LAE Pharmaceuticals Secures $2.85 Billion BD Deal for AKT Inhibitor LAE002 in Breast Cancer, Entering Commercialization Phase

Who understands the gold content of this order.

On November 12, Laekna Therapeutics (02105) granted the rights to its breast cancer candidate new drug LAE002 (afuresertib) in China to Qilu Pharmaceutical Co., Ltd. The total transaction amount reached 2.045 billion yuan, and Laekna Therapeutics is also entitled to receive tiered sales royalties ranging from over ten to twenty percent.

The upfront payment is usually the face of a BD deal, but this time it's different.

LAE002 is one of the two AKT inhibitors globally in late-stage clinical development for breast and prostate cancer, ranking among the top two globally and first in China.Based on its drug development potential, the significant potential of a single breast cancer product, and Qilu Pharmaceutical's exceptional commercialization capabilities, Laekna Therapeutics is highly likely to fully capitalize on the upfront payment, milestone payments, and tiered sales royalties.

The collaboration between the R&D-focused Biotech and traditional Big Pharma has achieved the optimal allocation of innovative resources and commercialization resources. After securing a long-term and stable cash flow through innovative drugs in the cancer field, Laekna Therapeutics, as a global leader in muscle growth and fat reduction, will accelerate the advancement of its subsequent rich pipeline of potential products.

Only large orders with real value are considered significant.

Laekna Therapeutics' First Innovative Drug Successfully Enters Commercialization Phase.

The commercialization of LAE002 in China, in collaboration with Big Pharma Qilu Pharmaceutical, has a highly predictable outlook.

Laekna Therapeutics Grants Qilu Pharmaceutical Co., Ltd. Exclusive Rights for Research, Development, and Commercialization of Breast Cancer Candidate Drug LAE002 in China.

Until the first indication receives new drug application approval in China, Laekna Therapeutics is entitled to receive non-refundable upfront and clinical development milestone payments totaling up to RMB 530 million.

According to the licensing agreement, Laekna Therapeutics is eligible to receive an upfront payment and milestone payments totaling up to RMB 2.045 billion, as well as tiered royalties ranging from over ten to twenty percent based on the product's net sales.

This is a highly valuable large order, and Laekna Therapeutics is expected to take in all of the above benefits.

Breast Cancer: A Hotbed of Molecular Stars

The large base of breast cancer patients is a cradle for nurturing star molecules.

Breast cancer is the second most common cancer globally. According to WHO data, there were approximately 2.3 million new breast cancer cases worldwide in 2022, accounting for 11.5% of all new cancer cases that year. The incidence rate of breast cancer among Chinese women is 51.17 cases per 100,000 people, with a mortality rate of 10.86 deaths per 100,000 people.

The global sales of CDK4/6 inhibitors ribociclib and abemaciclib exceeded $3 billion and $5.3 billion respectively in 2024, while the sales of HER2 ADC molecules Kadcyla and Enhertu also surpassed $2 billion and $3.8 billion respectively in 2024.

HR+/HER2- (Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative) accounts for approximately 60~70% of all breast cancer patients, making it the most common type of breast cancer. Although most patients initially benefit from first- or second-line endocrine therapy combined with CDK4/6 inhibitors and/or chemotherapy, after a period of time, the majority may develop resistance, leading to treatment failure. Patients urgently need new treatment options post-resistance.

AKT Inhibitors as a New Therapy for HR+/HER2- Breast Cancer After Drug Resistance Bring Hope to Patients and Will Spawn a New Generation of Star Molecules.

In November 2023, AstraZeneca's Capivasertib, the world's first AKT inhibitor, was approved for marketing by the FDA, providing dual validation of the drugability and commercial value of AKT inhibitors.

Capivasertib's first full sales year (2024) post-launch sees $430 million in revenue, securing a dominant position in the U.S. market as a second-line therapy. In the first three quarters of 2025, Capivasertib’s sales reached $495 million, marking an 85% year-over-year increase, continuing its rapid growth.

The Position of LAE002 in the Industry

LAE002 from Laekna Therapeutics is a potent AKT inhibitor that can inhibit all three AKT subtypes (AKT1, AKT2, and AKT3). Its progress in the HR+/HER2- breast cancer indication is second only to AstraZeneca's Capivasertib globally.

According to publicly available data, compared with other AKT inhibitors, LAE002 has multiple advantages such as higher efficacy, better potency, more significant tumor suppression exposure, and improved safety. Its indications broadly cover breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1 resistant solid tumors.

According to Guotai Haitong Securities, in the Phase Ib study of LAE002 combined with fulvestrant for locally advanced or metastatic HR+/HER2- breast cancer patients who failed standard treatment, the ORR reached 33.3% and mPFS was 7.3 months in the population with PIK3CA/AKT1/PTEN pathway alterations.

Compared with the Phase III China data of Capivasertib combined with fulvestrant, in the population with PIK3CA/AKT1/PTEN pathway alterations, the PFS was 5.7 months, while the PFS data for fulvestrant monotherapy was 1.9 months; LAE002 demonstrated a more significant benefit.

Laekna Therapeutics is confident in submitting the drug marketing application. Currently, the Phase III clinical trial (AFFIRM-205) of LAE002 for HR+/HER2- breast cancer is recruiting as planned. Laekna Therapeutics will be responsible for completing this Phase III clinical trial (AFFIRM-205), with the goal of completing participant enrollment by Q4 2025, and plans to submit the NDA to the CDE in 2026.

According to a broker's research report, the peak domestic sales of LAE002 are expected to be around 2 billion yuan, and the global sales peak can be referenced to Capivasertib. The sales forecast for Capivasertib this year is 700-800 million US dollars, with a sales peak expected to be 1-2 billion US dollars.

The Invisible Giant: Qilu Pharmaceutical

Large Single Product Potential + Drugability Validation: The Logic Behind LAE002 Being Favored by the Invisible Giant Qilu Pharmaceutical Co., Ltd. is Now Clear.

As a non-publicly traded company, Qilu Pharmaceutical, this veteran pharmaceutical enterprise, is shrouded in a layer of mystery. What kind of legendary existence is it?

In 2023, the United States faced a shortage of the chemotherapy drug cisplatin injection and urgently purchased from Qilu Pharmaceutical, even without having time to replace the Chinese packaging, highlighting Qilu Pharmaceutical's position in the global pharmaceutical industry chain.

Qilu Pharmaceutical ranked among the top three in China's pharmaceutical industry in 2024. It currently has 12 subsidiaries globally, 11 manufacturing bases within China, and more than 36,000 employees. Its products are exported to over 100 countries and regions worldwide, with more than 300 products launched cumulatively, of which over 55 were first introduced in China.

Qilu Pharmaceutical, known as the king of first generics, focuses on major varieties and its speed in taking the lead is breathtaking.

Less than a month after AstraZeneca's original drug, dapagliflozin metformin sustained-release tablets, was officially commercialized in China, in December 2023, Qilu Pharmaceutical's submission of a Category 4 generic drug, dapagliflozin metformin sustained-release tablets (I) / (III), received acceptance from the CDE. The original manufacturer of the CDK4/6 inhibitor palbociclib is Pfizer, with its sales steadily exceeding 5 billion US dollars from 2020 to 2022. In January 2023, the Chinese compound patent for palbociclib expired, and in February 2023, Qilu Pharmaceutical’s palbociclib capsules were officially launched, marking the first generic version of palbociclib in China.

Qilu Pharmaceutical Makes a Fortune Quietly, Repeatedly Verifying the Ability to Create Major Products.

The patent protection for Bevacizumab's originator drug Avastin in China expired in 2018. In December 2019, Qilu Pharmaceutical launched the first generic version of Bevacizumab biosimilar Ankeda. By 2020, its sales rapidly climbed to 1.8 billion yuan. In 2021, Ankeda’s sales in sample hospitals were almost twice that of Avastin, making it the first biosimilar in China to achieve local substitution. By 2022, its sales exceeded 4 billion yuan.

Everything is the best arrangement. Laekna Therapeutics transferring the China rights of LAE002 to Qilu Pharmaceutical can maximize commercial value. As a major player in each round of centralized procurement, Qilu Pharmaceutical also needs to invest more in innovative drugs to seek new growth points.

Strengthening the Fundamentals of Muscle Gain and Fat Loss

The collaboration between Laekna Therapeutics and Qilu Pharmaceutical achieves the optimal allocation of research and development and commercial resources. This represents the increasingly clear division of labor in China's pharmaceutical industry chain, focusing on what to do and what not to do. Moreover, complementary resource matching between different types of enterprises is also a breakthrough against internal competition and homogenization.

LAE002 is only the prologue, fully validating Laekna Therapeutics' BD capabilities, clinical execution, and financial strength, while also solidifying Laekna's foundation in muscle gain and fat reduction. Weight-loss drugs are being redefined, with preserving or even increasing lean body mass becoming a key goal of next-generation weight-loss therapies. Combination therapies, muscle protection, dosage form innovation, and mechanism expansion will become the core competitive areas in the future.

At the end of October, AstraZeneca completed the acquisition of SixPeaks for a total transaction value of $300 million. This offer is not low, as SixPeaks' pipeline assets targeting ActRIIA/B are still in the preclinical stage. Moreover, similar to Bimagrumab, these compounds inhibit both A and B receptors simultaneously, and their potential side effects remain an unknown factor for the future.

The advantage of Laekna's LEA102 is that it only inhibits ActRIIA, with clinical data validating its muscle-building and fat-reducing mechanism. If ActRIIB needs to be inhibited separately, there is also LAE103.

On September 29, Laekna Therapeutics disclosed positive preliminary results from the Phase I multiple ascending dose study of LAE102 (ActRIIA monoclonal antibody) for the treatment of obesity conducted in China. At week 5, subjects in the LAE102 6mg/kg dose group showed an average increase in lean body mass of 1.7% from baseline, while average fat mass decreased by 2.2%. After adjustment for the placebo control group, the average increase in lean body mass reached 4.6%, and the average reduction in fat mass was 3.6%. This MAD study demonstrated good tolerability and safety, with no serious adverse events reported. Most treatment-emergent adverse events were mild (Grade 1) laboratory abnormalities. No cases of diarrhea, muscle cramps, or acne were reported.

As a global leader in muscle gain and fat loss, Laekna Therapeutics is actively negotiating with several global and regional leading pharmaceutical companies to find the best partners for its high-quality assets in the pipeline. The out-licensing of LAE002 adds to its already robust financial position, giving Laekna greater confidence to maintain strategic selectivity in negotiations, ensuring that each collaboration maximizes mutual benefits and systematically unleashes the global potential of its R&D platform.

Laekna Therapeutics previously had over 1.2 billion yuan in cash (including placement), plus the 530 million yuan upfront payment and clinical development milestone payments from this deal, bringing the total cash assets to 1.8 billion yuan. This means Laekna Therapeutics' current non-cash market value is only over 3 billion yuan. Referring to the market value changes after the domestic project of Andes China was implemented, with over 1.5 billion yuan in milestone payments and double-digit sales royalties, Laekna Therapeutics has sufficient support for a 10-billion-yuan market value.

LAE102 was not priced at all, representing additional value given to shareholders.

As one of the leading players in the next generation of weight-loss therapies, Laekna Therapeutics' journey of value discovery has just begun.

This article is reprinted from the WeChat Official Account "Archimedes Biotech", authored by Archimedes; edited by Xu Wenqiang of Zhitong Finance.