Securities code: Ningbo Menovo Pharmaceutical Co.Ltd(603538) securities abbreviation: Ningbo Menovo Pharmaceutical Co.Ltd(603538) Announcement No.: 2022020 bond Code: 113618 bond abbreviation: Meinuo convertible bond
Ningbo Menovo Pharmaceutical Co.Ltd(603538)
Announcement on the acquisition of project filing by holding subsidiaries
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 individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Special risk tips:
The namatvir API studied by the company has not yet obtained relevant authorization and is only used for laboratory research and development. Due to the patent protection of relevant APIs, the company may have legal risks caused by patent infringement, such as the inability to continue to develop and declare APIs, the inability to form regulatory market sales, and the retroactive infringement liability of regulatory market sales.
The company's nimatovir (API) is currently in the stage of laboratory research and development. In the follow-up, it still needs to carry out pilot scale production process verification, further research, registration and filing of quality standards and stability, and arrange production certification according to the requirements of the target market. There may be risks such as failure of process research and development and failure of registration and declaration, There is uncertainty whether commercial production can be realized.
Intermediates SM1, SM2 and T13 are pharmaceutical and chemical products without compound patents, with full market competition and are not produced exclusively by the company. They may face risks such as intensified market competition and changes in market demand in the future. At present, there are many similar types of APIs and intermediates on the market, the market competition is fierce, and there is uncertainty about whether the market demand will change in the future.
The key raw materials required for the project are obtained through external procurement. There are risks such as unstable raw material supply and sharp rise in raw material supply price.
The project has only completed the filing, and the approval procedures for planning, land, environmental protection, safety, energy assessment, fire protection, etc. need to be handled according to law. The construction can be started only after the relevant requirements are strictly implemented. There are risks such as not being approved by relevant government departments, passing the approval but taking a long time.
The project is planned to start in 2022 and complete in 2023. At present, it is still in the preparatory stage, and there is uncertainty risk in energy saving such as equipment installation, commissioning and trial production.
The project is affected by many factors such as epidemic situation change, technical change, macro policy and industrial policy, and there are risks of project termination, change, unrecoverable premise investment, and failure of production capacity and income to meet expectations.
Recently, Xuancheng Ningbo Menovo Pharmaceutical Co.Ltd(603538) (hereinafter referred to as "Xuancheng Ningbo Menovo Pharmaceutical Co.Ltd(603538) Pharmaceutical Co., Ltd. (" Xuancheng Ningbo Menovo Pharmaceutical Co.Ltd(603538) "), a holding subsidiary of Ningbo Menovo Pharmaceutical Co.Ltd(603538) (hereinafter referred to as" Xuancheng Ningbo Menovo Pharmaceutical Co.Ltd(603538) ), received the project filing form issued by the Management Committee of Xuancheng high tech Zone. The details are as follows:
1、 Briefing
(I) basic information of project filing
Project Name: new project with an annual output of 60 tons of anti covid-19 drug nimatovir API and its key intermediates legal person: Xuancheng Ningbo Menovo Pharmaceutical Co.Ltd(603538) Pharmaceutical Co., Ltd
Project code: 220234180204-01196895
Detailed address of the project: in Xuancheng high tech Industrial Development Zone
Construction nature: new construction
Industry: Medicine
National standard industry: chemical drug API manufacturing
Construction content and scale: implement project construction on the basis of existing land. New reactors, vacuum systems, drying systems and separation systems will be added, and supporting automatic facilities such as environmental protection treatment and safety instruments will be built.
Annual new production capacity: annual output of 60 tons of anti covid-19 drug nimatovir API and its key intermediates
Total investment: 90 million yuan
Source of funds: self raised by the enterprise
Planned commencement time: 2022
Planned completion time: 2023
(II) basic information of APIs and intermediates involved in the project
The name of the API is nimatrilvir, and the names of the key intermediates are SM1 (n-tert butoxycarbonyl-l-tert leucine) (CAS No.: 6296535-9), SM2 ((1R, 2S, 5S) - 6,6-dimethyl-3-azabicyclo [3.1.0] hexane-2-methyl formate hydrochloride) (CAS No.: 56545677-1) and T13（ α- Amino-2-oxo-3-pyrrolidine Propionamide hydrochloride) (CAS No.: 262828048-6). (III) R & D, production and clients of APIs and intermediates involved in the project
At present, the production process of namatvir (API) needs further research and development; In the follow-up, it is still necessary to conduct pilot scale production process verification, quality standards and stability, further research and registration, and arrange relevant production certification according to the specific requirements of the target market. At present, there are no conditions for commercial production and relevant authorization.
At the same time, the company has realized the commercial production of intermediates SM1 and SM2 required for the production of namatovir (API) and achieved ton delivery. T13 is still in the process development stage, and the commercial production conditions can be reached only after the production process of pilot scale is verified.
In view of the above situation, the company plans to build and put into operation the intermediate project first, and plans to add 90 tons of SM1 production capacity and 120 tons of SM2 production capacity (equivalent to 60 tons of nematevir (API)). The company will accelerate the construction of the above intermediate production capacity. In the future, according to the R & D Progress of nematevir (API) and T13 and the market demand, Adjust the corresponding production capacity or implement the next step of production expansion.
The main customers involved in the project are related companies in the MPP industrial chain.
2、 Impact on the company
The filing of this project is conducive to expanding the company's existing production capacity and improving the company's industrial competitiveness and market influence.
The capital source of this project construction is all self raised funds, which will not have an adverse impact on the company's financial and operating conditions, and is in line with the interests of the company and all shareholders.
3、 Risk tips
(I) the API of nimatovir studied by the company has not been authorized yet and is only used for laboratory research and development. Due to the patent protection of relevant APIs, the company may have legal risks caused by patent infringement, such as the inability to continue to develop and declare APIs, the inability to form regulatory market sales, and the retroactive infringement liability of regulatory market sales.
(II) nimatovir (API) of the company is currently in the stage of laboratory research and development. In the follow-up, it is still necessary to carry out pilot scale production process verification, further research, registration and filing of quality standards and stability, and arrange production certification according to the requirements of the target market. There may be risks such as failure of process research and development and failure of registration and declaration, There is uncertainty whether commercial production can be realized.
(III) intermediates SM1, SM2 and T13 are pharmaceutical and chemical products, without compound patents, with full market competition. They are not produced exclusively by the company, and may face risks such as increased market competition and changes in market demand in the future.
At present, there are many similar types of APIs and intermediates on the market, the market competition is fierce, and there is uncertainty about whether the market demand will change in the future.
(IV) the key raw materials required for the project are obtained through external procurement. There are risks such as unstable raw material supply and sharp rise in raw material supply price.
(V) the project has only completed the filing, and the approval procedures for planning, land, environmental protection, safety, energy assessment, fire protection, etc. need to be handled according to law. The construction can be started only after the relevant requirements are strictly implemented. There are risks such as not being approved by relevant government departments, passing the approval but taking a long time.
(VI) the project is planned to start in 2022 and complete in 2023. At present, it is still in the preparatory stage, and there is uncertainty risk in energy saving such as equipment installation, commissioning and trial production.
(VII) the project is affected by many factors such as epidemic situation change, technical change, macro policy and industrial policy, and there are risks of project termination, change, unrecoverable premise investment and failure of production capacity and income to meet expectations.
Please invest rationally and pay attention to investment risks.
It is hereby announced.
Ningbo Menovo Pharmaceutical Co.Ltd(603538) board of directors March 15, 2022
