Astellas Partners with Beijing Biostar for Upcoming China Launch of Leukemia Drug Gilteritinib (XOSPATA®)

By Linan

Accelerating the priority review and approval of innovative drugs, establishing a list of overseas new drugs urgently needed for clinical use... In recent years, accompanied by the reform of China's drug review and approval system, an increasing number of global innovative drugs have been accelerating their entry into the Chinese market. Against the backdrop of China’s vigorous encouragement of pharmaceutical innovation, efforts to accelerate the introduction of new drugs, and the optimization of the business environment, the Chinese pharmaceutical market has become increasingly attractive to multinational pharmaceutical companies. These companies are successively establishing manufacturing facilities in China and increasing their R&D investments. Meanwhile, how to rapidly commercialize more innovative drugs to meet the needs of a larger patient population is also a close concern for these pharmaceutical giants.

Signing Ceremony

On December 16, ahead of the imminent launch of a new leukemia drug in China, Astellas announced a deepened partnership with Baheal Medical. Baheal will provide integrated solutions covering bonded import customs clearance, warehousing, and logistics, along with an omnichannel commercialization platform for XOSPATA® (generic name: gilteritinib fumarate tablets). This collaboration aims to comprehensively improve medication accessibility for adult patients with FLT3-mutated acute myeloid leukemia (AML).

In 2018, XOSPATA® was successively approved for marketing in Japan and the United States, followed by approval in Europe in 2019. In April this year, China’s National Medical Products Administration (NMPA) accepted the new drug application (NDA) for XOSPATA®. In July, the NDA was included in the priority review program, and in November, the drug was added to the third batch of the List of Overseas New Drugs Urgently Needed for Clinical Use. Industry experts anticipate that XOSPATA® is expected to be launched in the Chinese market in the first quarter of next year.

XOSPATA® is a drug discovered through a research collaboration between Astellas and Kotobuki Pharmaceutical Co., Ltd. Astellas holds exclusive global rights for the development, manufacturing, and commercialization of gilteritinib. This medication is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations.

Data indicates that acute myeloid leukemia (AML) is a malignancy affecting the blood and bone marrow, with its incidence increasing with age. AML is one of the most common types of leukemia in adults. Statistics show that approximately 80,000 people are diagnosed with leukemia annually in China. Over the past decade, progress in the treatment of relapsed or refractory acute myeloid leukemia has been slow, characterized by short survival times and numerous complications. Apart from salvage chemotherapy and hematopoietic stem cell transplantation, therapeutic options remain very limited.

Patients with FLT3 mutation-positive acute myeloid leukemia (AML) have a very poor prognosis, with a median survival of less than 6 months after salvage chemotherapy. During the course of AML treatment, and even after relapse, the FLT3 mutation status may change. Therefore, confirming the patient’s FLT3 mutation status helps determine the optimal treatment approach. Gilteritinib, an inhibitor of FMS-like tyrosine kinase 3 (FLT3), demonstrates significant inhibitory activity against the two common FLT3 mutations—FLT3-ITD and FLT3-TKD—found in approximately one-third of patients with acute myeloid leukemia.

A set of studies on XOSPATA showed that in the population with relapsed or refractory acute myeloid leukemia (AML) after chemotherapy, researchers compared the overall survival rate between 247 patients taking XOSPATA and 124 patients receiving chemotherapy. The results indicated that the median OS for patients taking XOSPATA was 9 months, while it was 6 months for those receiving chemotherapy; among patients who achieved complete remission with XOSPATA, the median duration of maintained remission was 15 months, whereas it was 2 months for chemotherapy.

Regarding the inclusion of gilteritinib in the Priority Review program and its addition to the List of Overseas New Drugs Urgently Needed for Clinical Use, Hiroshi Hamaguchi, Chairman and General Manager of Astellas Pharma (China) Co., Ltd., stated that this development was highly encouraging and deeply reinforced their perception that the continuous optimization of China’s drug evaluation and approval system has significantly accelerated the introduction of new medicines.

As early as March 2019, Astellas and Baheal Medical initiated their first collaboration, joining forces to accelerate the introduction of Astellas’ tamsulosin hydrochloride sustained-release capsules (brand name: Harnal) into retail channels. This effort aimed to improve the quality of life for a broad population of patients with benign prostatic hyperplasia (BPH) by further expanding patient access to high-quality medications. In 2020, the two parties entered into a strategic partnership regarding the original febuxostat tablets (brand name: Feburic), indicated for the long-term treatment of hyperuricemia in patients with gout symptoms.

Driven by a series of pharmaceutical policies, China’s pharmaceutical industry structure is undergoing intensified adjustment and transformation. It is predictable that innovation will become the core competitiveness of pharmaceutical companies, while cost control will also be crucial. The era of high gross margins is gone for good, and thereafter, the entry barriers for commercialization platforms in China’s pharmaceutical sector are expected to rise continuously. It can be seen that Astellas’ renewed collaboration with Baheal Medical is attributable to the unique “appeal” of its commercialization platform.

It is also worth noting that in 2019, the Ninth Meeting of the Central Committee for Comprehensively Deepening Reforms approved the “Overall Plan for the Construction of the China-SCO Local Economic and Trade Cooperation Demonstration Zone,” aiming to build a new platform for international cooperation under the Belt and Road Initiative (BRI) in Qingdao, the core city of the demonstration zone, thereby promoting an open pattern characterized by mutual reinforcement between eastward and westward flows and coordinated linkage between land and overseas markets. As the leading private enterprise in Qingdao’s pharmaceutical industry, Baheal Medical has actively integrated into the national strategy of building this new BRI international cooperation platform. With comprehensive qualifications for drug imports and Customs AEO certification, Baheal demonstrates its robust capabilities in overseas pharmaceutical import operations.

It is reported that Baheal Medical has a professional import operations team providing end-to-end services, covering bonded import customs clearance, cold-chain warehousing, and efficient logistics distribution, thereby facilitating international logistics channels for overseas pharmaceuticals. In the future, products can be imported directly from Japan into China via the Qingdao port through both air and sea freight. This will help enterprises improve efficiency and reduce costs, contributing to Qingdao’s development of the SCO Demonstration Zone.

Breaking away from the traditional brand-oriented corporate image previously held by the public, Baheal Medical is now striving to become the largest third-party professional pharmaceutical commercialization platform in the downstream sector of China’s pharmaceutical industry, aiming to build a “highway” for health brands. Leveraging 15 years of deep industry expertise, Baheal currently boasts a robust marketing network. Through its differentiated capabilities in omni-channel coverage, multi-category synergy, and digital marketing, it provides comprehensive omni-channel solutions for upstream manufacturers, facilitating the rapid integration of high-quality products and services into their application scenarios.

Baheal Medical’s commercialization platform not only helps original research drugs unlock their brand value in retail channels and provides new retail operational services for big health brands such as medical aesthetics products, but also accelerates the market entry of new and specialized drugs, optimizes costs for pharmaceutical companies, enhances efficiency, and promotes industry development. With its increasingly robust commercialization platform, Baheal Medical has attracted numerous partners in recent years, including Mylan, Xian Janssen, Takeda, Grifols, and 3SBio.