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Laekna, Inc. — M&A Activity 2025
Nov 12, 2025
50372_rns_2025-11-12_01923525-3a50-4963-a979-672906b5fd08.pdf
M&A Activity
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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
LAKNA
Laekna, Inc.
來凱醫藥有限公司
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 2105)
INSIDE INFORMATION
EXCLUSIVE LICENSE AGREEMENT WITH QILU PHARMA FOR LAE002 (AFURESERTIB) IN THE CHINA REGION
This announcement is made by Laekna, Inc. (the "Company", together with its subsidiaries, the "Group") pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the "Listing Rules") and the Inside Information provisions (as defined under the Listing Rules) under Part XIVA of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong).
INTRODUCTION
The board (the "Board") of directors of the Company (the "Directors") is pleased to announce that on November 12, 2025, the Group and Qilu Pharmaceutical Company Limited ("Qilu Pharma") have entered into an exclusive licensing agreement (the "License Agreement").
PRINCIPAL TERMS OF THE LICENSE AGREEMENT
Subject to terms and conditions of the License Agreement, Qilu Pharma is granted an exclusive license for research, development, and commercialization of LAE002 (afuresertib) in the China region (including Chinese Mainland, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan) (the "Licensed Territory"). The Group is responsible for completing the ongoing HR+/HER2- breast cancer Phase III clinical trial (AFFIRM-205). In return, the Group is entitled to receive non-refundable upfront and clinical development milestone payments up to RMB530 million upon new drug application ("NDA") approval for the first indication in China. Under the License Agreement, the Group is eligible to receive up to RMB2,045 million in total in upfront and milestone payments and is also entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the Licensed Territory, at percentages ranging from the low teens to the low twenties.
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Hong Kong, November 12, 2025
REASONS FOR AND BENEFITS OF THE LICENSE AGREEMENT
The Board believes that entering into the License Agreement is in the best interests of the Company and its shareholders as a whole. The Group can leverage this opportunity to accelerate the regulatory approval and commercialization of LAE002 (afuresertib) in the Licensed Territory and maximize its commercial value. The upfront and milestone payments will strengthen the Group's financial position for its future development. Currently, the Group is in active discussions with multiple potential partners and intends to pursue strategic partnerships to accelerate clinical development and commercialization of its drug candidate assets. Maintaining solid financial positions allows us to be selective in evaluating potential partnership structures that align the interests of all parties to maximize the potential of our assets.
ABOUT LAE002 (AFURESERTIB)
LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 (afuresertib) in patients with HR+/HER2- breast cancer. Study recruitment is on track and Laekna is responsible for completing this Phase III clinical trial (AFFIRM-205). The Group targets to complete subject enrollment in the fourth quarter of 2025 and to submit NDA to the center for drug evaluation of China's National Medical Products Administration ("CDE") in 2026.
ABOUT QILU PHARMA
Qilu Pharma is one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Dedicated to offering high-quality & trustworthy medicines to the world and improving people's well-being, Qilu Pharma is vigorously exporting its products to over 100 countries and regions around the world.
To the best knowledge and belief of the Company, Qilu Pharma and its shareholders are independent of and not connected with the Company and its connected persons (as defined in the Listing Rules). The transactions contemplated under the License Agreement do not constitute any notifiable transactions or connected transactions of the Company under the Listing Rules.
RISK WARNING
LAE002 (AFURESERTIB) MAY ULTIMATELY NOT BE SUCCESSFULLY DEVELOPED AND COMMERCIALIZED. THE COMPANY'S SHAREHOLDERS AND POTENTIAL INVESTORS ARE REMINDED TO EXERCISE CAUTION WHEN DEALING IN THE SECURITIES OF THE COMPANY.
By Order of the Board
Laekna, Inc.
Dr. LU Chris Xiangyang
Chairman
As at the date of this announcement, the Board comprises Dr. LU Chris Xiangyang, Ms. XIE Ling and Dr. GU Xiang-Ju Justin as executive Directors; Dr. WANG David Guowei and Mr. SUN Yuan as non-executive Directors; and Dr. YIN Xudong, Dr. LI Min and Mr. ZHOU Jian as independent non-executive Directors.
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