The IPO qualification of medical device enterprises is relaxed, 0 income can also be listed on the market

On June 10, the Shanghai Stock Exchange issued the "Guidelines for the Fifth Setting Standards for Science and Technology Plate Equipment Enterprises" to repair the largest bug in the IPO of pharmaceutical companies.

The exchange pointed out that for medical device companies, the CSRC will guide guidance from the aspects of core technical product scope, staged achievements, market space, technical advantages, continuous operation capabilities, and information disclosure. Whether there is revenue, whether there is a product to be listed or will no longer be a hard indicator for assessment.

The launch of the new regulations is equivalent to opening up the listing of all innovative medical device companies.

The "fifth set of rules" of the original undergraduate board is only applicable to biomedical companies. The standard is that at least one core product has entered the second phase of the clinic, which is not difficult for many innovative pharmaceutical companies. However, medical device companies cannot refer to this standard. They can only wait for the product to be listed, and the IPO will be declared in accordance with other standards after income.

Today, investment institutions and startups on medical device circuit are welcoming major benefits.

Insufficient support for the medical device industry is difficult to innovate

The "fifth set of standards" of the science and technology board has always been controversial, mainly due to insufficient support for innovative medical device companies.

In June 2019, the Lujiazui Forum once a year was held in Shanghai. The Science and Technology Board officially opened on this forum. The registration system began to be further implemented, and the opportunity to listed financing for innovative companies that had not yet been profitable.

Among the several listing standards, only the fifth set of fifth sets of revenue and profits of the enterprise does not require any requirements, but only the pharmaceutical industry enterprises can apply this standard. Soon, the pharmaceutical industry ushered in the climax of investment and financing.

According to the "2020 H1 Global Medical Health Industry Capital Report", a total of 31 medical and health projects in the first half of 2020 completed the IPO, and 12 innovative drug projects accounted for the largest proportion.

The active in the secondary market also has a reverse impact on investment in the first -level market. Also in the first half of 2020, the first -level market financing of biomedical fields reached 24.7 billion yuan, becoming a popular field of capital flow. The entire industrial chain of innovative drugs has also been reused.

It can be said that the fifth set of science and technology boards gives the pharmaceutical industry's gold -like confidence, and also revitalize the domestic innovation pharmaceutical market.

However, the fifth set of standards is only for "medicine", not "weapon".

The Shanghai Stock Exchange is well understood. The staged progress of the research and development of medical equipment is not as good as medicines, and the regulatory authorities cannot clearly understand the considerations of the development of medical device products.

In August 2019, Tianzhi Hang, who was the main orthopedic surgery robot, submitted the prospectus to the Shanghai Stock Exchange, intending to log in to the science and technology board with reference to the fifth set of standards. However, the sponsors at that time obviously did not understand the IPO rules of the exchange. Five months later, Tianzhi Hang changed his caliber: Refer to the second set of standards.

Tian Zhihang's attempt was alert to the medical device company who went to the IPO. Subsequent Chunli Medical, Sano Medical, Bairen Medical, Lianying Medical, etc. have not tried to adopt the fifth set of listing standards from the beginning.

To some extent, it is impossible to enjoy the fifth set of standards, which makes medical device companies have encountered many difficulties in the early financing and development of medical device companies. Enterprises must develop to a certain stage to mature in order to go to science and technology board financing.

According to the person in charge of a FA agency in the industry: Due to the unclear exit mechanism and the recent downturn in the Hong Kong stock market, the development of medical device projects requires confidence to continue to develop.

Accelerate the medical device industry to push out the new

The attitude of the science and technology board on the medical device company has changed at the end of March this year: minimally invasive electronic and physiological IPO has successfully met.

This is the first company to successfully listed on the fifth set of standards for science and technology innovation boards, which releases the signal of the science and technology board to open the embrace of medical device projects.

The new "Guidelines" issued this time, which clearly stated that under the adopting the fifth set of standard agglomeration and demonstration effects, the Securities Regulatory Department will "support the listing of enterprises that have not yet formed a certain income during the R & D stage."

According to new regulations, medical device companies without revenue can also obtain vouchers in the secondary market with their own technological hard power.

"In fact, this reflects the call for the securities regulatory department to see the industry's appeal." Tang Hao, the director of investment of Tianfeng Capital, told Jianzhi Bureau.

The Jianzhi Bureau was informed that before, many medical device companies communicated in depth with the competent authorities during the IPO of the science and technology board. The industry also spoke through different channels. The regulatory layer gradually realized the significance of encouraging medical device innovation.

During the two sessions of 2021, Shen Nanpeng, member of the National Committee of the Chinese People's Political Consultative Conference and the founder of Sequoia China, made clear suggestions in the proposal that it was expected to start from the development law of medical device enterprises. Medical device companies that meet the science and technology attributes stand out and accelerate their research and development and results transformation process.

At present, the release of the "Applicable Guidelines for the Fifth Listing Standards for Science and Technology Plate Equipment Enterprises" will help the industry's survival of the fittest.

Since the beginning of this year, the international and domestic situation has great fluctuations, and the financing environment of startup companies has difficulty. For the supply chain that needs to be stable and the medical device company that requires stable layout and research and development innovation, there are obvious survival dilemma, and companies with insufficient innovation capabilities will face the ending of elimination;

On the other hand, the "Guidelines" clearly supports the support of innovative medical device companies, and will also strengthen the investment in the investment of high -quality enterprises, further screening high -quality enterprises, and changing the opportunity investment direction.

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