Yantai Zhenghai Bio-Tech Co.Ltd(300653) (300653)
matter:
The company announced that the "Supplementary information" of the product has been submitted recently in accordance with the relevant requirements of the "information supplement notice" of the medical device technical evaluation center of the State Food and Drug Administration for the technical evaluation stage of the product, and has entered the state of "main review".
Ping An View:
The company is expected to get the registration approval within 90 working days. According to the operation specification for registration and approval of medical devices, the registration and approval of three types of devices includes four links: acceptance, technical review, administrative approval and approval document production. At present, the bioactive bone is still in the stage of technical review after it is submitted to the hair supplement. According to the regulations, the medical device technical review center of the State Food and drug administration shall complete the technical review within 60 working days from the date of receiving the supplementary materials. Since then, the time limits for administrative examination and approval and approval production are 20 and 10 working days respectively. Therefore, we believe that the active biological bone will get the registration approval within 90 working days.
Active biological bone is the first product in China, which helps the company enter the orthopedic field with broad market space. Active biological bone belongs to the "combined product of medicine and machinery based on the role of medical devices", which is expected to be used for "the treatment of bone defects, bone nonunion and other diseases caused by various reasons", which is the first product in China. China has more than 6 million patients with bone defects or dysfunction due to various reasons every year, and the market demand is broad. The successful listing of active biological bone will help the company enter the orthopedic field with larger market scale. At present, autologous bone is the "gold standard" for clinical bone defect repair, but its use proportion shows a downward trend. According to the data of Nanfang Institute, the application proportion of autologous bone in China decreased to 62% in 2017, still higher than about 45% in the United States. In addition to autologous bone, bone repair materials are widely used, mainly including natural bone repair materials and artificial bone repair materials. In 2018, the market of orthopaedic bone repair materials in China was 2.02 billion yuan, which is expected to reach 5.34 billion yuan in 2023, with a CAGR of 22.7%.
Active biological bone is expected to become a large variety with a scale of more than 1 billion. 1) Considering that active biological bone is based on bone repair materials and BMP-2 factor, which can induce bone tissue growth, and has obvious advantages over existing bone repair materials, We assume that active biological bone occupies 20% of the market (according to the current market share of oral repair membrane and dura mater (spinal membrane) of the company), the market space of active biological bone will reach 1.068 billion yuan; 2) at present, about 1.33 million orthopedic operations in China actually use bone defect repair materials per year, assuming that 20% of them use active biological bone, and the unit price is about 5000 yuan per person (with reference to the pricing of similar overseas products), the market scale is 1.33 billion yuan. Therefore, we believe that active biological bone is a large variety with a market scale of more than 1 billion yuan.
Investment suggestion: the company's core products maintain rapid growth, the heavy product active biological bone is about to be listed, and the negative concerns about the centralized collection of dura mater are released. Considering the performance flexibility brought by the listing of active biological bone, we raised the company's net profit attributable to the parent company from 2021 to 2023 to 164 million, 223 million and 299 million yuan (originally predicted to be 164 million, 203 million and 258 million yuan). The current stock price corresponds to 36 times of PE in 2022, maintaining the "recommended" rating.
Risk statement 1) Product concentration risk: the company's main revenue is concentrated in the two products of prosthodontic membrane and dura mater, and the deterioration of the competition pattern will affect the company's performance; 2) R & D risk: the company is currently developing many varieties, which may fail or be less than expected; 3) Policy risk: the company's intensive purchase of relevant products may exceed market expectations.
