On December 18th, the industrialization project for the research and development of cardiovascular products and high-value consumables by Yixin Medical was officially unveiled in Hefei.

As a leading global provider of cardiovascular intervention product solutions, the world's first non-invasive heart failure monitoring and management device independently developed by Heart Medical has opened a new era of non-invasive monitoring for heart failure disease management and injected new momentum into the biopharmaceutical industry in Hefei.

The biopharmaceutical industry is related to people's lives and health. It is not only a sunrise industry, but also a livelihood cause.

In recent years, Hefei has vigorously promoted scientific and technological innovation and industrial innovation, focusing on cultivating the biopharmaceutical industry as a leading industry. At present, the city has gathered nearly a thousand biopharmaceutical industry chain enterprises, with annual revenue exceeding 100 billion yuan, forming a complete industrial chain covering chemical pharmaceuticals, biopharmaceuticals, traditional Chinese medicine, precision medicine, medical devices, and medical services.

Heart failure management ushers in a non-invasive era

Cardiovascular disease is one of the biggest threats to human health.

The summary of the 2023 China Cardiovascular Health and Disease Report shows that the number of cardiovascular disease patients in China has reached 330 million. In the proportion of disease deaths among urban and rural residents in China, cardiovascular disease ranks first, with an average of 2 out of every 5 deaths caused by cardiovascular disease. In addition, with the aging population, the population of cardiovascular disease patients in China will become increasingly large.

Therefore, abnormal signals involving the heart are particularly worthy of timely monitoring and early intervention.

Our non-invasive lung water meter is the world's first non-invasive heart failure monitoring and management device, which can quantitatively detect lung water content and timely guide the adjustment of diuretics and other medication treatment plans for heart failure patients. "Wang Li, the chairman of Yixin Medical, told reporters that the device sends low-power electromagnetic signals to the lungs to obtain absolute lung water content. The normal lung water content of a person is 20% -35%, and the detection range of this device can reach 15% -60%.

Under normal circumstances, the human lungs only require an appropriate amount of fluid to remain moist and facilitate gas exchange. Once the function of the heart, the "pump" that transports blood, weakens, it can lead to fluid accumulation in the lungs and an increase in lung water content.

For most patients who have not progressed to advanced stages, the pain point of heart failure is not initial diagnosis but post diagnosis heart failure management. Among them, monitoring and evaluating lung water is key to blocking the progression of this cardiovascular disease.

It is worth mentioning that the non-invasive lung water meter from Heart Medicine only requires patients to wear it externally without invasion, and the entire measurement process only takes about 45 seconds, opening a new era of non-invasive monitoring for heart failure disease management.

Previously, there has been a lack of a non-invasive and accurate method for detecting lung water in clinical practice. Traditional methods, such as stethoscopes, are simple but cannot quantify, while CT and other examination methods can quantify but are not convenient enough. ”

As a leading global provider of cardiovascular intervention product solutions, Heart Medical is considering Hefei as an important base for development.

On December 18th, the industrialization project for the research and development of cardiovascular products and high-value consumables by Yixin Medical was officially unveiled in Hefei. The project is located in Hefei Economic and Technological Development Zone, with a total investment of about 2 billion yuan. It mainly aims to build a research and development, production, and commercialization base for non-invasive monitoring of heart failure and lung water, drug balloons, structural heart (biological and polymer valve series products), and other products.

Prior to this, the non-invasive lung water measurement device of Yixin Medical was approved for market by the Anhui Provincial Drug Administration in April 2023, and it only took 23 working days from application to certification.

In the future, we will continue to take root in Hefei, with the mission of realizing the universal nature of cardiovascular medical diagnosis and treatment, constantly innovating products, and striving to benefit more Chinese cardiovascular patients, "said Wang Li.


Empowering Capital and Innovation Together

The "accompanying run" of patient capital is an important force for the development and growth of the biopharmaceutical industry.

In September 2023, in the nearly $100 million Series C financing of Yixin Medical, patient capital from Hefei such as Hefei Haiheng Capital, Hefei Production Investment Capital, and Binhu Science City competed to lend their support.

In March 2024, Xingtai Capital announced the completion of a 30 million yuan equity investment in Shanghai Zhizhi Precision Instrument Co., Ltd. (hereinafter referred to as "Zhizhi Precision"), a precision optical enterprise, and facilitated the landing of its research and development production base in Hefei High tech Zone through "investment introduction linkage", with a total investment of 550 million yuan.

Zhizhi Precision focuses on the field of micro precision micro optics and has established a globally leading ultra precision micro optical system technology system, which has enabled China to surpass foreign counterparts in the field of ultra precision optics. Its main products include live cell optical scanners, medical endoscopes, lymph node scanning bedside rapid detection equipment, and other ultra precision micro optical instruments. The products have a wide range of applications and promising market prospects.

The biopharmaceutical industry is characterized by high risk, high investment, and long cycle, and has a strong dependence on industrial capital. There is a saying often used to describe the enormous risks and high costs of new drug development, called 'a billion dollars in ten years'. From research and development, clinical practice to production, application... any link requires a lot of "burning money".

In response to the characteristics of the biopharmaceutical industry, Hefei adheres to the principle of emphasizing both attraction and cultivation, consolidating and expanding the "fund+platform+merger and acquisition" attraction path, and becoming a city level partner of enterprises. At the same time, leveraging the guiding role of the parent funds of provincial and municipal governments, 13 funds in the field of life and health have been selected and established, and a municipal level biopharmaceutical special fund with a total scale of 5 billion yuan has been set up, continuously building a fund jungle with a scale of over 50 billion yuan, and empowering the innovative development of the biopharmaceutical industry with patient capital.

Innovation driven, the industry's momentum can continue to strengthen.

Relying on the Hefei Comprehensive National Science Center Big Health Research Institute, Hefei continues to empower innovative biopharmaceutical research and development, focusing on research directions such as biomacromolecules and cell dynamics, immunity and tumors, brain function and brain diseases, innovative biological therapies and new drug development, and promoting the "laying eggs along the way" and on-site transformation of scientific and technological achievements.

Focusing on cutting-edge fields such as life sciences and disease prevention and control, relying on leading enterprises, research institutes and other resources, 11 new research and development institutions in the field of biomedicine have been established to facilitate the rapid transformation of scientific and technological achievements. Encourage key technological innovation backbone enterprises to break through key core technologies through methods such as unveiling rankings and targeted commissions.

In terms of attracting and nurturing professional talents, Hefei has established a regular cooperation mechanism with many universities such as the University of Science and Technology of China, Hefei University of Technology, and Anhui Medical University to support the strengthening of the construction of life and health disciplines and address the shortage of high-precision and cutting-edge talents in the industry.

Creating full lifecycle services

With the rapid development of the biopharmaceutical industry in Hefei, batches of new drugs and devices have been approved one after another, showing a good situation of simultaneous improvement in both quantity and quality.

Data shows that in 2023, the number of newly obtained drug approvals and Class III medical device registration certificates in Hefei increased by 90.9% and 100% respectively year-on-year, accounting for 38% and 65% of the total number of certificates obtained in the province.

Multiple key products are in a leading position in China: Anke Biotechnology's recombinant human growth hormone has the second highest market share in China; Meiya Optoelectronics' CBCT and Opcon Vision's rigid corneal reshaping lenses have the highest market share in China; Ruishi Medical's PET/CT single bed scanning speed ranks first in the world; Qihao Medical's biodegradable expandable hemostatic cotton ranks second globally and first domestically, breaking through key technologies and achieving domestic substitution

On February 23 this year, the Second People's Hospital of Anhui Province held a start-up ceremony for the all digital PET/CT (DigitMI930) equipment, marking the first use of this high-end medical imaging diagnostic equipment in the province.

PET/CT， Positron emission and X-ray computed tomography imaging system. The fully digital PET/CT equipment introduced by the hospital this time is independently developed by Hefei Ruishi Medical, mainly used for the examination and evaluation of diseases such as tumors, nervous system, cardiovascular system, etc. It uses full process intelligent operation, has advantages such as "precise sampling" and "fully digital processing", and all key indicators are at the international leading level.

Our product obtained a Class III medical device certificate by the end of 2022 and was included in the provincial 'Three First' product catalog in 2023. With the help of provincial and municipal specialized teams, we quickly established connections with intended medical institutions and obtained our first order, "said Zhang Bo, General Manager of Ruishi Medical.

The development of biopharmaceutical enterprises cannot be separated from a good industrial ecology. In recent years, Hefei has adhered to the principle of putting service first, actively creating high-quality services covering the entire life cycle of biomedicine, and continuously improving element guarantees, supporting platforms, and scenario applications.

Strengthen the front-end of key elements, coordinate and integrate resources throughout the city, accelerate the transformation of chemical industrial parks, focus on the manufacturing of raw materials and intermediates for pharmaceutical enterprises, and coordinate the resolution of environmental impact assessments, water, electricity, and gas security issues for key projects.

Layout mid end services, establish two provincial-level pharmaceutical innovation flexible service stations in the High tech Zone and Economic Development Zone, and provide free flexible services such as policy consultation and legal training for biopharmaceutical enterprises. Relying on the Shanghai Medical Device Inspection Institute to establish a high-end medical device service station in Hefei, we will cooperate to build the Hefei Medical Device Inspection and Testing Center to enhance local testing service capabilities. Establish the first life and health industry platform company in the province, and do a good job in industry investment and ecological construction.

Expand the backend of the market, build the first scenario application hospital in China - Hefei Xinqiao International Hospital, create a concentrated application scene display area for high-end pharmaceutical and medical products, formulate key cultivation varieties and key product catalogs for the biopharmaceutical industry, regularly organize scenario application docking activities, and promote high-quality pharmaceutical and medical product varieties.

The relevant person in charge of Hefei Municipal Bureau of Industry and Information Technology stated that in the next step, we will adhere to the goal of "building a first-class industrial ecology in the country", do a good job in attracting high-quality projects, cultivating landing projects, optimizing industrial ecology, etc., promote the high-quality development of Hefei's biopharmaceutical industry, and make new contributions to improving people's health.

Hefei Tong Client - Li Houxiang, a full media reporter from HeBao