The board of directors of the Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd. announced that, the Company has received the Acceptance Notice issued by the National Medical Products Administration of the PRC (the ?NMPA?). The investigational new drug (the ?IND?) application for Phase II clinical trial of aminolevulinic acid granules (the ?Drug?) for intraoperative visualisation of breast cancer in adult breast conservative surgery has been accepted. Relevant information is as follows: Drug name: Aminolevulinic acid granules; Registration type: Class 2.4 improved new drug; Application matter: Registration of Clinical Trial of Domestic Production of Pharmaceutical Product; Acceptance No.

CXHL2301260; Applicant: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd; Review conclusion: Accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People's Republic of China. Breast cancer is one of the most common malignant tumors in women with the incidence ranking the first in female tumors, which seriously endangers women's physical and mental health. According to IARC data, China ranks first in the world in the number of new breast cancer cases in 2020, with about 420,000 cases.

At present, the main diagnosis and treatment methods of breast cancer include surgical treatment, radiotherapy, chemotherapy, targeted therapy and immunotherapy, among which breast- conserving surgery for patients with early breast cancer has been widely recognized. The goal of breast- conserving surgery is to completely remove the tumor while preserving the surrounding healthy tissues as much as possible. However, the current technology is not yet sufficient to doctors to determine in real-time whether the tumor has been completely removed.

The Company intends to develop this intraoperative fluorescence-guided technology to visualize the residual tumor and the resection margin, so as to guide the resection range in real time, to help the patients in China and fulfill the unmet medical needs in clinical practice. The IND application for the Drug submitted to the NMPA by the Company was the Phase II clinical trial application of the effectiveness and safety of fluorescence diagnosis during breast-conserving surgery for early breast cancer.