Brand dynamics
Group Real-Time Dynamics And Cutting-Edge Information In The Field Of One Health
Healthy Element: The company is a potential leading domestic enterprise in the field of respiratory inhalation preparations.
Published Time：
2019-06-06
The company's wholly-owned subsidiary, Tai Tai Pharmaceutical, has obtained new GMP certification for its non-hormonal liquid inhalation solution production line, enabling the production and sale of combined ipratropium bromide inhalation solution. This is the first domestically-produced biosimilar, presenting a favorable competitive landscape. Combined ipratropium bromide inhalation solution is used clinically for patients with moderate to severe asthma and COPD. Its components, ipratropium bromide and salbutamol sulfate, act on both muscarinic and β2-adrenergic receptors in the lungs. Currently, only the original manufacturer, BI, has a combined ipratropium bromide solution on the market in China. According to IQVIA data, the product's sales in China in 2018 were approximately RMB 340 million. Among companies developing this product, only Shandong Jingwei Pharmaceutical submitted a registration application in early 2019, which is still under review. As the first biosimilar, the company's combined ipratropium bromide inhalation solution is expected to gain significant market share through price and first-mover advantages.
Inhalation formulations have high R&D barriers. The combined ipratropium bromide inhalation solution is the first inhalation formulation in China approved under the new Class 4 regulations, demonstrating the company's R&D capabilities. As of April 11, 2019, the only inhalation formulation listed in the "China National Drug List" as a "generic drug approved under the new chemical drug registration classification" is Hengrui's inhaled desflurane. However, Hengrui's inhaled desflurane was actually listed under the old registration classification, possibly due to its simultaneous overseas sales. Therefore, the company's combined ipratropium bromide inhalation solution is the first inhalation formulation in China approved under the new Class 4 regulations. The R&D barriers for generic inhalation formulations are high, and the company is the first to obtain product approval through a higher-standard inhalation formulation approval pathway, fully demonstrating its R&D strength in the respiratory inhalation formulation field. The company has an elite R&D team led by Professor Jin Fang, with years of experience in inhalation formulations. We believe this reliable team will continue to steadily advance the company's inhalation formulation R&D activities. The combined ipratropium bromide inhalation solution is the first approved product in the company's respiratory pipeline, with other products under development progressing steadily.
Profit Forecast and Rating: The company is a potential leading domestic respiratory inhalation formulation company, with a comprehensive product layout and relatively advanced R&D progress. The combined ipratropium bromide inhalation solution has been approved, budesonide aerosol and ipratropium bromide aerosol have been reported for production, and four major products, including budesonide suspension and Symbicort generics, have entered clinical trials. Two products, including levosalbutamol inhalation solution, are undergoing registration. The company's existing western medicine preparation sector is experiencing stable growth, and the raw material medicine sector is currently in a booming stage. It is expected that the company's net profit attributable to the parent company will be RMB 822 million, RMB 978 million, and RMB 1.214 billion in 2019, 2020, and 2021, respectively, with EPS of RMB 0.42, RMB 0.50, and RMB 0.63, corresponding to current price PEs of 19, 16, and 13 times, respectively. As new products are launched, the company's growth space will gradually open up. We maintain a buy rating.
Risk Warning: Clinical or BE test results may not meet expectations; market development may not meet expectations; product price decline; R&D failure risk; regulatory standard change risk.
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