R&D News
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- 2025-11-19
WHO Approves Fosun Pharma’s First Child-friendly Primaquine Formulations for Malaria Treatment
(19 November 2025, Shanghai, China) Recently, the World Health Organization (WHO) awarded prequalification to two child-friendly formulations of primaquine, which was independently developed by Guilin Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharma. These are the first pediatric formulations of primaquine phosphate prequalified by WHO. The products are intended for the most vulnerable group, which is also the most susceptible to repeated malaria infections, and will provide more suitable and accessible treatment options for young malaria patients globally.
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- 2025-08-18
Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablets Gains Breakthrough Therapy Designation in Saudi Arabia
(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.
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- 2025-07-17
Fosun Pharma’s Self-Developed New Drug XH-S004 for the Treatment of Chronic Obstructive Pulmonary Disease Enters Phase 1b Clinical Trial
On July 17, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that S-INFINITY Co., Ltd. (“S-INFINITY”), a subsidiary of Fosun Pharma, has recently initiated the Phase 1b clinical trial on its self-developed new drug, XH-S004 (hereinafter the “New Drug”), for the treatment of chronic obstructive pulmonary disease (COPD) in China (excluding Hong Kong SAR, Macau SAR, and Taiwan region).
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- 2025-07-09
Fosun Pharma's Self-developed Innovative Drug Luvometinib Tablets for the Treatment of Pediatric Low-grade Glioma Indication Enters Phase 3 Clinical Trial in China
(July 9, 2025, Shanghai, China）— On 9 July, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK), announced that its self-developed MEK1/2 selective inhibitor Fu Mai Ning (generic name: Luvometinib Tablets; the “Drug”) has entered Phase 3 clinical trial for the treatment of pediatric low-grade glioma (pLGG) in China (excluding Hong Kong SAR, Macau SAR and Taiwan region).
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- 2025-05-29
Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablet Approved in China
(May 29, 2025, Shanghai, China） — On 29 May, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK), announced that its self-developed innovative drug Luvometinib Tablets (Chinese trade name: 复迈宁®, project no.: FCN-159, the “New Drug”) has been officially approved for marketing by the National Medical Products Administration (NMPA).
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- 2025-05-12
Fosun Pharma's Self-Developed Innovative Drug FCN-159 Tablet Granted Breakthrough Therapy Designation for the Treatment of Children with Langerhans Cell Histiocytosis
On 12 May 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that the self-developed innovative drug FCN-159 tablets (Luvometinib tablets, hereinafter the “New Drug”) has been granted breakthrough therapy designation for the treatment of children with Langerhans cell histiocytosis by the National Medical Products Administration (the “NMPA”). Currently, the New Drug is at the stage of Phase II clinical trial in Chinese Mainland.
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- 2025-03-13
Fosun Pharma’s Independently Developed Innovative Drug XH-S003 Capsule for PNH Indication Approved for Clinical Trials
March 13, 2025 – Fosun Pharma announced that its subsidiary S-INFINITY Co., Ltd. (“S-INFINITY”) recently received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for XH-S003 Capsule (registration category: chemical drug Class 1; hereinafter referred to as “XH-S003”) for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). S-INFINITY plans to initiate Phase 2 clinical trials in Mainland China (excluding Hong Kong, Macao, and Taiwan regions) once conditions are met.
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- 2025-03-10
Fosun Pharma's Independently Developed Innovative Lung Cancer Drug Foritinib (SAF-189) Marketing Authorization Application Has Been Accepted by NMPA
March 10, 2025 – Recently, Fosun Pharma announced that the marketing authorization application for its independently developed new drug, foritinib Succinate Capsules (project code: SAF-189, foritinib, hereinafter referred to as "New Drug"), has been accepted by the National Medical Products Administration (NMPA). The New Drug is primarily indicated for the treatment of non-small cell lung cancer (ALK+) and non-small cell lung cancer (ROS1+), etc. The indication under this application is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
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- 2025-02-26
Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)
(26 February, 2025, Shanghai, China) — Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma Industrial”), has received approval from the National Medical Products Administration (“NMPA”) for the New Drug Application (“NDA”) for Tenapanor Hydrochloride Tablets (Chinese trade name: Wan Ti Le, the “New Drug”), an innovative phosphate absorption inhibitor with a novel mechanism, with the indication being for the control of serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders.
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