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.




This new drug is an innovative small molecule chemical drug independently developed by Fosun Pharma, which is a selective inhibitor of MEK1/2 and is mainly intended for the treatment of advanced solid tumors and NF1. As of the announcement date, the new drug is in Phase I clinical trial stage in China (excluding Hong Kong, Macao and Taiwan) for the treatment of advanced melanoma with NRAS mutations and NF1.


As of April 2021, Fosun Pharma has invested about RMB 82.27 million (unaudited) in the R&D of this new drug at this stage.

As a leading and innovation-driven international pharmaceutical and health industry group in China, Fosun Pharma takes innovative R&D as the core driver in a patient-centered and clinical demand-oriented manner, continuously increases R&D investment and improves innovation efficiency, and strives to bring higher quality and more accessible innovative therapeutic drugs and clinical solutions to Chinese and global patients around unmet clinical needs.


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 deeply rooted in China with strategic layouts in the pharmaceutical and healthcare industrial chain. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, 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 takes pharmaceutical manufacturing as its core business and sticks to innovative research and development. Through independent R&D, cooperative development, license-in, and in-depth incubation, Fosun Pharma had established platforms for small molecule innovative drugs, antibody drugs and cell therapy in such major disease areas as tumors, immunological diseases, 4 high health risks (hypertension, hyperlipidemia, hyperglycemia and hyperuricemia) and their complications, as well as central nervous system diseases. Moreover, Fosun Pharma keeps close track of cutting-edge technologies, such as targeted protein degradation, RNA, oncolytic virus and gene therapy to enhance its innovation ability.

Looking forward, under the guidance of 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma practices innovation and transformation, integrated operation and steady development, as well as the concept of sustainable development. Fosun Pharma strives to be a leading enterprise in the global pharmaceutical and healthcare markets.

For more information, please visit our official website:www.fosunpharma.com.
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