Securities code: 300558 securities abbreviation: Betta Pharmaceuticals Co.Ltd(300558) Announcement No.: 2022-005 Betta Pharmaceuticals Co.Ltd(300558)
Announcement on bpi-371153 capsule obtaining clinical trial approval notice
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.
Recently, Betta Pharmaceuticals Co.Ltd(300558) (hereinafter referred to as “the company”) received the notice of approval of drug clinical trial (Notice No.: 2022lp00057, 2022lp00060) issued by the State Drug Administration (hereinafter referred to as “nmpa”), The clinical trial of bpi-371153 capsule applied by the company for the treatment of patients with advanced or metastatic solid tumor or recurrent / refractory lymphoma has been approved by nmpa. The specific situation is hereby announced as follows:
1、 Basic information of the clinical trial
Product Name: bpi-371153 capsule
Acceptance No.: cxhl2101649; Cxhl2101650 countries
Applicant: Betta Pharmaceuticals Co.Ltd(300558)
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, bpi-371153 capsule accepted on November 11, 2021 meets the relevant requirements of drug registration, and it is agreed to carry out the clinical trial of advanced or metastatic solid tumor or recurrent / refractory lymphoma.
2、 Research status of drug use in this clinical trial
Bpi-371153 is a new molecular entity compound independently developed by the company with completely independent intellectual property rights. It is an innovative and oral small molecule PD-L1 inhibitor. It is intended to be used in the treatment of patients with advanced or metastatic solid tumors or recurrent / refractory lymphoma. Preclinical data show that bpi-371153 has a good effect of stimulating antitumor immunity. Compared with PD-1 / PD-L1 antibody drugs, oral small molecule PD-L1 inhibitors may have similar clinical benefits, convenient administration, lower production cost and significantly improved drug accessibility.
In November 2021, the company submitted the drug clinical trial application of bpi-371153 to nmpa and accepted it. For details, see the company’s disclosure on cninfo.com on November 15, 2021（ http://www.cn.info.com.cn. ）Announcement on acceptance of bpi-371153 capsule drug clinical trial application (Announcement No.: 2021-116).
As of the disclosure date of this announcement, no small molecule PD-L1 inhibitor has been approved for listing in the world. Bpi-371153 belongs to “innovative drugs that are not listed at home and abroad”, and its registration is classified as class 1 chemical drugs.
3、 Impact on the company and risk tips
The clinical trial approval will not have a significant impact on the company’s recent performance. According to the requirements of relevant national laws and regulations on drug registration, drug clinical trials need to be reviewed and agreed by the ethics committee and China human genetic resources management office. The review results and the progress of subsequent clinical trials are uncertain. Please pay attention to preventing investment risks and make prudent decisions.
It is hereby announced.
Betta Pharmaceuticals Co.Ltd(300558) board of directors January 16, 2022
