The Zhitong Finance App learned that Fangzheng Securities released a research report stating that Kangzhe Pharmaceutical (00867) was given a “highly recommended” rating, and that the net profit returned to the mother in 2023-25 is expected to be 35.04/4133/5.110 billion. The company announced on May 30 that the new drug marketing license application for tiriquizumab injection (yilutsu), an innovative drug for treating adult patients with moderate to severe plaque psoriasis suitable for systematic treatment or phototherapy, was approved by China's National Drug Administration on May 26, 2023, and obtained a drug registration certificate on May 30. This drug is the first IL-23 antibody marketed in China. Clinical progress is rapid, long-term safety and tolerance are good, and product value is expected to be released quickly.
The report's main points are as follows:
(1) IL-23 targets have the best clinical results in treating psoriasis. Yilutsu has obvious advantages in terms of number of injections and compliance, making it the first IL-23 antibody to be marketed in China.
The incidence rate of psoriasis in China is about 0.47%, and the number of patients exceeds 7 million. Of these, more than 30% of patients have developed moderate to severe conditions. Currently, the IL-23 antibody is the target with the best clinical results for psoriasis treatment and the fastest increase in global sales. The clinical effect is superior to IL-17, IL-12/23 antibodies, and TNFα antibodies. The market size reached 7.83 billion US dollars in 2022 and an increase of 54.6%. Yilutran is a humanized LGG1/kappa monoclonal antibody that aims to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with IL-23 receptors, thereby inhibiting the release of pro-inflammatory cytokines and chemokines. The maintenance period is only 4 doses per year, which can lead to higher patient compliance. The product has patents for substances and formulations in China, and has been approved for listing in the United States, the European Union, Japan, the United Kingdom and other countries. It is the first IL-23 antibody marketed by local domestic pharmaceutical companies.
(2) Yilutsu is rapidly progressing clinically and has good long-term safety and tolerability, and product value is expected to be released quickly.
Yilutsu only took 14 months from obtaining the Chinese Drug Clinical Trial Approval Notice (IND) to submitting the NDA, including 2.5 months (including the Spring Festival) to completing the enrollment of 220 subjects. An expandability study of phase III clinical trials in China showed that the PASI75 response rate, the main efficacy evaluation indicator, continued to rise over the course of treatment. A high level of response could be achieved during 28 weeks of treatment, the PASI75 response rate remained at 91.3% in week 52, and long-term application safety and tolerability were good. The product will be promoted by the subsidiary Kangzhelei. It relies on experts on the skin platform and network resources to collaborate with the products on sale, Xiliaotuo, Ansuxi, and Lucotinib cream to be marketed, to further strengthen the company's comprehensive competitiveness in the field of skin treatment and quickly release product value.