(August 18, 2025, Shanghai, China）— On August 18, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; SSE: 600196, HKEX: 02196) announced that its self-developed innovative drug Luvometinib Tablets(Chinese trade name:复迈宁^®; the “Drug”) has gained Breakthrough Therapy Designation by the Saudi Food and Drug Authority(SFDA) for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms. This milestone marks the acceleration of the Drug’s registration and commercialization process in Saudi Arabia.

“We are delighted that Luvometinib Tablets has gained Breakthrough Therapy Designation from the SFDA for the indication of adult patients with LCH. This not only reflects the international recognition of the Drug’s clinical value, but also marks another important milestone in Fosun Pharma’s globalization journey.”  Xingli WANG, Co-President of Fosun Pharma and CEO of Global R&D Center, said, “Fosun Pharma remains patient-centered, focuses on unmet medical needs, and accelerates the development of innovative medicines by leveraging our global footprint and integrating global resources. Looking forward, we will collaborate closely with local authority and partners to speed up access to this breakthrough therapy of the Drug in Saudi Arabia, contributing to the development of the local healthcare industry and creating better health for families worldwide.”

The SFDA’s Breakthrough Therapy Designation pathway is designed to accelerate the development and review of innovative medicines, in order to address serious or life-threatening diseases with unmet medical needs. Breakthrough therapies are drugs that demonstrate significant advantages over existing treatments in managing serious or life-threatening diseases. These drugs typically demonstrate significant improvements in efficacy or safety and have the potential to transform the course of disease treatment. Drugs granted Breakthrough Therapy Designation can be reviewed within 60 working days after the submission of a New Drug Application, significantly shortening the time to market.

Luvometinib Tablets is a highly selective MEK1/2 inhibitor. The Breakthrough Therapy Designation for the indication of adult patients with LCH in Saudi Arabia is based on the Drug’s compelling efficacy and favorable safety profile demonstrated in clinical studies. Previously, the Drug has already been approved in China with two indications, including the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms; and the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection, filling important treatment gaps in the domestic rare disease field.

The New Drug is the first and only drug approved in China for both adult LCH/histiocytic neoplasms and NF1-associated PN in children aged two and above. As an innovative small molecule chemical drug self-developed by Fosun Pharma (i.e., the Company and its subsidiaries/units, the same applies below), the New Drug works by selectively inhibiting MEK1/2, blocking abnormal activation of the MAPK pathway, suppressing tumor cell growth, and inducing apoptosis.^[1],[2],[3]Based on clinical data, the New Drug demonstrates proven efficacy, good safety, and faster onset than current therapies, providing a valuable new option for clinical use. Abnormal MAPK activation is common in many solid tumors and rare diseases, such as adult histiocytic neoplasms and NF1-associated PN in children. These mutations are considered key drivers of disease onset and progression.^[4] Compared to traditional chemotherapy and surgery, MEK-targeted therapies offer greater precision and manageable side effects, providing patients with a more effective treatment option^[5].

As an innovation-driven global healthcare company, Fosun Pharma is committed to delivering high-quality innovative medicines to patients worldwide through its global footprint, global R&D and commercialization capabilities. Fosun Pharma’s R&D focuses on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. Fosun Pharma is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. Currently, Fosun Pharma has established a mature commercialization network across overseas markets including the United States, Europe, Africa, India, and Southeast Asia, supported by an international commercial team of around 1,000 people. Meanwhile, Fosun Pharma is also actively expanding into the Middle East and Southeast Asia. In April 2025, Fosun Pharma forged strategic partnership with Fakeeh Care Group in Saudi Arabia to promote the introduction of innovative products and leading therapies in Saudi Arabia. In November 2024, Fosun Pharma’s subsidiary Henlius entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company (“SVAX”) to establish joint ventures in Saudi Arabia, promoting the accessibility of innovative and high-value products across the Middle East, North Africa, and Türkiye (MENAT) countries.

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About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce.

Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its “4IN” strategy - Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide.

Looking ahead, Fosun Pharma remains anchored in its core values of “Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership”. By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide.

For more information, please visit our official website: www.fosunpharma.com

[1]Cacciotti C, et al. J Neurooncol. 2025 Jan;171(2):265-277.

[2]Hanrahan AJ, et al. Nat Rev Clin Oncol. 2024 Mar;21(3):224-247.

[3]Anaya YA, et al. Int J Mol Sci. 2025 Mar 16;26(6):2676.

[4]Chen J, Zhao AL, Duan MH, at al. Leukemia. 2022 Feb;36(2):573-576

[5]Histiocytic Neoplasms NCCN guidelines 2024.V3