() The business review of the Board of Directors in the first half of 2022 is as follows:
I. Description of the industry and main business of the company during the reporting period.
(I) The industry of the company during the reporting period.
1. Development trend of global pharmaceutical industry
According to the report "The Global Use of Medicine 2022 Outlook to 2026" released by IQ via in December 2021, the global pharmaceutical market will reach 1.8 trillion US dollars in 2026, with a compound growth rate of about 3-6% from 2022 to 2026.
2. Development trend of domestic pharmaceutical industry
The aging population in China is on the rise year by year, and by 2050, the aging population in China will reach one third of the total population. With the aging of the population, the demand for medicine market in China has increased sharply. At the same time, the government of China proposed to coordinate the promotion of medical reform and the release of medical policies to benefit the people one after another, which promoted the growth of the medical market. In the future, the pharmaceutical industry in China will face a reshuffle, and the market system will be constantly standardized and improved in the adjustment of policies to enhance market supply. With the expiration of a large number of patents of "heavy drugs" around the world, pharmaceutical enterprises in China will have great development opportunities.
3. The pattern and development trend of contract customization R&D and production (CDMO) business
The market capacity of global pharmaceutical customized R&D and production industry is growing rapidly. In recent years, in order to reduce the R&D cost of new drugs, improve the R&D efficiency, shorten the R&D marketing cycle and reduce the post-marketing drug production cost, the penetration rate of customized pharmaceutical R&D production services has been increasing continuously. According to Frost&Sullivan’s data, in terms of CMO/CDMO, the proportion of global pharmaceutical companies’ R&D investment in CMO/CDMO in 2017 was 36.04%, and it is expected to increase to 52.22% by 2022. The continuous growth of global pharmaceutical R&D investment and the increasing penetration rate of pharmaceutical customized services will promote the continuous growth of market demand in the pharmaceutical customized services industry. CMO/CDMO industry not only benefits from the market demand brought by the continuous growth of R&D investment in the pharmaceutical industry, but also can share the growth dividend after the listing of innovative drugs, and the market space continues to grow. According to Frost&Sullivan data, the global small molecule CDMO/CMO market scale has increased from 42.3 billion US dollars in 2014 to 64.6 billion US dollars in 2018, with an average compound annual growth rate of 11.2%. It is expected to keep growing at an average compound annual growth rate of 10.7% and reach 107.2 billion US dollars by 2023.
4. Development trend of characteristic API industry
In November 2021, the National Development and Reform Commission and the Ministry of Industry and Information Technology jointly issued the Notice on the Implementation Plan for Promoting the High-quality Development of the API Industry. This notice was based on the Guiding Opinions on Promoting the Green Development of the API Industry issued by the Ministry of Industry and Information Technology in December 2019 with the Health and Health Commission, the Ministry of Ecology and Environment, National Medical Products Administration and other ministries and commissions, and further put forward a more systematic guiding direction for the production of APIs in China, including "adjusting the industrial structure of APIs". "Optimizing the layout of API industry", "accelerating technological innovation and application", "promoting green production standards" and "promoting the construction of centralized production bases" indicate the future trend of China’s characteristic API industry led by policies.
According to "Active pharmaceutical ingredients (API) market-growth, trends, and forecast (2020-2025)" published by Mordor Intelligence, the global API market has reached 165.7 billion US dollars in 2018, and it is estimated that the market size will reach 236.7 billion US dollars in 2024, with a compound annual growth rate of 6.12%. From the perspective of API supply areas, it is mainly concentrated in China, India, Italy, the United States, Europe and other regions. Western Europe, represented by Italy, was once the largest country in the world.
Material and medicine production base. According to Evaluate Pharma, between 2020 and 2024, a total of nearly $160 billion of patented drugs will expire. According to the price of generic drugs is about 10%-20% of patented drugs, the replacement space of generic drugs in the past five years is about 16-32 billion US dollars. The expiration of a large number of patented drugs will stimulate the sustained growth of the generic drug market and drive the expansion of the characteristic API market.
5. The pattern and development trend of preparation business
In recent years, the centralized procurement policy organized by the state has promoted the reform of the preparation industry. In the context of slowing economic growth, aging population, and the gradual decline of per capita income growth and fiscal revenue growth, it is imperative to control medical insurance fees, and purchasing generic drugs with quantity is an important means to control medical insurance fees. Since 2018, in order to improve the utilization rate of medical insurance funds and reduce the unreasonable profiteering of generic drugs and original research drugs that have passed the patent period, the speed of quantity procurement has been accelerating, and it has been promoted routinely. According to the data of previous centralized purchasing published by the National Medical Insurance Bureau, the average price reduction of drugs in the first, second, third, fourth, fifth, sixth and seventh rounds was 52%, 53%, 53%, 52%, 56%, 48% and 48% respectively. In the old drug sales model, the sales expenses accounting for about 40% were almost completely squeezed. The substantial reduction in the price of generic drugs has promoted the increase in drug penetration and led to the increase in sales.
With the normalization and institutionalization of centralized procurement in pharmaceutical industry, the company will follow the development of the industry, seize every opportunity to win the bid in centralized procurement and regional alliance, and have more varieties of centralized procurement is the long-term strategy for the company’s development and growth.
(II) Main business of the company during the reporting period
Minova is a comprehensive international pharmaceutical technology manufacturing enterprise specializing in the research, development, production and sales of characteristic APIs (including intermediates, the same below) and finished drugs. It is one of the top 100 pharmaceutical enterprises, one of the top 100 manufacturing enterprises in Ningbo, and a quality supplier and partner in the international market (ranked in the top 60). It focuses on the integration of CDMO, characteristic APIs and preparations, and its services cover mainstream countries and regions around the world. Its core products cover cardiovascular and central nervous system. The company is one of the enterprises that export the most varieties of raw materials with European characteristics in China.
During the reporting period, the company achieved a total operating income of 897 million yuan in half a year, an increase of 29.74% over the same period of last year; The net profit attributable to shareholders of listed companies was 185 million yuan, an increase of 58.71% over the same period of last year; The net profit attributable to shareholders of listed companies after deducting non-operating gains and losses was 171 million yuan, up 74.48% over the same period of last year. The net cash flow generated by the company’s operating activities was 151 million yuan, up 35.29% over the same period of last year.
Adhering to the business tenet of "pursuing perfection in product quality, keeping promises in business operation, and advancing with people and enterprises", the company has been deeply involved in its main business for a long time, serving the European and other medical standard markets for 19 years. With strict quality management and EHS management capabilities, solid process development and high-standard large-scale manufacturing capabilities, as well as fine and efficient team fighting capacity, We have established long-term, deep and stable cooperative relations with well-known pharmaceutical enterprises at home and abroad, such as KRKA, MSD (Merck), Servier (Servier), Bayer (Bayer), GEDEON RICHTER (Jirui Pharmaceutical), SANOFI (Sanofi), () and Kaituo Pharmaceutical. The company has formed a high brand international reputation and competitive advantage in CDMO sub-sectors and characteristic API sub-sectors, and gradually established a leading position in domestic and foreign markets.
Since its listing in 2017, the company has taken advantage of the capital market, driven by the two-wheel drive of "connotative growth+extensional expansion", consolidated and strengthened the characteristic API business, and firmly deepened the integration strategy of "pharmaceutical intermediates, APIs and preparations" by relying on continuous R&D innovation and business expansion, expanding and extending the upstream intermediates and downstream preparations business, so as to further improve the industrial chain layout and fully expand the integration advantages; At the same time, based on the competitive advantage in the field of characteristic APIs and customer network resources, the company continued to lay out CDMO business, accelerated the creation of a one-stop integrated service platform for CDMO, and provided strong impetus for the company’s subsequent development. With continuous improvement of multi-dimensional strategic layout, the company actively develops and commercializes cutting-edge medical products with CDMO business and preparation integration business as the core, helps the company to "start a second venture" and is committed to making Minova a first-class domestic, internationally renowned and highly competitive international pharmaceutical technology manufacturing enterprise.
Second, the discussion and analysis of the business situation
In the first half of 2022, the company has always been based on high-starting planning, high-standard construction, high-level operation and efficient management, and has always adhered to and focused on the specialization, synergy and integration of its main business, achieving steady operation and rapid development.
In the first half of 2022, under the background of increasingly severe international political and economic forms, the COVID-19 epidemic occurred repeatedly at home and abroad, and the global economy continued to decline as a whole, the company actively responded to changes in the internal and external environment, made overall plans to promote epidemic prevention and control and business development, actively adapted to the new normal production and operation mode, followed the company’s development strategy and work plan to carry out various production and business operations in an orderly manner, and ensured the stock business.
At the same time, we strengthened the development of incremental business, and finally realized the steady growth of operating income, and set up a layout in various business sectors, forming diversified business types and deepened products, laying a more solid foundation for the sustainable development of enterprises.
The company has practiced the core values of "taking responsibility bravely and achieving value" with actual operation and development.
During the reporting period, the Company’s main business activities were as follows:
(A) Strategic layout of new business, CDMO growth can be expected
CDMO business is the core driving force of the company’s development. Relying on the existing base, driven by talents leading innovation, the company continuously increased R&D investment, established an independent CDMO process development technology platform, strengthened quality control capability, safety and environmental protection capability and information security capability, optimized project management and production process, and comprehensively shaped CDMO hard core strength.
With the signing of the strategic agreement of the international pharmaceutical giant enterprise, the influence of the company’s CDMO international brand has been greatly improved, and the development progress of the company’s major customers has been accelerated. With the continuous development of CDMO business, the company undertakes more and more customer project pipelines. Through the delivery of each project, it realizes the sticky binding with customers, and the customer cooperation continues to deepen. The CDMO business volume will continue to show a trend of double growth. At the same time, as the main target of the company’s CDMO business in the future, small nucleic acid drugs have developed from 0 to 1, and the customized synthesis business of pharmaceutical intermediates in COVID-19 has begun to take shape. It is expected that the CDMO business will become the company’s biggest revenue and profit growth point in 2022 or 2023. During the reporting period, the company completed the complete holding of its subsidiary Xuancheng Menuohua. As the core base of the company’s CDMO business, it will contribute all profits to the company in the future.
1. The CDMO business of small molecular intermediates and APIs has made great strides.
In the first half of 2022, we adhered to the established strategic transformation policy and vigorously promoted the CDMO business. At present, the company’s CDMO business has established business cooperation with more than 100 outstanding pharmaceutical companies at home and abroad.
Since the outbreak of Xinguan epidemic, the company has paid close attention to the research and development progress of COVID-19 drugs at home and abroad, focused on the mainstream technical route, carried out technical reserve work in a planned way, and laid out corresponding production capacity. At present, the company has a number of production processes of key intermediates and APIs of COVID-19 specific drugs, and some of them have been commercialized.
2. The small nucleic acid platform is ready to go
In 2021, the company took the lead in the field of nucleic acid drugs and gene sequencing. After R&D and development, the company has undertaken the CDMO business of nucleoside intermediates used in small nucleic acid drugs, nucleic acid detection, gene sequencing and other fields, providing raw materials for mainstream products such as nucleic acid detection and gene sequencing at home and abroad. Although the small nucleic acid raw material business is still in its infancy, as one of the main targets of the company’s CDMO business in the future, the company will unswervingly develop according to the established plan and continue to become bigger and stronger.
3. Reach a ten-year strategic cooperation with Merck, a large multinational pharmaceutical company, and comprehensively accelerate the construction of CDMO hard core strength.
In 2021, the company signed a ten-year CDMO strategic cooperation agreement with Merck, a large multinational pharmaceutical company, in the fields of pet medicine, veterinary medicine and animal health care. By the end of the reporting period, the nine projects in the first phase have been carried out in different stages according to the schedule and will soon be commercialized; A number of projects are being evaluated in the later period, and both sides are committed to continue to explore more projects and more diversified cooperation possibilities. The cooperation project between the company and Merck will become a new growth point for the company’s performance contribution after it is transferred to the stage of commercial mass production.
Merck is a global health care company, mainly engaged in prescription drugs, vaccines, biological products and animal health products, providing innovative medical solutions for more than 140 countries and regions. This strategic cooperation reflects Merck’s full recognition of the company’s research and development technology, production and quality in the field of APIs, which has a far-reaching and significant impact on the company’s development, especially the development of CDMO’s new business. The company will take this cooperation as an opportunity to strengthen the interconnection with Merck in order to form more broad consensus and promote the company to reach more fields and deeper future cooperation with Merck. At the same time, the company will continue to improve its R&D technical capabilities, project management capabilities and delivery capabilities, accelerate the strategic layout of CDMO business, and further build the company’s international competitiveness in the CDMO field.
4. Acquisition of 49% equity of Xuancheng Menuohua to further improve the strength of CDMO software and hardware.
During the reporting period, in order to speed up the layout and improve the strength of CDMO software and hardware, the company completed the acquisition of 49% equity of Xuancheng Meinuohua held by Meinuohua Ruihe Fund. So far, the company holds 100% equity of Xuancheng Meinuohua.
Xuancheng Minova is an important service platform for the company’s CDMO business, and multi-functional workshops supporting CDMO business have been put into production one after another. It has a complete multi-functional GMP workshop and safety and environmental protection facilities. The production equipment adopts the domestic leading closed, automatic and pipeline design, and the equipment is flexibly connected to achieve the purpose of multi-function. The reaction types cover many kinds of chemical reactions, including complex reactions such as format, fluorination, cyanidation, hydrogenation, oxidation, azide, etc. The hydrogenation reaction pressure is up to 9.9MPa, and a number of standardized and multi-functional fine baking packages are built, and the scale can range from kg to 100 kg. The production process is controlled by DCS, and the production data is recorded electronically and kept permanently to ensure the integrity of the production data. High-risk reactions are escorted by SIS system, which can provide sustainable, flexible and reliable CDMO services in line with international GMP standards for global customers. Adequate wastewater and solid waste treatment capacity and advanced RTO and carbon fiber adsorption waste gas treatment equipment can also provide sustainable services to escort.
(2) Promote the development strategy of "integration of intermediates, APIs and preparations" and accelerate the pace of strategic transformation.
In the first half of 2022, under the background of generic drug collection policy, the company’s preparation sector developed strongly. The company takes the integration of "intermediates, APIs and preparations" as the strategy, and makes use of the advantages of the company’s API industrial chain to concentrate on developing preparations of superior varieties of APIs to help the company develop. The company actively implemented the development strategy of "technology transfer+independent declaration+domestic MAH cooperation", deepened the vertical integration and coordination of the whole industrial chain, enhanced the company’s comprehensive competitive strength, grasped the opportunity of rapid commercialization and heavy volume brought by the national centralized purchasing policy, and achieved phased results.
1. The centralized procurement was successfully renewed, and the preparation business continued to increase in volume.
In the first half of 2022, the company’s perindopril tert-butylamine tablets realized the renewal of the drug alliance procurement of thirteen provinces (autonomous regions, municipalities and corps) of the new corps of Yujin, Menge, Hubei, Hunan, Guiqiong, Chongqing and Guiqingning and the centralized drug procurement in Hebei Province. The delivery of pregabalin capsules, losartan potassium tablets, atorvastatin calcium tablets and lisinopril tablets which won the bid in 2021 is in normal progress. Under the background that the policy of purchasing with quantity weakens sales promotion, winning the bid for centralized purchasing of drugs can not only bring new profit growth points for the company, improve market share and brand influence of the company, but also promote the pace of preparation transformation of the company.
2. Accelerate the pace of self-research and registration of cooperative preparation varieties, and many varieties will be approved for listing one after another.
During the reporting period, the company’s apixaban tablets and valsartan tablets were approved for listing, and isoniazid tablets passed the consistency evaluation. It is expected that 2-3 varieties will be approved in the second half of the year. As of the reporting date, the company has accumulated 10 preparation products approved for listing in China.
During the reporting period, the company newly established 11 varieties, and 3-5 projects are about to enter the BE stage. Five projects, including Propofovir Fumarate Tablets, Engelje Tablets and Dapagliflozin Tablets, have passed the formal BE test, and 10 varieties are under CDE approval. It is expected that 8-10 varieties will be submitted to CDE for review in the second half of the year. At present, the company has more than 20 projects under research.
3. Layout the "heavy drugs" with patent expiration in advance, and the company has a huge development opportunity.
In recent years, the drugs whose patents have expired mainly focus on cardiovascular system, hypoglycemic drugs, antineoplastic drugs, nervous system drugs, mental disorders drugs, digestive system drugs and other therapeutic fields. At present, the company has laid out products such as sitagliptin metformin tablets, Aggliptin benzoate tablets, Dapagliflozin tablets, Vonolasone fumarate tablets, Shakubatrivalsartan sodium tablets, Ibtinib capsules and so on. Among them, the company cooperates with strategic customers KRKA raw materials and preparations, and rivaroxaban and dabigatran axetil have been listed for the first time in Europe and have been commercialized.
(3) Continuous cultivation and long-term layout of characteristic APIs
Characteristic APIs and intermediates are the traditional core business of the company. During the reporting period, the company continued to strengthen market development, deepen cooperation with strategic customers, expand cooperation scope, and strive to develop and cultivate new customers at home and abroad, constantly optimizing customer structure and product structure.
1. Continuously optimize the customer structure and cultivate key customers.
During the reporting period, the company continuously strengthened its contact with international head original research companies, and added supplier certification of two original research companies. For existing strategic customers, the company has continuously explored the depth of cooperation and expanded the scope of cooperation. The cooperation with Sylvia has expanded from single product and upstream intermediates to advanced intermediates and API, and two new projects have made progress in stages. The company further strengthened its strategic cooperation and deep binding with KRKA. Based on years of cooperation in the European market, the two sides jointly tapped the market potential of China, and added seven new project cooperation on the basis of the original cooperation varieties.
In addition, many core varieties of the company entered the project stage with many global multinational pharmaceutical giants, and carried out substantive cooperation and communication with many top 100 domestic pharmaceutical companies, especially Qilu Pharmaceutical, Zhengda Tianqing, Yangzijiang, (), etc., laying a solid foundation for business growth in the next 2-3 years.
During the reporting period, by giving full play to its comprehensive competitive advantages and resisting the pressure of epidemic situation, the company actively strived for incremental growth and overcame various difficulties. The company actively explored channels and cultivated new customers, especially in South America, Japan and South Korea, and made breakthrough progress.
2. Implement multi-category and multi-market routes of APIs, and accelerate the development and registration of new products.
During the reporting period, the company accelerated the development and registration of new products, so as to expand the access of existing API products to China market and European and American standardized markets. At present, there are 54 varieties of APIs under research, of which 20 varieties have been converted to production, 6 varieties have been submitted for overseas market registration and certification, 1 variety has been submitted for domestic CDE registration, and 1 variety has been submitted for domestic veterinary drug product approval number application.
During the reporting period, one variety of losartan potassium obtained the EU CEP certificate; Valsartan, clopidogrel bisulfate crystal form II, mirtazapine and rivaroxaban have passed the domestic review and approval. As of the date of this report, another API of esmomeprazole magnesium has passed the domestic review and approval.
3. Strictly abide by the quality lifeline and continue to maintain excellent compliance records.
In recent years, with the continuous introduction and improvement of a series of new regulations and systems of domestic and foreign regulatory agencies, the requirements for all aspects of drugs from research and development, production to listing have become stricter, and the company has also raised its own requirements for quality management and risk management. The company absorbs advanced ideas and experiences from all parties, tamps down the quality management system, pays close attention to detail management, traceability management and on-site management, and continuously strengthens the quality defense line.
The company continuously optimizes the GMP system with high requirements, high standards and high quality work norms, and constantly consolidates the foundation of quality management. During the reporting period, the group company successfully passed 9 domestic official inspections and 21 customer audits, including well-known enterprises at home and abroad such as Novartis Pharmaceutical, Merck and Boehringer Ingelheim. All previous audits have passed smoothly, and the company’s quality system has been highly recognized by officials and customers.
At the same time, the company adheres to the enterprise purpose of "pursuing perfection in product quality", continuously improves the quality management system in line with international standards, improves the quality awareness of all staff, and continuously strengthens the study of laws and regulations. The company continued to carry out quality month activities, actively promoted the construction of quality culture and informatization, raised the awareness of all staff to ensure the company’s cGMP management level to a higher level.
(D) Continue to build and enhance the capacity of scale, and the harvest period of high-quality production capacity is approaching gradually.
By the end of the reporting period, the main body of the first phase of Anhui Minova’s "Technical Transformation Project with an annual output of 400 tons of APIs" has been completely completed, and the installation of workshop equipment has been basically completed, and some workshops are ready for trial production; Zhejiang Meinuohua’s "annual output of 520 tons of APIs" phase I project has all been completed, and some workshops have completed electromechanical installation; The fundraising project "Construction Project of Export Solid Preparations with an Annual Output of 3 billion Tablets (Granules)" was completed during the reporting period and is ready for trial production; The convertible bond fundraising project "high-end preparation project" is under construction, and some of the buildings have been capped.
All production bases are coordinated and complementary, and CDMO business and API business are distributed in many places. By building the competitiveness of large-scale production capacity, taking high-quality scarce production capacity as a springboard for development, we will seize the opportunity of rapid development of the industry, seize market share, improve the company’s development speed and lay the foundation for future growth.
Major changes in the company’s operation during the reporting period, as well as matters that have a significant impact on the company’s operation during the reporting period and are expected to have a significant impact in the future.
Third, possible risks
1. Risk of product quality control: Most of the company’s products are raw materials used to produce preparations, and quality management is particularly important. The company’s product quality is affected by many factors due to its long production process and complicated technology. If there are occasional factors in the process of purchasing raw materials, storing and transporting products, it may cause physical and chemical reactions of products and lead to product quality problems.
Risk control measures: the company will always implement the concept of "quality is the lifeline of the enterprise", start from the details, strengthen process management, improve management level and quality awareness, strengthen internal inspection, and implement international quality standards with high standards.
2. Safety production and environmental protection risks: flammable, explosive and toxic substances need to be used in the production process of the company. Improper operation or aging and disrepair of equipment may lead to safety accidents. The company’s industry is an industry with high requirements of national environmental protection supervision, and the relevant state departments have always attached great importance to the environmental protection management of the pharmaceutical industry. With the enforcement of the Discharge Standard for Water Pollutants in Pharmaceutical Industry, the environmental protection pressure of pharmaceutical manufacturing enterprises involved in fermentation, chemical synthesis, extraction, traditional Chinese medicine, bioengineering and mixed preparations has increased.
Risk control measures: Each production base of the company has established an EHS management system based on international standard capabilities, always increased the investment in safety and environmental protection facilities, adhered to prevention, improved the safety management and three wastes treatment capabilities, and effectively reduced the safety, environmental protection and safety production risks.
3. Market competition risk: API business may be affected by factors such as capacity certification cycle, technology transfer, technology redevelopment, etc. As domestic and foreign competitors participate in market competition, the company will face the risk of market competition.
Risk control measures: The company deepens the cooperation mode with existing customers, actively expands new customers and markets, and actively develops new varieties to continuously enhance its own market competitiveness.
4. Risk of exchange rate fluctuation: overseas markets account for a high proportion of the company’s operating income, and most of them are priced and settled in foreign currencies such as US dollars, while the company’s expenses are mainly paid in RMB. If the exchange rate of RMB against the US dollar and other foreign currencies continues to rise, even if the company’s foreign currency sales price remains unchanged, the converted RMB sales revenue will decline, and vice versa. Therefore, exchange rate fluctuations directly affect the level of profitability.
Risk control measures: the company relies on the advantages of product quality, technology and cost to provide quality services to customers, expand the market, enhance customer trust and satisfaction, and increase market share and bargaining power of product sales. At the same time, the company chose the right time to lock the forward exchange rate of some US dollar assets, and moderately increased foreign currency loans with low interest rates to hedge the risk of the decline of the US dollar exchange rate of unilateral US dollar assets.
5. Risk of product R&D not meeting expectations: The product R&D in the pharmaceutical industry has the characteristics of high technical difficulty, large capital investment and long approval period. Therefore, in the process of continuous investment in R&D projects of the company, there may be the risk of product R&D not meeting expectations.
Risk control measures: the company continues to invest in R&D, increase the introduction of excellent R&D talents, and improve the success rate of R&D projects.
6. Risk of raw material supply and price increase: The company has established a stable cooperative relationship with major suppliers. However, in case of force majeure factors such as natural disasters, or the domestic safety and environmental protection requirements are becoming stricter, the production capacity of some suppliers is limited, and raw materials may be in short supply, price increase or raw materials cannot meet the quality standards required by the company’s production, which may affect the profitability of related products of the company to a certain extent.
Risk control measures: Facing the risks of raw material supply and rising prices, the company will strengthen the management of supply chain, sign strategic cooperation agreements and increase binding terms of price adjustment.
7. Depreciation risk of fixed assets: With the commissioning of the company’s reconstruction and expansion projects, the projects under construction will be converted into fixed assets one after another, which will lead to the increase of depreciation expenses of fixed assets. If the company can’t reach the expected level due to the depressed industry environment in the future, the new benefits brought by the use of fixed assets may not make up for the amount of depreciation.
Risk control measures: The company will actively expand new customers and new products, and through the release of new production capacity, continuously improve customer service capabilities and increase operating income.
Iv. analysis of core competitiveness during the reporting period
The company has been deeply involved in the pharmaceutical industry for many years, and has accumulated rich experience in industrial investment layout, industrial transformation and upgrading, industrial resource integration and other aspects, forming a systematic core competitiveness with technology research and development, quality control, EHS management, customer service and talent team.
(A) the advantages of integrated pharmaceutical industry chain
Through years of industrial layout, the company has a complete industrial chain of "pharmaceutical intermediates, raw materials and preparations". The core products of the company, such as valsartan, losartan, clopidogrel, perindopril, rosuvastatin calcium, atorvastatin calcium and pregabalin, have formed a commercial R&D, production and sales system of the whole industrial chain. The layout of intermediates and APIs ensures the high standard and consistency of preparation quality from the source, ensures the stability of key raw materials supply, and brings strong quality advantages and cost advantages. The company will continue to promote the optimization and upgrading of the whole industrial chain of core products, strengthen the core advantages of integration, and provide efficient, high-quality and cost-effective products, services and solutions for domestic and foreign partners.
(B) API quality management and EHS system compliance advantages
The company always regards quality management as the most important lifeline, and has established a comprehensive and leading cGMP standard quality system with the concept of systematic and scientific cGMP for a long time. All staff practice the advanced quality concept, inherit the advanced quality culture, and always implement all aspects of the quality system with the principles of high requirements, high standards and high quality, and continue to carry out learning and training to provide strong support for product research and development, production and sales, and constantly meet the new standards and requirements of customers. Its subsidiaries have successfully passed the official GMP on-site review of FDA, EU, NMPA of China and PMDA of Japan and the supplier audit of several large multinational pharmaceutical companies for many times.
(3) Reasonable production layout and advantages of large-scale production
The company has been deeply involved in the raw material medicine industry for many years, focusing on standardizing the production management of high-standard raw materials in the market. It has four raw material medicine production bases (Zhejiang Menuohua, Anhui Menuohua, Xuancheng Menuohua and Liaoyuan Pharmaceutical), which are located in major pharmaceutical and chemical parks in Zhejiang and Anhui. The reaction kettle has complete specifications, covering production capacity ranging from 50L to 12500L. At the same time, through the continuous upgrading and transformation of the base, the facilities and equipment for the production capacity of the company’s raw materials are complete, with a DCS control system with full coverage and an EHS system with leading wastewater, waste gas and solid waste treatment capacity, covering many kinds of chemical reactions, including Grignard reaction, azide reaction, Friedel-Crafts reaction, hydrogenation reaction, cyanidation reaction and redox reaction. The company makes full use of the leading chemical synthesis ability and high-standard production capacity of APIs to give full play to the scale effect of APIs.
At present, the company has sufficient reserves of high-standard, modern and advanced production capacity. The total production capacity of the four API production bases is about 3,700 tons/year, and the production capacity of Minolta Tiankang is 1.5 billion tablets/year. With the continuous development of the company’s operation and production, the continuous promotion of strategic transformation, and the increasing number of high-quality customers, the company actively deployed capacity expansion, in which the "3 billion tablets (granules) export solid preparation construction project" of Minolta was completed during the reporting period and is ready for trial production; The main body of the civil works in the first phase of Anhui Meinuohua’s "Technical Transformation Project with an annual output of 400 tons of APIs" has been completely completed, and the installation of workshop equipment has been basically completed, and some workshops are ready for trial production; The main body of the first phase project of "520 tons of pharmaceutical raw materials per year" in Zhejiang Meinuohua has been completed, and some workshops have completed electromechanical installation. In addition, the second phase expansion project of Xuancheng Meinuohua has been started.
(D) Rich international customer resources and diversified strategic cooperation modes.
The company has been deeply involved in overseas markets for many years. Since its inception, it has accumulated rich international high-quality customer resources and established long-term and deep and stable cooperative relations with many internationally renowned pharmaceutical companies. Among them, the company and KRKA have sublimated from strategic cooperation to strategic binding in the long-term win-win cooperation, and formed diversified cooperation modes such as joint research and development, joint declaration and joint imitation, which not only maintained long-term and stable cooperative relations in the fields of pharmaceutical intermediates and raw materials, but also expanded in-depth cooperation in the field of preparations.
The company adheres to the market development concept of "exploring new customers and deeply cultivating old customers", keeps up with the development pace of customers, keenly understands the market development trend and responds to customer needs quickly. With the release of the company’s production capacity and business expansion, the company’s brand influence and international popularity have been further enhanced, and the product market share has continued to rise.
(E) Advantages of high-end R&D technology platform
Adhering to the international R&D concept and combining scientific and rigorous quality research, the company has established an efficient R&D management system. The company currently has three R&D centers, including Zhejiang Menuohua Pharmaceutical Research Institute, Pharmaceutical Innovation Research Institute and Hangzhou Xinnuohua Pharmaceutical, with a total experimental site of more than 13,000 square meters. After years of development, the company has reserved talents through self-cultivation and external introduction, brought into full play the role of European experts, Indian experts and scientific research forces in universities, and cooperated with postdoctoral workstations and foreign expert workstations to successfully build a core talent team with outstanding technology, efficient management and high loyalty. As of June 30, 2022, the company has 376 R&D personnel of APIs and 139 R&D personnel of preparations, and the number of R&D personnel has increased by 13% compared with last year. It has rich experience in drug synthesis and preparation process development, quality research and strong technical level of process amplification. Continuous R&D innovation is one of the important factors for the company to maintain its competitive advantage and achieve rapid growth. The company will continue to increase investment in R&D and build its core technological advantages.
The company’s innovative ability of API R&D is outstanding, among which the API R&D Center has established a perfect R&D quality system and project management process to ensure the scientificity, authenticity, integrity and traceability of R&D projects. The R&D center can carry out various multi-step complex organic synthesis reactions, including hydrogenation (conventional high-pressure hydrogenation and asymmetric hydrogenation), various N- alkylation reactions, cyanidation reactions, azide reactions, chiral synthesis and resolution, redox reactions (reactions involving hydrogen peroxide, TEMPO, DIBAL-H, NaBH4, etc.), biological enzyme catalytic reactions, crystallization processes with special particle size or physical properties, etc. The center is equipped with advanced R&D equipment and technology.
In terms of process safety research, the company set up a special safety laboratory, trained a special reaction safety risk assessment team, and equipped with the latest high-precision instruments and equipment such as RC1max, ARC, TGA and DSC. The safety laboratory passed CNAS certification, which further provided safety guarantee for the company’s process safety and could also provide reaction safety risk assessment services for other enterprises.
In the aspect of chemical process amplification, aiming at the "three-pass and one-reverse" of chemical production, a process amplification department based on process and engineering experts was established, and a special process amplification research laboratory was set up, equipped with laboratory research equipment to simulate chemical production, and each process parameter was simulated and studied, and a systematic research and evaluation report on process parameters was put forward, thus avoiding various defects in the process of process amplification and ensuring the success rate of process amplification.
In quality research, the company’s quality research ability is excellent. The company has experienced quality researchers, equipped with several semi-preparative chromatographs, high-resolution triple quadrupole LC-MS and GC-MS, and can carry out evaluation and research on all kinds of impurities, including evaluation of genotoxic impurities and nitrosamine impurities, verification and detection of method development, separation and structure identification of unknown impurities, etc.
The company attaches great importance to the study of physical properties of APIs, and has set up special crystal research laboratories and particle size research laboratories. The company is not only equipped with different types of crushing research equipment, but also equipped with precise analysis equipment such as Brooke powder diffractometer, which can carry out crystal development, detection, stability research and particle size research.
GMP management is implemented in the company’s quality research work, which can provide a complete set of analytical method development, verification, sample testing and other services for domestic and foreign research units.
The Institute of Medical Innovation is a medical innovation platform integrating applied technology research and development, public technology service, introduction of high-level talents and incubation of high-end projects. It conducts research and development and pilot tests of various new technologies and new products around drugs and new materials, incubates entrepreneurial projects in related fields, and builds industrial clusters of drugs and new materials. The company has established a professional team with complete functions such as process development, quality analysis, clinical medicine, international and domestic registration, project management, technology transfer, etc., equipped with advanced equipment and instruments for preparation research and development at home and abroad; At the same time, a key technology platform for the development of pharmaceutical preparations has been established, and through this key technology platform, the industrialization of the company’s independent research and development preparation projects and the incubation of high-end projects have been realized, and public technical services have been provided to external pharmaceutical enterprises.
The company established the CDMO business unit, which is dedicated to the development of CDMO business and helps the company to transform and upgrade its strategy. Through the strategy of "Novartis+"and the extension Development, the company brings the development of D-end.
In order to enrich product reserves and cultivate long-term competitiveness, the company has always adhered to independent research and development innovation and continuously increased R&D investment. During the reporting period, 10 patents were declared and 26 patents were granted (including 3 inventions and 23 utility models). By the end of the reporting period, the company had authorized 163 patents (including 70 inventions and 93 utility models).
(6) Excellent management team and talent echelon
The company has established a leading pharmaceutical service platform in the world, with an international team of more than 2,700 people with rich experience in the industry. According to the characteristics of the international pharmaceutical market, the company actively introduced all kinds of medical professionals at home and abroad, and established professional teams in drug research and development, quality, pharmaceutical administration registration, process optimization, market development and intellectual property management that meet the international pharmaceutical industry standards. During the reporting period, in order to attract, retain and motivate outstanding talents and fully mobilize the enthusiasm of managers, core technicians and business backbones at all levels of the company, the company implemented the "2021 Stock Option and Restricted Stock Incentive Plan" and completed the first grant. The incentive covers key company management talents and core technical talents, so that the interests of shareholders, the company and the personal interests of the core team can be combined to jointly promote the long-term development of the company.
