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Fosun Pharma’s Innovative Drug ORIN1001 Receives U.S. FDA Fast Track Designation, Marking a Milestone for the treatment of Triple-negative Breast Cancer

06-16 2019
SHANGHAI, June 16, 2019-Shanghai Fosun Pharmaceutical (Group) Co., Ltd.(“Fosun Pharma; stock code: 600196.SH, 02196.HK)), a leading healthcare group in China announced that its investigational drug ORIN1001 has received Fast Track designation (FTD) from U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed, refractory and metastatic breast cancer (including triple-negative breast cancer [TNBC]).

ORIN1001 is an investigational first-in-class small molecule drug that has a novel molecular target, novel mechanism of action and novel chemical structural class and identity, and is independently developed by Fosun Orinove, a subsidiary of Fosun Pharma. The new drug is for the treatment of advanced solid tumors and relapsed refractory metastatic breast cancer. As of May 2019, Fosun Pharma has invested RMB 45.47 millions in this investigational drug.

Established in July 2017 by Fosun Pharma and a team of American scientists, Fosun Orinove focuses on cancer cell metabolism-related small molecule anticancer drugs, and has set up R&D locations both in Suzhou and Los Angeles. 

Dr. Qingping Zeng, CEO of Fosun Orinove said, "The fast track designation of ORIN1001 reflects a recognition for our R&D aspirations of getting novel therapeutics to patients and addressing unmet medical needs. The molecular target is related to a stress mitigation mechanism for diseased cells, and has commonality for various therapeutic indications. We will accelerate ORIN1001 development in multiple indications in the near future and reach the global market expeditiously."

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious or life-threatening disease or condition and fill an unmet medical need. A therapeutic that receives Fast Track designation may be eligible for frequent communication with the FDA, priority review, potential accelerated approval according to data, and rolling submission, which allows a company to submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.
Dr. Aimin Hui, the Senior Vice President and Chief Medical Officer of Fosun Pharma said, “We are thrilled to treat cancer patients in the United States and receive FDA Fast Track Development Program designation within six months since initial IND submission. It implies that the research and development for innovative medicine and globalization at Fosun Pharma is moving to a new stage.”

Breast cancer is one of the major cancer-caused deaths for women nowadays. TNBC refers to breast cancer tumors that do not express the estrogen receptor (ER), progesterone receptor (PR) and Her2/neu, and is diagnosed more frequently in younger and premenopausal women under 40 years old. TNBC accounts for about 15 to 25% of breast cancer patients, and because of the high heterogeneity of its tumor cells, triple-negative breast cancer has very high invasiveness, recurrence rate and metastasis. Due to the lack of effective targeted therapy, there is a huge unmet clinical need for TNBC.

“Receipt of FDA Fast Track designation has marked another innovative breakthrough of Fosun Pharma in oncology treatment area.” Executive Director and Co-President of Fosun International, Chairman of Fosun Pharma, Mr. Chen Qiyu said, “In the future, we’ll continue to innovate in unmet medical needs, to find treatment for refractory diseases, and to provide more accessible, more qualified, and more affordable products and services to global patients.”

Cancer severely threats human health. Tradition treatment could hardly curing cancer. In recent years, Fosun Pharma continues to expand investment on innovation and oncology research, and has layout on small molecular innovative drugs, biologics and cellular immunotherapy. Now, Fosun Pharma owns a rich pipeline, with more than 30 projects on clinical development stage in oncology. In February 2019, its independent innovative product HLX01(trademark: 汉利康®) which is developed by Henlius, Fosun Pharma’s biologics platform has been approved by NMPA as the first biosimilar in China. It helps to increase the accessibility of high-quality biosimilar, and would benefit more lymphoma patients. Facing with unmet medical needs, Fosun Pharma also introduces a number of advanced and cutting-edge products and technologies via corporate cooperation and license-in. Fosun Kite’s first product FKC876 was accepted in the clinical trial and registration review of the NMPA, with an aim to provide advanced treatment to Chinese cancer patients. In the future, Fosun Pharma will leverage on the advantages and stick to independent innovation and internationalization benefiting from industry and market opportunities, to contribute better and more affordable medicines for society.