Jianyou Co., Ltd. (603707): Heavy Enoxaparin Approved for Export Breakthrough in EU
Event: The company announced that Enoxaparin Sodium Injection was approved for UK marketing.
Heavy block Enoxaparin approved by EU.
The company submitted an Enoxaparin listing application in 2015. Considering the complexity of the heparin review, the historical approval cycle is 6-7 years, and the approval in 4 years progresses rapidly.
The company’s first batch of products was declared to the United Kingdom, Germany, Spain and Sweden. The United Kingdom is the first to issue approval documents. The other three countries are expected to obtain approval in the next few weeks.
In addition, the company will gradually submit applications for mutual recognition of listing permission to other EU countries. The subsequent application countries can reuse technical assessments. The mutual recognition process generally takes 90 days from application to approval in each country. We expect that other regions of the EU will be approved quickly.
Enoxaparin injection is Sanofi’s original research product, and its sales volume in the European Union is relatively stable, about 8 billion to 1 billion euros per year.
There are many European countries. The main markets are the Western European countries, such as the United Kingdom, France, and Germany.
At present, in addition to the company, there are 2 generic drug companies in Europe. In September 2016, Hyprox’s subsidiary Tiandao Pharmaceutical’s Enoxaparin was approved in Europe for the first batch. In 2017, Rovi’s generic drugs were approved in Germany 杭州桑拿 and the United Kingdom.
With reference to the performance commitment of Haipu Rui’s acquisition of Doppler (Tiandao Pharmaceutical), Doppler’s non-deduction net profit for 2018-2020 is not less than 1.
9 and 3.
We expect that the European market for Enoxaparin is expected to contribute 120-200 million profit per year.
2018 is the first year of export of injections. At the beginning of 2019, heavy varieties have been approved, and subsequent varieties have continued.
2018 was the first year of the company’s injection export breakthrough. A total of 7 injections ANDA were approved, one of which was self-declared (heparin sodium), one was technology transfer (gemcitabine), and the remaining five were agents to purchase transferred varieties.
The heavy-weight Enoxaparin Sodium has been harvested in 苏州夜网论坛 the European Union in early 2019, and is expected to be approved in the United States in the second half of 2019 or early 2020.
The company’s follow-up research injectable products are rich, focusing on the development of the full range of tumors, and also in the large areas of anesthesia and cardio-cerebral blood vessels; and the introduction of technology transfer to accelerate the approval of products, ANDA varieties continue to be enriched, expected in the next 2-3 yearsDozens of products have been approved in the United States, bringing continuous growth momentum.
Classical swine fever has further strengthened the heparin boom cycle, and a large stock of crude products has benefited significantly.
The only source of heparin is the pig’s small intestine, which is used clinically for anticoagulation. The industry maintains an annual growth rate of about 10%. Demand is rigid and cannot be replaced.
At present, China’s heparin production accounts for more than 60% of the world’s total, and the small intestine of pigs has reached 90%. The small intestine of pigs that are considered for dispersed slaughter cannot be used, and currently there is little room for improvement.
During 2016, upstream and downstream inventory bottomed out, demand growth and environmentally-friendly clearing small production capacity, heparin APIs have been tightly balanced, heparin has entered a new cycle of boom, and prices have shown a modest increase.
With the spread of swine fever, the production capacity of pigs has increased. In the second half of the year, the slaughter of pigs may be further shifted. Corresponding to the supply of heparin, the swine fever will further strengthen the heparin boom cycle.
Because the cost of raw materials in the downstream preparations is relatively low, the gross profit margin of the preparations is relatively high, and the downstream price acceptability is strong in the context of demand.
In the second half of the year, the conversion of pigs to the slaughterhouse will be realized. Heparin APIs are expected to replicate the 2008-10 market.
The company has the significant benefit of having a large inventory of crude products, and the centralized model has become stronger in upstream control.
Profit forecast and estimation discussion: Without considering the impact of swine fever, we expect 2018-2020 operating income to be 18.
00 and 34.
20,000 yuan, an increase of 62 in ten years.
07% and 25.
Net profit attributable to mother 4.
18 and 8.
22 ppm, an increase of 43 in ten years.
06% and 33.00%, the current total corresponds to 31 times PE in 2019.
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, maintaining a “buy” rating.
Risk warning 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 not meeting expectations; revealing the limitations of forecasting methods and results