Announcement on Granting Ellipses Pharma Paid License
Stock Code: 002422 Stock Abbreviation: Kelun Pharmaceutical Announcement No. 2021-050
Sichuan Kelun Pharmaceutical Co., Ltd.
Announcement on Granting Ellipses Pharma Paid License to Develop and Market RET Kinase Inhibitors Outside Greater China and Part Asia-Pacific Regions
The company and all members of its Board of Directors hereby confirm that all information disclosed herein is true, accurate and complete with no false or misleading statement or material omission.
I. Overview of Contract Signing
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (hereinafter referred to as "Kelun-Biotech"), a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as "the company" or "Kelun Pharmaceutical"), reached a regional license cooperation agreement with Ellipses Pharma LTD (hereinafter referred to as "Ellipses") in March 2021. Ellipses is licensed exclusively by Kelun-Biotech with paid regional rights of the project of innovative small molecule tumor-targeted RET kinase inhibitor (hereinafter referred to as "project A400") in Europe and the United States and other regions, and Kelun-Biotech reserves the rights in Greater China and some Asia-Pacific regions such as South Korea, Singapore, and Malaysia, etc. Both parties will carry out development, commercialization and other activities in their respective regions, and use the data from their regions to support the global research and development of the project.
II. Information of the Other Party to the Agreement
The other party to the agreement is Ellipses Pharma, an international drug research and development company focusing on the research and development of innovative cancer drugs and therapies. Ellipses, based in London, is managed by a world-class leadership team. With the expertise from the world's largest group of key opinion leaders focusing on oncology, Ellipses manages a rapidly growing product line with potential of high-quality clinical treatment for oncology. Its worldwide business and asset-centric method have changed the process of clinical trials and provided cancer patients with the best drugs and therapies at an unprecedented rate.
Except for the business relationship arising from the transaction of the license agreement mentioned in this announcement, Ellipses has no relationship with the listed company and the top ten shareholders of the listed company in terms of property rights, business, assets, credits and debts, personnel, etc., and has no other relationship that may or has caused the listed company to tilt interests to it.
III. Subject Matter of the License Agreement
Project A400 is a small molecule selective targeted RET kinase inhibitor researched and developed by Kelun-Biotech with independent intellectual property rights. IND application of this project has been officially submitted to NMPA in March 2021 and a number of international patents have been laid out. Preclinical studies have shown that A400 has good kinase inhibitory activity and selectivity in vitro and in vivo. It has advantages in animal blood/brain exposure and etc. It is also effective for a variety of clinical drug resistance mutations that have been reported in clinical practice. A400 has the potential to overcome clinical drug resistance mutations and to improve clinical efficacy for brain metastases.
IV. Impact of Signing Agreement on the Company
The signing of this license agreement will be beneficial to the global development speed of the RET kinase inhibitor which will provide a new treatment option for cancer patients worldwide after its marketing. It also will further improve the internationalization of the company's innovation programs.
V. Risk Analysis
The agreement is a license agreement of an innovative drug. Development of innovative drugs has the characteristics of huge investment, high risk and long period. The licensed product`s safety and efficacy shall be verified through each process of human clinical trials. There are considerable uncertainty and risk.
Please make careful decisions and pay attention to preventing investment risks. The Company shall actively promote the agreement mentioned above in accordance with relevant state regulations, and timely fulfil the information disclosure obligation of the subsequent progress.
It is hereby announced.
Board of Directors
Sichuan Kelun Pharmaceutical Co., Ltd.
March 25, 2021
This document is a translated version of the Chinese version announcement, and the published Chinese version announcement shall prevail. The complete published Chinese version announcement may be obtained at www.kelun.com.