According to the data, as of the evening of February 15, 58 of the 107 medical device enterprises in Shanghai and Shenzhen had disclosed the performance forecast of 2021. Among them, 41 companies are expected to have good performance, accounting for more than 70%. 19 companies doubled their performance, Beijing Hotgen Biotech Co.Ltd(688068) net profit increased by more than 1684% year-on-year, and Sonoscape Medical Corp(300633) performance increased by more than 543%.
Insiders said that with the promotion of the new medical reform, policies such as unified consumables coding, centralized procurement of consumables and DRG / Dip medical insurance payment have reconstructed the product pattern of medical device manufacturers, and enterprises that actively promote technological innovation and seek opportunities to go to sea are expected to open up market space.
covid-19 testing enterprise performance
Among the 41 companies with promising performance, the performance of covid-19 testing sector is particularly bright. Beijing Hotgen Biotech Co.Ltd(688068) , Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) all doubled their performance.
In terms of covid-19 antigen detection, Andon Health Co.Ltd(002432) the performance forecast on January 20 shows that the net profit attributable to shareholders of listed companies is expected to be RMB 900 million to RMB 1.2 billion in 2021, with a year-on-year increase of 271.40% to 395.19%; Deduct non net profit of 850 million yuan to 1.15 billion yuan, with a year-on-year increase of 243.46% to 364.68%. During the reporting period, the sales of New Coronavirus antigen self testing OTC kit in the US market increased significantly.
In terms of covid-19 nucleic acid detection, the performance forecast disclosed by Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) shows that the net profit attributable to shareholders of listed companies is expected to reach 1.3 billion yuan to 1.5 billion yuan in 2021, with a year-on-year increase of 177.23% to 219.88%; Non net profit attributable to shareholders of listed companies was RMB 1.3 billion to RMB 1.5 billion, with a year-on-year increase of 185.66% to 229.61%. During the reporting period, the company added more than 1500 customers of molecular diagnostic medical institutions in China, and the sales of covid-19 nucleic acid detection reagent increased significantly.
The 2020 China in vitro diagnostic industry report released by the 8th China in vitro diagnostic industry development conference shows that the development trend in the next five years will be that the amount of routine detection will decrease in at least two years (2020-2021), the income of nucleic acid detection related to covid-19 will increase greatly, the amount of antibody detection will fluctuate, and the demand for rapid antigen detection will increase, Covid-19 testing business may last until 2024 and promote the rapid development of the global IVD market.
accelerate innovative R & D
In the performance forecast of 2021, many medical device companies said that innovative products have become the "engine" of rapid performance growth.
According to the performance forecast, the net profit in 2021 increased by 40% to 50% year-on-year. During the reporting period, the company's innovative products including castor branch aortic covered stent and delivery system, Minos abdominal aortic covered stent and delivery system, reewarm PTX drug balloon dilation catheter and other new products continued to grow rapidly, The above products further consolidate and improve the competitiveness of the company in the aortic and peripheral vascular intervention market. At the same time, with the continuous expansion of the company's innovative products in the international market, the overseas business income has also increased rapidly.
Eyebright Medical Technology(Beijing) Co.Ltd(688050) according to the performance forecast, the net profit in 2021 increased by 65.70% to 86.42% year-on-year. The increase in net profit in the reporting period was mainly due to the rapid growth in the sales of the company's core products intraocular lens and corneal shaping lens and the increase in operating revenue. Among them, the sales volume of "pronomin" and other series of intraocular lenses is expected to increase by more than 40% compared with the same period of last year, and the sales volume of "pronomin pupil" corneal plastic lens is expected to increase by more than 110% compared with the same period of last year.
Kaiyuan Securities said that the DRG / Dip policy has no payment restrictions on treatment outside the hospital, which will be conducive to the large amount of postoperative auxiliary consumables; Innovative products can be declared with special payment by local government departments, or there will be great prospects.
On January 26, the national development and Reform Commission issued a document proposing to relax the market access restrictions of medicine and medical devices in Shenzhen. It is allowed to accept the medical device registration inspection report issued by the third-party inspection institution recognized by CNCA and the State Food and drug administration. Support the promotion of real-world data application in the full life cycle clinical evaluation of local drugs and medical devices in Shenzhen (including pre-market approval and registration of new drugs and devices, modification of approved drug device instructions, post-market safety research and active monitoring), focusing on clinical evaluation in the fields of clinical urgent need, rare disease treatment, AI medical algorithm, precision medicine, traditional Chinese medicine and so on, Further accelerate the listing process of new products, and timely discover and control the use risks of listed products.
As soon as the news came out, the reporter noticed that a number of Sonoscape Medical Corp(300633) products located in Shenzhen were registered and approved one after another. On February 11, Sonoscape Medical Corp(300633) said in response to investors' questions that the company's accelerated registration of endoscopic products has a certain relationship with the State Food and Drug Administration's adjustment of the classification of some medical devices since the end of 2020. The management category of some endoscopic products has been reduced from "III" to "II", which shortens the registration cycle. At the same time, the quality of endoscopic products developed by the company is good, The registration process of clinical trials is relatively smooth, so the registration progress is accelerated.
