Lakewood Pharma Accelerates Commercialization Amid Mounting Losses and Intense Competition

Source: Beijing Business Today

Under the dual pressures of continuous losses and industry competition, Laekna Therapeutics has reached a key milestone in commercialization. On November 12, Laekna Therapeutics announced that it had entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. ("Qilu Pharmaceutical"). Under the agreement, Qilu Pharmaceutical has been granted an exclusive license to research, develop, and commercialize LAE002 (afuresertib) in China (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan), with the total agreement amount reaching up to 2.045 billion yuan.

Beijing Business Today reporters noticed that, during the two and a half years since its listing, Laekna Therapeutics has accumulated losses exceeding 700 million yuan, with no products yet commercialized. Meanwhile, its fastest progressing core product, LAE002, faces competition from similar products by multinational pharmaceutical companies that are hitting the market earlier. Whether this "stimulus"-like collaboration can help Laekna Therapeutics catch up in the fiercely competitive AKT inhibitor field will be a critical test of its commercialization capabilities.

Leveraging Commercialization

As one of the core fields in Laekna Therapeutics' strategic layout, most of the key products in the oncology drug pipeline have been introduced from Novartis. From 2017 to 2020, Laekna Therapeutics successively introduced LAE001, LAE002, LAE003, and LAE005 from Novartis. According to Laekna Therapeutics’ semi-annual report, currently only LAE002 and LAE001 are still being advanced independently, and they are the fastest progressing products in the company’s R&D pipeline.

Among them, LAE002 is a potent AKT inhibitor that can inhibit all three AKT subtypes. It is also one of the two globally advanced AKT inhibitors in late-stage clinical development for breast cancer and prostate cancer. Laekna Therapeutics has planned five indications for it. Currently, the HR+/HER2- breast cancer indication is progressing rapidly. A Phase III clinical trial (AFFIRM-205) was initiated in 2024, 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 China's National Medical Products Administration in the first half of 2026.

Notably, Laekna Therapeutics has already lost the first-mover advantage in the commercialization of LAE002. Capivasertib (Kapisetib Tablets), as AstraZeneca's first approved AKT inhibitor, was approved by the U.S. FDA (U.S. Food and Drug Administration) in November 2023 for the treatment of HR+/HER2- breast cancer. In April this year, the drug was also approved for marketing in China, for the treatment of adult patients with advanced or metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2-negative.

Facing a less than optimistic competitive landscape, Laekna Therapeutics revealed in its semi-annual report that it is in discussions with potential partners for strategic cooperation to accelerate the regulatory approval and commercialization of LAE002. This collaboration with Qilu Pharmaceutical is a response to that announcement, leveraging Qilu’s mature commercialization experience to expedite the product's market entry in China while alleviating Laekna Therapeutics' financial pressures during subsequent clinical development and commercialization stages.

Regarding the future commercialization plans of LAE002 and related issues, Beijing Business Today reporters contacted Laekna Therapeutics and Qilu Pharmaceutical respectively, but no response had been received as of press time.

Accumulated losses exceed 700 million yuan in two and a half years

The pressing push for commercialization is driven by the ongoing financial losses caused by costly research and development. Since its listing in 2023, the company's performance has been under continuous pressure. In 2023, 2024, and the first half of 2025, Laekna Therapeutics' net profits were -369 million yuan, -254 million yuan, and -130 million yuan respectively, with cumulative losses exceeding 700 million yuan. During the same periods, the R&D expenses were 230 million yuan, 215 million yuan, and 105 million yuan respectively.

Despite this collaboration bringing a glimmer of hope for the commercialization of Laekna Therapeutics' products, in the field of metabolic diseases where Laekna Therapeutics has made significant investments, the key candidate drug LAE102 is still in urgent need of a breakthrough.

Unlike other weight-loss products, LAE102, a self-developed ActRIIA monoclonal antibody by Laekna Therapeutics, can control body weight while preserving muscle mass, reducing fat and increasing muscle. When used in combination with GLP-1 receptor agonists, it further reduces fat and significantly mitigates muscle loss caused by GLP-1 receptor agonists, showing great development potential. By the end of December 2024, Laekna Therapeutics has successfully completed the SAD (Single Ascending Dose) study of LAE102 for the treatment of obesity in China. In September this year, Laekna Therapeutics announced that the Phase I MAD (Multiple Ascending Dose) clinical study of LAE102 achieved positive preliminary results, demonstrating an encouraging trend of muscle gain and fat reduction.

In addition, Laekna Therapeutics is also accelerating the global development of LAE102 for the treatment of obesity. In November 2024, Laekna Therapeutics signed a clinical cooperation agreement with Eli Lilly, under which the latter will be responsible for conducting and covering the costs of Phase I clinical trials in the United States, while Laekna Therapeutics retains global rights to LAE102. Currently, Laekna Therapeutics submitted an IND (Investigational New Drug) amendment application to the U.S. FDA in March 2025 for the use of LAE102 in treating obesity, and the first subject was dosed in May 2025. The goal is to complete the main research phase of the U.S. Phase I clinical trial by the fourth quarter of 2025.

In addition to LAE102, Laekna Therapeutics has also developed multiple candidate drugs based on ActRII antibodies, including LAE103, a selective ActRIIB antibody, and LAE123, a dual antagonist monoclonal antibody targeting ActRIIA/IIB. Both are self-developed by Laekna Therapeutics for muscle-related and other disease indications, and IND-enabling studies were initiated in 2024.

Pharmaceutical industry analyst Zhu Mingjun stated that the collaboration with Qilu Pharmaceutical is a crucial step for Laekna Therapeutics to address ongoing losses and industry competition. As the self-developed pipeline, including LAE102, advances, whether Laekna Therapeutics can leverage both external partnerships and internal R&D efforts to overcome current challenges and break through in relevant fields will become an important benchmark for testing Laekna Therapeutics' market competitiveness.

Editor: Gao Jia