Zhitong Financial APP News, Shanghai Fosun Pharmaceutical (01969) issued an announcement, recently The recombinant anti-HER2 domain II humanized monoclonal antibody injection (HLX11) independently developed by Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and its holding subsidiary (hereinafter referred to as "Fuhong Hanlin") started phase III clinical trials in China (excluding Hong Kong, Macao and Taiwan) for HER2-positive and HR-negative early or locally advanced breast cancer neoadjuvant therapy.
It is reported that the new drug is a biological similar drug independently developed by the group (that is, the company and its holding subsidiary / unit, the same below). The original drug is used for the following indications: (1) early breast cancer: in combination with trastuzumab and chemotherapy, as part of the overall treatment plan for early breast cancer, neoadjuvant therapy for HER2 positive, locally advanced, inflammatory or early breast cancer patients (diameter > 2cm or lymph node positive), and adjuvant therapy for HER2 positive early breast cancer patients with high risk of recurrence. And (2) metastatic breast cancer: combined with trastuzumab and docetaxel to treat locally recurrent breast cancer patients with HER2 positive, metastatic or unresectable breast cancer who had not received anti-HER2 treatment or chemotherapy.
As of the date of this announcement, the Patuzumab injection listed in China is Padate ®of Shanghai Roche Pharmaceutical Co., Ltd. According to information provided by IQVIA CHPA (provided by IQVIA, IQVIA is the world's leading provider of professional information and strategic consulting services for the pharmaceutical and health industry IQVIA CHPA data represents the drug sales market in hospitals with more than 100 beds in China, and the actual sales of different drugs may differ from IQVIA CHPA data to varying degrees due to their different sales channels). In 2021, the sales volume of Patouzumab injection in China is about RMB 2.613 billion.
As of March 2022, the Group's cumulative R & D investment for the new drug at this stage is about 122 million yuan (unaudited).