Core views:
The company's star products are expected to be approved at an accelerated pace. According to the interactive exchange announced on the Shanghai Stock Exchange Roadshow, the “self-inflating intracranial drug coating stent system” independently developed by the company has obtained special review approval for innovative medical devices by the Medical Device Technology Review Center of the State Drug Administration and is in the registration process. We expect this star product to be close to the final process of approval for launch.
The company's star products are at the leading international level. According to the interactive exchange announced by the Shanghai Securities Roadshow: The company's self-expanding intracranial drug coating stent uses a design method for release through a microcatheter, uses a closed loop asymmetric polygonal grid design structure, and is equipped with rapamycin drugs that are more effective in reducing cytotoxicity. The optimal drug release kinetics is achieved through patented eG electronic graft coating and drug coating double coating technology with controlled release, and also satisfies the comprehensive effects of self-adhesive stent wall expansion after release through a microcatheter and drug coating to prevent re-narrowing of blood vessels. It ensures that the product is safe and non-neurotoxic, and effectively reduces the incidence of re-stenosis in the stent. Recurring rate. The main working principle or mechanism of action of this product is the first in China. Currently, it is at the leading international level in terms of technology, and has significant clinical application value.
The company's main products continue to be promoted to accelerate the development of international markets. According to the company's annual report for '23, in September '23, the coronary spinous balloon dilatation catheter was approved; the world's first self-inflating intracranial drug-coated stent system passed the National Drug Administration's “Special Examination Procedure for Innovative Medical Devices” review; and the dense mesh stent was submitted for approval through the Innovation Channel in '24. The company underwent an on-site inspection by the US FDA for entry into the US market. This on-site inspection is for the quality system review of the company's coronary drug-eluting stent HT Supreme before it is marketed. Currently, all FDA audits are still being carried out in an orderly manner.
Profit forecasting and investment advice. The corresponding revenue for 24-26 is estimated to be $5.00, 7.33, and $1,086 million, respectively. Taking into account the company's industry position and business growth, the company was given a 24-year PS10X (considering that some of the company's products are currently in the development and new product introduction stage, so the PS valuation is more reasonable), maintain a reasonable value of 12.21 yuan/share, and give it a “buy” rating.
Risk warning. Procurement policy risks, new product launches falling short of expectations, and risk of continued losses.