Shengnuo Biotechnologynology focuses on the field of peptide APIs and preparations

The IPO registration of Shengnuo Biotechnology Innovation Board took effect a few days ago. Shengnuo Biotechnologynology is a high-tech enterprise with core technologies for peptide synthesis and modification, and has advanced and efficient peptide drug technology research and development and large-scale production capabilities. The company plans to raise 349 million yuan this time for projects such as an annual production line of 395 kilograms of peptide APIs.

Rich product line

Shengnuo Biotechnologynology’s main business is independent research and development, production and sales of peptide APIs and preparation products. At the same time, the company relies on the advantages of peptide drug research and development and large-scale production technology to provide pharmaceutical companies with peptide innovative drug pharmaceutical research services, peptide product customized production services, and peptide drug production technology transfer services.

In addition, the company provides small-molecule chemical drug levosimendan preparations on behalf of processing and levosimendan bulk drug production, export sales business.

The company is well-known in the field of peptide drug research and development and production, and has successively provided pharmaceutical research services for more than 30 projects for new drug research and development companies and scientific research institutions such as Paige Biotech, Biotech Pharmaceuticals, and Eight Plus One.

Among them, 1 product was approved for marketing and entered the commercialization stage, and 7 innovative peptide drugs entered the clinical trial stage. The company selects peptide generic drugs with greater market capacity and strong market competitiveness for research and development, and has mastered the large-scale production technology of 15 varieties of APIs.

Among them, 7 varieties have been approved for domestic production, 8 varieties have been registered with the US DMF (activated state), and 8 peptide preparation varieties for extended development have received 12 domestic production approvals. The products cover immune system diseases, tumors, and cardiovascular diseases. , Treatment of chronic hepatitis B, diabetes and obstetric diseases.

Enfuvirtide and carbetocin injections for injection of the company’s peptide preparation products are the first imitation peptide drugs in China; synthesis of bivalrudine, liraglutide, thymosin, icatibant, enfuvirtide, etc. The more difficult generic APIs have been exported to international markets such as Europe, America, India, and South Korea.

The end customers include Fresenius, Aurobindo, Mylan, Lupin, and Sinopec. Litai, Shanghai Pharmaceutical First Biochemical, Yangzijiang and other well-known pharmaceutical companies; the two preparations of icatibant and posaconazole that the company has submitted drug registration applications are listed in the “First Batch of Encouraged Generic Drugs List” by the National Health Commission “.

According to QYResearch, the global peptide drug market will grow at a compound annual growth rate of 7.9%, and the market size will reach 49.5 billion U.S. dollars in 2027. The peptide drug market still has huge room for growth.

Although the peptide drug market in my country 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 overall growth of the global peptide drug market. speed.

With the introduction of 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, and the peptide drug market in my country will further expand.

Master multiple core technologies

From 2018 to 2020 (reporting period), the company’s R&D investment was 15.6843 million yuan, 11.5981 million yuan, and 22.4851 million yuan, accounting for 5.64%, 3.55%, and 5.94% of operating income in the same period.

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

The number of varieties of peptide APIs and the number of foreign service projects owned by the company are among the best in China. With its own advantages in peptide drug synthesis route design, process research and development, industrial chain platform and technical personnel experience, the company has mastered the long-chain peptide coupling technology, the large-scale production technology of monosulfide cyclic peptides, and the synthesis of multiple pairs of disulfide cyclic peptides.

Technology, PEGylation modification, fatty acid modification and other independent core technologies for peptide synthesis and modification have successfully solved the technical bottleneck of the large-scale production of multiple peptide APIs.

At present, the company has 25 invention patents. In addition, the company has a large number of non-patented technologies, mainly including pharmaceutical production formulas and corresponding production and processing techniques.

The company has 5 core technical personnel, all of whom have rich theoretical and practical experience in peptide research and development. Among them, Wen Yong, the company’s chief scientist and chairman, is one of the earliest experts in the field of peptide drugs in China. Other core personnel have more than 15 years of research and practical experience. The company’s core technical personnel are stable, and the research and development capabilities continue to grow.

Proposed to raise 349 million yuan

During the reporting period, the company’s operating income increased from 278 million yuan in 2018 to 379 million yuan in 2020; net profit increased from 29,861,300 yuan in 2018 to 59,997,800 yuan in 2020. The main business income accounted for more than 98%, and the other business income was mainly from the sale of raw and auxiliary materials.

According to preliminary calculations, the company expects its operating income from January to March 2021 to be RMB 82.22 million to RMB 86,785,200, a year-on-year increase of 15% to 21.38%; net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses is expected to be RMB 8,215,600. To 9,128,700 yuan, an increase of 0.74% year-on-year to 11.94%.

The company stated that operating income and net profit attributable to the parent company after deducting non-recurring gains and losses are showing an increasing trend, and it has the ability to continue operations.

The company plans to raise 349 million yuan this time for the production line project of 395 kilograms of peptide APIs, the technological transformation project of preparation industrialization and the upgrading project of the engineering technology center.

Among them, the peptide API production line project expands the company’s peptide API production capacity by building a new high-standard peptide API production base in Meishan, promotes the industrialization of the company’s approved or registered key varieties, and lays a foundation for the production of products under research.

To meet the rapidly growing market demand; 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, add new dosage forms, and consolidate the integration of the company’s peptide raw materials-peptide preparations Competitive advantages;

the engineering technology center upgrade project introduces a series of industry-leading R&D software and hardware through the newly built R&D building, further improves the level of peptide drug research and development, supports foreign pharmaceutical research services and independent peptide drug research and development business, and makes full use of the company’s core technology to cultivate more New varieties, while improving the research and development environment, attracting high-end talents, and further improving the company’s peptide drug research and development efficiency.

The company said that after the completion of the fund-raising investment project, the company’s production scale, product structure, and research and development capabilities will be significantly improved.

The project construction is in line with the company’s future strategic layout. It not only captures the future development trend of the peptide drug industry, is conducive to the company’s new product research and development and industrialization, but also helps the company expand its production scale, alleviate the company’s insufficient production capacity, and consolidate the company’s “innovative peptide drug pharmaceutical The competitive advantage of research services + independent peptide drug products will maintain and consolidate the company’s various advantages in the industry, enhance its comprehensive market competitiveness, and provide a strong guarantee for the company’s future development.