（August 19, 2021, Hainan, China) On August 18, Takeda Pharmaceutical Company Limited announced that brigatinib tablets (Brigatinib), an innovative lung cancer therapeutic, has received approval from the Hainan Provincial Medical Products Administration. As an urgently needed clinical treatment for patients who have progressed on crizotinib, the drug has officially been launched at the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port, with the first patient recently receiving treatment at Boao Evergrande International Hospital. Takeda’s brigatinib tablets is an innovative product indicated for the treatment of ALK-positive non-small cell lung cancer (NSCLC) and has previously been approved in Europe and the United States. Benefiting from the "early access" pilot policy, brigatinib tablets have expedited their approved use in Boao Lecheng, enabling patients in China to access internationally advanced innovative therapies without leaving the country, thereby addressing their urgent clinical needs for this medication.
Medical staff at Boao Evergrande International Hospital deliver Takeda's new lung cancer drug, Brigatinib tablets, to the ward.
Lung cancer is one of the cancers with the highest incidence and mortality rates worldwide. According to statistics, 1.8 million people globally die from lung cancer annually, accounting for 18.4% of all cancer-related deaths. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 80%–85% of newly diagnosed lung cancer cases worldwide each year. Among these, ALK-positive non-small cell lung cancer (ALK+ NSCLC) is a relatively rare but highly aggressive and distinct subtype. In China, nearly 35,000 new cases of ALK+ NSCLC are diagnosed annually. Patients are typically diagnosed at a relatively young age. Up to 30% of patients present with brain metastases at the time of diagnosis, and 75% experience intracranial progression within two years of diagnosis. This significantly compromises patients' quality of life, underscoring the urgent unmet treatment needs for these patients.
Takeda Brigatinib Tablets are a second-generation selective tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). According to results from the international clinical study ALTA-1L, investigator-assessed median progression-free survival (mPFS) reached 29.4 months (HR=0.43, P<0.0001) following treatment with Brigatinib Tablets, with a confirmed objective response rate (ORR) of 74%. For patients with baseline measurable brain metastases, the confirmed intracranial objective response rate in the Brigatinib treatment group reached 78%, helping to address the unmet medical needs of this patient population. Consequently, it was selected as Takeda’s first product introduced in Boao to accelerate patient access in China.
Brigatinib Tablets (Brigatinib)
Prof. Ye Gang, Director of the Department of Medical Oncology at Boao Evergrande International Hospital, stated: “Brain metastasis is relatively common in patients with ALK-positive non-small cell lung cancer (NSCLC). Constrained by the inability of conventional chemotherapy agents to cross the blood-brain barrier, and further compounded by drug resistance, current treatment options remain relatively limited. I am very pleased to witness the introduction of brigatinib tablets in Lecheng. Through the ‘first-to-try’ special medical policy, this will accelerate the delivery of another novel therapy to patients, contributing to the continuous improvement of long-term survival rates and the enhancement of patients’ quality of life.”
The Boao Lecheng International Medical Tourism Pilot Zone is the first “medical special zone” in China to pilot the application of clinical real-world data, and has now become an important window for international innovative drugs to enter China with priority. Since 2020, Takeda and Lecheng have comprehensively deepened their cooperation. During the 3rd China International Import Expo (CIIE), the two parties officially signed 《Memorandum of Strategic Cooperation》, establishing a comprehensive and in-depth strategic partnership in the fields of medical innovation and medical technology to jointly enhance patient access to innovative medicines. To date, multiple innovative drugs from Takeda have been included in the pilot zone's Permitted List. In the recently released 2021 edition of the Hainan Free Trade Port Boao Lecheng Global Special Drug Insurance, brigatinib tablets are also included.