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智翔金泰(688443):多款产品取得重要阶段性进展

Zhixiang Jintai (688443): Major milestones have been made in various products

財通證券 ·  May 13

Incident: Recently, the company released its 2023 annual report. In 2023, the company's products have not been approved for sale. The company achieved revenue of 1,211,500 yuan, and the company invested 620 million yuan in R&D, an increase of 36.50% over the same period last year.

Significant milestones have been made in a number of products. In March 2023, the company's core product, Celikizumab, was accepted for moderate to severe plaque psoriasis. It was the company's first product to be marketed as a new drug, and the first anti-IL-17A monoclonal antibody drug by a domestic company to submit a new drug marketing application; as of the disclosure date of this report, the two indications of Celizumab for moderate to severe plaque psoriasis and axial spondyloarthritis were in the new drug marketing review stage, and commercialization of the product is imminent; the core product GR1801 has completed phase III clinical enrollment, and GR1802 is adaptable to moderate to severe atopic dermatitis The symptom has started In phase III clinical trials, GR2001 has applied for EOP2 communication, and other products under development have made significant progress.

Production capacity and commercialization preparations are adequate. The first phase of the company's antibody industrialization base project has completed the addition of 20,000 L of biofermentation production capacity, which can quickly achieve large-scale commercial production of products such as Celizumab, GR1802, and GR1603. At the same time, the company's autoimmune disease product line commercialization team has begun to take shape. The core management personnel have rich experience in promoting and commercializing innovative drugs and drugs in the field of autoimmunity. Team building will continue to advance steadily to meet the commercialization needs of the company's listed products.

Investment recommendations: As of the disclosure date of the report, the company is developing 15 products. Of these, 9 products have been approved for clinical use with 17 indications, 2 NDAs have been accepted, and 2 are in clinical phase III. We expect the company to achieve revenue of 0.24/3.31/721 billion in 2024-2026, maintaining the “gain” rating.

Risk warning: risk of changes in industry policies, risk of new drug development, risk of uncertain marketing of products under development, risk of poor progress in internationalization, risk of market competition, etc.

The translation is provided by third-party software.


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