Innovative medical devices will not be collected for the time being; CR and Fosun announced cooperation; 33 medical consumables face network withdrawal; The in vitro diagnostic sector is pulling up strongly...

The National Medical Insurance Administration's instructions on innovative medical devices will not be included in the centralized procurement and re-issuance for
the time being.

On October 12, the National Medical Insurance Bureau issued the "Letter of the National Medical Security Bureau on the Reply to the Proposal No.
02866 (Social Management No.
263) of the Fifth Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference" (hereinafter referred to as the "Reply Letter"), Respond again to questions
about the procurement of innovative medical device products.

The National Medical Insurance Administration said: Considering that 3D printing products are still in the initial stage, the market competition is not sufficient, and the product characteristics are more complex, some products have the characteristics of personalized customization, and their cost and efficacy are difficult to compare
with mass production products.
At the same time, for 3D printing products that do not participate in collective procurement, the online price will be standardized
in the follow-up work.

The National Medical Insurance Administration also further clarified: for innovative products such as 3D printed orthopedic consumables, considering the characteristics of technical characteristics, production costs, usage, clinical efficacy and other characteristics, adopt the "one product and one policy" approach, determine appropriate procurement rules, improve the market-oriented price formation mechanism, promote the high-quality development of the medical device industry, and provide more innovative products
for the people at reasonable prices.
The green light
is lit up in front of innovative medical devices.

Not long ago, in the "Reply of the National Medical Security Administration to Recommendation No.
4955 at the End of the Fifth Session of the 13th National People's Congress" released on September 3, the National Medical Insurance Bureau also said that because the clinical use of innovative medical devices is not yet mature and the amount of use is temporarily difficult to estimate, it is still difficult to implement the dosage method
.

Innovative medical devices are not included in centralized procurement, which also leaves a certain market in addition to centralized procurement and provides space
for innovative products to open up the market.
For enterprises, the initial investment in innovation and research and development may be a lot, and after entering the centralized procurement, the cycle of cost recovery will also be lengthened
.
Once the government limits the price of innovative medical devices, it is likely to cause fluctuations
in the industry's innovation enthusiasm.

What other "equipment" news in the medical equipment circle is worth paying attention to this week? Industry new policy insights, enterprise new trend observation, market investment and financing review, "Pharmaceutical Economic News" tracking report!

【New Industry Policy Insights】

1.
Revision of the Guidelines for the Verification of Quality Management System for Medical Device Registration

On October 10, in order to do a good job in the verification of the registration quality management system under the medical device registrant system and improve the quality of the verification of the medical device registration quality management system, according to the Regulations on the Supervision and Administration of Medical Devices (Order No.
739 of the State Council), the Administrative Measures for the Registration and Filing of Medical Devices (Order No.
47 of the State Administration of Market Regulation), the Administrative Measures for the Registration and Filing of in Vitro Diagnostic Reagents (Order No.
48 of the State Administration of Market Regulation), and the Measures for the Supervision and Administration of Medical Device Production.
(Order No.
53 of the State Administration for Market Regulation) and other requirements, the State Medical Products Administration organized and revised the "Guidelines for the Verification of Quality Management System for Medical Device Registration" (see annex), which is hereby issued and implemented
from the date of promulgation.
The Notice of the State Medical Products Administration on Issuing Guidelines for the Verification of Quality Management System for Medical Device Registration (No.
19 of 2020) was abolished
at the same time.

2.
The strongest policy for medical equipment procurement has landed!

On October 10, the first trading day after the end of the National Day Golden Week, some sectors of A-share medical devices flew red
.
It is reported that within a week, a number of subsidized loans for equipment renovation in the field of health have been issued
.

In September this year, the National Assembly decided to support the upgrading and transformation of equipment in some fields with special refinancing and
financial interest discounts.
According to a number of media reports, the Health Commission recently issued a notice that it intends to use financial subsidized loans to modernize medical equipment
.
Relevant departments are negotiating the specific details of the policy, and the relevant financial subsidized interest loans are fully liberalized to all public and non-public medical institutions in principle, and the loan amount of each hospital is not less than 20 million yuan
.

A phased incentive policy will be implemented for new loans for the purchase and renovation of medical institutions' equipment, with a central financial interest discount of 2.
5 percentage points and a term of 2 years
.
The policy requires loan entities that sign loan agreements before December 31, 2022 and pay for the first batch of loans for equipment procurement (not less than 20% of the total value of goods) to apply for subsidized interest loans
from lending financial institutions on their own.

【Observation of new corporate trends】

1.
China Resources Pharma and Fosun Pharma announced cooperation, which is related to the medical device sector

On October 10, CR Pharma announced a strategic cooperation
with Fosun Pharma.

According to the content of the cooperation, the two parties will carry out comprehensive cooperation in the field of general health, focusing on innovative drugs, biological drugs, medical devices and other fields through strategic and business cooperation, to strengthen the global layout and industrialization development
of both parties in related fields.

The marketing director of a domestic pharmaceutical company said that this is mainly because it is basically difficult to have room for cooperation in other fields such as generic drugs and general medicines, and the price is not attractive
.
Innovative drugs, biological drugs, innovative medical devices, etc.
also have the potential for
cooperation.

From the perspective of CR Pharmaceutical, as one of the four major pharmaceutical companies in China, it has a comprehensive product supply and extensive distribution network, and its national distribution network has more than 200 logistics centers, strategically covering 28 provinces, municipalities directly under the central government and autonomous regions, and customers include nearly 9,000 secondary and tertiary hospitals
.

As commercial and industrial giants respectively, China Resources Pharma and Fosun Pharma are public information that this cooperation is expected to take advantage of CR Pharma's strong industrial precipitation and resource advantages and Fosun Pharma's strong new drug R&D and globalization capabilities to deepen international cooperation and jointly expand overseas markets
.
 

2.
Face removal! 33 medical consumables and reagent products were complained about, involving Weigao, Lepu, Unilit.
.
.

On September 28, the Inner Mongolia Autonomous Region Pharmaceutical Procurement Network issued the Notice on Clarifying the Prices of Some Medical Consumables Products (hereinafter referred to as the "Notice"
).

According to the "Notice", 33 medical consumables and reagent products have been complained about and are facing the crisis of network withdrawal, involving 22 machinery companies
such as Bausch & Lomb, Shandong Weigao, Shenzhen Mindray, Guangzhou Wanfu, Guilin Youlit, Lepu Diagnostics, and Jiangsu Huaxing.
There are two main reasons for the complaint: first, "failure to supply at the actual purchase price"; The second is "failure to truthfully declare the minimum online price"
.

The Notice points out that if an enterprise fails to clarify as required within the specified time, it will suspend the qualification of relevant medical consumables products to be listed on the network without affecting clinical supply, and the violation of the enterprise will be handled
in accordance with the "Discretionary Benchmarks for Drug Price and Recruitment Credit Evaluation (2020 Edition)".

3.
Mindray! I "want" to swallow 20 billion!

In a recent survey by investors, Mindray said that in response to the decision of the National Assembly on September 7 and in order to cooperate with the notice issued by the Health Commission on September 15 to use financial subsidized loans to modernize and transform medical equipment, the National Health Commission issued suggestions and reference materials
related to the purchase of equipment.

In terms of funds, in addition to the issuance of medical special bonds with a record high scale in the first half of this year and the hospital's own funds, subsidized interest loans will become another important source of funds for
medical equipment procurement.
Up to now, the country has reported more than 200 billion yuan of medical equipment loan demand, and it is expected that the loan demand related to the company's products will exceed 20 billion yuan, which greatly improves the certainty of achieving performance goals
.

4.
Philips and Langrun are major customers, and domestic MRI core component suppliers will IPO

Recently, according to the official website of the Beijing Stock Exchange, Chenguang Medical, an independent third-party supplier of domestic MRI equipment, has successfully passed the IPO
meeting.
It is reported that the company's IPO application materials were accepted on June 30, 2022, and the inquiry response
was completed on September 8.

According to the prospectus, since its establishment in 2004, Chenguang Medical has focused on the research and development of various radio frequency detectors that capture human body signals in MRI systems, and then gradually covered superconducting magnets and gradients; At present, it has been recognized as a strategic supplier
by well-known enterprises such as Philips.
The company intends to raise about 150 million yuan in the IPO, which is mainly used for the research and development and industrialization of core components of magnetic resonance imaging, the research and development of customized superconducting magnets, and supplementary working capital
.

【Market Investment and Financing Review】

1.
Collective procurement of a pharmaceutical sector but set off a tide in vitro diagnostic multi-share harvest of 20CM, what is the situation?

On October 14, the in vitro diagnostic sector rose strongly, and as of press time, the sector rose by more than 7%.

Individual stocks such as Dirui Medical, Howob, Mike Biotechnology, New Industry, etc.
gained 20cm up and down, Antu Biotech, Gongdong Medical, Jinyu Medical and other stocks rose by 20cm, and Novizan Medical, Mindray Medical and Yahuilong rose by more than 12%.

On the news, favorable policies in the field of medical equipment are frequent
.
Yesterday evening, a draft of the collection and procurement plan for liver function biochemical reagents led by Jiangxi was released
.
Judging from the content, the agency believes that the intensity of this collection is better than expected
.

In addition, the recent discount loan for medical equipment modernization is also a favorable policy
for the medical equipment sector.
According to Kaiyuan Securities statistics, as of October 11, the amount of interest discounts in various provinces and cities has been about 19.
155 billion yuan, and the financial discount loans are expected to release hundreds of billions of medical device market demand
.