Fosun Pharma's Innovative Drug ORIN1001 Granted FDA Fast Track Designation for Triple-Negative Breast Cancer Treatment

On June 16, 2019, VCBeat learned that Fosun Pharmaceutical (stock codes: 600196.SH, 02196.HK) announced in a filing on the same day that the U.S. Food and Drug Administration (FDA) had recently granted Fast Track designation to its new drug, ORIN1001, for the treatment of recurrent, refractory, metastatic breast cancer (including triple-negative breast cancer).

ORIN1001 is a first-in-class small-molecule drug independently developed by Fosun Hongchuang (Suzhou) Pharmaceutical Technology Co., Ltd. (“Fosun Hongchuang”), a subsidiary of Fosun Pharmaceutical. It features a novel enzymatic target, a new mechanism of action, and a new chemical structural class, and is indicated for the treatment of advanced solid tumors, with its first exploratory indication being recurrent, refractory, and metastatic breast cancer. As of May 2019, the cumulative R&D investment by Fosun Pharmaceutical Group in this new drug amounted to approximately RMB 45.47 million.

Fosun Hongchuang was jointly founded by Fosun Pharmaceutical and an overseas team of scientists in July 2017. It has currently established R&D bases in Suzhou and Los Angeles, focusing on small-molecule anticancer drugs related to cancer cell metabolism. Zeng Qingping, President of Fosun Hongchuang, stated, “The granting of Fast Track designation by the U.S. FDA for ORIN1001 represents a milestone recognition of our company’s steadfast commitment to addressing unmet clinical needs through innovative medicines and bringing new hope to patients. Meanwhile, as this drug targets stress mechanisms in pathological cells, it holds potential applicability across multiple indications. We aim to rapidly expand its use to other indications in the near future and expedite its global approval and market launch.”

Fast Track Designation (FTD) is designed to accelerate the development and expedited review of drugs for serious conditions, addressing significant unmet medical needs in critical areas. When an investigational drug receives Fast Track designation, the sponsoring pharmaceutical company may engage in more frequent meetings with the FDA during the research and development phase. Furthermore, if relevant criteria are met after submission of a marketing application, the drug becomes eligible for Accelerated Approval, Priority Review, and Rolling Review. Rolling Review allows the sponsor to submit completed sections of its Biologics License Application (BLA) or New Drug Application (NDA) to the FDA for evaluation, rather than waiting until all sections are complete before submitting the entire BLA or NDA for review.

Dr. Aimin Hui, Senior Vice President and Chief Medical Officer of Fosun Pharmaceutical, stated, “We began patient enrollment within six months of submitting our Investigational New Drug (IND) application in the United States and received Fast Track designation from the FDA. This indicates that Fosun Pharmaceutical’s innovative drug development and internationalization are entering a new phase.”

Breast cancer has become one of the leading threats to women's health. Triple-negative breast cancer (TNBC) is a distinct subtype characterized by negative expression of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2). TNBC predominantly affects young women under the age of 40, accounting for approximately 15%–25% of all breast cancer cases. Due to the high heterogeneity of its tumor cells, TNBC exhibits marked aggressiveness, as well as high rates of recurrence and metastasis. The lack of effective targeted therapies has resulted in a significant unmet clinical need for this disease.

“ORIN1001’s receipt of Fast Track designation from the U.S. FDA marks another groundbreaking achievement for Fosun Pharmaceutical in innovative oncology R&D,” stated Chen Qiyu, Co-President of Fosun International and Chairman of Fosun Pharmaceutical. “Moving forward, our innovation will continue to focus closely on unmet medical needs, committed to tackling refractory diseases or those with no existing treatments, so as to provide more accessible, higher-quality, and more affordable products and services to patients worldwide.”

Cancer poses a severe threat to human health, and traditional treatments struggle to achieve a fundamental cure. In recent years, Fosun Pharmaceutical has continuously increased its R&D investment, accelerating research and innovation in cancer therapy. The company has established a strategic presence in small-molecule innovative chemical drugs, biologics, and cellular immunotherapy technologies. Currently, Fosun Pharmaceutical boasts a robust R&D pipeline with more than 30 oncology projects in clinical stages. In February 2019, Rituximab Injection (brand name: Hanlikang®), independently developed by Henlius, the biologics platform of Fosun Pharmaceutical, received marketing approval. This milestone filled the gap for domestically produced biosimilars, enhanced access to high-quality biologics, and benefited more lymphoma patients. Addressing unmet needs in the healthcare sector, Fosun Pharmaceutical has also introduced multiple cutting-edge products and technologies through product collaborations and market licensing agreements. FKC876, the first product from Fosun Kite, the cellular immunotherapy platform of Fosun Pharmaceutical, has obtained clinical trial approval from the National Medical Products Administration and initiated clinical studies, committed to bringing globally leading treatment options to lymphoma patients in China. Upholding innovative R&D as the core driver of corporate development, Fosun Pharmaceutical will further seize policy and market opportunities, leverage its competitive advantages, adhere to the path of innovation and internationalization, and continue to contribute higher-quality, more affordable medicines to society.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharmaceutical”; stock codes: 600196.SH, 02196.HK), founded in 1994, is a leading healthcare industry group in China. With the mission of promoting human health, Fosun Pharmaceutical Group covers the entire pharmaceutical and healthcare value chain, including pharmaceutical manufacturing and R&D, medical services, medical devices and diagnostics, and pharmaceutical distribution and retail. The Group focuses on pharmaceutical manufacturing and R&D as its core business, with medical services as a key area for development.