Stock abbreviation: Zhejiang Hisun Pharmaceutical Co.Ltd(600267) Stock Code: Zhejiang Hisun Pharmaceutical Co.Ltd(600267) Announcement No.: Lin 202260 bond abbreviation: Haizheng fixed transfer bond Code: 110813
Zhejiang Hisun Pharmaceutical Co.Ltd(600267)
Announcement on signing strategic cooperation agreement and entrusted production framework 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 responsibility for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
● major risks and uncertainties in performance: the strategic cooperation agreement signed this time is a strategic and framework agreement reached by both parties based on their willingness to cooperate. It is a principled agreement on the rights and obligations of both parties, and the way of strategic cooperation is not exclusive. Zhejiang Hisun Pharmaceutical Co.Ltd(600267) (hereinafter referred to as "the company") does not enjoy the ownership of the "jt001 / vv116 tablets and / or APIs" (hereinafter referred to as "vv116") products involved in the commissioned production framework agreement. It is only a commissioned production enterprise. The specific quantity, price, special requirements, etc. will sign a separate business contract based on the commissioned production framework agreement. There are uncertainties in the signing and signing time of the final contract, And the relevant production lines can formally accept the entrustment only after the approval of drug entrusted production registration is required. Vv116 is currently in the phase III clinical trial stage of international multi center, and its indications for the treatment of novel coronavirus pneumonia have not been approved by the State Food and drug administration, so there is uncertainty about whether it has been approved.
Impact on the performance of listed companies: the impact of the signing of the above agreement on the company's financial status and operating results in 2022 and in the future depends on the promotion and implementation of specific projects. Please pay attention to investment risks.
1、 Basic information of agreement signing
On May 19, 2022, the company and Shanghai Wangshi Biomedical Technology Co., Ltd. (hereinafter referred to as "Wangshi biology") signed the strategic cooperation agreement and the entrusted production framework agreement. Now the relevant information is announced as follows:
(I) basic information of the counterparty
1. Name: Shanghai Wangshi Biomedical Technology Co., Ltd
2. Unified social credit Code: 91310000ma7fut5l
3. Registered capital: 10 million yuan
4. Type: other limited liability companies
5. Date of establishment: December 31, 2021
6. Legal representative: Xiong Jun
7. Registered address: room n, floor 3, No. 780 Cailun Road, China (Shanghai) pilot Free Trade Zone
8. Business scope: licensed items: drug retail; Wholesale of drugs; Commissioned production of drugs; Drug production; Import and export of drugs. (for projects that must be approved according to law, business activities can be carried out only after being approved by relevant departments, and the specific business projects shall be subject to the approval documents or licenses of relevant departments) general projects: technical services, technical development, technical consultation, technical exchange, technology transfer and technology promotion; Medical research and experimental development; Import and export of goods; Technology import and export. (except for the items that must be approved according to law, the company shall independently carry out business activities according to law with its business license)
9. Major shareholders: Shanghai juntuo Biomedical Technology Co., Ltd. (hereinafter referred to as "Shanghai juntuo") and Suzhou Wangshan wangshui biomedical Co., Ltd. each hold 50% equity of Wangshi biology, and Shanghai juntuo is consolidated with Wangshi biology. Shanghai juntuo is a holding subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as " Shanghai Junshi Biosciences Co.Ltd(688180) "), and Shanghai Junshi Biosciences Co.Ltd(688180) holds 68.125% of the equity of Shanghai juntuo.
10. Main financial indicators: Wangshi biology is a non listed company. It believes that the financial data involve trade secrets and cannot be provided. Its parent company Shanghai Junshi Biosciences Co.Ltd(688180) 2021 achieved an operating income of 40248409 million yuan and a net profit attributable to shareholders of the listed company of -7209097 million yuan; By the end of 2021, the total assets were 11034911100 yuan, and the net assets attributable to shareholders of listed companies were 7945095400 yuan.
Wangshi biology, Shanghai juntuo and Shanghai Junshi Biosciences Co.Ltd(688180) have no relationship with the company.
(II) time, place and method of signing the agreement
On May 19, 2022, due to the epidemic, after friendly negotiation, the above agreement was signed by the company and Wangshi biology through network in Taizhou and Shanghai.
(III) review and decision-making procedures, approval or filing procedures that have been performed in signing the agreement
The above agreement is a cooperation framework agreement. According to the relevant provisions of the Shanghai Stock Exchange Stock Listing Rules, the articles of association and so on, it is not necessary to submit it to the board of directors or the general meeting of shareholders for deliberation, and there is no need to perform relevant approval or filing procedures.
2、 Main contents of the agreement
(I) strategic cooperation agreement (Party A: Wangshi biology; Party B: the company)
1. Party A and Party B intend to establish strategic cooperation in the fields of product processing, production, international registration and market development of small molecule innovative drug vv116, so as to achieve the strategic objectives of complementary advantages, mutual benefit and win-win and common development. This agreement is a framework agreement, a guiding document for long-term cooperation between the two parties in the future, and also the basis for the two parties to sign relevant business contracts; The purpose of this agreement is to build a strategic cooperation framework and promote both parties to give full play to their respective advantages, cooperate with each other and develop together within the cooperation framework.
The strategic cooperation mode of Party A and Party B is not exclusive and will not change their independent status. Party A and Party B bear business responsibilities in their own names.
2. Cooperation content and mode
(1) Entrusted processing
Party A entrusts Party B to produce pharmaceutical products. Party B shall establish production quality management documents related to products, verify analytical methods, and carry out research on product scale-up test, sample production for clinical research, process verification, commercial production, etc. in accordance with relevant agreements and GMP standards.
(2) Production management
Party B shall make full use of the equipment advantages and production conditions of the enterprise to provide a good product production environment for Party A and promote the transformation and implementation of Party A's technical achievements. Both parties should strengthen the communication of information and experience in production management to ensure that the products they cooperate with are managed and controlled with high quality in the whole production process.
(3) International Registration
For the cooperative products of both parties, if the registration in the international market is involved, Party B shall provide international registration services according to the instructions and needs of Party A.
(4) Market development
For the professional promotion field where Party B has advantages, Party A can discuss specific cooperation with Party B.
(5) Cooperation project
The two sides will cooperate in many fields in the future, actively promote the implementation of Party A's innovative R & D products, promote medical development and benefit more patients.
(6) Specific cooperation
According to the cooperation principles determined in this agreement, both parties shall separately agree on the cooperation details on the actual contents of each project and sign relevant agreements.
3. Duration of this strategic cooperation
Both parties agree that this Agreement shall be valid for eight years from the effective date of this agreement.
4. Dispute resolution
This Agreement shall be governed by Chinese law. All disputes arising from the performance of this Agreement shall be settled through friendly negotiation. If the negotiation fails, either party has the right to bring a lawsuit to the people's court with jurisdiction where Party A is located.
5. This Agreement shall come into force after being signed and sealed by the legal representatives or authorized representatives of both parties.
(II) entrusted production framework agreement (Party A: Wangshi biological; Party B: the company)
In accordance with the civil code of the people's Republic of China, the drug administration law of the people's Republic of China and other relevant laws and regulations, Party A and Party B intend to reach an agreement on vv116 cooperation through equal, voluntary and friendly negotiation. This agreement is hereby entered into and observed by both parties.
1. Cooperation mode
Party A, as the holder of the drug marketing license, has fully known the current situation of Party B and confirmed that Party B has the ability to complete the entrusted production and the requirements of China GMP and cGMP agreed by both parties (hereinafter collectively referred to as "GMP standard"). Party A will entrust Party B to produce the product. The specific quantity, price and special requirements shall be subject to the specific contract signed by both parties based on the entrusted production framework agreement (hereinafter referred to as "business contract").
2. Rights and obligations of both parties
(1) As the holder of drug marketing license, Party A has all rights related to drug marketing license.
(2) Party A shall provide Party B with the materials, processes and auxiliary materials required for the agreement products, and timely inform Party B of the order information, or Party A entrusts Party B to purchase on behalf of Party A.
(3) Party A is responsible for auditing and confirming Party B's production conditions, production technology level and quality management status. If it meets Party A's standards, Party A can sign a business contract on specific cooperation matters according to this agreement. (4) Party B shall confirm the materials, processes, auxiliary materials and packaging materials in strict accordance with the GMP standards and the quality standards formulated by Party A. they can be used only after they are qualified.
(5) Party B shall organize production in strict accordance with the prescription, production process and production process quality control requirements provided by Party A, and shall not change at will, so as to ensure that the whole process of production inspection meets GMP standards.
(6) Party B shall carry out production and quality control in strict accordance with the production process provided by Party A, strictly manage the production process and quality control, and ensure the integrity, authenticity and standardization of production and inspection data.
(7) Party B shall not subcontract or sub entrust the production obligations under this agreement to a third party for production. Without the prior written consent of Party A, Party B shall not sell the products under this agreement by itself or entrust any third party.
3. Cooperation period
This agreement is valid for 5 years. During the validity period, both parties can sign multiple business contracts. If the agreement expires and a business contract has not been fulfilled, the terms of this framework agreement shall remain valid until the business contract is terminated. 3、 Impact on the company
The strategic cooperation involved in the above agreement will help both parties expand cooperation in product R & D, production, sales and other aspects and related fields, improve the business development space of the company, meet the needs of the company's future development, and there is no situation that damages the interests of the company and all shareholders, especially small and medium-sized shareholders, The impact of the signing of the agreement on the company's financial status and operating results in 2022 and in the future depends on the promotion and implementation of specific projects.
4、 Risk tips
1. The above agreement is a strategic and framework agreement reached by both parties based on their willingness to cooperate. It is a principled agreement on the rights and obligations of both parties, and the way of strategic cooperation is not exclusive.
2. The cooperation involved in the above agreement is based on the needs of the company's strategic development and the judgment of the market prospect of the industry. There are certain market risks and business risks, which will produce uncertainty for the realization of future business benefits. 3. The listing license holder of vv116 products involved in the entrusted processing framework agreement is Wangshi biology. The company is only the entrusted manufacturer of the products and does not enjoy its ownership. The agreement only reached a framework agreement on the cooperation principle of entrusted production of vv116 products. The specific quantity, price and special requirements will be based on the entrusted production framework agreement. There is uncertainty whether the two parties can finally sign the corresponding contract and the signing time.
4. For the above-mentioned entrusted processing of vv116 products, the relevant tablet production line has passed the GMP compliance inspection. In the follow-up, the drug entrusted production can be formally accepted only after the variety is approved for listing and the drug entrusted production registration is approved.
5. Vv116 is in the phase III clinical research stage of international multi center, and a number of registered clinical studies for patients with mild, moderate and severe novel coronavirus pneumonia (hereinafter referred to as "covid-19") are in progress. At present, vv116 has been approved in Uzbekistan for the treatment of moderate and severe covid-19 patients. The indication of vv116 for the treatment of novel coronavirus pneumonia has not been approved by the State Food and drug administration, and whether it is approved is uncertain. This cooperation may be affected by macroeconomic environment, industrial policies, market environment, management and operation and other factors, and the benefits generated by the cooperation in the future are uncertain.
6. The agreement signed this time is a strategic cooperation agreement and does not need to be submitted to the board of directors or the general meeting of shareholders for deliberation. The follow-up company will perform necessary approval procedures and information disclosure obligations according to the progress of relevant matters and relevant provisions such as the Listing Rules of Shanghai Stock Exchange and the articles of association.
Please invest rationally and pay attention to investment risks.
It is hereby announced.
Zhejiang Hisun Pharmaceutical Co.Ltd(600267) board of directors may 20, 2002
