Jianyou Co., Ltd. (603707): Du Calcidol ANDA Approved for Export of Injectables to the Next City
Event: The company announced that the ANDA injection ANDA was approved by the US FDA.
Ducalitol ANDA was approved, and the injection was exported to the next city.
On September 26, 2018, the company submitted its registration application to the FDA for the first time and obtained ownership of the drug 4mcg / 2mL (2mcg / ml), and was approved on February 11, 2020.
The company’s export of injectables went to the next city, and the pipeline was further enriched.
The drug was originally developed by the United States Genzyme Corporation, and is mainly used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease and diabetes. It was launched in the United States in 2000.
The original research product is called Heterol, the specification is 2ml: 4μg.
According to the Orange Book, there are currently 16 docecalcid injections in the United States, owned by 10 companies.
According to Bloomberg data, the market size of docalciferol is USD 200-300 million, and only 4 companies produce and sell it.
In addition, the company has filed a domestic application in April 2019, and was approved for clinical use in December. At present, there is no domestic market for the sale of docecalol products, and only two companies have applied for the application.
We expect the company to become the first domestic listed company of this product and further enrich its product pipeline.
In 2020, the company is expected to usher in the rise in the price of heparin API, the price of heparin preparations, and the fundamental resonance of the heavy volume of heparin preparations.
With the completion of the tightening and restructuring of the heparin industry chain in 2018, the price of heparin API has increased significantly, and the supply caused by overlapping swine fever has become increasingly scarce. The standard heparin price in Europe and the United States has already increased, and the price of low-molecular-weight heparin preparations is expected to rise.
The company’s standard heparin ANDA has been approved in the United States in 2018. 杭州夜网论坛 Enoxaparin ANDA was approved in the European Union, Brazil and the United States in March, August and December 2019, and the global core market layout has been basically completed.
In 2020, the accelerated approval of products, varieties + production capacity + channels, export of injections is imminent.
The company acquired 83 of Meitheal in 2019.
33% equity in the US market.
At the same time, convertible bonds were issued to raise 5 trillion, and 2 high-end injection production lines were built to enrich subsequent production capacity.
The company’s R & D platform has been completed and its products have been approved one after another.
At the beginning of 2019, the heavy-duty Enoxaparin injection has been approved in the global core markets such as the United States, the European Union, and Brazil. Besylate cisatracurium and levobolic acid have been approved by the United States ANDA. Full standard heparin specifications have been obtained in the United States.Approved.
It is expected to usher in accelerated product approval in 2020. It is expected that 5-10 products will be approved each year in the next 2-3 years, which will continue to accelerate.
The company’s research, production and sales layout is complete, and the export of injections is worth looking forward to.
Profit forecast and estimation discussion: We expect the operating income for 2019-2021 to be 24.
79 and 41.
0.6 million yuan, an increase of 41 in ten years.
64% and 21.
Net profit attributable to mother 6.
32 and 10.
89 ‰, an increase of 41 in ten years.
08% and 30.
Considering that the company is a leading company in the export of domestic injections, the export logic has been continuously strengthened, and swine fever has continued to strengthen the boom cycle of the heparin industry.
Risk alert events: the risk of narrowing the price gap between raw materials and APIs; the risk of concentration of sales customers; the risk of ANDA approval or sales not meeting expectations; the limitations of forecasting methods and results were found