According to authoritative statistics, the global male infertility treatment income is about 1.341 billion US dollars in 2020, and it is expected to reach 1.796 billion US dollars in 2026, and the compound annual growth rate can be maintained at 7.6% from 2021 to 2026. Around 15% of couples worldwide are affected by infertility, of which around 50% are male infertile. China's infertility rate has risen from 3.5% in 1997 to 16.4% in 2019, and is expected to rise to 18.2% by 2023, and couples with fertility difficulties are trending younger.
The key to the treatment of infertility is to clarify its etiology and mechanism, which is conducive to the treatment of the disease. In clinical work, some male patients with primary or secondary infertility use the existing routine semen quality test items to indicate whether the sperm and semen quality is abnormal. However, there are still more men with unexplained fertility difficulties who have failed to detect the cause through routine semen quality tests.
Project introduction
01
Product introduction
A "production, university and research" carrier company relies on a strong team of experts and professors to transform male reproductive health detection related in vitro diagnostic reagents (IVD) with independent intellectual property rights (sperm sialase Neu1 and Neu3). This product can provide a new functional indicator for male fertility evaluation, and also has clinical significance for the evaluation of sperm quality and intervention related factors.
02
Technical introduction
Sialase is a glycoprotein with antigenic properties, which can catalyze sialic acid hydrolysis. The sialase on the sperm cell membrane will fall off with the flow of the membrane, and participate in the cutting of sialic acid on the sperm surface, and eventually cause the shedding of sialic acid molecules and participate in the capacitation process of sperm. Sperm capacitation is a necessary condition for sperm-egg union.
Studies have confirmed that sialase Neu1 and Neu3 are distributed on the surface of sperm, and the content of sperm sialase Neu1/Neu3 is correlated with male fertility. Therefore, the content of sperm sialase Neu1/Neu3 can indicate the risk of male infertility.
Project value
The clinical significance of NEU1/NEU3 was detected
1. Provide new functional test related indicators for male fertility assessment.
2. Combined with existing semen analysis, innovative multi-index model analysis.
3. To provide more indicators for the evaluation of sperm quality and the efficacy of intervention related factors.
R&d stage
It has obtained five invention patents, two PCTS, and the human sperm sialase immunochromogenic kit was approved for filing in 2022, which is the first self-developed human sperm sialase detection reagent approved for filing.
Financing plan
