Securities code: Yifan Pharmaceutical Co.Ltd(002019) securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022017 Yifan Pharmaceutical Co.Ltd(002019)
Announcement on the signing of exclusive license agreement by holding subsidiaries
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.
Important content tips:
1. Type of agreement signed: exclusive license agreement
2. Signing content of the agreement:
Singapore Yiyi, the holding subsidiary of the company, agreed to license the exclusive distribution right of f-627 under development in Germany to apogepha company, so that apogepha company can obtain the exclusive sales right in the cooperation area. Apogepha company needs to pay Singapore Yiyi a non refundable advance payment of US $400000 Development milestone payments up to $1000000 and sales milestone payments up to $37500000.
3. Risk tips:
(1) New drug research and development has the characteristics of high risk and long cycle. On September 30, 2021, the company received the acceptance letter of f-627 marketing license application issued by the European Drug Administration (hereinafter referred to as “EMA”) and entered the review procedure. After acceptance, 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 relevant European departments, Whether it can be approved for listing is still uncertain.
(2) The sales situation of new drugs after listing is affected by many factors, including market environment and industry development. The milestone payment agreed in this cooperation needs to meet certain conditions. Therefore, there is still uncertainty whether this cooperation can reach the agreed milestone payment. Please make careful decisions and pay attention to preventing investment risks.
1、 Contract signing overview
On February 28, 2022, Yifan Pharmaceutical Co.Ltd(002019) (hereinafter referred to as “the company”) holding subsidiary evive biotechnology Singapore Pte.Ltd. (hereinafter referred to as “Singapore Yiyi” or “party a”) and
Apogepha arzneimittel GmbH (hereinafter referred to as “apogepha company” or “Party B”) signed the exclusive license agreement, which agreed that Xinjia Poyi agreed to develop the product Albertine α The exclusive distribution right of injection (hereinafter referred to as “f-627”) in Germany is licensed to apogepha, which is responsible for the market planning and sales of f-627 in Germany. Therefore, apogepha needs to pay a non refundable advance payment of US $400000 to Singapore Yiyi Development milestone payments up to $1000000 and sales milestone payments up to $37500000. This transaction is within the approval scope of the chairman and fails to meet the deliberation standards of the board of directors and the general meeting of shareholders. According to relevant laws and regulations and the provisions of the articles of association, this transaction does not constitute a connected transaction.
2、 Introduction to counterparty
1. Company name: apogepha arzneimittel GmbH,
2. Enterprise type: private enterprise
3. Registered address: kyffh ä user Strasse 27, 01309 Dresden, state Saxony, Germany
4. Registration date: May 1, 1990
5. Registered capital: 5000000
6. Registration Certificate No.: HRB 515
7. Association relationship: there is no association relationship with the company and its holding subsidiaries, nor property rights, business, assets, creditor’s rights and debts, personnel and other relationships.
8. Controlling shareholder: gesta GmbH
9. Company overview: apogepha is a family pharmaceutical company with a long history and high competitiveness in Germany, headquartered in Dresden. The company focuses on the treatment field of Urology and urology oncology, and has professional technology and rich experience in the development, production and sales of innovative products. Apogepha is committed to providing cutting-edge products for medical professionals and continuously bringing better treatment options to patients. At present, its products have been sold in 25 markets around the world, with marketing and distribution partners in more than 20 countries, and its main markets are in Europe, the Middle East and Asia.
10. Main financial data:
Unit: RMB
December 31, 2020 December 31, 2021
Total assets 2858855664027850927357
Total liabilities 69636613886078658084
Total receivables 52853201316130725535
Net assets 2162489454521772268567
January December 2020 January December 2021
Operating income 4423919706939994877088
Total profit 1963127219021901076327
Net profit 2499281427853584728
Net cash flow from operating activities -1440668400 -1159170975
3、 Products involved in this transaction
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) for f-627, 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.
On January 28, 2022, Singapore Yiyi signed an exclusive license agreement with kalteq S.A. (hereinafter referred to as “kalteq company” or “Party B”), which agreed that Xinjia Poyi agreed to license the exclusive distribution right of f-627 in Greece and Cyprus to kalteq company, which is responsible for the market planning and sales of f-627 in Greece and Cyprus, For this purpose, kalteq is required to pay a non refundable one-time milestone payment of US $100000 to Singapore Yiyi and a sales milestone payment up to US $6.5 million.
On February 23, 2022, the subsidiary of Yiyi biology received the acceptance notice of the application for registration and listing license of domestically produced drugs issued by the State Drug Administration, and officially entered the review procedure in China.
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.: 2020001), 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.: 2020044), 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.: 2020046), announcement on the progress of the holding subsidiary’s product under research f-627 project (Announcement No.: 2021038), announcement on the progress of the holding subsidiary’s product under research f-627 project (Announcement No.: 2021047) Announcement on the signing of product commercialization cooperation agreement between the company and its holding subsidiaries (Announcement No.: 2021070), announcement on the progress of f-627 project of products under research of its holding subsidiaries (Announcement No.: 2021082) and announcement on the progress of f-627 project of products under research of its holding subsidiaries (Announcement No.: 2022015).
4、 Main contents of exclusive license agreement
1. Parties
Party A (licensor): evive biotechnology Singapore Pte.Ltd,
Party B (licensee): apogepha arzneimittel GmbH,
2. Main contents of the agreement
Singapore Yiyi will license the exclusive distribution right of f-627 in Germany to apogepha, which is responsible for the market planning and sales of f-627 in Germany. Therefore, apogepha needs to pay the down payment, development and sales milestone payment to Singapore Yiyi.
3. Agreement amount
The total amount of the agreement consists of a non refundable advance payment of US $400000, a development milestone payment of up to US $1000000 and a sales milestone payment of up to US $37500000, as follows: (1) a non refundable down payment of US $400000;
(2) Development milestone payments up to US $1000000;
（3
