R&D News
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- 2025-02-06
Fosun Pharma’s Self-developed anti-PD-1 mAb Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
(February 6 2025, Shanghai, China) On February 5, Fosun Pharma (600196.SH; 02196.HK) announced that the Marketing Authorization Application (MAA) for serplulimab injection (marketed as Hetronifly® in Europe and Han Si Zhuang in mainland China), a self-developed anti-PD-1 monoclonal antibody (mAb) by its subsidiary Shanghai Henlius Biotech, Inc. (02696.HK), has recently been approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). With this approval, serplulimab has received a centralized marketing authorization covering all EU member states as well as Iceland, Liechtenstein, and Norway—countries within the European Economic Area (EEA)—making it the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.
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- 2024-09-10
Fosun Pharma announces NMPA approval for Daxxify® Marking the license-in of the world’s first and only peptide-powered botulinum toxin product to Mainland China
(September 10 2024, Shanghai, China) On September 9, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “the Group”; Stock Code: 600196.SH; 02196.HK) announced that the Biologics License Application (“BLA”) for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®, English trademark: DAXXIFY®, hereinafter referred to as "the product") for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was recently approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Mainland China.
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- 2023-08-18
Fosun Pharma's Self-developed MEK1/2 Inhibitor FCN-159 Tablet Gains Second Breakthrough Therapy Designation
(25 July, 2023, Shanghai, China）Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that the MEK1/2 inhibitor FCN-159 tablet (the “Investigational New Drug”) for the treatment for adult patients with inoperable or post-operative residual/recurrent NF1-associated plexiform neurofibromas, which was self-developed by its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial"), have been granted breakthrough therapy designation by the Centre for Drug Evaluation (CDE) of National Medical Products Administration (the “NMPA”). This is the second breakthrough therapy designation that FCN-159 tablet has approved, since its indication for histiocytic tumor in April this year.
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- 2023-07-14
Fosun Pharma Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China
(12 July, 2023, Shanghai, China）Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that the New Drug Application (“NDA”) for Tenapanor Hydrochloride Tablets (the “New Drug”) for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on hemodialysis, which was submitted by its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial") through license-in, was accepted for review by the National Medical Products Administration (“NMPA”).
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- 2023-07-10
China's NMPA Accepts Fosun Pharma’s BLA for Innovative Botulinum Toxin Product DAXXIFY® for the Treatment of Cervical Dystonia
(July 7, 2023, Shanghai, China) On July 7, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH, 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group, announced that the Biologics License Application (“BLA”) for DAXXIFY® (DaxibotulinumtoxinA for injection) for the treatment of cervical dystonia in adults, which was submitted by its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial") through license-in, was recently accepted for review by the National Medical Products Administration (“NMPA”).
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- 2022-12-23
BioNTech and Fosun Pharma Announce Full Regulatory Approval of their Mono- and Bivalent COVID-19 Vaccine COMIRNATY® in Individuals 12 Years and Older in Hong Kong
HONG KONG, CHINA, December 23, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) today announced that the Fosun Industrial Co., Limited (as a sub-licensee of Fosun Pharmaceutical Industrial) has received the certificates of registration as pharmaceutical product in relation to the official registration (the ‘‘Registration’’) of the monovalent COVID-19 vaccine (also known as BNT162b2 or COMIRNATY® Original) and the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (also known as COMIRNATY® Original/Omicron BA.4/BA.5) by the Health Bureau of the Hong Kong Special Administrative Region of the People’s Republic of China (“Hong Kong”) which is equivalent to a Biologics License Application.
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- 2022-05-25
Axicabtagene Ciloleucel - Fosun Kite's CAR-T Cell Therapy Approved to be Included in the 2022 Version of Shanghai “Huhuibao”
(Shanghai, China on May 25, 2022) On May 25, 2022, the 2022 version of Shanghai’s urban customized commercial supplementary medical insurance “Huhuibao” was officially launched for pre-sale. In this year, the premium is priced at RMB 129/year, with a total coverage of RMB 3.1 million, and the new version of “Huhuibao” covers a wider range of partici
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- 2022-05-10
Fosun Diagnostics obtained CE mark for Its Self-developed Covid-19 Antigen CARD Kit
（10 May 2022, Shanghai China）On May 10 2022, the Covid-19 Antigen CARD Kit (the Kit) self-developed by Fosun Diagnostics, a subsidiary company of Fosun Pharma was awarded the CE certificate and it will be now made available across 27 EU countries as well as regions that recognize the CE marked.
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- 2022-04-13
Fosun Diagnostics Receives China NMPA Approval for Its Independently Developed Novel Coronavirus Antigen Detection Kit Amidst of The National Efforts in Pandemic Prevention and Control
(13 April 2022, Shanghai, China) 13 April 2022, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “the Group”; Stock Code: 600196.SH, 02196.HK) announced that the Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) self-developed by Fosun Diagnostics Co., Ltd. (“‘Fosun Diagnostics”), a subsidiary company of Fosun
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