On 20 October 2016, as stated in the A Share announcement of Fosun Pharma, phase I clinical study of recombinant humanized anti-HER2 monoclonal antibody for injection (“New Drug”) developed by Shanghai Henlius Biotech Co., Ltd.* (“Shanghai Henlius”), the controlling subsidiary of the Company, has been completed. The results of phase I clinical trial confirmed that: the New Drug is safe and has same effectiveness of Herceptin®. Shanghai Henlius indicated that phase III clinical trial of the New Drug would be officially started in the near future.
The New Drug, a biosimilar drug of monoclonal antibody biological drug self-developed by Fosun Pharma’s controlling subsidiary Shanghai Henlius, is suitable for breast cancer and metastatic stomach cancer treatments.
The New Drug was approved for clinical trial on indications for breast cancer and metastatic stomach cancer by China Food and Drug Administration in July 2015 and January 2016, respectively. According to the result of phase I clinical trial of the New Drug, Shanghai Henlius and experts from 45 renowned hospitals including the Cancer Institute and Hospital, Chinese Academy of Medical Sciences and the 307th Hospital of Military Chinese People’s Liberation Army have provided adequate evidence for phase III clinical study on the application of the New Drug on indication for breast cancer. Currently, preparation work for phase III clinical trial of the New Drug including Ethics and trial drugs is being conducted orderly.
Breast cancer incidence rate is the highest among all cancers for Chinese women. It is the sixth most common cause of cancer death. According to the information of Chinese Anti-cancer Association, the incidence of breast cancer continually increases over recent years. Nearly 0.2 million women are diagnosed with breast cancer every year.
To date, Trastuzumab Injection (Herceptin®) is the main HER2 inhibitor launched in China (excluding Hong Kong, Macau and Taiwan). According to the information of IMS MIDAS, in 2015, the sales of Trastuzumab Injection (Herceptin®) in China amounted to approximately RMB0.89 billion. If the New Drug passes phase III clinical trial, the launch will be subject to the approval of national department for drug evaluation according to relevant regulatory requirements of drug research.