The company's star products were successfully accepted for medical device registration by the State Drug Administration, further speeding up the marketing speed. According to the company's “Voluntary Disclosure Notice on the Subsidiary's Self-Expanding Intracranial Drug Coating Stent System Application and Acceptance of Domestic Medical Device Registration”, the company's self-inflating intracranial drug coating stent system was registered and accepted by the State Drug Administration. This product is the world's first self-expanding nickel-titanium alloy drug coating stent system specially developed by the subsidiary Sano Shenchang (ICAS). The company's stent product uses a design method of releasing through a microcatheter, using a closed loop asymmetric polygonal grid design structure, and is equipped with rapamycin drugs that can reduce cytotoxicity more effectively. Through patented eG electronic graft coating and drug-loaded coating double coating technology with controlled release, the product satisfies the comprehensive effects of self-adhering the stent to dilate and drug coating after release through a microcatheter to prevent further narrowing of blood vessels. It effectively reduces the incidence of re-stenosis within the stent and the recurrence rate of stroke. This time, the company's product has been approved for medical device registration by the State Drug Administration. We expect to further accelerate the launch of this product and enrich the company's product line in the field of neurology.
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.