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先健科技(01302.HK):左心耳快速放量 产品陆续获批

Xianjian Technology (01302.HK): Rapid release products for the left ventricle have been approved one after another

興業證券 ·  Sep 23, 2021 00:00

Main points of investment

Revenue grew rapidly, and the net interest rate reached an all-time high: the company's operating income in the first half of the year reached 461 million yuan, up 68.95% over the same period in 2020, 49.47% over the same period in 2019, and 24.85% over the second half of 2020.

In terms of net profit, the company made a net profit of 201 million yuan in the first half of the year, an increase of 108.62% over the same period in 2020 and 80.99% over the second half of 2020. The net interest rate reached 43.51%, a record high, an increase of 8.27 pct over the same period in 2020 and 13.52 pct over the same period in 2019. This is mainly due to the economies of scale resulting from the rapid growth of income, which has led to a decline in various expense rates.

Fully blooming, LAA occluder enters the release period: LAmbre LAA occluder was approved by CE in June 2016 and NMPA in June 2017. As the only domestic brand in the world with both CE and NMPA, LAA occluder has entered the release stage after pre-tender admission and market training. At the same time, in March this year, LAnavi segmental bending guidance system, a matching product of LAA occluder, was approved by NMPA, becoming the first segmented bending guidance system in the world for LAA occlusion. This product can effectively reduce the doctor's learning curve and is expected to further promote the continuous increase of LAA occluder.

In December 2020, LAmbre LAA occluder was approved by FDA in the United States and local researchers initiated premarket clinical (IDE). Clinical instruments need to be purchased from Shanjian at the market price, marking the successful opening of the American market for the LAA occluder. In addition, in the first half of this year, the LAmbre LAA occluder was approved by FDA for "compassionate use" and successfully implanted, which will further promote the access process of LAA occluder in the North American market.

The iliac artery has been approved in China, the chest and abdomen have completed the clinical entry of FIM, and the large stent business continues to develop: the company's exclusive iliac artery bifurcation covered stent G-iliac has been approved for listing by NMPA in January this year, becoming the first domestic stent product for internal iliac artery reconstruction. Thoracic and abdominal aortic covered stent G-Branch has completed the domestic FIM clinical group, the success rate of operation is 100%, and the mid-term follow-up data are positive. In terms of aortic arch covered stent, the company's first product designed for chimney technology is currently under clinical follow-up and is in good condition and is expected to be approved for market in the first half of 2023; products designed for windowing technology have been registered in China since July this year.

Iron-based absorbable stents, innovative breakthroughs in the field of materials science: the iron-based materials independently developed by the company have a more reasonable degradation cycle and stronger support than polyethylene and magnesium-based. At present, the first three indication products are in different stages of clinical trials in China. Overseas, IBS Angel children's pulmonary vascular absorbable stents were "sympathetically used" by FDA in May this year.

Approved, approved for listing in Malaysia in June; IBS Titan knee Absorbable Stent was approved for "compassionate use" by FDA in July and the implantation was completed. It is expected that iron-based products will have strong competitiveness in the future and have a broad global market.

Profit forecast and valuation: we raised the company's operating income from 2021 to 2023 to 992 million yuan, 1.332 billion yuan and 1.733 billion yuan respectively, and increased net profit to 377 million yuan, 478 million yuan and 615 million yuan respectively. We maintain our "prudent overweight" rating.

Risk tips: the epidemic has been repeatedly affected, the progress of research and development is not as expected, and market competition has intensified.

The translation is provided by third-party software.


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