China’s First AKT Inhibitor Capivasertib Arrives at Jiahui International Hospital
Capivasertib is the first and only AKT inhibitor approved in China for breast cancer patients with PIK3CA, AKT1, or PTEN alterations. The drug was first approved in the United States in 2023, and in 2024 it entered the Japanese and EU markets, receiving positive clinical feedback. In April this year, Capivasertib was approved in China and is now available at the Jiahui International Hospital Cancer Center in Shanghai.
A New Option for HR-Positive Advanced Breast Cancer Patients
Breast cancer is the second most common cancer worldwide, and HR-positive breast cancer is one of its most prevalent subtypes, driven primarily by estrogen receptor signaling.
In advanced HR-positive breast cancer, endocrine therapy combined with CDK4/6 inhibitors is a common first-line treatment. However, tumors often develop resistance to these therapies, leading to disease progression—particularly in patients carrying PIK3CA, AKT1, or PTEN alterations. Once resistance develops, treatment options are limited and survival rates are low, with only an estimated 35% of patients surviving more than five years after diagnosis.
Capivasertib’s approved indication specifically addresses these HR-positive, endocrine-resistant advanced breast cancer patients, especially those with one or more PIK3CA/AKT1/PTEN alterations. These genetic changes are common in this population; in China, approximately 57% of HR-positive, HER2-negative breast cancer patients carry one or more of these alterations. Capivasertib provides a precise therapeutic target for this challenging patient group.
Precisely Blocking Cancer Cell Growth Signals
Capivasertib inhibits AKT phosphorylation, thereby blocking key signals for cancer cell proliferation and survival. It remains effective in patients resistant to traditional hormone therapy. Combined with fulvestrant, Capivasertib significantly prolongs progression-free survival (PFS).
A global, multicenter, double-blind, randomized Phase III CAPItello-291 clinical trial in 2022 included 708 patients worldwide, including 134 from mainland China and Taiwan. The results showed that Capivasertib combined with fulvestrant significantly prolonged median PFS, from 3.1 months (fulvestrant alone) to 7.3 months, reducing the risk of disease progression or death by 50% (HR 0.50; 95% CI 0.38–0.65; p < 0.001). In the Chinese subgroup, the combination therapy also demonstrated substantial benefits, reducing disease progression or death risk by 59% in patients carrying PIK3CA, AKT1, or PTEN alterations (HR 0.41; median PFS 5.7 months vs. 1.9 months).
Shanghai Jiahui International Hospital: International-Standard Care, Globally Synchronized
· Testing First: Confirmation of PIK3CA, AKT1, or PTEN mutation status is required before therapy.
· One-Stop Oncology Care: After testing, patients are advised to consult our specialists at Jiahui Cancer Center to discuss and create a personalized treatment plan. Clinicians dynamically monitor efficacy and safety throughout therapy.
· Multidisciplinary Medication Management: During Capivasertib therapy, clinical staff and pharmacists closely monitor adverse reactions and comprehensively assess patients’ conditions, ensuring safe and effective treatment.
The introduction of Capivasertib marks the AKT inhibitor era in breast cancer targeted therapy in China, offering significant survival benefits to patients with resistant disease.
Our goal is to rapidly introduce globally leading oncology therapies, bringing hope to patients.
Pharmacy Services Include:
Jiahui International Cancer Center & Pharmacy Services
· Drug Supply & Quality Management:
1. Fully comply with GSP (Good Supply Practice), ensuring traceable procurement, storage, and dispensing.
2. Import original international drugs and high-quality generics to meet the needs of cancer and rare disease patients.
· Clinical Pharmacy Services:
1. Pharmacists participate in multidisciplinary team (MDT) consultations, providing optimized medication plans for complex cases.
2. Therapeutic Drug Monitoring (TDM): individualized dosing adjustments for anti-infectives, antitumor agents, and more.
3. Medication Oversight: 24-hour online review of all prescriptions, with pre-prescription auditing systems to promote safe, standardized clinical use and reduce risks.
· Comprehensive Patient Education:
Provide consultation windows and online guidance. All patients receive face-to-face medication counseling, bedside instructions upon discharge, and enhanced education/follow-up for special cases (e.g., first-time antitumor therapy), reducing fear and improving adherence.
