On September 13th, Kanoya (2162.HK) officially obtained the approval of the National Medical Products Administration (NMPA) for the listing of Sipukibai single antibody (CM310) injection after submitting a new drug application (NDA) for 9 months. It is used for the treatment of moderate to severe atopic dermatitis in adults.

It is understood that this is the first drug application for listing submitted by Kanoya since its establishment. With this approval, Sipukibai single antibody has not only become the first domestically approved IL-4Rα antibody drug, but also the second IL-4Rα antibody drug approved worldwide.

For Connoa, the most direct impact of the approval of Sipukibai single antibody may be the hope of helping to get rid of the situation of relying on project authorization to support income.

For example, in February 2023, Connoa reached an exclusive license agreement with AstraZeneca for the ADC drug CMG901 targeting Claudin 18.2. That year, Connoa confirmed the receipt of relevant revenue of 0.319 billion yuan for cooperation first payment, accounting for more than 90% of the annual revenue of 0.354 billion yuan. In the first half of 2024, Connoa achieved revenue of 54.682 million yuan, of which the confirmed cooperative revenue related to CMG901 was RMB 54.261 million, accounting for more than 99%.

Regarding the listing of Sipukibai single antibody, a reporter from the Science and Technology Innovation Board Daily sent a letter to Connoa, inquiring about the commercialization work arrangements for the next product and the expected sales in the future, etc. As of the publication, no response has been received from the other party.

However, the market space for IL-4Rα antibody drugs can be seen from the first approved product. In March 2017, Dupilumab, an IL-4Rα monoclonal antibody developed by Sanofi in collaboration with Regeneron, was approved by the FDA for the treatment of moderate to severe atopic dermatitis in adults, with the trade name Dupixent.

According to the data disclosed by Sanofi, the sales of Dupixent reached 0.25 billion US dollars in the year of its listing. Subsequently, with the approval of more indications such as Dupixent for asthma and chronic nasal-sinusitis with nasal polyps, the sales of the product increased rapidly. In 2023, the global sales of Dupixent were approximately 11.6 billion US dollars, a year-on-year increase of 33%. In the first half of 2024, the sales of Dupixent further increased to approximately 6.7 billion US dollars.

Sanofi previously projected that the sales of Dupixent for the full year of 2024 would further increase to approximately 14 billion US dollars (approximately 13 billion euros).

In addition to the approved indication of severe atopic dermatitis in adults, dupilumab also has several other indications in progress. Among them, the NDA for the treatment of seasonal allergic rhinitis was accepted in April of this year, and the NDA for the treatment of chronic nasal-sinusitis with nasal polyps was accepted in June of this year and included in the priority review and approval program.

In addition, a phase III clinical study of dupilumab for severe atopic dermatitis in adolescents was initiated in February of this year, and the patient enrollment for this clinical study is currently underway.

Perhaps it is because of the market prospects demonstrated by IL-4Rα antibody drugs. In addition to ConoGenetech, several domestic companies are intensively developing IL-4Rα monoclonal antibody drugs, which means that ConoGenetech is facing multiple potential competitors.

According to incomplete statistics, as of the first half of 2024, at least 10 companies including Zhixiang Jintai, Quansin Biotech, Jiangsu Hengrui Pharmaceuticals, and Sunshine Guojian Pharmaceutical are developing IL-4Rα monoclonal antibody drugs, and 9 of them are developing indications that include atopic dermatitis.

In terms of progress, Zhixiang Jintai, Jiangsu Hengrui Pharmaceuticals, and Sunshine Guojian Pharmaceutical are all at the forefront of the development of IL-4Rα monoclonal antibody drugs in China. They are currently in phase III clinical trials, and Sunshine Guojian Pharmaceutical's "SSGJ-611" is also conducting phase I clinical trials in the United States at the same time.