pharmaceutical, Xinxiang Pharmaceutical is a unit that is associated with preparation companies for approval, is a real bio-qualified supplier, and is also the first manufacturer of azvudine APIs. Up to now, the official website of the Center for Drug Evaluation of the State Drug Administration has not found any related approvals between other companies and preparation companies.
In other words, Tuoxin Pharmaceutical is the only domestic company that holds the approval/completion of the azvudine API.
Before the approval of Azvudine Tablets to increase the indications for the treatment of COVID-19, Tuoxin Pharma once stated that Xinxiang Pharmaceutical’s Azvudine production and sales volume was relatively small, and the rate of production and sales of Azvudine in the last year was relatively small. The operating income realized during the period accounts for less than 5% of the company’s operating income. Tuoxin Pharmaceutical’s 2021 annual report shows that last year’s revenue was around 500 million yuan, which means that the production of azvudine brought Tuoxin Pharmaceutical’s revenue below 25 million.
At that time, Tuoxin Pharmaceutical once stated in March this year that Xinxiang Pharmaceutical has supplied to Real Biology in 2022, but so far the company has no orders in hand. In this regard, on April 22, Tuoxin Pharmaceutical responded to the Red Star Capital Bureau, saying, “Supply has started in early 2022, and all deliveries have been completed when replying to the Shenzhen Stock Exchange, and no follow-up orders have been signed by the time of the reply letter to the Shenzhen Stock Exchange, so It is not contradictory to reply ‘there are currently no orders in hand’.”
As for the new production line of Azvudine put into production, Tuoxin said, In the future, with the increase of market demand , which will bring new profit growth points to the company. On August 1, the Red Star Capital Bureau contacted Tuoxin Pharmaceuticals, regarding Xinxiang Pharmaceutical’s production volume of azivudine API last year and the expected production volume this year, they both stated that no specific data has been disclosed for the time being.
Red Star News reporter Deng Lingyao
Editor Yang Cheng
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