\u3000\u3 Guocheng Mining Co.Ltd(000688) 198 Beijing Balance Medical Technology Co.Ltd(688198) )
Core view
Event: Recently, the clinical enrollment of the company’s ophthalmic biological patch was completed. Led by the people’s Hospital of Peking University, the product participated in a multicenter clinical trial with 6 hospitals including Beijing Tongren Hospital and the eye, ear, nose and Throat Hospital Affiliated to Shanghai Fudan University, and 100 patients were enrolled.
There is an urgent need for the treatment of pathological myopia in China, and the market space is broad. Pathological myopia refers to the obvious extension of the ocular axis for unknown reasons, and the diopter of patients is more than -8.00d, accompanied by pathological changes of fundus. If patients do not receive treatment, they will eventually have the risk of blindness. At present, posterior scleral reinforcement is the only way to prevent blindness in patients with pathological myopia. The operation is less difficult, but the operation has high requirements for materials. Due to the factors of rejection and eye ductility, the materials are generally donated eyeballs from the human body, so the supply is very limited, which leads to many patients not receiving effective treatment. Therefore, the clinical demand for ophthalmic patches is very urgent. From the perspective of space, the market space of pathological myopia is broad. According to relevant research statistics, the prevalence rate of pathological myopia in China is about 3%, and there are about 10-30 million potential patients in China. Among them, according to the statistics of the Health Commission, there are about 30W young people in China who are blind due to myopia every year (most of them are expected to be caused by pathological myopia). These patients have strong demand. Assuming that the cost of a single ophthalmic patch is 2W yuan / piece, Then the space of pathological myopia will correspond to 6 billion, and the demand space is broad. The company’s ophthalmic biological patch is the only biological patch product in China to carry out prospective research for the treatment of pathological myopia by posterior scleral reinforcement, which is expected to fill the gap of relevant products
The company’s ophthalmic patch products have excellent clinical performance and look forward to subsequent listing. From the results, the clinical performance of the company’s ophthalmic patch is excellent. On the one hand, from the clinical data, up to now, 16 patients have completed the follow-up of one year after operation, and nearly 50% of the enrolled patients have completed the follow-up of half a year after operation. The whole group of patients recovered well after operation. The preliminary clinical data showed that the extension of ocular axis was inhibited, and the degree of myopia of patients was significantly controlled, reflecting the characteristics of good biocompatibility and excellent tensile strength of ophthalmic biological patch as posterior scleral reinforcement implant material. It can also effectively control the complications such as macular splitting caused by pathological myopia in adult patients. On the other hand, in principle, the company’s ophthalmic patch mainly achieves certain toughness and anti rejection requirements through mild crosslinking of bovine pericardium materials. However, the company has a leading technical level in the field of animal tissue material treatment, especially bovine pericardium, which has been fully verified in surgical bioprosthetic valves and other patch products. The company’s ophthalmic patch is expected to achieve the same safety, biocompatibility and degradation resistance. According to the relevant laws and regulations on product registration, the product registration can be submitted after the last patient is followed up for one year. We expect that the company’s products will submit the registration application before the second quarter of next year. According to the conventional approval time, it is expected to be listed at the end of 2023 or the beginning of 2024. From the perspective of post market sales, on the one hand, the difficulty of posterior scleral reinforcement is not great, and the general resident can carry out it at the level of 2-3 years; On the other hand, there are a large number of ophthalmologists in China. It is expected that the company’s ophthalmic patches may achieve rapid and large-scale growth after they are listed on the market.
R & D has gradually entered the harvest period and is optimistic about the long-term development of the company. At present, many core heavy products of the company have been incorporated into the group, such as ball expanded TAVR (the first in China), ball expanded middle valve (the first in China), ophthalmic patch (the first in China), etc. the company’s products have gradually entered the harvest period. In the future, with the large-scale listing of the company’s products, we are optimistic about the long-term development of the company.
Profit forecast and investment suggestions
We expect that the net profit attributable to the parent company in 202224 after deducting share based payment will be 160 / 242 / 438 million yuan. Considering that the company has sufficient reserve pipelines (interventional valve, TAVR valve, ophthalmic patch, vascular patch, etc.) and the clinical trial is progressing smoothly in the future, we maintain the early target price of 207.59 yuan and maintain the “buy” rating according to the DCF valuation method.
Risk tips
Risks caused by R & D failure; Risk of product sales falling short of expectations; The risk of price decline caused by volume procurement and intensified competition; Valve market share is lower than expected; And the risk that the assumption does not meet the expectation is unfavorable to the valuation.
