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长春高新(000661):促卵泡注射液获批上市 辅助生殖管线持续丰富

Changchun Gaoxin (000661): Follicle promotion injection approved for marketing, continued to enrich assisted reproduction lines

國金證券 ·  Jan 9

Brief performance review

On January 9, 2024, the company announced that the holding subsidiary Changchun Jinsai Pharmaceutical Co., Ltd. received the “Drug Registration Certificate” approved and issued by the State Drug Administration. Jinsai Pharmaceutical's recombinant human follicle-stimulating hormone injections 22 μg (300 IU), 33 μg (450 IU), and 44 μg (600 IU) met the relevant requirements for drug registration, approved registration, and issued a drug registration certificate.

Management analysis

Follicle promotion needles have significant advantages in compliance, and the company continues to enrich its pipeline in the field of assisted reproduction.

According to the “Expert Consensus on Assisted Reproduction and Ovulation Promoting Drug Treatment” issued by the Reproductive Medicine Branch of the Chinese Medical Association, one of the important elements of assisted reproductive technology (ART) is ovulation promotion treatment, and its application has improved clinical pregnancy rates. Gonadotropin (Gn) drugs are one of the most commonly used drugs to promote ovulation, including gonadotropin (hMG), human follicle-stimulating hormone (FSH), and human chorionic gonadotropin (hCG). Among them, human follicle-stimulating hormone (FSH) includes urogenic human follicle-stimulating hormone (UFSH) and recombinant FSH (FSH) RFSh). According to expert consensus, recombinant folliculatory stimulating hormone has two dosage forms: powder injections and water injections. Among them, recombinant follicle stimulating hormone injections have mild adverse effects and can stimulate ovulation more efficiently in a shorter period of time.

The company's recombinant Follicle Promoter Jinsaiheng was approved for listing in 2015. It is the first domestically produced recombinant follicle stimulating hormone injection. The company's pipeline in the field of assisted reproduction has been further enriched.

Driven by scientific and technological innovation, the R&D pipeline is expected to continue to be implemented. In recent years, the company has greatly increased its R&D investment level, continued to focus on innovation capabilities, built diversified management capabilities, and steadily promoted continuous improvement of the strategic layout, talent introduction, and structural adjustment of business sectors such as pediatric endocrinology, pediatric integration, adult endocrinology, women's health, oncology, and dermatology. Currently, the company continues to promote pipeline layout in multiple fields, and has created a series of R&D and innovative technology platforms such as long-term controlled release of protein drugs, and strives to promote the creation of leading products with differentiated advantages. The company's R&D pipeline is expected to continue to be implemented in the future, laying a solid foundation for long-term growth in performance.

Profit Forecasts, Valuations, and Ratings

The company's leading position in growth hormone is stable, and the long-term growth logic remains unchanged. We expect the company to achieve net profit of 47.8 (+15%), 55.1 (+15%), and 6.22 billion yuan (+13%) in 2023-2025, respectively, and EPS of 11.81, 13.60, and 15.38 yuan, respectively, corresponding to the current P/E of 12, 10, and 9 times, respectively. Maintain a “buy” rating.

Risk warning

Risk of medical insurance price reduction and fee control; increased risk of growth hormone competition; vaccine sales fell short of expectations; research and development progress fell short of expectations, etc.

The translation is provided by third-party software.


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