Yantai Zhenghai Bio-Tech Co.Ltd(300653) (300653)
Event: on November 29, the company announced that the active biological bone of the variety under development had completed the data supplement in the technical review stage and entered the “main review” stage.
According to the device review process, the active biological bone is expected to be approved within 100 working days after completing the data supplement. According to the operation procedure for medical device review, after completing the data supplement as required, the remaining review processes are (1) technical review (60 working days), (2) administrative approval (20 working days), (3) certificate preparation (10 working days) and (4) document preparation (10 working days), totaling 100 working days.
Active biological bone is the best economic treatment for bone defect, which is widely used. Active biological bone is mainly used to treat bone defects. At present, the scale of China’s bone repair material industry is about 3.93 billion yuan, which is expected to increase to 9.69 billion yuan by 2023, with a compound growth rate of 19.8%. Bone defect treatment materials generally include autologous bone, allogeneic bone, synthetic bone and active biological bone. Autologous bone has the best curative effect, but the source is limited. Allogeneic bone and synthetic bone have no bone induction function, and allogeneic bone has the possibility of immune rejection. Active biological bone has good bone induction ability, and the clinical curative effect is not inferior to autologous bone, although the cost is high, However, it has higher comprehensive economic benefits and is a bone repair material with great application potential.
The peak sales of the benchmark variety infuse bone reached US $1 billion, and the company’s products have been optimized with good prospects. The company’s active biological bone benchmarking variety is Medtronic’s infuse bone. Since its listing in 2002, the peak sales of this product has been close to US $1 billion, once accounting for 50% of the global market share of bone repair materials. The company’s active biological bone has greatly enhanced the binding force between BMP-2 and carrier through genetic engineering, significantly reduced the dosage of BMP-2, overcome the side effects of complications such as ectopic bone formation caused by too high concentration of BMP-2 in influebone, and has a better sales prospect.
The performance increased rapidly and the pipeline under research was promoted smoothly. The core variety of oral repair film will continue to benefit from planting, and the high landscape will maintain rapid growth, Q1-3 achieved a revenue of 301 million yuan (+ 39.26%), a net profit of 126 million yuan (+ 32.64%), and a deduction of 123 million yuan (+ 38.48%). In addition, degradable hemostatic materials have received the notice of acceptance of medical device registration application issued by Shandong food and Drug Administration, which is expected to be listed in the near future, and the approved listing of new products is expected to open the growth space of the company.
Investment suggestion: the penetration rate of dental implants in China has great room to improve, and the dental implant field will maintain rapid growth. As a high-quality and scarce target in the field of oral consumables in China, the company has benefited from the rapid development of the oral industry and the import substitution of oral repair film, and its performance has increased rapidly. The approval of the company’s active biological bone will open a broad orthopedic market. Other varieties under research guide tissue regeneration membrane and a new generation of biofilm are upgraded versions of existing varieties, which will further enhance the competitiveness of products. We expect that the net profit attributable to the parent company from 2021 to 2023 will be RMB 159 / 199 / 250 million respectively, and the corresponding PE will be 50 / 40 / 32 times respectively. We will continue to give the “buy” rating.
Risk prompt: risk of changes in centralized purchase policies; Market competition risk; R & D risk.
