Why is FDA Fast-Tracking Fosun Orinove’s Cancer Drug a Groundbreaking Achievement?

Why is FDA Fast-Tracking Fosun Orinove’s Cancer Drug a Groundbreaking Achievement?

US Food and Drug Administration recently approved a Chinese experimental drug, ORIN1001, to be fast-tracked. Fast-tracking is a practice intended to aid the development and expedite the appraisal of drugs created for the treatment of life-threatening diseases or medical conditions.

This drug is designed for the treatment of patients with relapsed, resistant and secondary breast cancer, including triple-negative breast cancer, or TNBC. ORIN1001 has been independently developed by Fosun Orinove, an ancillary of the Shanghai Fosun Pharmaceutical (Group) Co., Ltd, a primary healthcare group in China.

Fosun Pharma has invested over 45.47 million Yuan (US$6.57 million) in this investigational drug. Their plan is to further accelerate the development of ORIN1001 in order to quickly and efficiently reach the international market.

A medicine that gets fast-track approval becomes entitled to regular communication with the FDA and prioritized appraisals. The fast-track designation (FTD) also permits a company to present separate completed sections of its New Drug Application, instead of waiting till the completion of every section before submission of the entire NDA for review, which increases the potential for accelerated approval of the drug.

ORIN1001 has received fast-track approval within six months of the initial submission of New Drug Application by Fosun Orinove. This endorsement marks a major groundbreaking advancement for Fosun Pharma in the field of oncology.

Breast Cancer is one of the major causes of death for women at the present time. Triple-negative breast cancer is a highly invasive form of cancer which is resistant to treatment and metastasizes frequently. It is a recurring breast cancer in young, premenopausal women aged 40 and under. About 15 to 25 percent of all breast cancer patients in China are diagnosed with TNBC.

Fosun Orinove has taken a step in the right direction with ORIN1001, and plans on continuing to find treatment for drug-resistant diseases. In February 2019 FosunPharma’s independent groundbreaking drug HLX01, developed by Henlius (Fosun Pharma’s biologics platform), was approved by the National Medical Products Administration as the first ever biosimilar in China. Fosun Kite’s (a joint venture of Kite Pharma and Fosun Pharma) first product FKC876, aimed at providing advanced treatment to cancer patients, got accepted in the clinical trial of the NMPA.

Fosun Pharma currently has more than 30 oncology projects in the clinical development stage. It is committed to further expand its investment in innovation and oncology research and make more affordable and accessible drugs.