Securities code: 688136 securities abbreviation: Shan Dong Kexing Bioproducts Co.Ltd(688136) Announcement No.: 2022-004 Shan Dong Kexing Bioproducts Co.Ltd(688136)
Voluntary disclosure on the acceptance of EMA for drugs in cooperation with Haichang biology
Progress announcement of and drug cooperation agreement
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 legal liabilities for the authenticity, accuracy and integrity of its contents according to law.
Recently, Zhejiang Haichang Biomedical Technology Co., Ltd. (hereinafter referred to as “Haichang biology”), the partner of Shan Dong Kexing Bioproducts Co.Ltd(688136) (hereinafter referred to as “the company”), received the acceptance notice issued by the European Drug Administration (hereinafter referred to as “EMA”), EMA officially confirmed and accepted the application for marketing license (MAA) of paclitaxel for injection (albumin bound) (hereinafter referred to as the “target drug”) jointly developed by the company and Haichang biology, and entered the technical review procedure.
For details of the cooperation between the company and Haichang biology, please refer to the website of Shanghai Stock Exchange (www.sse. Com. CN.) Announcement on signing drug cooperation agreement with Haichang Biology (Announcement No.: 2021-022). On January 13, 2022, the registration and marketing license of the target drugs for domestic production was accepted by the State Drug Administration. For details, the company disclosed it on the website of Shanghai Stock Exchange (www.sse. Com. CN.) on January 15, 2022 Announcement on voluntary disclosure of progress in signing drug cooperation agreement with Haichang Biology (Announcement No.: 2022-002).
The relevant information is hereby announced as follows: I. relevant information of drugs
Abraxane, the original research drug of paclitaxel for injection (albumin binding type), was initiated and developed by abraxis Bioscience and later acquired by celgene. It is now a wholly-owned subsidiary of Bristol Myers Squibb. The European Medicines Agency has approved the first line treatment for breast cancer, metastatic pancreatic adenocarcinoma and non-small cell lung cancer.
At present, only Bristol Myers Squibb, the original drug manufacturer, and ratiopharm GmbH (a subsidiary of Teva Pharmaceutical Industries Limited) are the manufacturers of paclitaxel for injection (albumin bound) sold in the EU. The subject drug was studied according to the quality requirements of complex injections in the United States, the European Union and China. The quality indexes met the international bioequivalence standard of complex injections and were consistent with the original reference preparation. 2、 Impact on the company
The formal acceptance of the application for marketing license of the target drugs by EMA is another important progress made by the target drugs worldwide after the State Drug Administration accepted the application for marketing license. The EU is an important region for the global commercialization of the subject drug. This listing application is a centralized procedure (CP), which is applicable to all 27 EU Member States and Norway, Iceland and Liechtenstein, laying a solid foundation for the European commercialization of the subject drug and opening the European market. The acceptance notice of the subject drug will not have a significant impact on the company’s recent performance. 3、 Risk tips
After the subject drug is officially accepted by EMA, it still needs to go through the verification procedures such as technical review and production site inspection by relevant European departments. It is uncertain whether it can be approved for listing. The acceptance notice of the subject drug will not have a significant impact on the company’s recent performance. The company will timely perform the obligation of information disclosure on the follow-up progress of the above drugs according to relevant regulations. Please make careful decisions and pay attention to preventing investment risks. It is hereby announced.
Shan Dong Kexing Bioproducts Co.Ltd(688136) board of directors January 24, 2022
