Securities code: 002019 securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022-015 Yifan Pharmaceutical Co.Ltd(002019)
Announcement on the progress of the f-627 project of the product under research of the holding subsidiary
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.
Yifan Pharmaceutical Co.Ltd(002019) (hereinafter referred to as "the company"), a holding subsidiary of Yiyi biopharmaceutical (Beijing) Co., Ltd., is developing the product Albertine α Injection (once used common name: recombinant human granulocyte colony stimulating factor Fc fusion protein, proposed trade name: Yilishu, hereinafter referred to as "f-627") was used to prevent and treat neutropenia caused by chemotherapy in tumor patients. It was received by the State Drug Administration (hereinafter referred to as "FDA") on February 23, 2022 The notice of acceptance of the application for registration and marketing license of domestically produced drugs issued. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Product Name: Albertine α injection
Applicant: Yiyi biopharmaceutical (Beijing) Co., Ltd
Application item: registration and marketing license of domestically produced drugs
Acceptance No.: cxss220001 8 countries
Drug registration classification: Class 1 biological products for treatment
Specification: 20 mg (1.0 ml) / piece
Examination and approval 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、 Drug related information
F-627 is an innovative biological drug variety developed based on the existing di kinetm bimolecular technology platform with independent intellectual property rights of the holding subsidiary evive biotech Ltd. (hereinafter referred to as "Yiyi biology"). It is a rhG CSF dimer expressed by CHO cells based on Fc fusion protein technology, with long-term and powerful biological characteristics. At present, f-627 is mainly used to prevent and treat neutropenia caused by chemotherapy in tumor patients, which can make neutrophils in tumor chemotherapy patients proliferate and recover rapidly, so as to enhance the ability of immune system to resist infection, so as to prevent patients from dying of infection or other related complications during chemotherapy.
In January 2018, Yiyi biological completed the first phase III clinical trial of f-627 in the United States (hereinafter referred to as "04 trial"), and reached the preset primary efficacy endpoint. The subjects were well tolerated and the safety reached the expectation. On January 5, 2020, Yiyi biological received the collection of statistical data and charts of phase III clinical trial of f-627 in China. The statistical results show that the effectiveness results of phase III clinical trial of f-627 in China have fully met the preset evaluation criteria of clinical trial, and the curative effect is equivalent to that of the control drug (recombinant human granulocyte colony stimulating factor, an imported drug); In June 2020, Yiyi biological received the second international phase III clinical trial (hereinafter referred to as "05 trial") in the United States and Europe. The results showed that the second international phase III clinical trial successfully reached the preset primary efficacy endpoint and secondary efficacy endpoint, and the drug efficacy was equivalent to that of the control drug; In July 2020, the company completed the neutralizing antibody test related to immunogenicity in 05 test, and the result was negative, indicating that no drug-related antibody was produced; Since then, the phase I, phase II and phase III clinical trials of f-627 carried out outside China have successfully achieved the preset objectives of clinical trials. On March 30, 2021, Yiyi biological submitted the biological product license application (BLA) of f-627 to the U.S. Food and Drug Administration (FDA), and received the acceptance letter from FDA on May 27, 2021, officially accepting the listing application of f-627.
On August 26, 2021, the company, Yiyi biology, Zhengda Tianqing Pharmaceutical Group Co., Ltd. and its wholly-owned subsidiary Zhengda Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. (hereinafter referred to as "Tianqing Nanjing Shunxin") signed the commercial cooperation agreement, which agreed to exclusively license the commercialization rights and interests related to f-627 in China to Tianqing Nanjing Shunxin, Sunny Nanjing Shunxin needs to pay a license fee of no more than 21 million yuan to Yiyi biology and a graded royalty on net sales.
On September 30, 2021, Yiyi biological received the acceptance letter of f-627 marketing license application issued by the European Drug Administration (EMA) and entered the review procedure.
For details of the above matters, see the company's securities times on January 6, 2020, June 29, 2020, July 8, 2020, March 31, 2021, May 29, 2021, August 30, 2021 and October 8, 2021 The announcement on the holding subsidiary's in-process research product f-627 China phase III clinical trial results meeting the preset evaluation criteria (Announcement No.: 2020-001), the announcement on the holding subsidiary's in-process research product f-627 international phase III key clinical trial results meeting the preset evaluation criteria (Announcement No.: 2020-044), and Announcement on the progress of the second international phase III key clinical trial results of the holding subsidiary's product under research f-627 (Announcement No.: 2020-046), announcement on the progress of the holding subsidiary's product under research f-627 project (Announcement No.: 2021-038), announcement on the progress of the holding subsidiary's product under research f-627 project (Announcement No.: 2021-047) Announcement on the signing of product commercialization cooperation agreement between the company and its holding subsidiaries (Announcement No.: 2021-070) and announcement on the progress of f-627 project of products under research of its holding subsidiaries (Announcement No.: 2021-082).
3、 Impact on the company
The formal acceptance of the domestic listing application of f-627 is another important progress made by f-627 in the world after the U.S. FDA and European EMA accepted the listing application. At present, f-627 is a research in progress product in the global G-CSF therapeutic drugs, which carries out head-to-head comparative research with both long-acting and short-acting original research products, achieves the clinical preset goal and realizes the synchronous declaration of China, the United States and Europe, lays a solid foundation for China's commercialization and global sales, and is conducive to the global sales of the product after listing.
The application for domestic listing of f-627 has been officially accepted by the food and drug administration, which will not have an impact on the company's recent performance. If it is approved in the future, it will have a positive impact on the company's performance.
4、 Risk tips
After the f-627 listing application is officially accepted by the FDA, it also needs to go through the verification procedures such as technical review, on-site verification of clinical trial data and on-site inspection of production by national departments. It is still uncertain whether it can be approved for listing. The company will actively promote the follow-up progress of the above-mentioned projects under research in accordance with relevant regulations at home and abroad, and timely fulfill the obligation of information disclosure on the follow-up progress of the project in accordance with relevant laws and regulations. Please make careful decisions and pay attention to investment risks.
5、 Documents for future reference
Acceptance notice
It is hereby announced.
Yifan Pharmaceutical Co.Ltd(002019) board of directors February 24, 2022
