Securities code: Sichuan Kelun Pharmaceutical Co.Ltd(002422) securities abbreviation: Sichuan Kelun Pharmaceutical Co.Ltd(002422) Announcement No.: 2022027 Sichuan Kelun Pharmaceutical Co.Ltd(002422)
Announcement on the company's innovative drug kl130008 capsule (Jak1 / 2 inhibitor) receiving the notice of clinical trial
The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete without false records, misleading statements or major omissions.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) (hereinafter referred to as "the company" or " Sichuan Kelun Pharmaceutical Co.Ltd(002422) ") recently learned that kl130008 capsule (Jak1 / 2 inhibitor) developed by Sichuan Kelun Botai biomedical Co., Ltd., a holding subsidiary of the company, was notified by the State Drug Administration (nmpa) of the clinical trial of adding new indications. The relevant information is hereby announced as follows: I. Basic information of drugs
1. Drug name: kl130008 capsule
Dosage form: capsule
Specification: 0.5mg; 1mg； 2mg
Registration classification: Class 1 Chemical Drugs
Applicant: Sichuan Kelun Botai biomedical Co., Ltd
Acceptance No.: cxhl2101850, cxhl2101851, cxhl2101852
Indication: severe alopecia areata
Review conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after review, kl130008 capsule accepted on December 30, 2021 meets the relevant requirements of drug registration and agrees to carry out clinical trial.
2. Other relevant information of drugs
Kl130008 capsule is a class 1 innovative drug with global independent intellectual property rights developed by Sichuan Kelun Botai biomedical Co., Ltd. and a selective inhibitor targeting Jak1 and JAK2 kinases. At present, kl130008 capsule has carried out four clinical trials in China. This application adds new indications for kl130008 capsule for the treatment of patients with severe alopecia areata.
At present, no similar products for this indication have been approved for listing outside China. On January 31, 2022, Lilly announced that the listing application for a new indication (alopecia areata) submitted by baricitinib in the United States was in the regulatory review stage.
Sichuan Kelun Botai biomedical Co., Ltd. will organize and implement the clinical trial of kl130008 capsule for the newly added indications in accordance with the requirements of the clinical trial notice issued by the State Drug Administration. 2、 Risk tips
As the R & D process of innovative drugs has a long cycle and many links, and there is a certain uncertainty during the period, please make careful decisions and pay attention to preventing investment risks. The company will timely fulfill the obligation of information disclosure according to the follow-up progress.
It is hereby announced.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) board of directors March 23, 2022
