China's first long-acting recombinant human follicle-stimulating hormone approved for market launch, potentially reshaping the 5-billion-dollar assisted reproductive medicine market

On August 25, Anke Biotech's exclusively distributed product, recombinant human follicle-stimulating hormone-CTP fusion protein injection(Product name: Shengnuowa®)Approved for marketing by the National Medical Products Administration, the product isThe first in the countryLong-acting recombinant human follicle-stimulating hormone approved for marketing（FSH-CTP）。

For a long time, the domestic assisted reproductive market has been dominated by short-acting recombinant human follicle-stimulating hormone(short-acting FSH)Daily dosage regimen dominates. The launch of Shengnuowa® has changed the traditional treatment approach for patients.No need for daily injections, greatly reducing the physical and psychological burden during the treatment process.

As the first long-acting recombinant human follicle-stimulating hormone in the country（FSH-CTP）The launch of Shengnuowa® not only fills the market gap for long-acting follicle-stimulating hormone formulations in China, but also marks a significant innovation in the field of assisted reproductive technology. Shengnuowa® is expected to greatly enhance the convenience of clinical treatment and patient compliance, drawing considerable attention from the industry regarding its clinical significance and commercial value.

 Technological breakthrough: FSH-CTP's long-acting mechanism addresses clinical challenges, achieving parity with international standards.

Long-acting recombinant human follicle-stimulating hormone（FSH-CTP）As a key drug in the field of assisted reproduction, gonadotropin-releasing hormone (GnRH) Antagonist combined with controlled ovarian stimulation（COS）, which can induce the development of multiple follicles, thereby achieving the purpose of promoting reproduction.

Clinical data indicate that,FSH-CTP is comparable to short-acting FSH in terms of oocyte yield, embryo quality, and pregnancy outcomes, and has a better safety profile.. Moreover, due to a single injectionReduce the frequency of administration, reducing the physical burden on patients and greatly enhancing their convenience and compliance.

Shengnuova® recombinant human follicle-stimulating hormone-CTP fusion protein injection was successfully developed by Shanghai Baoji Pharmaceutical Co., Ltd. and its wholly-owned subsidiary Suzhou Shengji Pharmaceutical Co., Ltd. after 11 years of research and development. Its amino acid sequence is identical to that of the foreign Corifollitropin alfa.（CFA）Exact match, phase III clinical trial results show,Both treatments have comparable efficacy and yield more oocytes compared to the short-acting FSH group.。

 Commercial value becomes evident: a 5-billion market awaits reshaping, with first-mover advantage building competitive barriers

On one hand, as assisted reproductive technology achieves full medical insurance coverage across 31 provinces nationwide and the Xinjiang Production and Construction Corps, the treatment demand among infertility patients in China is accelerating. Data from the National Healthcare Security Administration shows that, by the end of 2024, the number of people benefiting from assisted reproductive technology has exceeded one million. With the continuous expansion of medical insurance coverage, the market size for ovulation induction in China's assisted reproductive sector is estimated to reach5 billion RMB。

On the other hand, as the current market is dominated by short-acting daily FSH formulations, the long-acting formulation of Senova® offers patients more treatment options, and Senova® has already gained a favorable position in market access, it is expected thatNo direct competitor competition in the short term, with broad market prospects.

It is reported that Anke Biotech has proactively established market access and distribution channels to rapidly reach patients. In the future, with continuous optimization of medical insurance policies and growing market demand, Shengnuowa® is expected to achieve rapid sales growth leveraging its first-mover advantage, clinical value, and commercialization capabilities, becoming a benchmark product in the assisted reproductive drug segment and driving domestic assisted reproductive treatments into a new era of "higher efficiency and greater safety." Anke Biotech is poised to become one of the key players in the domestic FSH market.

Screenshot source: Official corporate WeChat account