We are a leading player in the neuro- and peripheral-vascular interventional medical device market in China in terms of our comprehensive product portfolio. As an integrated medical device company supported by our in-house R&D and manufacturing capabilities, proprietary technological platforms, and commercialization capabilities evidenced by our track record and led by our experienced management team, we provide physicians and patients in China and overseas with medical devices to treat and manage neuro- and peripheral vascular diseases. Our current therapeutic areas include acute ischemic stroke (AIS), intracranial aneurysm, carotid artery stenosis, peripheral arterial and venous diseases, and dialysis related diseases.
We provide solutions to patients and physician with the most comprehensive product portfolio covering neuro- and peripheral-vascular interventional medical devices among domestic neuro- and peripheral- vascular medical device companies in China according to Frost & Sullivan. Our current neurovascular product portfolio covers a full suite of products in five major categories, namely ischemic, hemorrhagic, stenosis, carotid artery, vascular access device, and according to Frost & Sullivan, we are the only domestic company in China that has developed a neurovascular product portfolio covering all these five major categories. With 22 approved products and product candidates, we have the most comprehensive peripheral-vascular interventional product portfolio among domestic players in China covering a full spectrum of arterial and venous products including stents, balloons, catheters and filters, according to Frost & Sullivan. In addition, our product portfolio also includes two vascular closure device candidates which makes us the first domestic medical device company that has developed vascular closure device candidates. Since our inception in 2012, we have systemically and methodically developed a portfolio of 45 products and product candidates to cover neuro- and peripheral-vascular device market and vascular closure device market that are highly under-penetrated and fast growing. Our two Core Products are Thrombite Clot Retriever Device (“Thrombite CRD”) and UltrafreeTM Drug Coated PTA Balloon Catheter (“Ultrafree DCB”) which have been commercialized in China and we are conducting further research and development on our two Core Products. As of the Latest Practicable Date, our broad product portfolio included a total of 11 approved products in China and overseas, including 5 approved products for treating neurovascular diseases and 6 approved products for treating peripheral vascular diseases. We also have 37 product candidates at various development stages in China, including 7 at registration stage, 9 at clinical trial stage, 11 at type testing stage, and 10 at design stage. During the Track Record Period, we commercialized 6 products in China and overseas and generated revenue from the sales of such products. In 2020, we substantially increased our sales in China and revenue generated from our sales in China accounted for 87.9% of our total revenue for 2020. As our current products and product candidates receive more marketing approvals in China, we expect to generate more sales in China. As of the Latest Practicable Date, there was no price guidance set by the PRC government on stroke treatment and prevention devices.
In the neuro-vascular interventional medical device space, we are the only domestic company that are developing a full suite of products for major neuro-vascular categories, namely ischemic, hemorrhagic, stenosis, carotid artery, vascular access device, according to Frost & Sullivan. In the peripheral-vascular interventional medical device space, we have the most comprehensive product portfolio and with the most National Medical Products Administration (“NMPA”) approvals among domestic players in China according to Frost & Sullivan. We are also the only domestic medical device company that has obtained CE Mark and commercialized both neuro- and peripheral-vascular medical devices in Europe according to Frost & Sullivan.
In 2021, we expect to achieve significant advancement for our product portfolio. We expect to obtain NMPA approval and commercialize additional 8 product candidates including balloon guiding catheter, intracranial PTA balloon catheter (Rx), neurovascular embolization coils, microcatheter for coiling, microcatheter for clot retriever, distal access catheter, distal support catheter and vessel snare. We also plan to submit applications for NMPA approval for 6 product candidates in 2021, including microcatheter for coiling, carotid Rx PTA balloon catheter, PTA balloon catheter – large diameter, retrievable inferior vena cava filter, endovenous radiofrequency ablation (RFA) catheter, and suture-mediated closure system. Furthermore, we are currently conducting 9 clinical trials for our innovative devices, including intracranial drug coated balloon catheter, flow diverter, endovenous radiofrequency ablation (RFA) catheter, retrievable inferior vena cava filter, peripheral venous stent system, peripheral drug-eluting stent system, drug-coated PTA balloon catheter – dialysis access, peripheral detachable coil and suture-mediated closure system. We are advancing a total of 39 product candidates through different stages of development that we intend to obtain approvals in China by 2025. Regarding our two commercialized Core Products, Thrombite CRD and Ultrafree DCB, we are conducting further R&D including, among others, clinical trials required by NMPA to expand their indications and upgrade their features and bring Drug Coated PTA Balloon Catheter – BTK and Drug Coated PTA Balloon Catheter – Dialysis Access to commercialization. We believe all these approved products and product candidates in our comprehensive product portfolio will solidify our leading position in the neuro- and peripheral-vascular interventional medical device market in China.
Stroke is a leading cause of death and disability globally. Neurovascular disease is the leading cause of death in China which accounted for over 20% of the total mortality in 2019 in China and such percentage is constantly growing. The incidence of ischemic stroke continues to rise in China, primarily due to life style issues and aging population. The recommendation by the AHA for mechanical thrombectomy (MT) as the first-line treatment choice for ischemic stroke and its subsequent adoption in China have set off a revolution in ischemic stroke treatment that shifted traditional anti-coagulant drug regiment and intravascular thrombolysis to the new MT procedures with proven safety and significantly enhanced efficacy. MT procedures are expected to grow rapidly in China for the next 10 years, benefiting from a number of factors such as favorable government policies, rising living standard and increasing healthcare expenditure, which will propel the growth of neurovascular medical device market. The number of neuro-interventional procedures in China increased from 77.4 thousand in 2015 to 159.6 thousand in 2019 at a CAGR of 19.8% and is estimated to further increase to 1,781.0 thousand in 2030, at a CAGR of 24.5% from 2019 to 2030.
Peripheral-vascular interventional device market in China also represents a large, underdeveloped and rapidly expanding market that is currently dominated by multinational corporation (“MNC”) players. The recent approval and gradual adoption of drug-coated balloon (“DCB”) in treating various arterial diseases including lower extremity arterial diseases, are seen as a viable alternative to stenting, and a new paradigm of “leaving nothing behind” is taking hold of peripheral-vascular disease treatment in China, which is expected to propel the growth of the peripheral-vascular interventional device market in China for the next 10 years. The number of peripheral artery intervention procedures in China increased from 58.6 thousand in 2015 to 112.2 thousand in 2019 at a CAGR of 17.7%, and is estimated to further reach 600.1 thousand in 2030 at a CAGR of 16.5% from 2019 to 2030. According to Frost & Sullivan, peripheral artery intervention procedure mainly includes the procedure of peripheral artery stent, peripheral artery balloon, drug-coated balloon, peripheral plaque atherectomy device and other products (access device and embolization coil). We aim to capture such significant growth potential and solidify our leading market position in both neuro- and peripheral-vascular interventional medical device market in China.
We strive to provide all patients, regardless of their race, age and affluence, with accessible medical devices and services. Since the inception of the Company, we have adopted and executed our strategic business model of developing medical devices and solutions with advanced features with a focus on neurovascular and peripheral-vascular interventional market. Our product candidates are selected and developed in-house, and we hold global rights of our self-developed products and product candidates.
We have built a synergistic corporate platform with integrated R&D, manufacturing and commercialization capabilities, which enables smooth collaborations and accelerates development process during the full product life-cycle and therefore helps to achieve cost-efficiency.
‧ R&D. Led by our three experienced and multi-disciplinary R&D team leaders, including Dr. Jonathon Zhong Zhao, our founder and chairman of the Board, Dr. Zheng Li, our senior vice president, and Dr. Ning Pan, our senior vice president, who have an average of over 15 years of experience in global leading medical device companies with proven track record of successful product development, we have established in-house R&D capabilities which are manifested by our product innovations and our proprietary technologies and efficient product development process. Leveraging our strong R&D and product development capabilities, we have developed a portfolio of innovative products and product candidates with advanced features that are comparable in performance to imported products by established international brands in the industry in terms of safety and efficacy as demonstrated in clinical trials. For details, see “Business – Our Product and Product Pipeline”. We have two products, Thrombite CRD and Ultrafree DCB, that were approved through the Special Approval Procedures of Innovative Medical Devices promulgated by the NMPA (the “NMPA Special Approval Channel”), out of the 11 neuro- and peripheral-vascular medical devices that were approved through such NMPA Special Approval Channel as of January 2021. For details on the framework of the NMPA Special Approval Channel, please see “Regulatory Overview – Special Procedures for Examination and Approval of Innovative Medical Devices”. Our R&D capabilities, combined with our extensive registration experience and established strong collaboration with leading physicians and hospitals, also help improve our clinical trial efficiency and expedite our product advancement. For example, our patient enrollment timeline reduced by half from 25 months in our first large scale clinical trial to around one year, which is at the top level for similar product in the industry according to Frost & Sullivan. All subsequent patient enrollments of our clinical trials have generally followed around one-year timeline, which we believe is at a highly efficient level. Our in-house R&D capabilities are also evidenced by our patent portfolio. As of the Latest Practicable Date, we had 39 patents and 43 patent applications in China. As of the Latest Practicable Date, our core R&D team responsible for the development of the Core Products remained with the Company.
‧ Manufacturing. Manufacturing process of vascular interventional products is complex and technologically challenging because it requires the integration of several different manufacturing processes and different materials with high demand for precision. Over the years, we have accumulated extensive expertise and know-how in developing and manufacturing vascular interventional products and obtained a number of patents for our proprietary technologies. Our manufacturing expertise and know-how combined with advanced technologies applied during our manufacturing process help ensure both high quality and efficiency of our production. We had built manufacturing facilities of an aggregate area of approximately 3,800 sq.m. in Hangzhou and Zhuhai, China as of the Latest Practicable Date. In addition, we are in the process of expanding our production capacity with additional aggregate area of approximately 13,000 sq.m. in Hangzhou and plan to build a new manufacturing site in Zhuhai with an aggregate area of approximately 20,000 sq.m in preparation for the commercialization of further expanded product portfolio.
‧ Commercialization. We have a proven track record of commercializing 9 products since our inception in 2012. We employ an offline and online integrated marketing model with a focus on academic promotion to increase market and physician awareness and penetration of our products. We have a dedicated in-house sales team of 50 members led by Mr. Yang Xie with a focus on academic marketing driven by our extensive expertise and clinical resources. We had also established an extensive distribution network by collaborations with 23 domestic distributors who are authorized by us to cover over 1,500 hospitals across 22 provinces, 4 autonomous regions and 4 municipal cities in China as of the Latest Practicable Date. Over the years, we have developed strong collaborations with and established a well- recognized brand among leading physicians and hospitals in China in the field of neuro- and peripheral-vascular intervention.
Regulations on the Supervision and Administration of Medical Devices (2021 Revision) was passed in December 2020 and came into effect in June 2021, the major amendments under which include among others the introduction of regulatory measures such as unique product marks tracing, extended inspection and enhanced punishment. We closely follow the implementation progress of Regulations on the Supervision and Administration of Medical Devices (2021 Revision) to ensure our compliance. For details, see “Regulatory Overview – Laws and Regulations relating to Medical Devices”. According to our PRC Legal Advisor, the Regulations on the Supervision and Administration of Medical Devices (2021 Revision) are not expected to have any material impact on our ongoing and planned clinical trials, registrations and commercialization within our scope of operations or our ongoing operations.
Our business grew rapidly during the Track Record Period under the leadership of our senior management team. Our management team consists of seasoned industry executives with vast experience in leading medical device companies in China and globally, such as Dr. Jonathon Zhong Zhao, our founder and Chairman of the Board. We benefit from their proven track record of successful research and development, and commercialization of medical device. During the Track Record Period, our revenue increased by 461.9% from RMB4.9 million in 2019 to RMB27.6 million in 2020, our gross profit increased from RMB1.2 million in 2019 to RMB16.3 million in 2020, and our gross profit margin increased from 24.2% in 2019 to 58.9% in 2020. We currently mainly target the China market and do not have immediate plan to enter into new markets outside of China and Europe.
Source: ZyloxTB-B (02190) Prospectus (IPO Date : 2021/06/22) |