Securities code: 603858 securities abbreviation: Shandong Buchang Pharmaceuticals Co.Ltd(603858) Announcement No.: 2022-005 Shandong Buchang Pharmaceuticals Co.Ltd(603858)
Announcement on the acceptance notice of drug clinical trial obtained by the holding subsidiary
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Shandong Buchang Pharmaceuticals Co.Ltd(603858) (hereinafter referred to as “the company”) recently learned that the application for “bc004 for injection” clinical trial of Luzhou step biopharmaceutical Co., Ltd. (hereinafter referred to as “Luzhou step”) which is the holding subsidiary of the company has been accepted by the State Drug Administration and received the acceptance notice. Now the relevant information is disclosed as follows:
1、 Basic information of drugs
Drug name: bc004 for injection
Dosage form: injection
Specification: 0.5mg/bottle
Registration classification: therapeutic biological products: Class 1
Application item: registered clinical trial of domestically produced drugs
Applicant: Luzhou Buchang biopharmaceutical Co., Ltd
Acceptance No.: cxsl2200026
Acceptance conclusion: according to the provisions of Article 32 of the administrative license law of the people’s Republic of China, after examination, it is decided to accept it.
2、 Other information about drugs
BC004 is a recombinant humanized bispecific antibody against HER2/CD3. It is mainly used for the treatment of HER2 positive late solid tumors, including HER2 positive breast cancer, gastric cancer / gastroesophageal junction adenocarcinoma. At present, there are no drugs on the market with the same target outside China.
As of December 31, 2021, the R & D cost invested by the company in bc004 project is about 48.5763 million yuan. 3、 Risk tips
After the application for drug clinical trial is accepted, the implied permission for clinical trial shall be obtained before the clinical trial can be carried out in accordance with the relevant provisions and requirements of the national drug registration.
Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The company will timely perform the obligation of information disclosure on the follow-up progress of the project in accordance with relevant regulations.
It is hereby announced.
Shandong Buchang Pharmaceuticals Co.Ltd(603858) board of directors January 22, 2022
