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智翔金泰(688443):赛立奇单抗获批上市 核心产品进展顺利

Zhixiang Jintai (688443): Celiac monoclonal was approved for marketing, and the core product is progressing smoothly

德邦證券 ·  Sep 9

Results for the first half of 2024: Celikizumab was approved in August 2024. The company's 2024H1 did not generate main business revenue; it only obtained a small amount of other business revenue of 0.0127 million yuan due to land leasing; sales expenses of 36.97 million yuan; management expenses of 61.88 million yuan, a year-on-year decrease of 26%; R&D expenses of 0.284 billion yuan; as of June 30, 2024, the company's cash balance was 2.624 billion yuan. The company's antibody industrialization base has now completed the construction of 24,400L of biological fermentation production capacity, and 40,000L will be added after the completion of the second phase of the base.

Celizumab approved for marketing, ready for commercialization: In August 2024, celizumab (GR1501) was approved for marketing in moderate to severe plaque psoriasis, the first recombinant all-human anti-IL-17A monoclonal antibody drug approved for marketing by a domestic company; in addition, the NDA application for the treatment of axial spondyloarthritis was accepted in January 2024. The autoimmune disease product line commercialization team has begun to take shape, and the core managers have rich experience in promoting and commercializing innovative drugs and drugs in the field of autoimmune diseases.

The core product is progressing smoothly:

1) GR1801 (anti-rabies virus double antibody): Phase III of passive immunization indications after exposure to suspected rabies virus is ongoing. The GR2001 tetanus prevention indication has entered phase III clinical trials, leading the development progress.

2) GR1802 (IL-4Rα monoclonal antibody): Indications for moderate to severe atopic dermatitis and chronic sinusitis with nasal polyps have entered phase III clinical trials. The indications for asthma, chronic spontaneous urticaria, and allergic rhinitis are in phase II.

3) Phase II of GR1603 systemic lupus erythematosus indications and GR1803 multiple myeloma indications are ongoing.

Profit forecast: The company Celikizumab has been approved for listing, and we forecast its 24-26 revenue of 0.059, 0.256, and 0.745 billion yuan. Maintain a “buy” rating.

Risk warning: Risk of clinical development failure, risk of sales falling short of expectations, risk of clinical development progress falling short of expectations.

The translation is provided by third-party software.


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