Securities code: 688658 securities abbreviation: Youcare Pharmaceutical Group Co.Ltd(688658) Announcement No.: 2022-003 Youcare Pharmaceutical Group Co.Ltd(688658)
Voluntary disclosure on the development of broad-spectrum coronavirus membrane fusion inhibitor polypeptide drugs in cooperation with the Institute of pathogenic biology, Chinese Academy of Medical Sciences
Announcement of
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. Important content tips:
Youcare Pharmaceutical Group Co.Ltd(688658) (hereinafter referred to as ” Youcare Pharmaceutical Group Co.Ltd(688658) ” or “the company”) in order to further fulfill the corporate social responsibility, implement the development strategy of enterprise innovation and upgrading and layout innovative drugs around the field of advantageous indications, based on the urgent clinical drug demand under the current covid-19 epidemic situation, relying on the company’s strong R & D strength The transformation ability of scientific research achievements and the strong scientific research strength of the Institute of pathogenic biology of the Chinese Academy of Medical Sciences (hereinafter referred to as the “Institute” or “partner”), the company recently signed the technology transfer (patent right) contract with the Institute, We will work together to develop a broad spectrum coronavirus membrane fusion inhibitor peptide drug for New Coronavirus pneumonia (hereinafter referred to as “peptide drugs”). The pathogen will “broad spectrum coronavirus membrane fusion inhibitor and its anti HIV application” (patent application number: 202010407617) (hereinafter referred to as “patent 1”) and the tentative invention name is “a new method for designing virus membrane fusion inhibitors and the preparation and application of anti coronavirus lipopeptide” (hereinafter referred to as “patent two”). (the patent application right, future patent right and global exclusive rights and interests of the two technologies shall be transferred to the company. The total amount of the project is 50 million yuan, of which the down payment is 10 million yuan, and the subsequent transfer price is paid in installments according to the milestone progress agreed in the technology transfer (patent right) contract.
This transaction does not constitute a connected transaction
This transaction does not constitute a major asset restructuring
There are no major legal obstacles to the implementation of this transaction
Important risk tips:
1. At present, there are covid-19 preventive and therapeutic drugs in different R & D stages in the world. Many covid-19 vaccines have been listed in China, and many antibodies and small molecule drugs are also in different R & D stages. The polypeptide drug has the risk of uncertain market competition pattern after listing;
2, the technology patent application of “broad spectrum coronavirus membrane fusion inhibitor and its application against HIV” (patent application number: 202010407617) has been submitted and has not been granted patent right. The technical patent of “a new method for designing virus membrane fusion inhibitor and the preparation and application of anti coronavirus lipopeptide” has not been submitted yet, and there is a risk of patent application failure in the future;
3. The polypeptide drug is still in the preclinical exploration stage, and there is uncertainty whether the preclinical study can be completed. This cooperation may be terminated due to the safety, effectiveness and / or technical quality of preclinical research. There is uncertainty whether the preclinical research can be completed and enter the clinical stage.
4. Whether the polypeptide drug can obtain the clinical trial approval of the drug regulatory authority (including but not limited to the State Drug Administration, the same below) and the time required to obtain the clinical approval are uncertain.
5. According to the experience of drug research and development, there are certain risks in clinical trial research. If the polypeptide drug enters the clinical trial stage, the progress and results of the clinical trial are affected by (including but not limited to) the trial scheme, subject recruitment, epidemic development and other factors, and may be terminated due to the safety and / or effectiveness of the clinical trial.
6. In the process of drug R & D, the company may face risks such as failure to achieve continuous technological innovation and insufficient core technical personnel.
7. Affected by the development and control of overseas epidemic situation, selection of drug use, overseas market promotion and other factors, there is still uncertainty about whether the application for clinical trial of this polypeptide new drug and the product can be successfully approved for listing;
The above risks can directly affect the recovery of the company’s early investment and the realization of expected benefits. The company will orderly promote the preclinical research, clinical phase I, II and III research of the new drug project, and pay the expenses by stages according to the progress of the project. In the future, the total R & D investment of the project will be about 300-500 million yuan.
1、 Transaction overview
Youcare Pharmaceutical Group Co.Ltd(688658) in order to further fulfill the corporate social responsibility, implement the development strategy of enterprise innovation and upgrading and layout of innovative drugs around the field of advantageous indications, based on the urgent clinical drug demand under the current covid-19 epidemic situation, relying on the company’s strong R & D strength, scientific research achievement transformation ability and the strong scientific research strength of the pathogen Institute, Recently, the company signed the technology transfer (patent) contract with the pathogen, and co developed a broad spectrum coronavirus membrane fusion inhibitor peptide drug for New Coronavirus pneumonia.
The company held the 19th meeting of the first board of directors on January 7, 2022, deliberated and adopted the proposal on signing technology transfer contract with Institute of pathogenic biology, Chinese Academy of Medical Sciences. The Board agreed that the company was allowed to use the “broad spectrum coronavirus membrane fusion inhibitor and its application against HIV” by the Institute of pathogenic biology, China Academy of Medical Sciences (patent application No. 202010407617) and the provisional invention name was “a new method for designing the fusion inhibitors of viral membrane and the preparation and application of the anti coronavirus lipopeptide”. (the details shall be subject to the name of the invention actually submitted in the patent application document) the patent application right, future patent right and global exclusive rights and interests of the two technologies.
This cooperation does not constitute a connected transaction, nor does it constitute a major asset reorganization as stipulated in the measures for the administration of major asset reorganization of listed companies. According to the Listing Rules of Shanghai Stock Exchange on the science and innovation board and the articles of association, the proposal does not need to be submitted to the general meeting of shareholders for deliberation.
2、 Basic information of the polypeptide drug
Compared with antibody drugs, peptide drugs have the characteristics of low cost, simple preparation process, easier storage and transportation. The polypeptide drug is designed for the conserved sequence of virus S protein, which can block the fusion of virus and host cells to achieve the purpose of antiviral. At present, the new drug has completed early screening, cell level sars-cov-2 mutant and other HCoV activity detection, in vitro live virus activity detection, cytotoxicity detection and preliminary drug formation analysis, and is still in the stage of preclinical research.
As of this announcement, there is no global mechanism for the treatment of New Coronavirus pneumonia with the same mechanism polypeptide drugs approved.
3、 Basic information of partners
Partner: Institute of pathogenic biology, Chinese Academy of Medical Sciences
Unified social credit Code: 121000007178159013
Legal representative: Jinqi
Purpose and business scope: to carry out pathogen biology research and promote the development of medical science.
Research on pathogenic biology, immunology, application of antiviral microorganisms, detection of unknown pathogens, etiology of infectious diseases, epidemiology, vaccine, diagnostic reagent and drug research and development, postgraduate and doctoral training, continuing education and professional training, relevant scientific and Technological Development and consulting services.
4、 Main contents of technology transfer contract
(I) cooperation content
1、 Cooperation in patents and global interests: the patent application technology that the pathogen has applied for “broad spectrum coronavirus membrane fusion inhibitor and its application to HIV / AIDS” (patent application number: 202010407617) and the provisional invention to be submitted to the State Intellectual Property Office is named as “a new method for designing viral membrane fusion inhibitors and the preparation and application of anti coronavirus lipopeptide”. (the patent application right, future patent right and global exclusive rights and interests of the two technologies shall be transferred to the company. (II) main cooperation modes of both parties
1. Rights and obligations of the company
(1) The company enjoys the patent application right of the above patents I and II and 100% of the patent rights held by the partner after the authorization of the two patents.
(2) The company enjoys the global exclusive rights and interests of two patented technologies and has the right to apply for PCT patents without paying additional fees.
(3) Within the above implementation scope, the company, in its own name, permits any party or multiple third parties to carry out, including but not limited to the drug R & D and industrialization of the project. Before the company completes the payment of the total transfer price of the contract to the partner, the consent of the partner shall be obtained. If the company has paid the total transfer price of the contract to the partner, the company does not need the consent of the partner.
(4) The company has the right to use the patent application right and patent right transferred by the partner for subsequent improvement. The resulting new technological achievements with the characteristics of substantive or creative technological progress shall be owned by the company.
(5) When applying for approval notice of drug clinical trial and drug registration certificate, the company is the only drug application holder with exclusive ownership and disposal right.
2. Rights and obligations of the Institute
The partner shall provide relevant technical assistance and consultation to the company in drug development, including but not limited to: (1) assisting the company in PCT application for the second patent in Article 1;
(2) Assist the company to complete the CMC process development of peptide drugs and the preparation of GMP samples;
(3) Assist the company to complete the pharmacodynamic evaluation of polypeptide drugs in mice and other animals;
(4) Assist the company to complete the preclinical trial of polypeptide drugs;
(5) Assist and support the company’s clinical trial application of polypeptide drugs and provide technical guidance for clinical trials; (III) transfer fee and payment method
The total transfer price of the patent right is RMB 50 million (in words: RMB 50 million only). Payment method: the transfer price of the patent right shall be paid by the company to the partner in installments according to the milestone stage, including the down payment of RMB 10 million. The company shall pay it to the partner within thirty (30) working days after the signing of the contract as the threshold fee for technology licensing. The follow-up payment is 40 million yuan in total according to the milestone stage agreed in the contract.
Payment stage amount (10000 yuan)
Down payment 1000
Phase II 800
Phase III 800
Phase IV 800
Phase V 800
Phase VI 800
(IV) liability for breach of contract
1. For the partner: if the partner refuses to deliver all the materials specified in the contract without justified reasons and handle the transfer procedures of patent application right, patent right and priority of the second patent, the company has the right to terminate the contract, require the partner to return all the paid transfer price and pay liquidated damages of 3% of the total amount of contract transfer fee.
2. For the company: if the company refuses to pay the transfer fee without justified reasons, the partner has the right to terminate the contract, require the return of all materials, and require compensation for its losses or pay liquidated damages of 3% of the total amount of the contract transfer fee. If the liquidated damages are insufficient to make up for the losses suffered by the partner, the company shall also make up for them according to law.
3. After the contract comes into force, all parties shall fully perform the obligations agreed in the contract. If either party fails to perform or fails to fully perform its obligations under this contract, it shall bear corresponding liabilities for breach of contract and compensate the observant party for the losses caused thereby, including lawyer’s fees, preservation fees, litigation fees, notarization fees, appraisal fees, etc. paid by the observant party to realize its creditor’s rights.
5、 Impact on Listed Companies
(I) impact on the company’s business
This cooperation is based on the development needs of the company’s innovation and upgrading strategy, focusing on the advantageous fields of the company’s antiviral indications, taking advantage of the company’s own technology and platform advantages in drug R & D and production, and participating in the development of broad-spectrum coronavirus membrane fusion inhibitor peptide drugs, which is a further supplement and improvement to the company’s existing R & D pipeline, Enhanced the company’s core competitiveness in the field of innovative drugs and consolidated the company’s innovative drug development strategy. At the same time, New Coronavirus’s research is also based on the urgent demand for clinical drugs under the current COVID-19 epidemic situation, which is in line with the initial intention of the company’s R & D innovative medicine, and also contributes to the fight against the epidemic situation of all mankind.
(II) impact on the company’s future financial situation and operating results
In view of the agreement in the technology transfer (patent right) contract, the transfer price shall be paid by stages according to the milestone progress, with a total payment of 50 million yuan and a down payment of 10 million yuan. At present, the polypeptide drug is in the preclinical research stage. As of the third quarter of 2021, the company’s operating revenue was 3.345 billion yuan and the net profit attributable to the parent company was 374 million yuan. The company’s operation was in good condition and sufficient funds. This cooperation is not expected to have a significant impact on the company’s operating performance in 2022.
In view of the large investment, long cycle, many links and high risk of new drug R & D, if the polypeptide drug finally fails to pass the new drug registration and approval, it can directly affect the recovery of the company’s early investment and the realization of expected benefits.
6、 Risk tips
1. At present, there are covid-19 preventive and therapeutic drugs in different R & D stages in the world. Many covid-19 vaccines have been listed in China, and many antibodies and small molecule drugs are also in different R & D stages. The polypeptide drug has the risk of uncertain market competition pattern after listing;
2, the technology patent application of “broad spectrum coronavirus membrane fusion inhibitor and its application against HIV” (patent application number: 202010407617) has been submitted and has not been granted patent right. The technical patent of “a new method for designing virus membrane fusion inhibitor and the preparation and application of anti coronavirus lipopeptide” has not been submitted yet, and there is a risk of patent application failure in the future;
3. The polypeptide drug is still in the preclinical exploration stage. Can the preclinical study be completed
