Health Yuan (600380) incident review: Non-hormonal liquid workshop inhalation solution production line obtained GMP certification
Event: Recently, the company ‘s wholly-owned subsidiary, Mrs. Pharmaceutical ‘s 杭州桑拿 non-hormonal liquid workshop extraction solution production line, received the “GMP Certificate for Pharmaceutical Products”. This production line will be used for the production of a compound for replacement of tobromide solution.
Key points of investment: The company ‘s wholly-owned subsidiary, Taitai Pharmaceutical ‘s non-hormonal liquid workshop absorption solution production line has passed the new version of GMP certification, and will be able to produce and sell the compound for absorption instead of the ammonium bromide solution.
Compound inhalation of tropium bromide solution is the first imitation in China, and the competition pattern is good.
Inhalation compound toluene bromide solution is a clinical drug for patients with moderate to severe hypertension and COPD. It is composed of isopropyltolumonium bromide and salbutamol sulfate, which can simultaneously act on toxic serum base and β2-adrenergic receptor in the lungs.
At present, domestic manufacturers of compound solutions that replace toluene ammonium bromide have been listed in China. According to IQVIA data, the sales scale of this product in China is about 3.
4 billion yuan.
Among the research manufacturers, only Yamatokyo Pharmaceutical has submitted an application for registration in early 2019, and it is still under review and approval.
The company’s injection replaced the tolumonium bromide solution with the compound as the first generic drug. It is expected to gain a price advantage and a first-mover advantage in the future and gain a breakthrough market share.
The barriers to research and development of inhaled preparations are high, and the use of compound prescriptions to replace tropium bromide solution is the first injectable preparation approved in accordance with the new 4 categories in China, demonstrating the company’s research and development strength.
As of April 11, 2019, Hengrui ‘s inhaled halothane was the only alternative formulation in the “China List of Listed Drugs” that was approved as “generic drugs approved under the new registration classification of chemicals”, while Hengrui ‘s inhaled landHalothane is actually a list of the old registration classification, which may be a separate catalogue because the product is also sold overseas.
Therefore, the company’s inhaled compound to replace the tobromonium bromide solution is the first domestically approved absorption preparation in accordance with the new 4 categories.
The barriers to R & D of generic drugs for absorbent preparations are high. The company is the first company to obtain product approval in accordance with higher standards of alternative preparation approval, which fully demonstrates the company’s R & D strength in the field of respiratory absorbent preparations.
The company has an elite R & D team headed by Professor Jin Fang and has many years of research experience in the field of rehabilitation preparations. We believe that this reliable team will continue to promote the steady development of the company’s injection product development activities.
The compound for inhalation of toluene ammonium bromide solution is the first approved product in the company’s breathing ducts, and the remaining products under development are steadily in progress.
Earnings forecast and rating: The company is a potential domestic leader in respiratory alternative preparations with comprehensive product layout and relatively advanced research and development. Among them, the bromine bromide solution replaced by the compound has been approved.Aerosols have been reported to be produced. Four other varieties including Budesonide suspension and Shulidie generic have entered the clinic. Two varieties such as L-salbutamol absorption solution have been added. The company’s existing western medicine preparation sector has grown steadilyThe API sector is currently in the boom phase.
It is estimated that the company’s net profit attributable to the parent 西安耍耍网 in 2019-2021 will be 8 respectively.
2.2 billion, 9.
7.8 billion, 12.
140,000 yuan, EPS is 0.
42 yuan, 0.
50 yuan and 0.
63 yuan, PE corresponding to the current price is 19, 16, 13 times.
The company will gradually launch new products to the market in the future, which will gradually open up room for growth and maintain a buy rating.
Risk Warning: The clinical or BE test results are not as expected, the market development is not as expected, the product price is lower, the risk of R & D failure, and the risk of changes in regulatory standards