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- 2026-06-17
Exploring Earlier-Stage Treatment Potential: Fosun Pharma’s Subsidiary Henlius’ Phase 2 Clinical Trial of HLX43 in Combination with Serplulimab for Neoadjuvant Treatment of NSCLC Approved for Clinical Trial in Australia
Shanghai, China, June 16, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the phase 2 clinical trial (HLX43-NSCLC203) of HLX43 for injection, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with serplulimab for the neoadjuvant treatment of non-small cell lung cancer (NSCLC), has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The approval to conduct clinical trial in Australia is expected to further support the multi-regional development of the study and provide additional clinical evidence for the combination of HLX43 and immune checkpoint inhibitors (ICIs) in earlier-stage lung cancer treatment.
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- 2026-06-10
Fosun Pharma Subsidiary Henlius’ Serplulimab Approved for Perioperative Gastric Cancer, Pioneering a Chemotherapy-Sparring Adjuvant Approach
Shanghai, June 9, 2026 — Henlius (2696.HK), a subsidiary of Fosun Pharma, announced that the New Drug Application (NDA) for a new indication of its self-developed anti-PD-1 monoclonal antibody(mAb) HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly®) , in combination with Oxaliplatin and S-1 for neoadjuvant treatment of resectable gastric cancer with tumour PD-L1 expression CPS ≥ 5, followed by adjuvant monotherapy after surgery, has been officially approved by the China National Medical Products Administration (NMPA) under the priority review pathway.
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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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