Shengnuo Biotechnology: The layout of the whole industry chain One of the most powerful peptide drug synthesis and production platforms in China

Shengnuo Biotechnology: the layout of the whole industry chain, one of the most powerful peptide drug synthesis and production platforms in China

  ——Chengdu Shengnuo Biotechnology Co., Ltd. IPO and listed on the Science and Technology Innovation Board, a wonderful replay of the online investor exchange meeting

   guests attending

  Mr. Wen Yongjun, Chairman and General Manager of Chengdu Shengnuo Biotechnology Co., Ltd.

  Mr. Wen Fasheng, Director and Secretary of the Board of Directors of Chengdu Shengnuo Biotechnology Co., Ltd.

   Mr. Zhang Hongyan, Director, Deputy General Manager and Chief Financial Officer of Chengdu Shengnuo Biotechnology Co., Ltd.

   Mr. Ma Zhonggang, Deputy General Manager of Chengdu Shengnuo Biotechnology Co., Ltd.

  Mr. Zhu Binghui, Deputy General Manager and Sponsor Representative of Investment Banking Division of Minsheng Securities Co., Ltd.

  Mr. Bai Yingcai, Executive Director and Sponsor Representative, Investment Banking Division of Minsheng Securities Co., Ltd.

Mr. Feng Yan, Senior Manager of Investment Banking Department, Minsheng Securities Co., Ltd.

  Management

  Q: What is the company’s main business?

  Wen Yongjun: The company is a high-tech enterprise with core peptide synthesis and modification technologies, and has advanced and efficient peptide drug technology research and development and large-scale production capabilities. The company’s main business is independent research and development, production and sales of peptide APIs and preparation products with large market capacity and strong competitiveness at home and abroad.

At the same time, the company relies on its technical advantages in the field of peptide drug research and development and large-scale production. Foreign pharmaceutical companies provide pharmaceutical research services for innovative peptide drugs, customized production services for peptide products, and technology transfer services for peptide drug production. In addition, the company also provides small-molecule chemical drug levosimendan preparations on behalf of processing and levosimendan bulk drug production, export sales business.

  Q: Please introduce the complete situation of the company’s assets.

Wen Fasheng: The company has the main production system, auxiliary production system and supporting facilities related to production and operation, and legally owns the ownership or use rights of the main machinery and equipment related to production and operation, as well as trademarks, patents, and non-patent technologies, and has independent raw materials And product sales system.

Up to now, the company has not used the company’s assets to provide illegal guarantees for its controlling shareholders, actual controllers and other companies under its control, nor has its assets or resources been controlled by the controlling shareholders, actual controllers and other companies controlled by them. Situation of use or occupation.

  Q: Please introduce the company’s core technology and sources.

  Wen Yongjun: Since its establishment, the company has been engaged in the research and development of large-scale production technology of peptide drugs, accumulated advanced peptide synthesis and modification technology and experience, and successfully developed a number of popular API varieties at home and abroad.

At the same time, it provides pharmaceutical research services for peptide innovative drugs and customized production services for peptide products. The number of peptide raw material drugs and the number of external service projects it has are among the best in China.

Relying on its own advantages in peptide drug synthesis route design, process research and development, industrial chain platform, and technical personnel experience, after years of accumulation, the company has mastered long-chain peptide coupling technology, large-scale production technology of monosulfide cyclic peptides, and many-to-two The thiocyclic peptide synthesis technology, PEGylation modification, fatty acid modification and other independent core technologies of peptide synthesis and modification have successfully solved the technical bottleneck of the large-scale production of multiple peptide API varieties.

  Q: Please introduce the status of the evaluated projects of the company’s main scientific research achievements.

  Wen Yongjun: The company has successively participated in and won more than ten national and provincial scientific research projects, and has played an important role in the development and industrialization of peptide drugs in my country.

In 2009, the company’s five products industrialization research and development of atosiban acetate, octreotide acetate, somatostatin, thymofaxine and carbetocin were included in the “Eleventh Five-Year” National Major New Drug Development Special Project; 2012 The “Modern Biotechnology Peptide Medicine Industrialization Base Project” declared by the company was awarded the 2012 Industrial Revitalization and Technological Transformation Project of the National Development and Reform Commission.

  Q: Please introduce the changes in the company’s comprehensive gross profit margin.

   Zhang Hongyan: In 2018, 2019, and 2020, the company’s comprehensive gross profit margin was 70.36%, 80.12%, and 79.21%, respectively. The overall gross profit margin increased sharply in 2019 compared to 2018, mainly due to the impact of changes in product sales structure. The proportion of sales of preparations with higher gross margins in operating income has shown a significant increase year by year, which has led to a year-on-year increase in comprehensive gross profit margin.

Zhang Hongyan: The company’s operating income has increased from RMB 277,973,500 in 2018 to RMB 37,877,800 in 2020; net profit has increased from RMB 29,861,300 in 2018 to RMB 59,997,800 in 2020; net sales in 2018, 2019, and 2020 The interest rates are 10.74%, 14.73% and 15.84% respectively. The company’s net profit mainly comes from operating profit.

  Development

  Q: What is the business positioning of the company’s independent peptide drug products?

Zhu Binghui: The company is one of the earliest companies in the country that entered the research and development and production of peptide generic drugs. The early focus was on peptides with large market capacity in the fields of immunity and digestive tract, high difficulty in imitation, good clinical effects, and patent expiration or about to expire. Research and development of APIs.

With the improvement of the company’s funds and R&D capabilities, the company’s R&D fields have gradually expanded to multiple therapeutic areas such as anti-virus, obstetrics and gynecology, diabetes, cardiovascular and cerebrovascular, rare diseases, and orthopedics. Based on the market research of peptide drugs in the above therapeutic fields, the company carefully selects 2 to 3 peptide drugs in each field for echelon research and development. While the product line covers multiple therapeutic areas, it has enriched product categories in various therapeutic areas to meet a variety of therapeutic needs clinically, and enhance the company’s industry position in the polypeptide field.

  Q: What is the company’s overall development plan?

Zhu Binghui: In the future, the company will seize the rapid growth of the peptide drug market, continue to deepen the peptide drug market, continue to improve process technology, research and development strength, marketing management, channel construction and comprehensive management capabilities, and improve overall competitiveness and profitability.

The development trend of the global pharmaceutical industry is to focus on peptide API products, strengthen pharmaceutical research services for peptide innovative drugs, and customized production services for peptide products, actively integrate into the domestic and foreign pharmaceutical industry chain, extend the development of more peptide preparation varieties, and further increase The promotion strength and promotion management level of large preparations.

At the same time, the company will actively deploy the peptide innovative drug business field through cooperative research and development, and consolidate the company’s competitive position in the industry.

  Question: Please introduce the company’s long-term technological accumulation advantages in the field of synthetic peptides.

  Ma Zhonggang: As one of the few domestic companies with peptide drug research and industrialization transformation capabilities, the company has a wealth of technology accumulation in the field of chemical synthesis of peptides.

The company has mastered a series of core technologies for the large-scale production of peptide drugs through independent research and development, and has 25 invention patents (1 of which also obtained international patents), and also has a large number of non-patent technologies, mainly drug production formulas and corresponding Production Process.

  The advantages of long-term technological accumulation in the field of peptides have enabled the company to successfully develop multiple peptide APIs and preparations, and it has also made the company one of the few domestic companies that can undertake pharmaceutical research services for difficult peptide innovative drugs and customized production services for peptide products.

The company uses its own advanced process research and development and large-scale production capabilities to further improve its profitability, and at the same time promote the industrial transformation of new peptide drugs in China.

  Q: Please introduce the company’s advantages in large-scale API production.

  Ma Zhonggang: The production technology of peptide APIs is complex. From the laboratory’s single batch gram-level production capacity to several kilogram-level commercial production capacity, the difficulty of synthesis and purification increases geometrically.

The low-cost and industrialized mass production of peptide drugs, especially high-quality peptide APIs, is one of the main factors restricting the development of my country’s chemically synthesized peptide industry. “The development and application of large-scale pharmaceutical peptide synthesis and purification technology” was listed in 2011 And the 2019 version of the “Industry Adjustment Guidance Catalogue”.

The company currently has a modern automatic peptide synthesis and purification system, has accumulated various key core technologies, has many years of industrialization experience in the field of peptides, and has realized the large-scale production of 15 peptide APIs, and its quality standards have won domestic and foreign customers It is recognized that the products are exported to many countries and regions including the United States and the European Union, which can meet the needs of rapid, large-scale and high-quality peptide synthesis. At the same time, the production cost has a large advantage, which ensures the company’s competitiveness in the industry.

  Q: Please introduce the company’s rich product line advantages.

Ma Zhonggang: The company has always adhered to the product innovation of chemically synthesized peptide drugs. After nearly two decades of continuous development, the company’s main product lines cover various therapeutic areas such as digestive system, immune system diseases, anti-tumor, chronic hepatitis B, diabetes, and obstetrics. It is one of the peptide drug manufacturers with relatively complete product lines in China. In foreign markets, the company has 8 products of bivalrudine, eptifibatide, icatibant, liraglutide, octreotide acetate, ziconotide, teriparatide, and ganirelix that have obtained American DMF.

Filing (in active state). In the domestic market, the company has obtained 19 domestic drug registration approval numbers or domestic filings for peptide drugs, including 8 peptide APIs and 12 peptide preparation specifications. They are two domestic preparations of enfuvirtide and carbetocin. The first imitation enterprise of the product. Currently, the company is applying for registration approval for 11 products, and more than ten peptide drug products are in the research and development stage. In the future, the company’s product line is expected to be further expanded and enriched.

  Industry

  Q: What is the industry classification of the company?

Wen Yongjun: According to the “Guidelines for Industry Classification of Listed Companies” (revised in October 2012), the company’s industry is “Pharmaceutical Manufacturing (Classification Code C27)”; according to “Classification of National Economic Industries” (GB/T4754-2017) , The company’s industry belongs to “C2710 chemical drug raw material manufacturing” and “C2720 chemical preparation manufacturing” under “Pharmaceutical Manufacturing (C27)” in “C Manufacturing”.

  Q: Please tell us about the development of peptide drugs in my country.

Ma Zhonggang: Although my country’s peptide drug market started late, it has developed rapidly. Sales rose from 5.6 billion yuan in 2009 to 29.56 billion yuan in 2017, with an average annual compound growth rate of 23.12%, which is much higher than the global peptide drug market. The overall growth rate. With the introduction of my country’s policies to encourage the research and development of innovative drugs and promote the consistency evaluation of generic drugs, it is expected that more innovative peptide drugs and peptide generic drugs with significant clinical effects will be approved for marketing in the future, which will further expand the peptide drug market in my country.

   From the perspective of market distribution, there are more than 40 peptide drugs on the market in my country, which are mainly distributed in seven fields, including immunity, digestive tract, anti-tumor, orthopedics, obstetrics, diabetes and cardiovascular. Among them, immune drugs dominate, accounting for more than 50% of the domestic market; digestive tract and anti-tumor fields are second, each accounting for about 20%; orthopedics, obstetrics, diabetes, and cardiovascular markets are smaller, accounting for 7% of the total market. The market is dominated by primary products and has not yet entered a mature period.

From the perspective of the global peptide market, 85% of the market is concentrated in the treatment of chronic diseases such as tumors and diabetes. First aid and surgical aids account for only about 15%. The treatment of chronic diseases is the real bonanza of the peptide industry. In contrast, in my country’s peptide market, immunity, digestive tract, obstetrics, cardiovascular (angina pectoris, myocardial infarction, etc.) are all short-term medications or emergency drugs, while cancer, orthopedics (osteoporosis treatment), diabetes and other chronic disease treatments only With a market share of 26%, there is still a lot of room for development.

  Question: Please introduce the opportunities for the localization of generic drugs after the expiration of my country’s peptide drug patents.

  Ma Zhonggang: At present, the domestic peptide drug market is dominated by imported drugs, and high prices have become an important factor in inhibiting the volume of peptide drugs. The period from 2014 to 2022 is the peak period for patent expiration of heavy peptide drugs. Many varieties have not yet been listed in China or only imported original research drugs have been listed. Among them, there are many glatiramer and liraru with global sales of more than 1 billion US dollars. Peptides, exenatide, goserelin, etc.

Although Chinese pharmaceutical companies still have a certain gap with international giants in terms of innovative peptide drugs, in terms of peptide generic drugs, some domestic professional peptide drug manufacturers have reached a higher level, and have successively achieved bivarrudine and cannibalism. The localization of Rick, Cetrorelix, Enfuvirtide, Carbetocin, Atosiban Acetate, Etibatide and other varieties shows the R&D strength of local enterprises in the field of peptides. Therefore, the lack of localization of more patent expired drugs makes my country’s peptide generic drugs field great potential.

   Release

  Q: How many shares does the company issue this time?

   Wen Yongjun: The company plans to publicly issue 20 million shares this time, accounting for 25% of the company’s total share capital after the issuance.

  Q: Please introduce the strategic placement situation.

   Wen Yongjun: The strategic placement target for this issuance is Minsheng Investment, a subsidiary of the sponsor institution, and there is no other strategic placement arrangement. Minsheng Investment’s initial co-investment ratio is 5%, or 1 million shares.

  Q: What is the relationship between the fund-raising investment project and the company’s main business and core technology?

Zhu Binghui: The investment projects raised from the issuance of shares are all focused on the company’s main business and existing core technologies. Specifically: the “Peptide API Production Line Project” expands the company by building a new high-standard peptide API production base in Meishan The production capacity of peptide APIs will promote the industrialization of the company’s approved or filed key products and customer innovative peptide drug CDMO service projects.

At the same time, it lays the foundation for the production of products under research to meet the rapidly growing market demand and the needs of international competition; the “preparation industrialization technological transformation project” can enhance the company’s large-scale production capacity of peptide preparations, promote the industrialization of more preparation products, and increase New dosage forms to consolidate the company’s integrated competitive advantage of peptide APIs and peptide preparations;

the “Engineering Technology Center Upgrade Project” introduces a series of industry-leading R&D software and hardware through the newly built R&D building, and on the one hand, it further improves the level of peptide drug R&D and supports The two main businesses of external pharmaceutical research services and independent peptide drug research and development, make full use of the company’s core technology to cultivate more new varieties, on the other hand, improve the research and development environment, attract high-end talents, further improve the company’s peptide drug research and development efficiency, and increase the company’s technological accumulation.

The fund-raising investment project is carried out around the existing main business and core technology. The implementation of the project will not cause the company’s main business to change, and will not increase the horizontal competition between the company and the controlling shareholder, actual controller and its related parties. , Will not adversely affect the independence of the company.

Shengnuo Biotechnology: The layout of the whole industry chain One of the most powerful peptide drug synthesis and production platforms in China

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