MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors)

Therapeutic Areas

NeoplasmsNervous System DiseasesCongenital Disorders+ [5]

Active Indication

NF1 mutant Plexiform NeurofibromaHistiocytic and Dendritic Cell NeoplasmNeurofibromatosis 1+ [5]

Inactive Indication

Locally Advanced MelanomaMelanomaNRAS Mutant Melanoma

Originator Organization

Fochon Pharmaceuticals Ltd.

Active Organization

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.

Asymchem Life Science Tianjin Co. Ltd.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationPriority Review (CN), Breakthrough Therapy (CN)

Structure

Molecular FormulaC26H22F2IN5O4S

InChIKeyRJFDJJABNSVLRB-UHFFFAOYSA-N

CAS Registry2739690-43-6

Clinical Trials associated with Luvometinib

NCT06553365 / Not yet recruitingPhase 2IIT

An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.

Start Date15 Aug 2024

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

NCT05997602 / RecruitingPhase 2

A Multi-center, Open-label, Single Arm Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent Langerhans Cell Histiocytosis

This is a rare disease, single-arm, open-label,multi-center, non-randomized Phase 2 clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of FCN-159 monotherapy in pediatric patients with refractory/recurrent Langerhans cell histiocytosis (LCH).

Start Date28 Sep 2023

Sponsor / Collaborator

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.

CTR20232238 / RecruitingPhase 2

一项多中心、开放、单臂II期研究，评价FCN-159在儿童难治/复发性朗格罕细胞组织细胞增生症中的有效性、安全性和药代动力学特征

[Translation] A multicenter, open-label, single-arm Phase II study evaluating the efficacy, safety, and pharmacokinetic characteristics of FCN-159 in children with refractory/relapsed Langerhans cell histiocytosis

主要目的：评价FCN-159对难治/复发性朗格罕细胞组织细胞增生症（LCH）儿童患者的疗效。次要目的：评价FCN-159对LCH儿童患者的安全性；进一步评估FCN-159对难治/复发性LCH儿童患者的除IRC根据PET应答评估标准（PET Response Criteria，PRC）评估的ORR之外的其他有效性；评价FCN-159的PK特征。探索性目的：评价与基线检查相比，FCN-159对难治/复发性朗格罕细胞组织细胞增生症（LCH）儿童患者生活质量的改善情况；分析患者MAPK通路基因突变与疗效的关系。

[Translation]

Primary objective: To evaluate the efficacy of FCN-159 in children with refractory/recurrent Langerhans cell histiocytosis (LCH). Secondary objectives: To evaluate the safety of FCN-159 in children with LCH; to further evaluate the efficacy of FCN-159 in children with refractory/recurrent LCH in addition to the ORR assessed by IRC based on the PET Response Criteria (PRC); to evaluate the PK characteristics of FCN-159. Exploratory objectives: To evaluate the improvement of the quality of life of children with refractory/recurrent Langerhans cell histiocytosis (LCH) with FCN-159 compared with the baseline examination; to analyze the relationship between the patient's MAPK pathway gene mutation and the efficacy.

Start Date21 Sep 2023

Sponsor / Collaborator

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.

100 Clinical Results associated with Luvometinib

100 Translational Medicine associated with Luvometinib

100 Patents (Medical) associated with Luvometinib

Literatures (Medical) associated with Luvometinib

03 Jul 2023·BMC medicine

Phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1-related unresectable plexiform neurofibromas.

Article

Author: Lin, Hongmei ; Li, Shenglan ; Hui, Ai-Min ; Huang, Xin ; Wu, Zhuli ; Han, Pu ; Xu, Zhongyuan ; Li, Changxing ; Diao, Lei ; Zeng, Kang ; Kang, Zhuang ; Wang, Xingli ; Li, Ben ; Hu, Xiaojie ; Li, Wenbin ; Tan, Yan ; Lin, Xiaoxi

BACKGROUND:

Surgery is a common treatment strategy for patients with neurofibromatosis type 1 (NF1)-related plexiform neurofibroma (PN) and has limited efficacy. FCN-159 is a novel anti-tumorigenic drug via selective inhibition of MEK1/2. This study assesses the safety and efficacy of FCN-159 in patients with NF1-related PN.

METHODS:

This is a multicenter, open-label, single-arm, phase I dose-escalation study. Patients with NF1-related PN that was non-resectable or unsuitable for surgery were enrolled; they received FCN-159 monotherapy daily in 28-day cycles.

RESULTS:

Nineteen adults were enrolled in the study, 3 in 4 mg, 4 in 6 mg, 8 in 8 mg, and 4 in 12 mg. Among patients included in dose-limiting toxicity (DLT) analysis, DLTs (grade 3 folliculitis) were reported in 1 of 8 patients (16.7%) receiving 8 mg and 3 of 3 (100%) patients receiving 12 mg. The maximum tolerated dose was determined to be 8 mg. FCN-159-related treatment-emergent adverse events (TEAEs) were observed in 19 patients (100%); most of which were grade 1 or 2. Nine (47.4%) patients reported grade 3 study-drug-related TEAEs across all dose levels, including four experiencing paronychia and five experiencing folliculitis. Of the 16 patients analyzed, all (100%) had reduced tumor size and six (37.5%) achieved partial responses; the largest reduction in tumor size was 84.2%. The pharmacokinetic profile was approximately linear between 4 and 12 mg, and the half-life supported once daily dosing.

CONCLUSIONS:

FCN-159 was well tolerated up to 8 mg daily with manageable adverse events and showed promising anti-tumorigenic activity in patients with NF1-related PN, warranting further investigation in this indication.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT04954001. Registered 08 July 2021.

01 Mar 2023·Advances in therapy

Effect of Food (Low and High Fat) on Pharmacokinetics of FCN-159, a Selective MEK Inhibitor, in Healthy Chinese Males

Article

Author: Wang, Xuhong ; Qiu, Jingjun ; Wei, Zhen ; Hui, Ai-Min ; Tan, Yan ; Diao, Lei ; Li, Jiangfan ; Wu, Zhuli ; Han, Pu ; Li, Kexin

INTRODUCTION:

FCN-159 is a novel, oral, potent, selective MEK1/2 inhibitor in clinical development for the treatment of NRAS-mutant advanced melanoma and neurofibromatosis type 1. We investigated the effect of food on the pharmacokinetics (PK), safety, and tolerability of FCN-159.

METHODS:

In this single-center, open-label, phase 1 study with a three-period, three-sequence, crossover design, healthy Chinese male subjects (n = 24) were randomized (1:1:1) to receive a single, oral 8 mg dose of FCN-159 in the fasted state (overnight, > 10 h), and with a low-fat and a high-fat meal, separated by a 10-day washout. PK parameters including time to maximum plasma concentration (C_max) and area under the concentration-time curve (AUC) were compared using geometric least-squares mean ratios (GLSMR), with the fasted state as the reference. A 90% CI for the GLSMR within 80-125% indicated no significant food effect.

RESULTS:

A low-fat meal (n = 23) did not affect the PK profile of FCN-159: G LSMR for AUC from time 0 to t (AUC_0-t), 106.9% (90% CI 99.9-114.4%); AUC from time 0 to infinity (AUC_0-∞), 106.8% (90% CI 100.0-114.0%); C_max, 96.4% (90% CI 83.9-110.8%). A high-fat meal (n = 24) did not affect exposure to FCN-159 (GLSMR for AUC_0-t, 99.4%; 90% CI 99.0-106.3%; AUC_0-∞, 99.5 5%; 90% CI 93.2-106.1%), but modestly reduced C_max by 15% (GLSMR 84.9%; 90% CI 74.0-97.3%). Both the low-fat and high-fat meals slightly prolonged the median time to C_max by 0.5 h (90% CI 0.5-1.0 h). FCN-159 was generally well tolerated, with a lower incidence of treatment-emergent adverse events following administration in the fasted state than with a low-fat or high-fat meal (20.8%, 39.1%, and 37.5%, respectively).

CONCLUSION:

Food did not affect the PK profile of FCN-159 to a clinically meaningful extent compared with administration in the fasted state.

01 Jan 2023·Frontiers in Pharmacology

Population pharmacokinetics of FCN-159, a MEK1/2 inhibitor, in adult patients with advanced melanoma and neurofibromatosis type 1 (NF1) and model informed dosing recommendations for NF1 pediatrics.

Article

Author: Diao, Lei ; Tan, Yan ; Wu, Zhuli ; Cui, Ailing ; Han, Pu ; Huang, Xin ; Li, Chao ; Qian, Lixuan ; Yang, Yuchen

Objective: FCN-159 is a highly active mitogen-activated extracellular signal-regulated kinase 1/2 (MEK1/2) inhibitor in patients with advanced melanoma and neurofibromatosis type 1 (NF1). We report a population pharmacokinetic (PopPK) model-based analysis of FCN-159 and its application to inform dose selection for NF1 pediatric trials. Methods: PK data collected from patients with advanced melanoma and NF1 in two clinical studies (NCT03932253 and NCT04954001) were analyzed using a non-linear mixed effects model. The adult model was adapted by incorporating allometric scaling for PK projection in 2-17 years old children. Pediatric exposure in different body surface area (BSA) bins was simulated to identify nominal doses (i.e., dose amounts given as integers) and BSA bin cutoffs to achieve exposure comparable to adults' optimal exposure across the entire pediatric BSA range. Results: The final dataset consisted of 45 subjects with a total of 1030 PK samples. The PK of FCN-159 was well-described by a 2-compartment model with first-order linear elimination and delayed first-order absorption. Covariates, including BSA, age, sex, albumin, total protein, and cancer type, were identified as statistically significant predictors of FCN-159 disposition. Simulations based on the final model projected daily doses of 4 mg/m² QD with optimized BSA bin cutoffs would allow fixed nominal doses within each bin and result in steady state exposure approximating the adult exposure observed at the recommended phase 2 dose (RP2D) in NF1, which is 8 mg QD. Conclusion: The developed population PK model adequately described the PK profile of FCN-159, which was adapted using allometric scaling to inform dose selection for NF1 pediatric trials.

News (Medical) associated with Luvometinib

28 Aug 2024

·www.prnewswire.com

Fosun Pharma Announces 2024 Interim Results

Breakthroughs for Innovative Products Going Overseas with Global Operation Capabilities Continuing to Strengthen SHANGHAI, Aug. 28, 2024 /PRNewswire/ -- On August 27, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first half of 2024 (the "Reporting Period"). During the Reporting Period, Fosun Pharma achieved revenue of RMB20.46 billion, an increase of 5.31% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.3 billion. In the second quarter of 2024, the net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss was RMB646 million, a quarter-on-quarter increase of RMB37 million. As a global innovation-driven pharmaceutical and healthcare industry group, Fosun Pharma continuously advance its innovation transformation and the development and commercialization of innovative products. In the first half of 2024, Fosun Pharma's revenue from key innovative products in pharmaceuticals business grew steadily, exceeding RMB3.7 billion. In 2024, Fosun Pharma continued to boost operational efficiency and profitability, laying the foundation for long-term sustainable development. During the Reporting Period, the gross margin minus the selling and distribution expense ratio increased by 1.72 percentage points YoY; excluding the impact of newly acquired companies, the management expense decreased by about RMB0.2 billion. During the Reporting Period, Fosun Pharma ensured stable free cash flow through measures including optimizing operating cash flow, supply chain management, and controlling capital expenditures, achieving operating cash flow of RMB1.9 billion, a period-on-period increase of 5.36%, exceeding the growth of operating profit. In addition, the Group continued to optimize asset structure and improve asset efficiency. Since 2024, the cash inflow from asset disposals and the expected cash inflow from contracts signed by Fosun Pharma exceeded RMB2 billion in aggregate. Revenue from innovative products maintains steady growth, with a further focus on innovative drugs and high-value devices In the first half of 2024, Fosun Pharma further focused on innovative drugs and high-value devices. Four key innovative products with a total of 9 indications, independently developed and licensed-in by the Group, were approved for launch domestically and internationally. In addition to the key innovative products, Fosun Pharma also had 38 generic drug varieties approved for launch domestically and internationally. In the first half of 2024, Fosun Pharma's pharmaceutical manufacturing segment achieved revenue of RMB14.7 billion. The innovative drug business achieved breakthroughs in core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation, and realized multiple innovative achievements in hematologic tumors, breast cancer and lung cancer, benefiting patients worldwide. Han Si Zhuang (serplulimab injection), Fosun Pharma's first self-developed biopharmaceutical innovative drug, as well as the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), was commercialized in the domestic market in March 2022. Up to now, it has been approved for 4 indications, broadly covering high-incidence tumours including lung cancer and gastrointestinal cancer, benefiting over 75,000 patients globally. Additionally, the 5th NDA of Han Si Zhuang for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA) in China. During the Reporting Period, Fosun Pharma's self-developed biosimilar Han Da Yuan (adalimumab injection) received 4 new indications approval from the NMPA. It has now been approved for eight indications in China, covering all indications of originator adalimumab in China, providing more treatment options for adult and pediatric patients with autoimmune diseases. Fosun Pharma adheres to an open innovation strategy, and actively expands its pipelines through BD in addition to independent R&D. In June 2024, Su Ke Xin (avatrombopag malate tablets), which is exclusively commercialized by Fosun Pharma, received approval in Chinese mainland for a second indication for the treatment of adult patients with chronic primary immune thrombocytopenia (ITP) who have shown poor response to prior treatment, further benefiting ITP patients in China. Additionally, certain domestic innovative drugs licensed-in by the Group such as Bei Wen (keverprazan hydrochloride tablets) and Pei Jin (telpegfilgrastim injection), were officially included in the National Medical Drugs Catalogue in January 2024. This significantly enhanced the accessibility of drugs for relevant diseases within Chinese mainland and practically reduced the burdens of drugs on patients, aiming to improve the living and life quality of patients through regulated therapies. In the field of vaccines, Fosun Pharma has established an independent R&D system centered on two major technical platforms: bacterial vaccines and viral vaccines. In March 2024, the rabies vaccine (Vero cell) for human use (freeze dried), which is independently developed by the Group, has been approved for launch in Chinese mainland. The production line has also passed the GMP compliance inspection. Research progress on various pipelines develops rapidly to secure innovative development To meet the unmet clinical needs, through diversified and multi-level cooperation models such as independent R&D, co-development, license-in and industrial investment, Fosun Pharma continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. In the first half of 2024, Fosun Pharma's total R&D expenditure amounted to RMB2.7 billion, with R&D expenses totaling RMB1.9 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB2.4 billion, accounting for 16.4% of the segment's revenue. In particular, R&D expenses were RMB1.6 billion, accounting for 10.7% of the segment's revenue. In the first half of 2024, 4 innovative drugs/biosimilars with a total of 9 indications independently developed, co-developed and licensed-in by the Group had entered the pre-launch approval/critical clinical stage. The pharmaceutical manufacturing segment of the Group submitted 124 patent applications, including 2 American patents applications, 8 PCT applications, and the Group has obtained 37 licensed invention patents authorization. During the Reporting Period, the New Drug Application (NDA) of self-developed selective MEK1/2 inhibitor (project code: FCN-159) for two indications was accepted by NMPA in May and June 2024, both of which were included in the priority review procedure. The Marketing Authorization Application (MAAs) for five indications of the self-developed denosumab biosimilar HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) was accepted by the European Medicines Agency (EMA). Additionally, during the Reporting Period, the Phase 3 clinical trials for its self-developed Han Si Zhuang (serplulimab injection), in combination with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) patients, had commenced in the Chinese mainland. The combination dosing of OP0595 and cefepime or aztreonam, developed by Fosun Pharma in collaboration with Meiji Seika Pharma Co., Ltd., for the treatment of adults infected by aerobic gram-negative bacteria with limited options, had commenced two phase III clinical trials in China. During the Reporting Period, clinical data from multiple pipeline products and marketed products of Fosun Pharma were presented at global industry conferences, including the American Society of Clinical Oncology (ASCO), American Association for Cancer Research (AACR), and the European Hematology Association (EHA), further demonstrating the Group's innovative R&D capabilities on the international stage. In addition to independent R&D, Fosun Pharma actively practices an open R&D model, engaging in the incubation and investment of R&D projects through initiatives such as the establishment and management of industrial funds, ensuring the sustainability of its innovation pipeline. During the reporting period, Fosun Pharma successfully completed the establishment and filing of Shenzhen Biopharma Industrial Fund with fundraising size of RMB5.0 billion Continues to enhance global operation capabilities and gains international recognition for innovative products Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, two-way license, production and operations as well as commercialization to enhance operational efficiency and strengthen global market layout while covering major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia. As at the end of the Reporting Period, the Group had formed an overseas commercialization team of approximately 1,000 employees. For the first half of 2024, overseas revenue reached RMB5.5 billion, an increase of 15.13% YoY, accounting for 26.93% of total revenue. During the Reporting Period, Fosun Pharma's self-developed Han Qu You (trastuzumab injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) received the U.S. FDA approval for three indications covering the treatment of breast cancer and gastric cancer, becoming the first domestic biosimilar approved for launch in China, the EU and the United States. Additionally, through collaboration with global renowned pharmaceutical companies, Fosun Pharma has established a presence in Europe, the United States, Canada, and numerous emerging markets. Up to date, Han Qu You has been approved in 48 countries and regions, benefiting 200,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide. Self-developed biopharmaceutical innovative drug of Fosun Pharma, Serplulimab Injection (anti-PD-1 monoclonal antibody, Chinese trade name: Han Si Zhuang) completed the first international shipment in January 2024, making it the first Chinese anti-PD-1 mAb approved for launch in Southeast Asia. The marketing authorization application (MAA) of Han Si Zhuang has been accepted in March 2023 and its head-to-head bridging trial comparing to first-line standard of care with Atezolizumab for extensive-stage small cell lung cancer (ES-SCLC) had entered clinical enrollment stage in the United States. At the same time, Fosun Pharma has established an innovative drug team in the United States to advance the commercialization of Serplulimab Injection. Fosun Pharma actively introduces leading international technologies and products into the Chinese market to benefit more patients. During the Reporting Period, the Headquarters Industrial Base of the joint venture Intuitive Fosun officially opened and was put into operation in Shanghai Zhangjiang International Medical Park. The base integrates R&D, production and training, and its operation will further accelerate the localization process of the Da Vinci Surgical System. As at the end of June 2024, the accumulated total installation volume of the Da Vinci Surgical Robot in Chinese mainland and Hong Kong S.A.R.and Macau S.A.R. was over 380 in more than 300 hospitals. More than 540,000 patients had benefited from the Da Vinci Surgical Robot's precise treatment and returned to normal life. During the Reporting Period, Fosun Pharma's joint venture with Insightec, Fosun Insightec, made steady progress in the commercialization, clinical application and research of magnetic resonance-guided focused ultrasound treatment system for neurological diseases (MRgFus brain therapy system) in Chinese mainland, Hong Kong S.A.R and Macao S.A.R.. As a global pharmaceutical and healthcare industry group, Fosun Pharma continues to promote the building of production system with international quality standard, with its quality management system and production capabilities recognized by leading international certification authorities, laying a solid foundation for the overseas distribution of preparations. As at the end of the Reporting Period, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of the Group obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. "Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma consistently focuses on unmet clinical needs, prioritizes innovative R&D, adheres to technology-driven and product-driven approach, and strengthens global operation capabilities, ensuring steady and sustainable development." Wu Yifang, Chairman of Fosun Pharma, said, "Looking forward, Fosun Pharma's internal operation will be further improved in quality and efficiency, continuing to enhance its leading position in hematologic tumors, breast cancer, lung cancer and other fields while expanding footprint in immunity inflammation, chronic diseases and central nervous system. We will also intensify industry-university-research strategic cooperation with world-class universities and research institutions to capture innovative products at an early stage. At the same time, we will actively promote the overseas export of high-quality products and promote global simultaneous development, aiming to become the global leading integrator of pharmaceutical and healthcare innovation." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit our official website: SOURCE Fosun Pharma

Drug ApprovalPhase 3

30 Aug 2023

·www.prnewswire.com

Fosun Pharma Announces 2023 Interim Results: Continues to Promote Innovation Transformation and Optimizes Product Structure

SHANGHAI, Aug. 29, 2023 /PRNewswire/ -- On August 29, 2023, Shanghai Fosun Pharmaceutical Co., Ltd.* (Stock Code: 600196.SH; 02196.HK) announced its 2023 Interim Results for the first half of 2023. (the "Reporting Period"). During the Reporting Period, Fosun Pharma achieved revenue of RMB21.395 billion; the net profit attributable to shareholders of the listed company was RMB1.777 billion, with a period-on-period growth of 15.74%. As a global innovation-driven pharmaceutical and healthcare industry group, Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Group Co. Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. The pharmaceuticals business is the core business of Fosun Pharma. For the first half of 2023, pharmaceuticals business achieved revenue of RMB15.995 billion, with a period-on-period growth of 11.64%. Fosun Pharma's innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease). Over the years, through diversified and multi-level innovation models such as independent R&D, cooperative development, license-in, and in-depth incubation, Fosun Pharma accelerated the R&D and launch of innovative technologies and products, further expanded its innovative product portfolio, and continued to bring new momentum to performance growth. Adheres to open innovation strategy and speeds up the launch of new products In the first half of 2023, a number of innovative products and indications self-developed and co-developed by Fosun Pharma were approved for launch, further expanding the innovative product portfolio, contributing to the continuous optimization of product structure and maintaining rapid growth of revenue from innovative products. Among them, revenue from Han Si Zhuang which was approved for launch in March 2022 achieved RMB556 million during the Reporting Period, entering the "speeding up period" of commercialization. Revenue from Han Qu You increased 57.1% period-on-period, while revenue from Su Ke Xin increased 32.7% period-on-period. Han Si Zhuang is the first self-developed biopharmaceutical innovative drug of Fosun Pharma, as well as the world's first monoclonal antibody drug targeting PD-1 approved for the first-line treatment of extensive small cell lung cancer, which has been approved for three indications including the treatment of Microsatellite Instability-high (MSI-H) solid tumors, Squamous Non-small Cell Lung Cancer (sqNSCLC) and Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The NDA for fourth indication for first-line treatment of esophageal squamous cell carcinoma (ESCC) has also been accepted in Chinese Mainland. As at the end of Reporting Period, Han Si Zhuang has completed the online bidding in 29 provinces/ autonomous regions/ municipalities in Chinese Mainland and was included in the customized commercial insurance catalogue in various cities, including Shanghai, Ningbo, Zhuhai, benefiting more than 34,000 Chinese patients. During the Reporting Period, Yi Kai Da (ejilunsai injection), the domestic first CAR-T cell therapy product, obtained new approval for second-line indication in Chinese Mainland (for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line immunochemotherapy or that relapses within 12 months of first-line immunochemotherapy (r/r LBCL)) to benefit more lymphoma patients in China. Fosun Pharma adheres to an open innovation strategy and actively expands its pipelines through BD. During the Reporting Period, Bei Wen (Keverprazan Hydrochloride tablets), the first potassium ion competitive acid blocker (P-CAB) independently developed in China and exclusively commercialized by Fosun Pharma, Pei Jin (Telpegfilgrastim injection), the long-lasting recombinant human granulocyte colony-stimulating factor product, and Pang Bi Fu (Etelcalcetide Hydrochloride injection), the newgeneration of calcimimetic, were approved for launch in Chinese Mainland, further enriching its product portfolio in the innovative drugs field. Meanwhile, Fosun Pharma has been making rapid progress in its pipeline, with many products successively entered the critical clinical/approval stage. Up to now, the phase III clinical research of MEK1/2 selective inhibitor FCN-159 self-developed by Fosun Pharma for the treatment of neurofibromatosis type I in adults has commenced in Chinese Mainland. Two indications of ongoing projects have been included in the breakthrough therapy drug program; the enrollment of the phase III clinical trial of self-developed 13-valent pneumococcal conjugate vaccines (multivalent combinations) has been completed. In addition, the NDA for several pipeline drugs, including DaxibotulinumtoxinA (RT002) and Tenapanor, has been accepted in Chinese Mainland. Continues to optimize the R&D system and improve R&D efficiency Fosun Pharma continued to optimize its R&D system. Under an increasingly refined R&D strategy, it has promoted the layout of four core technology platforms such as small molecules, antibody/ADC, RNA and cell therapy, and continues to promote the R&D and launch process of various innovative products. In the first half of 2023, Fosun Pharma continued to increase its expenditures in innovative R&D, with a total R&D expenditures of RMB 2.88 billion during the Reporting Period, with a period-on-period growth of 19.77%, among which, the R&D expenses amounted to RMB 2.13 billion, with a period-on-period growth of RMB 0.31 billion or 16.80%. The R&D expenditures in the pharmaceutical manufacturing business amounted to RMB 2.52 billion, with a period-on-period growth of 22.16%, and the R&D expenditures in the pharmaceutical manufacturing business accounted for 15.75% of the revenue from the pharmaceutical manufacturing business, among which, the R&D expenses amounted to RMB 1.79 billion, accounting for 11.20% of the revenue from the pharmaceutical manufacturing business. As at the end of the Reporting Period, Fosun Pharma had over 70 major pipeline projects on innovative drugs and self-developed biosimilars. During the Reporting Period, 5 innovative drugs (indications) and 10 generic drugs (indications) were approved for launch; 4 innovative drugs/ biosimilar (indications) and 34 generic drugs (indications) had applied for launch (NDA); 7 innovative drugs/ biosimilar (indications) were approved for clinical trials (IND) in Chinese Mainland. To further strengthen scientific and technological innovation strategy and improve R&D efficiency, during the Reporting Period, Fosun Pharma has established a Scientific Advisory Board (SAB) at the group level, further endeavored to optimize the top-level structure of the innovation, introduced a number of senior scientists and C-level talents, and comprehensively upgraded domestic and overseas capabilities in early R&D, CMC, clinical medicine and clinical operations. At the same time, the Company reorganized its innovative drug project establishment and dynamically evaluated its pipeline value and competitiveness, thereby improving the quality and effectiveness of R&D. Steadily promote the multi-dimensional internationalization of R&D, production and marketing to enhance global operational capabilities While accelerating the development of innovation transformation, Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, two-way license, production and operations as well as commercialization to enhance operational efficiency and strengthen global market layout, while covering major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia. Fosun Pharma actively promotes the overseas expansion of high-quality products. The mature generic drug sales team of the Company in the United States has established collaborations with 5 large distributors and 16 group purchasing organizations (GPOs) to promote the sales of preparations products. At the same time, Fosun Pharma has initiated the establishment of an innovative drug team in the United States to advance the commercialization of Serplulimab Injection (PD-1 inhibitor, trade name in China: Han Si Zhuang). As China's first independently developed monoclonal antibody drug approved in both China and Europe, the U.S. biologics license application (BLA) of Trastuzumab for Injection (trade name in China: Han Qu You) has been accepted by the U.S. FDA; the marketing authorization application (MAA) of Serplulimab Injection (PD-1 inhibitor) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) has also been accepted in the European Union. Furthermore, through licensing collaborations with internationally renowned pharmaceutical companies such as Boston Oncology and KGbio, Fosun Pharma is expanding its presence in numerous emerging markets to enhance the accessibility and recognition of its high-quality products in the international market. In emerging markets, with a sales network covering more than 40 countries and regions, Fosun Pharma's pharmaceutical export and distribution business in the African market mainly targets the English-speaking and French-speaking regions of sub-Saharan Africa. During the Reporting Period, the Côte d'Ivoire hub, integrating drug R&D, manufacturing, and logistics distribution, has been constructed, aiming to achieve localized drug manufacturing and supply in Africa. With the purpose of consolidating the foundation for the overseas expansion of preparations products, Fosun Pharma continues to promote the certification of international production quality standards. The second-generation artesunate for injection (Argesun) independently developed by Fosun Pharma passed the WHO Prequalification (WHO PQ), becoming the first artesunate injectable presented with a single solvent system approved by WHO PQ. Gland Pharma, the Indian subsidiary of Fosun Pharma, completed the acquisition of European CDMO company Cenexi, to strategically establish its CDMO business presence in the European market and build up local manufacturing capabilities in Europe. In addition, Fosun Pharma has established a global marketing network combining direct sales and distribution for the medical device business. In the field of professional medical devices, the joint venture company Intuitive Fosun continues to promote the localization of medical devices, helping more Chinese surgeons master the world's leading robotic-assisted surgical technology. During the Reporting Period, the installation volume of the "Da Vinci Surgical System" is 34 units, and the "Thoracoabdominal Endoscopic Surgical Control System" obtained medical device registration approval from the National Medical Products Administration in June 2023, indicating that the locally produced Da Vinci Surgical System will soon be introduced to the public. Building an industry leading ESG system to improve product accessibility and affordability Fosun Pharma has always regarded innovation as the most important social responsibility for its sustainable development. It is committed to improving product accessibility and affordability. As of the end of the Reporting Period, Fosun Pharma has already launched two rare disease or orphan drug products, i.e. Su Ke Xin (Avatrombopag Malate tablets) and Wei Ge Ding (Vigabatrin powder for oral solution), and continuously promoted the construction of rare disease product lines, showing care for the rare disease community through innovative R&D. In addition, as of the end of June 2023, Yi Kai Da (Ejilunsai injection) has been included in over 90 urban customized commercial health insurances and over 60 commercial insurances, while the number of treatment centers on record exceeded 140, covering more than 25 provinces and municipalities across China, benefiting more than 500 lymphoma patients in China. Meanwhile, as one of the world's largest manufacturers of antimalarial drugs, as of the end of the Reporting Period, Fosun Pharma has supplied over 300 million injections of self-developed Argesun injection to the international market. In Africa alone, over 245 million children have benefited from the Seasonal Malaria Chemoprevention Program, which is based on the SPAQ-CO series of drugs, effectively reducing the incidence of malaria among local children. In terms of internal compliance supervision, Fosun Pharma has further strengthened the openness and transparency of the management system. In January 2023, it publicized a number of internal systems on the company's official website, including the " Regulations on Anti-Corruption ", "Provisions on Integrity Administration of Engineering Construction Projects (Trial))" and "Regulations on the Management of Integrity in Practice ", etc., aiming to creating a fair and honest business environment and culture. At the same time, Fosun Pharma continues to improve the ESG (Environmental, Social and Governance) system and improve the overall level of ESG to help maintain its long-term sustainable development. In 2023, Fosun Pharma maintained an A grade rating in MSCI ESG Ratings and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). "At present, China's healthcare industry is undergoing a period of accelerated adjustment. Fosun Pharma has maintained its strategic focus in the face of challenges, continued to promote innovation transformation, optimized product structure, adhered to an open innovation strategy and steady internationalization." Wu Yifang, Chairman of Fosun Pharma said, "Looking forward, the company will continue its technology-driven and product-driven approach, with a further expand into therapeutic areas with significant unmet needs. Also, Fosun Pharma will continue to enhance its R&D efficiency, strengthen independent research capabilities, foster external collaborations, and enrich its product pipeline. In addition, the company will focus on improving global operational capabilities, pursuing lean operations, enhancing quality and efficiency, and leveraging digital technology to drive business growth. These endeavors align with Fosun Pharma's vision to contribute to Healthy China and promote better health for families worldwide." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Group Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: SOURCE Fosun Pharma

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Indication	Highest Phase	Country/Location	Organization	Date
NF1 mutant Plexiform Neurofibroma	NDA/BLA	CN	Asymchem Life Science Tianjin Co. Ltd.	06 Jun 2024
NF1 mutant Plexiform Neurofibroma	NDA/BLA	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	06 Jun 2024
Histiocytic and Dendritic Cell Neoplasm	NDA/BLA	CN	Asymchem Life Science Tianjin Co. Ltd.	23 May 2024
Histiocytic and Dendritic Cell Neoplasm	NDA/BLA	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	23 May 2024
Neurofibromatosis 1	Phase 3	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	20 Jun 2023
Low grade glioma	Phase 3	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Histiocytosis, Langerhans-Cell	Phase 2	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	21 Sep 2023
Arteriovenous Malformations	Phase 2	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	26 Oct 2022
Plexiform Neurofibroma	Phase 2	US	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	26 Mar 2021
Plexiform Neurofibroma	Phase 2	ES	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	26 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04954001 (phase 2 trial, ASCO2024)	Phase 2	Neurofibromatosis 1 NF1 gene variants \| RAS pathway	46	FCN-159 5 mg/m2	rgjhsbtpaj(rudzmdnmzy) = 93.5% experienced TRAEs with grade ≥3 TRAEs occurred in 8 pts (17.4%), including dermatitis acneiform (4.3%), folliculitis (4.3%), pneumonia (2.2%), upper respiratory tract infection (2.2%), ejection fraction decreased (2.2%), and blood creatine phosphokinase increased (2.2%) empqaaktpj (ilivgvhoim ) View more	Positive	24 May 2024
NCT04954001 (phase 2 trial, ASCO2024)	Phase 2	Neurofibromatosis 1 NF1 gene variants \| RAS pathway	46	Placebo		Positive	24 May 2024
ChiCTR2300069156 (ESMO2023) Manual	Phase 2	Low grade glioma BRAF V600E \| KIAA1549-BRAF fusion \| NF1 Mutation	23	FCN-159 5mg/m2	bqvfdxgfzw(fmgwgycjas) = cylxjbqwot ocvkpeczwh (qziedopnfd ) View more	Positive	20 Oct 2023
NCT04954001 (ASCO2023) Manual	Phase 1/2	Neurofibromatosis 1	65	FCN-159	dnvrhnqmfp(nzfiepsehl) = aqqxbmewjd idzmnunvim (bilzpjpjyn ) View more	Positive	31 May 2023
NCT04954001 (ASCO2023) Manual	Phase 1/2	Neurofibromatosis 1	82	FCN-159	ecnrswrjss(fcldgaibzj) = omqvlpiskb spcriaihyk (rlzvcegcnn, 21.9 - 42.9) View more	Positive	26 May 2023
NCT04954001 (ASCO2022) Manual	Phase 1	Neurofibromatosis 1	19	FCN-159	nzogwymuei(uctlmuvmyw) = hoehvixvqu lswzacojsh (llljtixfjd ) View more	Positive	02 Jun 2022

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