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Lupeng Pharmaceutical Announces First Patient Enrolled in Phase II Pivotal Clinical Study of Lacutoclax(LP-108)
15 Jul 2026 15:10:00

GUANGZHOU, China, July 14, 2026 — Guangzhou Lupeng Pharmaceutical achieved another major milestone in its R&D pipeline with the successful enrollment of the first patient in the pivotal Phase II clinical study (CTR20261956; study number LP-10821) of its highly selective BCL-2 inhibitor, lacutoclax(LP-108), for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL).


The LP-10821 study is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the overall response rate, safety, tolerability and pharmacokinetic profile of lacutoclax monotherapy in patients with R/R CLL/SLL. The study is jointly led by Professor Li Jianyong from Jiangsu Province Hospital and Professor Zhou Keshu from Henan Cancer Hospital, in collaboration with more than 30 clinical research centers across China.


B-cell lymphoma 2 (BCL-2) protein belongs to the BCL-2 family and acts as a key regulator of cell survival by inhibiting apoptosis (programmed cell death). Its overexpression is a central pathogenic mechanism in a variety of hematologic malignancies, including CLL/SLL, mantle cell lymphoma (MCL) and acute myeloid leukemia (AML).


Lacutoclax(LP-108), an innovative anticancer drug independently developed by Lupeng Pharmaceutical, is a next-generation, orally administered, potent and highly selective BCL-2 inhibitor. In Phase I clinical studies conducted concurrently in China and the United States, lacutoclax has demonstrated encouraging clinical efficacy and a favorable safety profile across multiple relapsed or refractory B-cell malignancies and myeloid neoplasms. Clinical data from these studies have been presented at leading international and domestic hematology and oncology conferences, including EHA, CSH and ASH, where they have received broad recognition from the hematologic community.


Dr. Shen Yue, Senior Vice President of Lupeng Pharmaceutical, stated: "The BCL-2 target represents a core strategic focus of the company's hematologic malignancy pipeline. The enrollment of the first patient in the pivotal clinical study of lacutoclax (LP-108)marks another significant milestone in advancing our innovative R&D pipeline. We are fully committed to advancing this multicenter clinical program to accelerate the development and availability of this domestically developed apoptosis pathway-targeted therapy. Our goal is to relieve the burden on patients and provide a novel therapeutic option for patients with hematologic malignancies in China.”