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康哲药业(0867.HK):替瑞奇珠单抗获批上市 开启创新药的放量

Kangzhe Pharmaceutical (0867.HK): Tiriqizumab approved for marketing to start the release of innovative drugs

國元國際 ·  Jun 2, 2023 00:00  · Researches

Incidents:

The company's IL-23 antibody tirizizumab injection was recently approved by NMPA for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systematic treatment or phototherapy. The trade name is Eilutsu.

Comments and opinions:

Terricizumab is the first in China, with broad market space

Tiriqizumab is the first IL-23 antibody marketed by domestic pharmaceutical companies, and it is also the first Th17 channel antibody drug marketed by local domestic pharmaceutical companies. The IL-23 antibody is currently the target with the best clinical efficacy for psoriasis treatment, superior to IL-17, IL-12/23 antibodies, and TNFα antibodies; Yilu takes 52 weeks of PASI75 data to 91.3%, and the maintenance period only requires 4 doses per year. Patient compliance is high, clinical efficacy is remarkable, safety is good, and rapid release is expected. Yilutsu will be promoted by Kangzhe Beauty, collaborating with experts and network resources on the skin platform, which is expected to quickly release value; the peak of product sales is expected to reach more than 20-30 billion yuan.

The company actively expanded its innovation pipeline, and major new drugs were approved for marketing:

The company has deployed 30 innovative pipelines based on FIC and BIC around the world. Two innovative drugs have been marketed this year. The other is methotrexate injection: the indications are RA and psoriasis, and can be administered subcutaneously. It was approved for marketing by China's National Drug Administration (NMPA) on March 24, 2023. There are also 2 innovative drugs being reviewed by the Chinese NDA. Among them, the diazepam nasal spray will be approved within this year. It is expected to be the first innovative drug for people with epilepsy aged six and above in China. Its China bridge trial has met the expected goals, and the Chinese NDA is under CDE review. The company continues to launch new products, and the products sold by the company have high brand power and the company's strong OTC channels, so the company's performance is expected to maintain steady and rapid growth.

The dermatology and aesthetics business is progressing in an orderly manner, and the team is continuously strengthened:

Currently, Kangzhelimei has a team of more than 600 people, and the product line continues to be enriched. The new lucotinib cream introduced in 2022 is the first and only topical JAK inhibitor approved by the US FDA and the only multicolored vitiligo product, with a broad market space. Products also include Dermatological Journal skincare products and hyaluronic acid and botulinum toxin products; the “Carnation” platform has launched three series of products, such as FUBA focused ultrasonic fat reducer and LITU focused ultrasound skin treatment device.

The company's innovative drugs will be released in quantity, and the value is seriously underestimated:

The company's performance has continued to grow for more than 10 years, actively deploying innovative drugs. With an open innovation incubation platform, it has deployed 30 innovation pipelines centered on FIC and BIC around the world, and products have been launched one after another. The company has developed in depth around specialty fields. It has independently operated the medical aesthetic “Kangzhe Beauty” and the ophthalmology “Kangzhe Weisheng” and entered the Southeast Asian market. The company's management has more than 30 years of experience in the pharmaceutical industry, expanding medical aesthetics and health based on innovative drugs. We expect the company's performance to continue to grow steadily in the future. The current stock price corresponds to 7.4 times PE in 2023. The value is seriously underestimated. Long-term development is worth looking forward to, and maintaining the “buy” rating.

The translation is provided by third-party software.


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