AstraZeneca Gains First-Mover Advantage as Laekna Secures Over RMB 2 Billion Licensing Deal: How Much Commercial Upside Remains?

For Laekna Therapeutics, the significant moment of "commercializing clinical products" is drawing closer.

On November 12, the company announced that, according to the terms and conditions of the license agreement, Qilu Pharmaceutical Co., Ltd. has been granted an exclusive license to research, develop, and commercialize LAE002 (afuresertib) in the China region (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan, China).

In addition, as a return, until the first indication receives new drug application approval in China, Laekna Therapeutics is entitled to receive an upfront payment and clinical development milestone payments totaling up to RMB 530 million that are non-refundable, as well as an upfront payment and milestone payments totaling up to RMB 2.045 billion. Laekna Therapeutics is also entitled to receive tiered royalties on future net sales of LAE002 within the licensed territory, with royalty rates ranging from over ten percentage points to over twenty percentage points.

After the announcement, market sentiment was also lifted, with Laekna Therapeutics opening more than 4% higher in early trading today. In the eyes of the investment market, successfully integrating into the commercialization process makes a pharmaceutical company's "arduous R&D" truly meaningful, especially for the development of potential Best-in-Class/First-in-Class drugs, which should focus on pragmatism.

Is the commercialization speed still too slow?

LAE002, one of Laekna Therapeutics' core pipelines, is about to "make its debut."

According to the introduction, LAE002 is a potent AKT inhibitor that can simultaneously inhibit all three AKT subtypes. It is also one of only two AKT inhibitors in late-stage clinical development globally for breast cancer and prostate cancer.

In terms of product development, Laekna Therapeutics has initiated a Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer targeting LAE002. The trial recruitment is currently proceeding as planned, with the goal of completing participant enrollment by the fourth quarter of 2025 and submitting a new drug application to the Center for Drug Evaluation of the China National Medical Products Administration in 2026.

The market has actually been looking forward to the product LAE002 for a long time.

In terms of efficacy, AKT inhibitors are expected to become a "powerful tool against cancer." It is understood that AKT is a serine/threonine protein kinase with three subtypes: AKT1, AKT2, and AKT3, playing a crucial role in regulating cell proliferation, survival, and metabolism. In particular, combination therapies involving AKT inhibitors with other molecules for treating drug-resistant cancers, including acquired resistance to other anticancer drugs and adaptive resistance to chemotherapy and targeted therapies, have a strong preclinical theoretical foundation.

For example, at the 2024 European Society for Medical Oncology (ESMO) Congress, Laekna Therapeutics presented the final data from the Phase Ib study of LAE002 in combination with fulvestrant for patients with locally advanced or metastatic HR+/HER2- breast cancer who failed standard treatment: the median progression-free survival (PFS) was 7.3 months among 18 breast cancer patients with PIK3CA/AKT1/PTEN mutations.

In a horizontal comparison, AstraZeneca's similar AKT inhibitor Capivasertib (Capivasertib tablets) combined with fulvestrant showed a PFS of only 5.7 months in the same population, while the monotherapy group had just 1.9 months.

However, it is worth mentioning that although Laekna Therapeutics' LAE002 is actively racing ahead in terms of efficacy, its commercialization speed still lags behind AstraZeneca.

In April this year, an announcement released on the official website of the National Medical Products Administration showed that Capivasertib, a Class 1 innovative drug developed by AstraZeneca, has been approved for marketing. It has become the world's first AKT inhibitor, used to treat adult patients with advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.

Seeing that some pharmaceutical companies have already gained a first-mover advantage, Laekna Therapeutics may also feel a sense of urgency. Moreover, compared to established multinational pharmaceutical giants like AstraZeneca, Laekna Therapeutics has relatively weaker accumulation in areas such as product development and commercialization. In this situation, advancing strategic cooperation is indeed necessary.

In this collaboration, Qilu Pharmaceutical’s contribution is expected to be significant. As one of the leading vertically integrated pharmaceutical enterprises in China, it combines the research, production, and sales of finished dosage forms (FDF) and active pharmaceutical ingredients (API). Its products have now been exported to more than 100 countries and regions worldwide, showcasing a highly mature business model.

But one fact must be recognized: after a long product development cycle and with the increasingly complex market competition environment, the commercial rise of Laekna Therapeutics will obviously not happen overnight.

Waiting for another carriage to take over

These years, "loss" has already become a normal operating state for Laekna Therapeutics.

Public financial data shows that Laekna Therapeutics reported net losses of 7.49 billion yuan, 7.82 billion yuan, 3.69 billion yuan, 2.54 billion yuan, and 1.30 billion yuan for the years 2021-2024 and the first half of 2025, respectively. The good news is that, with the reduction in R&D expenses, the losses have significantly narrowed.

For example, in the first half of this year, Laekna Therapeutics' R&D expenses were 105 million yuan, a year-on-year decrease of 16.6%, mainly due to a milestone payment of 178 million yuan related to the Phase III clinical trial AFFIRM-205 incurred in the first half of 2024, while no such expenses were incurred during the same period in 2025.

However, the key to reversing losses completely still depends on the market performance of core products. Moreover, considering risks such as clinical results falling short of expectations and increasing market competition, "putting all eggs in one basket" is clearly insufficient.

In this case, we also noticed that Laekna Therapeutics has another highly anticipated new drug — LAE102. Reportedly, this is one of the few global pipelines targeting ActRII that has entered the clinical trial stage. It can be used in combination with GLP-1 receptor agonists to achieve the effect of reducing fat and minimizing muscle loss, also positioning itself at the forefront.

The World Obesity Federation predicts that the number of people with obesity worldwide will reach 1.2 billion by 2030. Currently popular weight-loss drugs, such as GLP-1 receptor agonists, still have certain limitations. It is reported that using GLP-1 drugs for weight loss always comes with about 25%-40% of muscle loss, which can increase the risk of osteoporosis and reduced immunity in the human body. This also highlights the application potential of candidate drugs like LAE102.

However, the development cycle of this product remains lengthy. Laekna Therapeutics' semi-annual report disclosed that the group will initiate the recruitment for the Phase I MAD study of LAE102 in China by the end of March 2025. This study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered LAE102 in 60 overweight/obese subjects.

In addition, there is no lack of participation from pharmaceutical giants in the ActRII lipid-lowering and muscle-enhancing field, such as Eli Lilly's Bimagrumab, which is already ahead of Laekna Therapeutics' LAE102 in terms of development progress.

But the relationship between the two drugs may be more about coexistence than competition. It is reported that in November 2024, Laekna Therapeutics and Eli Lilly signed a clinical cooperation agreement aimed at supporting and accelerating the global clinical development of LAE102 for the treatment of obesity. We also hope that the LAE102 "chariot" will reach its commercial destination as soon as possible.

Source: Medical Research Society

       Original Title: AstraZeneca Takes the Lead, Over 20 Million Yuan in Licensing – How Much More Commercial Opportunity Can This Bring to Laekna Therapeutics?