The scarcity of the R&D pipeline, potential market prospects, and the efficacy and safety of the drug are all important factors to consider when valuing pharmaceutical companies. With the positive progress of the blockbuster LUX-VALVE transcatheter tricuspid valve replacement series products in the world, Jianshi Technology-B (09877) has frequently won many praises from brokerages, investment banks and other institutions.
Specifically, CICC gave an outperform rating with a target price of HK$45, saying that Jianshi Technology is a global leader in tricuspid valve intervention, and the company's revenue is expected to increase rapidly from 2024Citi gave Jianshi Technology a "** rating, with a target price of HK$40, and pointed out that the existing share price is in the low valuation range compared to the IPO**;Huaan** is covered for the first time and given a "** rating, and the company is expected to achieve 6With an operating income of 1.9 billion yuan, we are optimistic about its ability to bring about a breakthrough in revenue from rapid commercialization and the expectation of globalization of large single products.
The commercialization of blockbuster products is imminent, and multiple positives catalyze the expected upward movement of the market
The commercialization of domestic self-developed medical devices is actively promoted, and the clinical data is outstanding.
The results of the recent one-year confirmatory clinical trial of the LUX-VALVE transcatheter tricuspid valve replacement system were officially presented at the 2023 PCR London Valves Conference.
Tricuspid regurgitation is caused by the failure of the tricuspid valve to close completely, and due to the complex anatomy of the tricuspid valve and the fact that most of the patients are elderly, the risk of thoracotomy is relatively high, and the mortality rate of patients with tricuspid valve disease who have undergone surgery for many years continues to be high during hospitalization.
According to the Zhitong Financial App, there are currently three main dimensions in the clinical evaluation of the efficacy of valvular products: improvement of the patient's cardiac function, reduction of regurgitation and paravalvular leakage, and improvement of the patient's physical condition. Both the LUX-VALVE and LUX-VALVE Plus demonstrated impressive clinical data.
A total of 126 patients with severe tricuspid regurgitation were included in this confirmatory clinical study of LUX-VALVE, which was designed to evaluate the safety and efficacy of the LUX-VALVE transcatheter tricuspid valve replacement system in patients with severe tricuspid regurgitation, and the primary endpoint of the clinical trial was cumulative all-cause mortality at one year after surgery. One-year access data from clinical trials showed that, according to ultrasound data, 99Improvement in tricuspid regurgitation grade in 1% of patients, 94The tricuspid regurgitation grade was reduced to mild or less in 4% of patients, 75Seven percent of patients recover to no microtricuspid regurgitation.
Source**: Jianshi Technology Official***
From the perspective of safety indicators, the one-year all-cause mortality rate was 96% (PPS set, in patients with valve implantation);The incidence of renal function and liver failure was 4., respectively0% and 2In 4%, the incidence of third-degree atrioventricular block or the need for a permanent pacemaker is only 16%, intraoperative transfer to surgical flap replacement or plasty 08%, stroke 24%, the data showed that the postoperative complications of patients were low, and the safety was effectively verified.
In terms of effectiveness measures, at 30 days of follow-up, 66Nyha cardiac function improved from grade III IV to grade I II in 3% of patients, and at one year of follow-up, 79Eight percent of patients improved from preoperative grade III IV to grade I IIIn addition, 6MWD (6-minute walk distance) at 30 days of follow-up compared with LUX-VALVE from baseline 3243 meters to lift 93 m to 3336 meters, which increased to 383 at one year of follow-up2 meters.
At the same time, the results of the multi-center clinical trial of the second-generation product, the LUX-Valve Plus transvascular tricuspid valve replacement system, were also officially released at the 2023 American Transcatheter Cardiovascular** Congress (TCT). A total of 96 patients were included in this clinical trial, and the endpoint of the one-month clinical data published was the incidence of composite events at 30 days after surgery. Data from the 30-day follow-up showed that 100% of patients had an improvement in tricuspid regurgitation grade based on ultrasound data, 97Tricuspid regurgitation is graded to none or minimal in 81% of patients.
Source**: Jianshi Technology Official***
Safety results showed that the 30-day composite adverse event rate of LUX-VALVE Plus was only 645%。At the same time, the incidence of myocardial infarction, stroke, use of ECMO or IABP, acute liver failure, long-term mechanical ventilation (>72 hours), cardiovascular injury requiring surgical intervention (cardiac perforation, vascular injury), and life-threatening major bleeding events were all 0;The all-cause mortality rate is only 108% and device-agnostic.
Efficacy results showed that 100% of patients with tricuspid regurgitation were reduced to mild or less at 30 days of follow-up, 92Thirty-one percent of patients showed no or only minimal paravalvular leakage;80.Forty-three percent of patients were upgraded from preoperative NYHA III IV to Class I II. As for the 6MWD (6-minute walking distance), the Lux-Valve Plus patient was lifted by 12 meters.
Due to the complexity of tricuspid valve anatomy, the development of interventional valves has been greatly improved, and only the LUX-VALVE series products of Jianshi Technology and the EVOQUE products of Edwards Life Sciences (EW) of the United States are leading the way in the world. The LUX-VALVE and LUX-VALVE PLUS transcatheter tricuspid valve replacement systems effectively break through the clinical pain points and difficulties of patients with severe tricuspid regurgitation through the unique "ventricular septal anchoring" prosthetic valve fixation method and the "adaptive leak-proof ring" design. Among them, the design of the "adaptive leak-proof loop" can effectively reduce the occurrence of paravalvular leakage, will not compress the tissues around the tricuspid valve, and is more conducive to the recovery of cardiac function after surgeryThe world's first "ventricular septal anchoring" design uses a special structure of force anchoring and clamping parts on the ventricular septum to solve the problem that the artificial valve is difficult to fix in the heart chamber from the root.
Notably, Edwards also recently disclosed clinical results from patients who received ** in the Triscend II study of its Evoque transcatheter tricuspid valve replacement system. The patients enrolled in the study received the best medications** at the same time, and clinical data showed that a certain percentage of moderate or highly functional or degenerative tricuspid regurgitation (TR) remained. According to its published data, the 30-day composite adverse event rate of EVOQUE in combination with the best drug** was 274%。At 6-month follow-up, 67In 4% of patients, NYHA cardiac function improved from grade III V to grade I II (22 were already present in the baseline data before excluding **).6% of patients were grade I II);93.The degree of reflux decreased to mild or less in 8% of patients, of whom 77Eight percent of patients show no or minimal paravalvular leaks. 6 MWD (6-minute walk distance) decreased at 30 days of follow-up and then rose at 6-month follow-up.
From the comparison of data, it can be seen that the first-generation product LUX-VALVE and the second-generation product LUX-VALVE PLUS have obvious advantages in terms of safety, effectiveness and long-term recovery of patients' physical condition, and have the world's leading level. We look forward to the continued publication of longer-term clinical data.
In addition, in the clinical practice of tricuspid valve replacement**, there are often cases where patients with very severe tricuspid regurgitation (TR) who are at high risk for surgery are unable to intervene due to the large annular valve**. The maximum annular diameter covered by LUX-VALVE is 65-75mm, which is much higher than the maximum annular diameter of 52mm in EVOQUE, and has a wider range of indications.
According to reports, Lux-Valve Plus, the second-generation tricuspid valve replacement product of Jianshi Technology, has successfully completed a series of paid compassionate treatment in many hospitals in the Asia-Pacific region, including several cases of rare and complex anatomical structures. The clinical performance, cardiac function and quality of life of patients after surgery have been significantly improved, which has fully proved that the product has excellent performance with wide range of applications, high reliability and simple operation.
Heart valve track "every second counts" The R&D progress of Jianshi Technology ranks firmly in the first echelon.
Cardiovascular disease is one of the most promising areas in the pharmaceutical industry. According to Zhitong Financial APP, in recent years, the global population of cardiovascular disease patients is huge, and the prevalence continues to rise. According to the 2022 Summary of China's Cardiovascular Health and Disease Report, cardiovascular disease (CVD) ranks first in the proportion of disease deaths among urban and rural residents in China. In the classification of cardiovascular diseases, valvular diseases account for the highest proportion of surgeries.
Compared with the aortic valve and mitral valve, the leaflets of the tricuspid valve are thinner and more fragile, and its complex structure also increases the difficulty of intervention**. According to American epidemiological data, the mortality rate of patients with severe tricuspid regurgitation (TR) in three years is as high as 50%. It can be seen that the tricuspid valve intervention** market is still in its early stages, and there is a huge ** gap.
According to the National Transcatheter Valve** Database (NTCVR), by the end of 2022, a total of 23,980 transcatheter aortic valve replacement (T**R) surgeries had been performed in Chinese mainland, and the cumulative number of surgeries reached 35,594 by October 31, 2023, showing a year-on-year increasing trendAccording to Frost &Sullivan**, China's transcatheter tricuspid valve intervention** (TTVI) market is expected to reach RMB 85.6 million in 2023 and increase to RMB 20.3 billion by 2030, with a compound annual growth rate (CAGR) of 118%.
The number of t**r surgeries in Chinese mainland from 2010 to 2023 (source: valve center, data**: NTCVR).
Unlike many mature medical fields, dominated by foreign brands, in the face of this vast blue ocean to be explored, domestic enterprises and foreign-funded enterprises are standing on the same starting line, it can be said that whoever can "seize" the R&D highland in this arms race is expected to share more market share with the rapid volume of commercialization.
In tricuspid valve intervention**, there are two different subdivided technical paths: interventional replacement (TTVR) and interventional repair (TTVR). Compared with transcatheter tricuspid valve repair, transcatheter tricuspid valve replacement has a broader potential target patient population and is less restrictive to the patient's native valve condition.
Up to now, there are only 4 prosthetic products in the world that have obtained CE certification, including Abbott Triclip and Edward Pascal for the edge-to-edge repair (T-Teer) pathway, Edward Cardioband for the annulus pathway and PF Tricvalve for the heterotopic rerouting pathway, while there are no approved products under the original repositioning pathway. However, even if there are a number of repair products on the market, after years of clinical practice, the number of surgeries is still limited, which shows that interventional repair surgery has obvious limitations in tricuspid valve regurgitation disease, and there are recent overseas literature to prove this. In the field of tricuspid valve replacement, the world's leading R&D progress is the first and second generation of LUX-VALVE products independently developed by Jianshi Technology and Edwards' EVOQUE.
Specifically, Lux-Valve, a first-generation product of Jianshi Technology, has completed confirmatory clinical trials and entered the registration review stage of the National Medical Products Administration (NMPA), and is expected to be approved in the near future, taking the lead in entering the Chinese market of transcatheter tricuspid valve replacement (TTVR).
The second-generation product, LUX-Valve Plus, has completed confirmatory clinical trials in the NMPA, and the clinical data has demonstrated excellent safety and efficacy.
In addition, the clinical and commercialization of LUX-Valve Plus in North America has accelerated, and dozens of clinical implants have been completed in North America, including the United States and CanadaThe Early Feasibility Study (EFS) pre-submission application for LUX-Valve Plus has been formally accepted by the U.S. Food and Drug Administration (FDA). Rapidly advancing enrollment in CE Mark registration clinical trials at clinical centers in several European countries.
In this regard, Huaan** pointed out that it is expected that the product progress of Jianshi Technology will be at least 3 years ahead of similar products of domestic counterparts. The blockbuster products entering the first echelon of R&D will undoubtedly enable Jianshi Technology to fully enjoy the market dividends during the commercialization window, and the company's rich pipeline layout is expected to bring sustained high growth momentum to the performance.
Multiple technical paths go hand in hand, and strive to create a full-coverage product matrix.
Based on a deep understanding of structural heart disease, Jianshi Technology has a rich product matrix and has become the only company in China that has achieved full coverage of structural heart disease. At present, the company has a total of 12 products in the clinical and registration stage, including 8 heart valve products, 2 heart failure products and 2 cardiogenic stroke protection products.
In the field of mitral valve intervention, there is currently no fully mature solution in the world, and Jianshi Technology will achieve a wider range of clinical needs coverage of patients in the future by simultaneously developing three completely different technical paths: repair, partial replacement and full valve replacement.
At present, the company's mitral valve product layout includes the innovative transcatheter mitral valve repair clamping system JENSCLIP, the mitral valve repair mitral valve repair MITRAPATCH using valve leaflet repair technology, the mitral valve leaflet enhancement system JENSFLAG, and the mitral valve full valve replacement system JENSRELIVE.
In addition to the two core products of LUX-VALVE in the tricuspid valve field, the company has also developed KEN-Valve, a product for the indication of aortic regurgitation, which is expected to become the third product in the global market and the second indication in the Chinese market to cover both aortic regurgitation (or aortic stenosis).
Recently, Ken-Valve's registration application was approved to enter the priority approval process for medical devices by the National Medical Products Administration (NMPA), and it also became the first product to be selected to enter the priority approval process in the field of heart valves after the State Food and Drug Administration opened the priority approval channel. The inclusion of the priority approval process will significantly increase the speed of product approval and accelerate the commercialization process.
In addition to the valve business, Jianshi Technology also has a variety of product layouts in the field of heart failure and cardiogenic stroke protection, such as the self-developed atrial septal stoma stent and delivery system Microflux, and the left atrial appendage occluder system SIMULOCK and PFO occluder system OMNISEAL, two cardiogenic stroke protection products, of which SIMULOCK has successfully completed the enrollment of multiple registered clinical FIMs.
Looking ahead, with the intensive commercialization of a number of products, the sales revenue of Jianshi will continue to grow in both the Chinese market and overseas markets, and the company's "full flowering" in the R&D layout of structural heart disease will also enhance its ability to resist risks and increase the certainty of subsequent performance. At a time when the pharmaceutical industry is more focused on originality and internationalization, Jianshi Technology, which has a rich product reserve, has sufficient upward momentum. It is also expected that more China's independent innovative medical devices will be able to achieve "corner overtaking" in subdivided fields.