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- 2021-06-23
Fosun Kite's First CAR-T Product Yescarta® (Axicabtagene Ciloleucel) Approved for Marketing
Axicabtagene Ciloleucel (FKC876) is an autologous CD19-directed CAR-T cell therapy manufactured in China pursuant to a license from Kite, a Gilead Company ("Kite") of Kite's Yescarta (axicabtagene ciloleucel)
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- 2021-06-11
Fosun Kite's FKC-876 Granted Approval for New Indication in Clinics
[Shanghai, China] Fosun Kite Biotechnology Co., Ltd. announced today that the National Medical Products Administration (NMPA) has officially approved the IND application [Acceptance No.CXSL2100098] for the registration of a new indication of Axicabtagene Ciloleucel (FKC876), a CD19-targeted autologous CAR-T cell therapy product of Fosun Kite for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) after two or more lines of systemic therapy.
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- 2021-06-02
Fosun Pharma: Loratadine Tablets Passes Generics Consistency Evaluation
Recently, Jiangsu Huanghe Pharmaceutical Co., Ltd., a member enterprise of Wanbang Biopharma under Fosun Pharma, received the Notice on Approval of Supplementary Drug Application for Loratadine Tablets (10 mg) from NMPA because the drug has passed the consistency evaluation of quality and efficacy of generic drugs.
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- 2021-06-01
Fosun Pharma's Independently Developed Small Molecule Innovator DrugFCN-159 Tablet Approved by FDA for Clinical Trials
[June 1, 2021, Shanghai, China] Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; Stock Code: 600196.SH; 02196.HK) issued an announcement that its holding subsidiary Shanghai Fosun Pharmaceutical Development Co., Ltd. (hereinafter referred to as"Fosun Pharma Development") recently received a notice from the US FDA (Food and Drug Administration) regarding the approval of its FCN-159 tablets (hereinafter referred to as"the new drug") for the treatment of neurofibromatosis type I (NF1) in adults and children for clinical trials. Fosun Pharma plans to conduct clinical trials of this new drug for this approved indication in the United States after the conditions are available.
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- 2021-04-23
Fosun Pharma: The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab Accepted by NMPA and Granted Priority Review
Shanghai, China, April 22th, 2021 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review. Serplulimab is potentially to be the first anti-PD-1 mAb in MSI-H solid tumors in China. For this indication, patients are screened for specific MSI-H tumor markers, rather than classifying the tumor types, covering a wide range of cancer types. Henlius adopts the “Combo+Global” development strategy for serplulimab, focusing on indication differentiation and combination therapy, with a total of 10 clinical trials conducted worldwide.
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- 2021-04-21
Third Clinical Trial Approval outside of China Received — EU Application for Clinical Trial of Henlius Bevacizumab HLX04-O Approved for Ophthalmologic Indication
In October 2020, Henlius entered into a co-development and exclusive license agreement with Essex. With this collaboration, Henlius and Essex plan to conduct global multi-centre clinical trials of HLX04 in China, Australia, the European Union and the United States, and apply marketing authorization in different countries and regions around the globe based on the research results.
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- 2021-04-16
Henlius New Immune Checkpoint Inhibitor — Henlius Receives IND Approval from NMPA for Novel Anti-LAG-3 mAb
Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor and is regarded as a new generation of immunotherapy target after PD-1/L1 and CTLA-4. Currently, there is no LAG-3 targeted product on the market around the globe.
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- 2021-04-12
Henlius News | Supplementary Application of Han Da Yuan® for New Indication for Uveitis Formally Approved
On April 12, 2021, Henlius (2696.HK) announced that the supplementary application (sNDA) of its independently developed Han Da Yuan® (HLX03, adalimumab injection) for the treatment of non-infectious intermediate, posterior and total uveitis in adults had recently been officially approved by the National Medical Products Administration (NMPA). This is the fourth approved indication of Han Da Yuan® in China following rheumatoid arthritis, ankylosing spondylitis and psoriasis.
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- 2021-03-22
Approval From US FDA — Henlius Bevacizumab Approved For Clinical Trials Of Ophthalmic Indication
Shanghai, China, March 19th, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application of HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody ophthalmic injection jointly developed by the Company and Essex has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (wAMD).
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