Incident: On November 17, 2023, Medtronic announced that Symplicity, an interventional product for treating high blood pressure, has been approved by the FDA and will begin commercialization immediately.
RDN products will soon be commercialized in the US. Up to now, all Recor (ultrasound) and Medtronic (radiofrequency) RDN products have been approved in the US, and commercialization of interventional treatment for hypertension is about to begin.
The approved indications for both products are “to lower blood pressure as an adjuvant treatment for hypertensive patients who cannot fully control blood pressure as lifestyle changes and antihypertensive drugs.”
Baixinan's RDN product has strong advantages, advanced domestic progress, and is expected to be approved in 2024. Iberis completed clinical trials in 2023 and submitted a registration application in 23Q2, making it one of the fastest progressing RDN manufacturers in China. If things go well, approval is expected in 2024. Iberis is the only renal artery ablation product in the world that can provide two types of intervention, and has a smaller catheter sheath size, and is expected to quickly seize the market with its first-mover advantage and strong product performance. The company has reached a strong strategic partnership with Termao, which is expected to explore overseas markets together, and the ceiling will continue to open up. The company also deployed a second-generation fully biodegradable scaffold with excellent performance and advanced progress. It is expected to be approved in 2024.
Profit forecast and investment advice: Considering that both products are cutting-edge innovative products, and there are currently no similar commercial products on the market in China, our estimates for these two products are still based on more conservative considerations. Since RDN products of the same type have already been approved for listing in the US, we believe that the probability that Baixinan's RDN products will be approved domestically will increase, so the profit forecast has been raised to maintain the “buy” rating.
Risk warning: Product launch progress falls short of expectations; risk of price reduction in collection; post-launch sales fall short of expectations