Chinese Biotech Laike Pharma Emerges as Contender in $10B+ AKT Inhibitor Market with LAE002 NDA Filing Planned for 2026

On November 12, 2025, Laekna Therapeutics and Qilu Pharmaceutical Co., Ltd. reached an exclusive licensing agreement for the AKT inhibitor LAE002 (afuresertib) in the China region (including mainland, Hong Kong, Macao, and Taiwan).

Figure 1.Source: Laekna Therapeutics Official Website

Laekna Therapeutics is a biotechnology company focused on the research and development of drugs for metabolic diseases and cancer treatment. Its core pipeline product, LAE002, is a highly potent AKT inhibitor that can simultaneously target the three subtypes AKT1, AKT2, and AKT3, precisely addressing the clinical treatment needs of HR+/HER2- breast cancer. Notably, globally, there is currently only one approved AKT inhibitor for HR+/HER2- breast cancer: AstraZeneca's Capivasertib (brand name: Quanqiu). Therefore, LAE002 has the potential to become the second drug in this field to reach the market, with extremely broad market prospects.

Industry analysts believe that this collaboration will create a win-win situation for Qilu Pharmaceutical and Laekna Therapeutics. It not only strongly supports the acceleration of Laekna Therapeutics' commercialization strategy of "global R&D, regional mutual benefits," but also significantly strengthens Qilu Pharmaceutical's strategic layout in the field of targeted breast cancer treatment.

New Hope for Breast Cancer Patients

Breast cancer is one of the most prevalent malignant tumors among women globally. The WHO report, *Breast cancer cases and deaths are projected to rise globally*, indicates that the number of breast cancer cases and deaths worldwide is on the rise, with approximately 1 in every 20 women likely to be diagnosed at some point in their lifetime. Among the various subtypes, HR+/HER2- breast cancer (hormone receptor-positive/human epidermal growth factor receptor 2-negative) is the predominant subtype, accounting for about 70% of all patients.

The mainstream therapy for treating this type of cancer is the combination of CDK4/6 inhibitors and endocrine therapy. Compared with single endocrine therapy, the combined therapy has been proven to significantly improve the overall survival benefits for patients. However, patients adopting this therapy cannot overcome endocrine resistance, resulting in suboptimal efficacy. Therefore, as one of the emerging therapies, the clinical value of the ATK target is becoming increasingly prominent.

AKT is a serine/threonine kinase and a key node in the PAM (PI3K/AKT/mTOR) signaling pathway, playing a central role in regulating processes such as cell growth, proliferation, survival, and metabolism. Dysregulation of this pathway is a common oncogenic event in breast cancer, including various subtypes such as HR+, HER2-amplified, and triple-negative. Therefore, targeting AKT has become an attractive strategy for treating multiple subtypes of breast cancer, particularly offering a new direction for overcoming resistance to conventional therapies.

Phase III trials are proceeding as planned, Laekna TherapeuticsAiming to complete subject enrollment in the fourth quarter of 2025 and planning to submit a new drug marketing application to the National Medical Products Administration in 2026.

Strategic Layout for Mutual Benefit

The cooperation between Laekna Therapeutics and Qilu Pharmaceutical on LAE002 is a strategic choice based on each company's respective strengths.

According to the agreement, Qilu Pharmaceutical has obtained exclusive rights for the research, development, and commercialization of the AKT inhibitor within the region, while Laekna Therapeutics will be responsible for completing the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer. In return, if LAE002 is approved for its first indication in China, Laekna Therapeutics is entitled to receive an upfront payment of 530 million yuan that is non-refundable, along with milestone payments totaling up to 2.045 billion yuan. Additionally, Laekna Therapeutics is entitled to receive sales royalties based on the future net sales of the drug in China, with royalty rates ranging from the teens to the twenties percentage points.

For Laekna Therapeutics, this licensing agreement marks a positive advancement in the company’s “Global R&D, Regional Win-Win” strategy. Through this collaboration, Laekna Therapeutics is able to achieve rapid asset monetization. The upfront payment and milestone payments will significantly strengthen the group’s financial position, supporting the future development of other projects in its pipeline. Meanwhile, Laekna Therapeutics can leverage Qilu Pharmaceutical's robust commercialization capabilities in China to accelerate the market penetration of LAE002 within the licensed territory, thereby maximizing its commercial value.

For Qilu Pharmaceutical, this acquisition further demonstrates its commitment to deeply cultivating the breast cancer field. Qilu Pharmaceutical already owns trastuzumab (brand name: Antutu®) and pertuzumab (Ansaizu®), forming a "Trastuzumab-Pertuzumab dual-sword" synergistic treatment regimen for HER2-positive breast cancer.

The acquisition of LAE002 will help Qilu Pharmaceutical expand its treatment portfolio in the breast cancer field, further strengthen pipeline differentiation, increase patient coverage, and maintain and grow its market share in the breast cancer sector.

In addition, AKT inhibitors can target multiple types of cancer, a characteristic that highlights the significant market potential of such drugs. On May 23, 2024, the combination therapy of LAE001 and LAE002 for prostate cancer received FDA approval for Phase III clinical trials. In the future, there may be potential research collaborations in the field of prostate cancer. Notably, LAE001 and LAE002 were globally licensed to Laekna Therapeutics by Novartis in 2017 and 2018, respectively.

"The Battle of the Two Titans" is Approaching

According to Precedence RESEARCH, the global breast cancer market size is expected to exceed 26 billion USD by 2025. AKT inhibitors, with their mechanism advantages, have become powerful new entrants in this field.

Among AKT inhibitors, LAE002 faces relatively few competitors.

On April 18, AstraZeneca's Capivasertib was approved for marketing by the NMPA, becoming the first AKT inhibitor to be launched in China, taking the lead in occupying the market.

In addition, Roche had also entered this field, but due to unsatisfactory results from the Phase III clinical trial, it shut down its AKT inhibitor Ipatasertib pipeline in early 2023. In China, research on AKT inhibitors is mostly in the early clinical stages, such as TQB3912 from Chia Tai Tianqing, which is currently in Phase Ib/II trials, and HRS7415 from Hengrui, which is in Phase I clinical trials.

If LAE002 can be submitted for NDA as planned in 2026 and successfully approved, it is expected to become the second AKT inhibitor launched in China. At that time, a "duel between giants" pattern may emerge between AstraZeneca and Laekna Therapeutics/Qilu Pharmaceutical.

The reference materials are from publicly available information on the Internet, including news, corporate official websites, and government documents.