LEE'S PHARM - Voluntary Announcement - Investigational New Drug Application in China for Proprietary ADC Project ZK2401 Accepted by NMPA
Lee's Pharmaceutical Holdings Limited
李氏大藥廠控股有限公司 *
(incorporated in the Cayman Islands with limited liability)
(Stock Code: 950)
VOLUNTARY ANNOUNCEMENT
INVESTIGATIONAL NEW DRUG APPLICATION IN CHINA
FOR PROPRIETARY ADC PROJECT ZK2401 ACCEPTED BY NMPA
This announcement is made by the board (the "Board") of directors (the "Directors") of Lee's Pharmaceutical Holdings Limited (the "Company" or "Lee's Pharm", together with its subsidiaries, the "Group") on a voluntary basis.
The Board of the Company is pleased to announce that, on 29 July 2026, the Group's Investigational New Drug ("IND") application in China for ZK2401, a proprietary antibodydrug conjugate ("ADC") project independently developed in-house by Lee's Pharm with full global intellectual property ownership of the entire molecule, has been accepted by the Centre for Drug Evaluation of the National Medical Products Administration ("NMPA") of China.
ZK2401 is built on Lee's Pharm's proprietary anti-PD-L1 antibody backbone, Socazolimab, and is conjugated with a novel topoisomerase I inhibitor payload. As the first project under Lee's Pharm's ADC platform, ZK2401 marks an important starting point for the Group's further development of this platform. The ADC is designed to specifically target and kill tumour cells, and multiple preclinical in vitro and in vivo studies have demonstrated encouraging safety and efficacy profiles.
For this IND application, the Group adopted a pre-ethics approach and utilised the national new policy for the review and approval of innovative drug clinical trials. Based on the current review pathway, the review period is expected to take approximately 30 working days, with potential clinical trial approval as early as September 2026 and first patient enrolment as early as October 2026.
The Board considers this IND application another important milestone for the Group's oncology innovation pipeline. The project reflects Lee's Pharm's sustained, independent R&D capability in developing innovative biologics and ADC assets entirely in-house, and is in line with the Group's strategic focus on differentiated products built on proprietary technologies with significant clinical potential and defensible competitive advantage.
- For identification purpose only
ABOUT SOCAZOLIMAB
Socazolimab is a fully human anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody owned by China Oncology Focus Limited ("COF"), a subsidiary of the Company. To date, Socazolimab has received marketing approval from the NMPA of China for two indications: (1) first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy, and (2) treatment of recurrent or metastatic cervical cancer.
ABOUT LEE'S PHARM
The Company is a research-driven and market-oriented biopharmaceutical company with more than over 30 years of operation experience in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with international companies and currently markets pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease therapeutic areas such as cardiovascular health, woman's health, paediatrics, rare diseases, oncology, dermatology and obstetrics. In addition, the Company has recently acquired U.S.-based assets in line with its strategy to broaden its portfolio of innovative drug delivery technologies through the Staccato® Platform, covering a wide range of indications and reinforcing the Company's global expansion strategy. More information available at www.leespharm.com.
By order of the Board
Lee's Pharmaceutical Holdings Limited Lee Siu Fong
Chairman
Hong Kong, 30 July 2026
As at the date of this announcement, Ms. Lee Siu Fong (Chairman) and Ms. Leelalertsuphakun Wanee are executive directors of the Company, Dr. Li Xiaoyi, Mr. James Charles Gale and Mr. Huang Zuie-Chin are non-executive directors of the Company, Dr. Chan Yau Ching, Bob, Ms. Cheang Yee Wah, Eva and Dr. Tsim Wah Keung, Karl are independent non-executive directors of the Company.