Pipelines going overseas have become one of the hottest topics in the innovative drug circle and even the entire pharmaceutical industry.
Recently, Systimmune, a subsidiary of Baili Tianheng Pharmaceutical, and Bristol-Myers Squibb (BMS) announced that they had reached an exclusive license and cooperation agreement on SYSTIMMUNE's BL-B01D1, which immediately detonated the attention and discussion of the market.
It is reported that BMS will make an upfront payment of US$800 million and contingent near-term payments of up to US$500 million to Systimmune, plus payments to achieve certain developmental, regulatory and sales performance milestones in the future, bringing the potential total value of the transaction to up to US$8.4 billion.
As a potential first-in-class HER3 EGFR bispecific antibody ADC product, BL-B01D1 has not only set a new record for the total amount of foreign licensing of domestic innovative drugs, but also proved the huge potential of domestic innovative products to go overseas.
This is undoubtedly an important milestone in the field of innovative drugs. So what does this mean for the pharmaceutical industry as a whole?Can innovators in other segments, such as medical devices, follow this path in search of greater growth?
** Gelonghui Ed. | echo
This article is for informational purposes only and does not constitute any trading advice
From innovative drug BD to medical devices going overseas,
The appeal and potential of a potential first-in-class product
Domestic innovative pharmaceutical companies have gradually realized that innovation must have a global vision. Expanding innovative technologies and pipelines to the global market can not only significantly improve the success rate of drug candidate R&D, but also lay a solid foundation for the sustainable growth and market expansion of products in the future, effectively enhancing the competitiveness of innovative pharmaceutical companies in the global market.
Public data shows that in the past decade, by comparing the R&D and commercialization of 50 first-in-class oncology drugs marketed in the United States, it is clear that while small biotech companies play a leading role in leading the discovery of first-in-class drugs, large pharmaceutical companies have played an important role in the subsequent development and commercialization of most first-in-class drugs through the BD pathway, which can help the drugs achieve higher sales peaks.
As a result, domestic innovative drug companies have accelerated the pace of external licensing of technologies and pipelines, the number of related BD projects has increased sharply, and the market heat continues to heat up.
In the author's view, this is not only limited to the R&D and commercialization of innovative drugs, but also a strategic layout from a global perspective.
According to this logic, if you zoom in on the perspective, you will find that this strategy is also worth learning from other innovation sectors, such as the field of innovative medical devices.
In recent years, with the continuous progress of technology and the gradual opening of the global market, the innovation of medical devices in China has also shown unprecedented vitality, and many innovative medical devices with independent intellectual property rights have shown the strength to match or even surpass overseas enterprises.
Like innovative pharmaceutical companies, the overseas strategy of innovative medical device companies is not only a new opportunity, but also a necessary development path. Only by integrating with international standards and actively exploring the global market can we stand out from the fierce competition and achieve a certain market position.
So, in this context, what kind of innovative medical devices can China have the potential to enter overseas markets and achieve the same imagination space as the innovative drug cooperation mentioned at the beginning of the article?
In the process of sorting out China's innovative medical device companies, the author noticed that Jianshi Technology (9877., a Hong Kong-listed company in the field of structural heart disease interventional devicesHK), which focuses on the complete field of structural heart disease and is a global leader in the tricuspid valve.
To have overseas market potential and imagination space, first of all,The huge market space is the foundation. In the field of structural heart disease**, for example, the heart, as the engine of the body, is one of the most important organs in the human body. Under the influence of various factors such as the acceleration of the aging process and people's poor living habits in recent years, the number of patients with structural heart disease is increasing, and the incidence of structural heart disease such as congenital heart disease and heart valve disease is showing an increasing trend, and the demand continues to rise.
With the advantages of small wounds, safer and faster recovery, interventional technology came into being. Nowadays, interventional medical devices play an increasingly important role in structural heart disease and become the first solution for doctors and patients.
Among them, the tricuspid valve is a blue ocean field due to the extremely high difficulty of surgery and the large demand for unmet patients. From the perspective of market size, Frost & Sullivan data shows that from 2023 to 2030, the global tricuspid valve interventional device market size will increase from 0$3.2 billion to $112$8 billion, with a CAGR of 13114%。During the same period, the overall domestic market for tricuspid valve interventional devices will increase from 08.6 billion yuan to 2031.3 billion yuan, CAGR of 11829%。
Secondly,Only true innovation can seize the opportunity in overseas markets. For example, as a giant in the field of structural heart disease, Edwards Life Sciences' self-developed SAPIEN, the world's first transcatheter aortic valve replacement (T**R) product, has rapidly emerged since its launch. Not only that, it has also continued to optimize and iterate its T**R products, and successfully launched a number of innovative spherical expansion products on the market, which has been able to consolidate its position as the leader in the industry.
According to the financial report, in the field of T**R, Edwards Life Sciences can achieve an annual revenue of $3 billion with the SAPIEN series alone, and the sales in the latest Q3 of 2023 are as high as 9$6.1 billion. Over the past decade, its sales have maintained an annual growth rate of more than double digits, which fully proves that only truly innovative medical device products such as the world's first can have strong competitiveness and potential to seize more market share.
References: Company announcement, Hua'an ** Research Institute.
In general,It is not difficult to see from the continuous heating trend of innovative drug BD that domestic innovative drugs are accelerating to go abroad and enter the global market. In the same way, it is also an inevitable trend for innovative medical devices to go international through this way, open up a broader market, and enhance the influence of domestic medical device manufacturers in the global market.
The LUX-VALVE range is full of innovation
Commercialization is poised to take off
Focusing on the domestic market, Jianshi Technology is a rare good case.
As an innovative interventional medical device company with the most complete layout in the field of structural heart disease in China, Jianshi Technology has developed a complete solution for different types of structural heart disease, including tricuspid valve disease, aortic valve disease, mitral valve disease, heart failure and cardiogenic stroke.
In the product portfolio, the most popular product in the market is its self-developed transcatheter tricuspid valve replacement LUX-VALVE series products.
That's because, after years of research and development, it is difficult to fix prosthetic valves in a minimally invasive way at the tricuspid valve position worldwide. At present, there is no tricuspid valve product approved for marketing in the Chinese market, and only the two products of Jianshi Technology, Lux-Valve and Lux-Valve Plus, have completed confirmatory clinical trials and gradually entered the stage of obtaining certification, and will have market monopoly advantages for at least 4-5 years or more. One of the first-generation products, LUX-Valve, has been accepted by the NMPA of the National Medical Products Administration and is expected to be approved for marketing in the near future.
The transcatheter tricuspid valve replacement system LUX-VALVE series products have the world's first design concept of "ventricular septal anchoring" and non-radial support, in which the "rabbit ear" valve leaflet clamping structure ensures the stable fixation of the artificial valve, and at the same time, with the adaptive braided ring, it can effectively cope with the paravalvular leakage caused by annular dilation in patients with tricuspid regurgitation, and avoid the occurrence of postoperative conduction block. As the second-generation transcatheter tricuspid valve replacement system, the LUX-VALVE PLUS further expands the coverage of the surgeon's department and the patient's anatomy, as well as optimizes the standardized procedures of the operation, which is conducive to the rapid penetration and volume of the product.
It is reported thatThe LUX-VALVE series products are expected to be approved for marketing in China in the near future, becoming the first transcatheter tricuspid valve replacement product approved for marketing in China, and the second-generation LUX-VALVE Plus will soon submit an NMPA registration application. Globally, only Edwards Life Sciences' EVOQUE product was approved in Europe in October this year. According to the author's understanding, EVOQUE still follows the traditional T**R product radial support fixation method, while the LUX-VALVE series products use the "ventricular septal anchoring" non-radial support fixation technology tailored to the tricuspid valve anatomy, which is expected to have significant advantages in the scope of application and prognosis of patients.
The latest clinical results of the LUX-VALVE series products have also been presented at a number of world-renowned academic events recently. Good safety and effectiveness not only show the original design advantages and excellent performance of the product, but also represent that the innovation of this series of products has been recognized by international authorities and the market.
At the 2023 American Transcatheter Cardiovascular** Congress (TCT), the multicenter clinical trial TR**EL II of Lux-Valve Plus showed a device success rate of 96 percent and a surgical success rate84%, and the average instrument operation time is only 3556±20.82 minutes. Tricuspid regurgitation decreased to mild or less in 100% of patients, 97Eighty-one percent of patients showed no or minimal paravalvular leakage.
At the 2023 PCR London Valves Conference, the one-year results of the confirmatory clinical trial of LUX-VALVE demonstrated significant reduction of tricuspid regurgitation, effective improvement of cardiac function and improvement of quality of life. 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.
In fact, with the uniqueness and innovation of the LUX-VALVE series products, Jianshi Technology has long been actively carrying out the global overseas layout of its products in Europe, North America and the Asia-Pacific region.
In Europe, LUX-VALVE PLUS is continuing to advance its clinical enrollment in CE Mark registration, and has been selected to join the Expert Panel Scientific Advice Pilot (EEC) Scientific Advice Pilot, which will help accelerate the company's clinical and commercial development in EuropeIn North America, the LUX-Valve family of products has also been granted Breakthrough Medical Device Designation by the FDA and selected to participate in the FDA's Product Life Cycle Consulting Program (TAP), which aims to ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices globally in the coming years, further accelerating clinical trials and commercializationIn the Asia-Pacific region, a number of hospitals have also successfully completed a series of fee-based compassionate treatment uses of LUX-VALVE PLUS, and the product has been able to bring in main business income before the official approval, further reflecting the global scarcity and market recognition of the product.
There is no doubt about itThe LUX-VALVE series is an epoch-making innovative product in the field of tricuspid valve intervention. For example, Huaan** pointed out that the LUX-VALVE series products are the first of its kind to be innovative medical devices, with huge market potential, and once commercialized, it will form a rapid breakthrough in the revenue side, with strong profit expectations and high growth.
It can be expected that this series of products may hope to achieve outstanding results in the future like the BD cooperation of China's innovative drugs.
Conclusion
Back to the beginning, what kind of magic can make Bristol-Myers Squibb bet a huge amount of money?The key point is the uniqueness and innovation of the product, which is the first of its kind, and the huge commercial space behind the product.
Extending to the field of innovative medical devices, Jianshi Technology has also shown the innovative strength that overseas giants may be willing to pay for. With the imminent launch of LUX-VALVE series products and the continuous commercialization of other innovative interventional medical device products, the value of Jianshi Technology is gradually recognized by the global market, and the value boundary will continue to expand, which deserves more attention.