Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablets Gains Approval for Adult NF1 Indication, Achieving Full Age-Coverage for NF1 Patients
(September 3, 2026, Shanghai, China) — Fosun Pharma (“the Company”, stock code: 600196.SH; 02196.HK) announced that its self-developed MEK1/2 inhibitor, Fu Mai Ning (luvometinib tablets), has received approval from the National Medical Products Administration (NMPA) for a new indication: the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The approval of this new indication marks full age-group coverage in the NF1 indication for this domestically developed innovative drug, providing a new treatment option for Chinese adult NF1-PN patients.
Prior to this, Fu Mai Ning had already received approval in China for three indications: for adult patients with Langerhans-cell histiocytosis (LCH) and histiocytic tumors; for pediatric and adolescent patients (aged 2 and above) with symptomatic, inoperable NF1-PN; and for pediatric and adolescent patients (aged 2 and above) with relapsed or refractory LCH following systemic therapy. The approval for the adult NF1-PN indication effectively completes the treatment continuum for NF1 patients, spanning from children and adolescents to adults.
Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder caused by mutations in the NF1 gene, with a global neonatal incidence of approximately 1 in 3,000. Plexiform neurofibromas (PN) develop in 30%-60% of these patients, potentially leading to pain, impaired organ function, and facial or other physical deformities. Historically, treatment options for adult NF1-PN have been extremely limited, mainly relying on surgery. However, surgical intervention is often incomplete due to the diffuse nature of the tumors, resulting in high recurrence rates and suboptimal long-term disease control. The recurrent surgical burden significantly impacts patients’ quality of life and places immense strain on families. No pharmacological treatments have been available for adult NF1-PN patients with inoperable tumors, highlighting a vast unmet clinical need in the adult NF1-PN space in China.
Fu Mai Ning is a highly selective MEK1/2 inhibitor independently developed by Fosun Pharma. By precisely blocking the aberrant activation of the MAPK signaling pathway, it inhibits tumor cell proliferation and induces apoptosis, offering a novel targeted therapeutic approach for MAPK pathway-driven diseases like NF1-PN. In a randomized, double-blind, placebo-controlled Phase III clinical study involving 167 adult patients randomized in a 2:1 ratio (112 receiving Fu Mai Ning), the confirmed objective response rate (ORR) evaluated by the Blinded Independent Central Review (BICR) reached 43.8% in the Fu Mai Ning arm, with a median time to response of 3.9 months. The drug effectively relieved tumor-related pain, delivering dual benefits in tumor shrinkage and clinical symptom improvement. Adverse drug reactions were mostly Grade 1-2 with a manageable overall safety profile, offering a new treatment choice for inoperable patients[1].
Fu Mai Ning is China’s first domestically-developed targeted therapy for the treatment of neurofibromatosis type 1. It is also the only innovative drug in China that simultaneously covers two major rare diseases, including Langerhans-cell histiocytosis (LCH) and neurofibromatosis type 1 (NF1), with a treatment scope extending across all age groups from children to adults. Its differentiated product positioning, supported by robust clinical data, underscores its significant value in the precision treatment of rare diseases in China. To date, over 20 academic papers and international conference abstracts related to luvometinib have been published, earning widespread recognition from the global academic community.
Furthermore, Fosun Pharma is actively advancing the diversified R&D pipeline for this drug, with multiple new indications progressing steadily, including a Phase 3 clinical trial for pediatric low-grade glioma, a Phase 2 trial for extracranial arteriovenous malformations, and a Phase 2 trial for the combination therapy with anlotinib in KRAS-mutant advanced non-small cell lung cancer.
As a flagship self-developed asset stemming from Fosun Pharma’s deep commitment to rare diseases and precision oncology, the approval of Fu Mai Ning for the adult NF1 indication significantly reinforces the company’s innovative leadership in China’s targeted therapy landscape for rare diseases. Looking ahead, Fosun Pharma remains dedicated to focusing on unmet clinical needs, accelerating the translation and development of innovative drugs, and striving to make more domestically-developed innovative therapies accessible to a broader patient population.
About Fosun Pharma
Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem.
Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia.
Looking ahead, guided by the strategy of “Innovation Driven, Deep Globalization, and AI Embracement”, Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health.
For more information about the Group, please visit the company website: https://www.fosunpharma.com/en/
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[1] Li W, et al. Luvometinib in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas: a randomized, double-blind, placebo-controlled, phase 3 trial. Presented at: 2026 ASCO Annual Meeting; May 29-June 2, 2026. Abstract
Prior to this, Fu Mai Ning had already received approval in China for three indications: for adult patients with Langerhans-cell histiocytosis (LCH) and histiocytic tumors; for pediatric and adolescent patients (aged 2 and above) with symptomatic, inoperable NF1-PN; and for pediatric and adolescent patients (aged 2 and above) with relapsed or refractory LCH following systemic therapy. The approval for the adult NF1-PN indication effectively completes the treatment continuum for NF1 patients, spanning from children and adolescents to adults.
Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder caused by mutations in the NF1 gene, with a global neonatal incidence of approximately 1 in 3,000. Plexiform neurofibromas (PN) develop in 30%-60% of these patients, potentially leading to pain, impaired organ function, and facial or other physical deformities. Historically, treatment options for adult NF1-PN have been extremely limited, mainly relying on surgery. However, surgical intervention is often incomplete due to the diffuse nature of the tumors, resulting in high recurrence rates and suboptimal long-term disease control. The recurrent surgical burden significantly impacts patients’ quality of life and places immense strain on families. No pharmacological treatments have been available for adult NF1-PN patients with inoperable tumors, highlighting a vast unmet clinical need in the adult NF1-PN space in China.
Fu Mai Ning is a highly selective MEK1/2 inhibitor independently developed by Fosun Pharma. By precisely blocking the aberrant activation of the MAPK signaling pathway, it inhibits tumor cell proliferation and induces apoptosis, offering a novel targeted therapeutic approach for MAPK pathway-driven diseases like NF1-PN. In a randomized, double-blind, placebo-controlled Phase III clinical study involving 167 adult patients randomized in a 2:1 ratio (112 receiving Fu Mai Ning), the confirmed objective response rate (ORR) evaluated by the Blinded Independent Central Review (BICR) reached 43.8% in the Fu Mai Ning arm, with a median time to response of 3.9 months. The drug effectively relieved tumor-related pain, delivering dual benefits in tumor shrinkage and clinical symptom improvement. Adverse drug reactions were mostly Grade 1-2 with a manageable overall safety profile, offering a new treatment choice for inoperable patients[1].
Fu Mai Ning is China’s first domestically-developed targeted therapy for the treatment of neurofibromatosis type 1. It is also the only innovative drug in China that simultaneously covers two major rare diseases, including Langerhans-cell histiocytosis (LCH) and neurofibromatosis type 1 (NF1), with a treatment scope extending across all age groups from children to adults. Its differentiated product positioning, supported by robust clinical data, underscores its significant value in the precision treatment of rare diseases in China. To date, over 20 academic papers and international conference abstracts related to luvometinib have been published, earning widespread recognition from the global academic community.
Furthermore, Fosun Pharma is actively advancing the diversified R&D pipeline for this drug, with multiple new indications progressing steadily, including a Phase 3 clinical trial for pediatric low-grade glioma, a Phase 2 trial for extracranial arteriovenous malformations, and a Phase 2 trial for the combination therapy with anlotinib in KRAS-mutant advanced non-small cell lung cancer.
As a flagship self-developed asset stemming from Fosun Pharma’s deep commitment to rare diseases and precision oncology, the approval of Fu Mai Ning for the adult NF1 indication significantly reinforces the company’s innovative leadership in China’s targeted therapy landscape for rare diseases. Looking ahead, Fosun Pharma remains dedicated to focusing on unmet clinical needs, accelerating the translation and development of innovative drugs, and striving to make more domestically-developed innovative therapies accessible to a broader patient population.
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About Fosun Pharma
Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem.
Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia.
Looking ahead, guided by the strategy of “Innovation Driven, Deep Globalization, and AI Embracement”, Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health.
For more information about the Group, please visit the company website: https://www.fosunpharma.com/en/
_________________________________________________________________________________________________________________________________________________________________
[1] Li W, et al. Luvometinib in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas: a randomized, double-blind, placebo-controlled, phase 3 trial. Presented at: 2026 ASCO Annual Meeting; May 29-June 2, 2026. Abstract