R&D Continues Burning Cash, Innovative Drug Out-Licensing Brings Gains, Lekai Pharmaceuticals' Loss Narrows Year-over-Year

The Beijing News (Reporter Wang Kala) reported that on the evening of March 18, Laikai Pharmaceutical released its 2025 annual performance announcement. During the reporting period, the company’s revenue was 107 million yuan, mainly derived from licensing transactions with Qilu Pharmaceutical for LAE002 (afuresertib). The annual loss narrowed from 254 million yuan in 2024 to 229 million yuan. As various clinical studies progress, R&D expenses increased by 16.2% year-on-year to 250 million yuan.

Laikai Pharmaceutical is a clinical-stage biopharmaceutical technology company that listed on the Hong Kong Stock Exchange on June 29, 2023. It has not yet commercialized any products. Among its pipeline, LAE002 is an oral potent AKT inhibitor, and it is one of only two AKT inhibitors in late-stage clinical development targeting breast and prostate cancers worldwide.

In November 2025, Laikai Pharmaceutical signed an exclusive licensing agreement with Qilu Pharmaceutical for LAE002. Qilu Pharmaceutical obtained exclusive rights to research, develop, and commercialize the drug in China. The upfront and milestone payments could total up to 2.045 billion yuan, and it has the right to receive tiered sales royalties based on future net sales within the licensed region. Currently, the Phase III clinical trial of LAE002 combined with fluticasone for HR+/HER2- breast cancer has completed patient recruitment. Laikai plans to announce topline data from this Phase III study in the first half of this year and submit a marketing application to the National Medical Products Administration within the year. This deal also brought Laikai its first commercial revenue.

Additionally, the combination therapy of LAE002 with LAE001 and prednisone for prostate cancer has completed international multicenter Phase II trials and has received approval for Phase III clinical trial plans in the United States. Laikai aims to seek strategic partners to accelerate the global development and commercialization of LAE002 and LAE001.

The market outlook for AKT inhibitors is broad. In November 2023, the world’s first AKT inhibitor, capivasertib, was approved in the U.S. for marketing. In 2024, global sales of capivasertib reached $430 million; in the first half of 2025, global sales hit $302 million. In April 2025, capivasertib was approved for marketing in China. LAE002’s development progress is among the top globally, and industry experts are optimistic about its market prospects.

Another core drug in Laikai’s pipeline, LAE102, is a monoclonal antibody targeting ActRIIA developed independently by the company. It is a promising candidate for weight control while preserving muscle mass. The development progress of this innovative drug once caused Laikai’s stock price to surge. Currently, competition in the weight loss sector is fierce. Ping An Securities estimates that by 2030, China’s weight loss drug market will reach 14.9 billion yuan. Guotai Haitong Securities’ research report pointed out that reducing fat and increasing muscle mass will be key areas of R&D in future weight loss drugs.

In the metabolic field, Laikai is building a globally competitive, differentiated product portfolio. Besides LAE102, there are also LAE103, LAE123, and a broader pipeline of metabolic candidates.

As various R&D projects advance, Laikai continues to spend heavily on research. From 2022 to 2025, total R&D expenditure has exceeded 1 billion yuan. During this period, the company’s total losses surpassed 1.6 billion yuan. Laikai states that it adopts prudent financial policies to maintain a stable financial position. As of December 31, 2025, the company’s cash and bank balances amounted to 1.262 billion yuan.

CITIC Securities’ research report noted that Laikai’s core pipeline is well-balanced, focusing on cancer and metabolic diseases. Besides its core products, the company maintains a broad portfolio, with several preclinical candidates awaiting development. However, overall operations face uncertainties; if clinical trials of ATK drugs fail or if clinical data for LAE102 do not meet expectations, it could impact the company’s profits and revenues in 2027.