Yongtai Technology (002326): The first FDA-certified preparation project has good prospects

Yongtai Technology (002326): The first FDA-certified preparation project has good prospects

The wholly-owned subsidiary Yongtai Pharmaceutical has obtained the approval of the US FDA. Yongtai Pharmaceutical issued an announcement on November 5. The wholly-owned subsidiary Yongtai Pharmaceutical received a notification from the US Food and Drug Administration (FDA).The rosuvastatin calcium tablets US generic drug application filed with the US FDA has been approved, and the company is eligible to sell the product in the United States.

We expect the company’s EPS for 2019-2021 to be 0.

47/0.

66/0.

86 yuan, maintaining the “overweight” level.

  Rosuvastatin has a broad market space, and generic drugs have been approved to improve and enhance the company’s brand influence. Rosuvastatin The original research drug was developed by AstraZeneca in the UK and was launched in the United States in 2003. According to the IMS database, rosuvastatin calcium tablets 2017From July to June 2018, there were about 39 new global additions.

US $ 7.8 billion, of which US yttrium is about 4.

1.2 billion US dollars, the global total 杭州夜网 from July 2018 to June 2019 is about 34.

USD 6.1 billion, of which the US headquarters is about 2.

9.5 billion US dollars, is a worldwide best-selling drug for treating hyperlipidemia.

Yongtai Pharmaceutical’s rosuvastatin generic ANDA application has been approved by the FDA, meanwhile, it means that the company has already been qualified to sell the product in the U.S. market, actively expanding the U.S. market sales network, and also marking the company’s challenge in the field of patented products.Steady progress will help the company to enhance its brand image and increase the competitiveness of its products.

  Yongtai Pharmaceutical Preparation Project officially entered the harvesting period Yongtai Pharmaceutical Preparation Project officially entered construction in 2016 and was fully solidified. In November 2018, it has obtained the domestic drug GMP certificate and passed the on-site inspection by the US FDA, but has not yet obtained approval.Therefore, in 2018, Yongtai Pharmaceutical realized revenue of 26.74 million yuan, a net decrease of 25.46 million yuan.

Recently, the US FDA has approved the supplementation of the Yongtai Pharmaceutical Preparation Project to the basic completion, and it has officially entered the harvest period. Due to the depreciation has been accrued in the early period, it is expected that the subsequent performance will be smoothly turned into profit from 2020.

  Maintaining the “overweight” rating We expect the company’s EPS for 2019-2021 to be 0 respectively.

47/0.

66/0.

86 yuan, combined with the comparable company’s assessment level (23 times PE in 2019), taking into account the company’s business differences (comparable company’s business is more biased towards electronic chemicals), giving the company 21-23 times PE in 2019, corresponding to a target price of 9.

87-10.

81 yuan, maintaining the “overweight” level.

  Risk Warning: New Projects Put Into Production Less Than Expected Risks, Raw Material Price Fluctuation Risk