These medical devices are "immunity" with volume!

Recently, the National Medical Insurance Bureau made a clear response on the procurement of "innovative medical devices".

As mentioned in the response to the proposal of the Fifth Session of the Thirteenth National People's Congress No. 4955:

As the clinical use of innovative medical devices has not yet matured, and the amount of use is temporarily difficult to estimate, it is difficult to implement the amount of volume.

Following the signal of DRG/DIP except for the release of DRG/DIP, the State Medical Insurance Bureau has once again relaxed the development space of "innovative medical equipment" -it is clear that it will not be incorporated into the band purchase.

This undoubtedly injected strong hearts into the "downturn" big health market. After being "encouraged" by this news, the stock price of many innovative medical device listed companies in the first trading day (September 5th) after the announcement opened high, the increase was nearly 20%.

So, which companies of the products will be "exemption" for purchasing? Will Chinese medical device companies usher in a new era of innovation?

1

How to become a "innovative medical device" product?

In the Chinese market, innovative medical device companies depend on policy dependence. Therefore, the product must be included in the "Special Examination Procedures for Innovation Medical Device".

On March 1, 2014, the "Special Approval Procedures for Innovation Medical Device (Trial)" issued by the Pharmaceutical Supervision Bureau began to implement it, and for the first time, it provided a green channel for the registration and approval of innovative medical devices.

On December 1, 2018, the newly revised "Special Examination Procedures for Innovation Medical Device" began to implement, suitable for second and third categories of medical devices.

The first category of medical devices: low degree of risk, implement product filing management.

The second category of medical devices: there is moderate risk, and product registration management is implemented, including: X -ray film machine, B -ultrasound, microscope, biochemical instrument, etc.

The third category of medical devices: has high risks and implements product registration management, including: implanted cardiovascular consumables, orthopedic consumables, creative monitoring systems, endoscopes, artificial crystals, ultrasonic surgery knives, etc.

The three major necessary conditions for the product to be included in the "Special Examination Procedures for Innovation Medical Device": with patent, clinical value, and high -quality innovation

1. Patent:

In China to have the core technology invention patent rights in accordance with the law, or to obtain the patent right or its use rights in China through the transfer of the law, the special review application time of the innovative medical device does not exceed 5 years.

Or the application of the core technology invention patent has been disclosed by the patent administrative department of the State Council of China, and a search report will be issued by the State Intellectual Property Office's patent search consulting center.

2. Product: Emphasize the actual application value of clinical clinical

The applicant has completed the preliminary research of the product and has basic styling products. The research process is real and controlled, and the research data is complete and traceable.

3. Innovation quality: original instead of improvement

The main working principle or mechanism of product work is the first in China. The product performance or safety is more fundamentally improved and similar to similar products. It is technically at the international leading level and has significant clinical application value.

The second and third types of medical devices that meet the above conditions are included in the second and third types of medical devices incorporated into the "Special Examination Procedures for Innovation Medical Device". After obtaining NMPA approval, it has become a "innovative medical device."

2

2014-2022H1

161 "Innovative Medical Device" was approved for listing

From the implementation of the policy in 2014, by the first half of 2022, a total of 161 innovative medical devices were passed through the "Special Examination Procedures for Innovation Medical Device", and NMPA has been approved to be listed in China. in,

8 imported products (5%)

153 domestic products (95%)

These products are "immunoists" for band purchases for a long time in the future. (The list is too long, see the end of the article for details)

Imported innovation products: Midunli is the biggest winner

Imported products mainly cover the two major areas of cardiovascular and tumor treatment. A total of 6 companies involved: Midunli (3), Abbott, Edward Life Science, W.L. Gore, Sequent Medical, Novocure each.

Midunli has three approved products, which is TOP1 of multinational medical weapon companies, including:

MC1VR01 (approved in 2019) by the catheter implantation -free pairing system;

Evolut Pro System (approved in 2021);

MC1AVR1 (approved in 2022) by the catheter implantation type;

The Micate's Micra series is the smallest wireless pacemaker in the world. MC1VR01 is its first generation of products. The MC1AVR1 approved in 2022 is its third -generation product. It uses the atrioventricular synchronous pairing technology. You can perceive the acceleration signal generated during heart machinery activity. This is the first at home and abroad.

The smallest wireless pacemaker in the world

EVOLUT Pro System is also the third generation of Midunli Active Artillery Elopella System. It is currently the most widely used self -expanded heart intervention in the world.

Evolut Pro System

The other five multinational enterprise products include:

The Abbott Catheter Mitraclip System (nominated by the Galen Awards is a minimally invasive, catheter -based treatment method. .) (Approved in 2020);

Edward Life Sciences Active Artillery Activated Valve System (nominated by the Galen Award, in addition to the improvement of durability, also uses VFIT extended valve technology to reserve a solution for the medium valve therapy). (2020 was won in 2020 Batch); Transcatheter Aortic Valve System

W.L. GORE Balcony Displayer's internal membrane stent system (provides new treatment options for patients with primary occlusion lesions of nectary iliac artery and external iliac artery), (approved in 2021);

Sequent Medical autoclave arterial tumor internal embolism system (provides new treatment methods for the treatment of rupture and unblied wide -necked metasarnexia), (approved in 2021);

Novocure tumor electric field therapy for wearable device Aipu Shield (the first use of electric field to inhibit cell division principles to treat collagenoblastoma), (approved in 2020);

Domestic innovative products: cover more than 100 Chinese companies, Pinchi Medical, Minimally Invent

The variety of domestic products is complete, covering cardiovascular (42%), surgical monitoring (21%), IVD (14%), image (7%), medical AI (6%), ophthalmology (4%), orthopedics (3%) (3%) ) Fields.

Pin Chi Medical Again (15 models) products, first. This is a device company focusing on central nervous treatment, mainly for Parkinson patients. The number of innovative medical devices approved is the related supporting equipment of implanted vagus nerve stimulation systems, sacral nerve stimulation systems, deep brain stimulation systems, and spinal cord nerve stimulation systems.

Pinchi brain deep part stimulus system to treat Parkinson's disease

The Minimally Invasive Department was approved (14) products, second.

Under the continuous split and mergers and acquisitions, minimally invasive medical care has existed:

Heart pulse medical care, heart -through medical, minimally invasive heart, minimally invasive electronic physiology, minimally invasive magic, minimally invasive orthopedic, creative heart rhythm, Mingyue medical care, minimally invasive heartpower, minimally invasive heart, minimally invasive department, minimally invasive department Weizhi, minimally invasive medical beauty, minimally invasive vision, minimally invasive sub -teeth, Rui Keyinica and many other subsidiaries.

The innovative products approved include:

Cardiovascular field: three -dimensional cardiac electrical bidding system, cold salt water irrigation radio frequency discharge catheter, branched aortic aortic gymnevis bracket and conveyor system, vascular reconstruction device, abdominal aortic arterialized membrane stent and transportation system, and catheter aortic valve valve system , Pharmaceutical balloon dilatation catheter, vertebral artery thoromycin targeting elimation bracket system, duct aortic valve valve and recyclable conveyor system, branches during branches, direct tube thoracic aorta regulatory bracket system;

Surgical field: three -dimensional electronic abdominal endoscopy, abdominal endoscopic surgical system;

Orthopedic field: knee replacement surgery navigation positioning system.

Lianying approved (5) products, third, including:

Medical imaging field: PET/MR UPMR 790, Digital Breast X -ray Machine UMAMMO 890i, PET/CT UEXPlorer, intracranial AI diagnostic system;

Radiotherapy field: integrated CT line-line accelerator URT-LINAC 506cc

Xianjian Technology was approved (4 models) products, the fourth, including:

Cardiovascular field: left heart ear seal block Lambre, implanted cardiac pacemaker, iliac arteries fork bracket system, temporary pacemaker

It is worth noting that, as a key cardiovascular and orthopedic product that focuses on collecting attention, relevant manufacturers have been "shocked" in recent years. Now, with the clear statement of the National Medical Insurance Bureau, innovative products will no longer worry about 80%. 90%of the price reduction threat.

Specifically, in addition to the minimally invasive and Xianjian products mentioned above, there are also Lepu (biological absorption of coronary threbomycin to elimate stent system) and Chunli (Single -knee prosthesis).

Main private enterprises for cardiovascular: minimally invasive, Xianjian, Lepu, Jiwei, Kim Ruiken, Yisheng Technology, Hengchen Medical, Wan Rui Feihong, Qiming, Peijia, Jiecheng;

Major private enterprises: minimally invasive, Weigao, Lepu, Chunli, Aikang, Dabo, Kellyta, three friends;

The cardiovascular and orthopedic enterprises that lack "innovative medical equipment" products, whether transnational or private, will continue to roll in the "price war".

In addition, in order to support innovation, the Medical Insurance Bureau also clearly stated that there will be more space for the outer market.

The "Answers" clearly states that according to the characteristics of clinical use, market competition pattern, and number of companies in the selected enterprises rationally determine the proportion of bands, leaving a certain market to provide space for innovative products to open up the market in addition to centralized band procurement.

3

Which "innovative medical devices" are about to be approved?

From 2021 to 2022, 107 products have entered the "Special Examination Procedures for Innovation Medical Device", including 13 imported products (12%) and 94 domestic products (88%). Become a "immune" with volume procurement.

Imported innovative products that are about to be approved: Siemens Medical and Boston Science Leading

The upcoming imported innovative medical device products

A total of 13 imported products cover 9 companies, namely: Siemens Medical (3), Boston Science (3), P + F -FEATURS GMBH, Trireme Medical, LLC, Biosense Webster, Stryker Neurovascular, Medibeacon, Inc. , MEVION Medical SYSTEMS, Eyeyon Medical LTD. each. Siemens Medical (including its enterprises) has three products in total:

Naeotom Alpha (photon count CT) is the first whole body CT product to enter the special review process of innovative medical devices to date;

The Corindus Inc. Coronary Aurional Invasion Surgery Control System Touling is the world's first interventional surgery robot;

PROBEAM, its Varry Anthine Treatment Equipment, is a non -invasive treatment method. Compared with traditional photon radiation therapy, it has lower side effects. Varian is the world's only proton treatment device+software overall solution. Enterprise.

Boston Science 3 products are included:

Farapulse Pulse Electric Farm Stitch (PFA) system, the latest treatment method of atrial fibrillation;

Vercise Genus implanted brain nerve stimulation (DBS) system for treatment of motion symptoms related to Parkinson's disease;

Vascular plaques rotary cutting system Jetstream, new therapy of lower limb arterial disease.

Three innovative products in Boston Science (slide left and right)

The upcoming domestic innovative products: nearly 50 products in the field of cardiovascular and orthopedics (nearly 50%)

The upcoming domestic innovative medical device products

Nearly 50 innovative products have the opportunity to avoid band purchases. Specific include:

Cardiovascular multiple -absorbing zinc alloy drugs to elute coronary bracket system, catheter aortic valve valve system, the two -pointed valve repair system of the catheter, and the duct trial valve repair system, etc.;

Orthopedic personalized knee prosthesis, knee joint prosthesis, etc.

Therefore, there has never been any "everything can be used", but your product is not "innovative".

The purpose of the purchase of volume is to return the market to "innovative products" for "changing birds".

The "Answers" clearly states that the country's tissue band volume procurement: the focus on some medical consumables with large clinical dosage, more mature clinical use, higher procurement amount, and sufficient market competition into the collection range. Through open and transparent competition rules, the price return to reasonable level, and at the same time allows enterprises to obtain clear market expectations.

The "imbalance" between medicine and equipment between China ’s big health market has a long history. At present, the Chinese market drug ratio is about 1: 0.35, while the American market drug ratio is close to 1: 1.

The fifth set of Hong Kong stocks and the fifth set of science and technology boards have opened a new way to financing for innovative pharmaceutical companies that have not yet been profitable. Today, innovative medical companies can finally enjoy this benefits.

On June 10, the fifth set of listing standards for science and technology boards expanded to the field of innovative medical devices for the first time, enhancing the tolerance of "hard technology" enterprises, and supporting innovative medical device companies that have not yet formed a certain income during the R & D stage.

On August 31, minimally invasive electronic physiology was listed on the science and innovation board, becoming the first unprofitable medical device enterprise listed through the "Fifth Set of Science and Technology Board Standards" through the medical device.

After the release of the "Fifth Set of Science and Technology Board" of the medical weapon, there are no revenue, net profit, and the proportion of R & D investment. As long as the market value is higher than 4 billion yuan, innovative medical companies can log in to the Science and Technology Board. Essence

With policy support and the capital market, Chinese innovative medical device companies may also usher in their own "golden decade".

161 "immune" list: immune:

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