Securities code: 002755 securities abbreviation: Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Announcement No.: 2022-001 Beijing Aosaikang Pharmaceutical Co.Ltd(002755)
Announcement on the approval notice of the subsidiary's biological innovative drugs for clinical trials
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Suzhou Beijing Aosaikang Pharmaceutical Co.Ltd(002755) biomedical Co., Ltd. (hereinafter referred to as "Suzhou Beijing Aosaikang Pharmaceutical Co.Ltd(002755) "), a wholly-owned subsidiary of Beijing Aosaikang Pharmaceutical Co.Ltd(002755) (hereinafter referred to as "the company"), recently received the approval notice of drug clinical trial on askg712 injection issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration"), and will carry out clinical trial in the near future. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Product Name: askg712 injection
Dosage form: injection
Application item: clinical trial
Registration classification: Class 1 biological products
Applicant: Suzhou Beijing Aosaikang Pharmaceutical Co.Ltd(002755) biomedical Co., Ltd
Acceptance No.: cxsl2101396
Notice No.: 2022lp00052
Approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, askg712 injection accepted on October 27, 2021 meets the relevant requirements of drug registration and agrees to carry out clinical trial. Indication: neovascular age-related macular degeneration (namd).
2、 Other relevant information of drugs
AMD is a progressive disease involving the central visual acuity of the macular retina. This disease will lead to the irreversible decline of visual acuity. It is one of the main blinding eye diseases in adults over 50 years old. Data show that about 21 million 400 thousand of AMD patients in China are suffering from an aging population. The incidence rate will increase year by year. At present, the standard therapeutic drugs are single target anti VEGF drugs, which need frequent intravitreal injection (every month), poor patient compliance and high economic burden.
Askg712 is a bispecific antibody independently developed by the subsidiary that targets VEGF and Ang2 at the same time. While blocking VEGF / VEGFR signal pathway and controlling neovascularization, it can effectively inhibit Ang-2 signal to improve vascular stability and reduce retinal inflammation. At present, there is no bispecific antibody with the same target in the world. Faricimab, the world's first developed for Roche, announced in 2021 that its four phase III clinical trials have reached the main focus, with remarkable curative effect. About half of the patients can be administered once every four months. The preclinical results of askg712 show that it has good safety and stronger binding activity to VEGF and Ang2. It is expected to achieve better clinical efficacy and reduce the times of vitreous injection.
At present, the subsidiary has obtained the notice of clinical trial approval and will carry out clinical trial research on askg712 in accordance with the requirements of laws and regulations related to drug registration in China. The project will further enrich the company's innovative drug pipeline, enhance the company's market competition and fill the market gap.
3、 Risk warning.
Drug R & D, especially new drug R & D, has high added value, but it has long cycle, many links and high risk, and is vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The board of directors of the company will actively promote the follow-up progress of the project and timely fulfill the obligation of information disclosure.
It is hereby announced.
Beijing Aosaikang Pharmaceutical Co.Ltd(002755) board of directors January 17, 2022
