Laikai Pharmaceutical-B (02105): LAE002 has been accepted by CDE, and domestic production of AKT inhibitors is coming

AstraZeneca released its 2026Q2 earnings report, and the oncology asset AKT inhibitor TruQAP has become one of the brightest stars.

The drug was seriously underestimated at the beginning of its launch (Evaluate Pharma predicts a peak of 690 million US dollars), but now it has drawn a beautiful and steep sales curve in less than 3 years. 2026Q2 reached a single quarter revenue of 233 million US dollars and showed a trend of accelerating quarterly. Some overseas analysts have already peaked Truqap's sales to 3 billion US dollars.

Across the ocean, another potentially best-in-class AKT inhibitor is scrambling. On August 11, the CDE accepted the NDA for Laikai Pharmaceutical-B (02105) /Qilu Pharmaceutical LAE002 (afluxerate). It is expected to be approved and commercialized in 2027.

You need to know that Qilu Pharmaceutical won the exclusive rights of LAE002 Greater China and spent up to a total of 530 million down payments and clinical development milestone payments. This amount can be squeezed into the first few places in the past domestic drug licensing history in Greater China. The two major factors of “overseas blockbuster+domestic pharmaceutical companies fully betting” go hand in hand. This makes it hard not to hope for LAE002's future market potential.

01 Truqap has always exceeded expectations, and LAE002 is no exception

Truqap's successful commercialization is based on the huge unmet clinical needs of second-line and late-line HR+/HER2- MBc.

HR+/HER2- is the largest part of breast cancer. The first-line standard treatment is endocrine therapy combined with CDK4/6 inhibitors. The problem lies after drug resistance: after CDK4/6i failed, the average progression-free survival (MPFs) of patients dropped from 2 years or more, cliff-style to the level of a few months, and this back-line market lacked uniform standard treatment for a long time, and patients could only be classified and cured by genetic testing. Among them, people with positive PAM pathway changes (PIK3CA/AKT1/PTEN) account for about 50% of second-line patients, which is Truqap's target market.

Breaking up the PAM pathway mutation market, AKT1 and PTEN mutants did not have any approved targeted drugs before. One year after the launch of Truqap, the share of these two groups of people is close to 100%. What really needs competition is the majority of PIK3CA mutants. In the past few years, the biggest competitor was Novartis's PI3Kα inhibitor apeliz, and in fact, the market share of apeliz is being increasingly encroached upon by Truqap.

TruQAP's ability to stand in Pik3ca populations relies on the balance between efficacy and safety, especially safety.

The incidence of any level of hyperglycemia with apeliside is 63.7%, and up to 36.6% of people above grade 3. Nearly 40% of people will experience severe hyperglycemia requiring drug intervention. Many people reduce or stop taking medication as a result; TruQAP is only 2.3% of hyperglycemia above grade 3 in Capitello-291. Hyperglycemia requires long-term monitoring of metabolic indicators, and the clinical side is more willing to switch to Truqap.

Truqap has completed the path of “seizing stock share with better tolerability” overseas, which provides a frame of reference for understanding LAE002. As a potential best-in-class molecule, LAE002 has the conditions to accept this logic in terms of “efficacy + safety + ease of administration”.

Efficacy is clearly the primary factor. Phase III AFFIRM-205, which was announced in April 2026, achieved strong positive top-line results and successfully reached its main end point — showing a highly statistically significant and clinically significant improvement in progression-free survival (PFS) compared to the control group.

The convenience of administration determines the commercial advantage. LAE002 is a continuous dose of 125 mg once a day, and TruQAP is an interval plan of 400 mg twice daily with a four-day break for three days. Obviously, the former is more compliant.

In terms of safety, the company disclosed that AFFIRM-205 was well tolerated by patients, and the withdrawal rate due to adverse events was extremely low. Adverse events (TEAE) associated with grade 3 or above treatment of capivasertib in Capitello-291 reached 42%, and the discontinuation rate due to adverse events exceeded 10%. The lower incidence of grade 3 adverse events is an important characteristic of LAE002 as a BIC.

What needs to be clarified is that the above comparison is an indirect comparison across trials. It is not head-to-head, but the direction seems to be the same: Truqap has proven that this market segment is valuable and can be quickly released. LAE002 has comparable or even better data on efficacy, dosage methods, and tolerability, and clearly has the foundation for replicating this path in commercialization in China and even global competition.

02 FDA gives Capitello-281 the green light to open up the large tumor market

If breast cancer determines the potential for AKT inhibitors to become a blockbuster, then the June 2026 FDA approval for prostate cancer confirmed the ability of AKT inhibitors to become major drugs.

On June 12, 2026, the FDA approved TruQAP in combination with abiraterone gapnisone for PTEN-deficient MAPMn/s (formerly MHSPC) prostate cancer, based on stage III capitello-281: imaging progression-free survival (rPFS) reduced risk of 19% (HR=0.81), and median rPFS extended from 25.7 months to 33.2 months. This is a milestone in the expansion of AKT inhibitors to the second major tumor category, confirming that AKT pathway blocking can also be translated into clinical benefits outside of breast cancer.

Notably, the market for prostate cancer is not as thick as breast cancer. The incidence of PTEN deficiency or AKT pathway activation is higher in prostate cancer than in breast cancer, and about a quarter of MAPMn/s patients have PTEN deficiency. After Truqap got rid of prostate cancer indications, foreign investment banks generally revised their pace expectations of breaking through the $1 billion threshold.

Back to LAE002, it follows the “LAE002+LAE001” self-developed combination route for prostate cancer. The layout is extremely differentiated, and the advantages can be disassembled at the three levels of mechanism, data, and market.

At the mechanism level, LAE001 is a CYP17A1/CYP11B2 dual inhibitor. According to vorosalivan data, it is a new generation of androgen synthesis inhibitors in the world. LAE002 is responsible for blocking the AKT pathway, which is a key drug resistance mechanism, and the combination of the two forms a double attack of “suppression of androgen synthesis plus blockade of the pathway.” This combination is self-developed by Lai Kai, and is more autonomous in patents and pipelines.

At the data level, in the phase II study, LAE201 enrolled 40 patients with mCRPC that progressed after 1- to 3-line standard treatment (containing abiraterone or second-generation AR antagonists), the median rPFS reached 8.1 months, which was a significant improvement compared to the level of 2 to 4 months under historical standard treatment. Based on this signal, its Phase III key trial protocol was approved by the FDA in May 2024 and is a globally registered study.

At the market level, AR pathway drugs for prostate cancer are a large market that is expanding. The AR inhibitor market in China alone is expected to grow from 7.2 billion yuan in 2024 to 23.9 billion yuan in 2030, with a compound annual growth rate of 22% (brokerage estimates). Globally, there is still a large amount of unmet demand in the castration resistance phase (mCRPC) after drug resistance. This is where LAE002+LAE001 enters.

The clinical layout differences between TruQap and LAE002 must be taken out separately. Truqap hits the hormone-sensitive period (MHSPC/mAPMn/s), which is relatively more advanced; LAE002 follows the castration resistance period (mCRPC) after ARPI treatment fails (such as abiraterone, enzalutamide, etc.), which is more difficult to treat later.

However, the two clinical development paths are similar: early data showed signs, the phase III plan was endorsed by the FDA, and later expanded with the strategy of “successful backline and forward”. The success of capitello-281 cannot linearly launch sufficient conditions for LAE002 prostate cancer success, but it is certain that AKT inhibitors can deliver value in prostate cancer.

03 The future can be expected: domestic+global market potential combined with Buff

In the domestic market alone, LAE002's potential market space is quite impressive.

China is one of the most burdened markets for breast cancer in the world, with more than 350,000 new cases and 75,000 deaths in 2022. At the same time, the accessibility of biomarkers is also gradually increasing: the proportion of PIK3CA/AKT1/PTEN changes in the HR+/HER2 population in China is about 57%, which is higher than the global level of about 50%; the risk of progression or death in the Capitello-291 Chinese cohort decreased by 59%, which is also higher than 50% of the global population.

Following the patient funnel, it is possible to construct a transparent peak estimate. Starting with 350,000 new cases per year, the HR+/HER2 ratio, advanced metastasis ratio, second-line treatment ratio and biomarker positive rate, the peak annual patient pool can reach about 33,000 cases; again, based on the pricing of card color changes, assuming an annual treatment cost of about 150,000 yuan, corresponding to a full market reach of about 5 billion yuan.

According to the three levels of peak market share of 25%, 50%, and 75%, LAE002's peak domestic sales for breast cancer alone can be divided into three levels, about 1.25 billion yuan for conservatives, 2.5 billion yuan for neutral, and 3.75 billion yuan for optimism, respectively.

What is more likely to be underestimated than domestically is LAE002's overseas value.

The key point is that LAE002+LAE001 is a global registered study approved by the FDA. Lai Kai only gave LAE002 China to Qilu. Overseas rights are still in their own hands, and they already have the foundation for international multi-center clinical trials. The pricing of prostate cancer assets in the global BD market can be clearly seen from some overseas cases.

In February 2026, Astellas and VIR reached a global cooperation on the prostate cancer research asset VIR-5500, with a down payment of US$335 million (240 million in cash plus 75 million in equity investment), reaching a high milestone of US$1.37 billion, with a total maximum total of about US$1.7 billion. Notably, the VIR-5500 was still in Phase I at the time. One direct reason Astellas is willing to take action at such an early stage is that its partner Xtandi is facing patent expiration and needs to fix the prostate cancer pipeline. This shows that major pharmaceutical companies are very willing to pay for prostate cancer assets, and there is no need to wait for later data.

LAE002+LAE001 has clear commonalities with the Astellas/viR case: it also targets large prostate cancer tumors, and also shows potential for early prostate cancer efficacy. The difference is that LAE002 also has an AKT mechanism that has been verified by Capitello-281. This is a certainty that the assets of the new mechanism do not have.

Before Truqap defeated prostate cancer, the market had almost no expectations for LAE002 to pack LAE001 and go overseas. After the FDA gave Capitello-281 the green light, the matter of going overseas is changing in a positive direction.

Conclusion: To bring the three lines together, we need to redefine LAE002's market potential.

The commercialization of breast cancer overseas and the commercialization bet of Qilu Pharmaceutical have laid the final stage for LAE002's domestic commercialization; the mechanistic verification of prostate cancer and global phase III clinical readiness have given LAE002 a clear second growth curve; while the expectation of overseas licensing gradually went from 0 to existence, this is a huge hidden option.

$1 billion or $3 billion? In any case, we will witness the fulfillment and growth of this future blockbuster.

This article is reprinted from “Gazelle Club”, Zhitong Finance Editor: Feng Qiuyi.