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Qilu Pharmaceutical Advances Afuresertib (LAE002), a Over RMB 2 Billion Exclusive New Drug, Toward NDA Submission

May 07, 2026 17:26 CST Updated 17:26
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Laekna Therapeutics

Innovative Drug Developer

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Breast cancer is one of the most prevalent malignant tumors among women globally.。WHO《Breast cancer cases and deaths are projected to rise globally》The report pointed out，The Incidence and Mortality of Breast Cancer Are on the Rise Globally，On average, 1 in every 20 women may be diagnosed in their lifetime.。
Among numerous subtypes，HR+/HER2- Breast Cancer（Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative）Is the absolute dominant subtype，Accounting for approximately 70% of the total patient population.
On April 30, 2026, Qilu Pharmaceutical officially announced that the pivotal Ib/III phase clinical study of the innovative targeted drug afuresertib (research code: LAE002), which it exclusively introduced for R&D and commercial rights in China, combined with fulvestrant for the treatment of HR+/HER2- advanced breast cancer, has reached its primary endpoint. Qilu will advance the application for marketing approval in China.
According to publicly available data, LAE002 (afuresertib) isLaekna TherapeuticsAn AK developed independentlyA potent inhibitor that can simultaneously suppress all three AKT subtypes (AKT1, AKT2, and AKT3), and isOne of the only two AKT inhibitors in late-stage clinical development globally for breast and prostate cancer.。
AKT is a serine/threonine kinase，It is also a key node in the PAM (PI3K/AKT/mTOR) signaling pathway.，For the regulation of cell growth、Proliferation、Plays a core role in survival and metabolic processes。The dysregulation of this pathway is breast cancer（Including HR+、HER2-amplified and triple-negative subtypes）Common Carcinogenic Events in China。Therefore，Targeting AKT becomes an extremely attractive strategy for treating various subtypes of breast cancer.，Especially, it provides a new direction for overcoming drug resistance in conventional treatments.
In November 2025, Qilu Pharmaceutical Co., Ltd. andLaekna TherapeuticsReach an authorized cooperation, exclusively introduce the drug.
According toAccording to the agreement, Qilu Pharmaceutical has obtained all exclusive rights for clinical research, drug development, production, and commercialization of this drug in China from Laekna Therapeutics.Responsible for completing the Phase III clinical trial of HR+/HER2- breast cancer.（AFFIRM-205）。
In return，If LAE002 is approved for its first indication in China，Laekna Therapeutics is entitled to receive a non-refundable upfront payment of 530 million yuan and total milestone payments of up to 2.045 billion yuan.。
In addition，Laekna Therapeutics is entitled to receive sales royalties based on the future net sales of the drug in China.，The sharing ratio ranges from over ten to more than twenty percentage points.
In the Phase Ib study, 20 patients with HR+/HER2- breast cancer received Afuresertib in combination with fulvestrant. The confirmed objective response rate (cORR) was 30%, the disease control rate (DCR) was 80%, and the median PFS was 7.3 months. Among the 11 patients with specific biomarker alterations (PIK3CA/AKT1/PTEN), the cORR was 45.4%, the DCR was 82%, and the median progression-free survival (PFS) was 7.3 months.
April 15, 2026Laekna TherapeuticsOfficially Announced, itsLAE002 (afuresertib), an investigational pipeline product, in combination with fulvestrant, achieved strong positive topline results in the Phase III clinical trial (AFFIRM-205) for the treatment of HR+/HER2- breast cancer, successfully meeting its primary endpoint.Becoming the first innovative drug in China to achieve positive Phase III results for this target.
Globally, the development of AKT inhibitors has long been considered a "tough challenge" in innovative drug research due to poor druggability of the target and high off-target toxicity, with only a few products such as AstraZeneca's Capivasertib and Roche's Ipatasertib advancing to later-stage clinical trials.
Among them, Capivasertib has been approved by the FDA in 2023 and is expected to enter the Chinese market in 2025, becoming the first AKT inhibitor in China. Its global sales reached $430 million in 2024, showing strong growth momentum.But at the same time，Roche terminated the pipeline development due to unsatisfactory Phase III data, highlighting the high-risk nature of R&D in this field.
Against this backdrop, Qilu Pharmaceutical Co., Ltd. totaledThis exclusive new drug, introduced at a cost exceeding 2 billion yuan, is about to be produced and is worth looking forward to.
Reference: Beijing Pharmaceutical Research Association
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Editor-in-Chief of PharmaCircle—Huaji Beauty (Ww_150525)

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