shengnuobiotechnology has been investigated by 3 institutions: the peptide API segment is the company’s key development segment. This business has grown rapidly in the past two years. After the completion of the capacity expansion, it is expected to bring further profit growth to the company.

shengnuobiotechnology has been investigated by 3 institutions: the peptide API segment is the company’s key development segment. This business has grown rapidly in the past two years. After the completion of the capacity expansion, it is expected to bring further profit growth to the company.

shengnuobiotechnology released the investor relations activity record form on September 15. The company accepted the investigation of 3 institutional units on September 6, 2022. The types of institutions are fund companies and securities companies.

The main contents of investor relations activities are introduced:

1. Company introduction Chengdu shengnuo Biotechnology Co., Ltd. was established in July 2001. It is a high-tech certified enterprise in Sichuan Province and has 680 employees. At the beginning of its establishment, the company mainly provided domestic polypeptide pharmaceutical companies and R&D institutions with CDMO services such as small test, pilot test, process research and development, and customized peptide production. The whole-process R&D pipeline and the whole-industry-chain platform have accumulated a high reputation in the domestic peptide drug field, and successively provided pharmaceutical research services for more than 40 projects for a number of new drug R&D companies and scientific research institutions, of which 1 product has been approved for marketing Entering the commercialization stage, 10 innovative peptide drugs entered the clinical trial stage. The company continues to accumulate experience in the process of drug R&D and production, and independently selects peptide generic drugs with large market space and development prospects at home and abroad for R&D, becoming one of the most powerful peptide R&D and production enterprises in China.

2. Investors’ main questions and responses

Q: For the future development of the company, have you considered doing other tracks besides peptides?

A: The core team members of the company have more than 15 years of research and practical experience in the field of peptide synthesis. The company has always focused on the field of peptides since its establishment. It is one of the only companies in China that focus on the field of peptides. The future development of peptide preparations and peptide CDMO services will mainly focus on the whole industry chain of peptides and different application fields of peptides.

The peptide API segment is the company’s key force. This business has grown rapidly in the past two years. After the capacity expansion is completed, it is expected to bring further profit growth to the company; for the peptide CDMO segment, the company will continue to participate in the domestic frontier projects of peptide innovative drugs. In the R&D and production, it can obtain customized production orders from customers and accelerate the development of overseas business; the peptide preparation sector mainly actively promotes the consistency evaluation work and selects products with good competition pattern for R&D. In addition, the company has also deployed beauty peptides, expanding the application of peptides to the fields of peptide medical beauty products, services, and cosmetic raw materials, bringing new growth points to the company.

Q: Your company has been developing in the industry for many years. What are the technical advantages of the peptide CDMO business in the main business?

A: Since its establishment, the company has gradually become one of the few domestic pharmaceutical companies with the ability to design, synthesize and prepare peptide drugs. Synthetic technology and other core technical means, the preparation process has achieved controllable parameters, stable quality, high yield, easy to scale up production and operation, and can quickly promote the industrialization of innovative peptide drugs.

Relying on the company’s core technology in the field of peptide synthesis and modification, it has provided CDMO services such as pharmaceutical research for more than 40 projects of many new drug R&D companies and scientific research institutions. At this stage, 10 innovative peptide drugs have entered the clinical trial stage, playing an important role in the research and development and industrialization of innovative peptide drugs in my country. The company is a leading enterprise in the field of peptide CDMO in China.

Q: So far, who are the company’s CDMO customers?

A: The company’s CDMO customers are mainly new drug R&D companies and scientific research institutions, with a total of more than 40, such as Frontier Biopharmaceutical (Nanjing) Co., Ltd., Bio-Tech Biopharmaceutical Co., Ltd., Paige Biopharmaceutical (Suzhou) Co., Ltd., Pulai Pharmaceutical Biotechnology Co., Ltd., Bajiayi Pharmaceutical Co., Ltd., Shanxi Jinbo Biomedical Co., Ltd., etc.

Q: Knowing that the company’s raw materials are sold abroad, can you introduce the registration and certification of the company’s products abroad?

A: The company has many APIs that have passed the certification of foreign authoritative organizations and are widely sold all over the world. Among them, bivalirudin has passed the U.S. DMF filing and is the first company to submit bivalirudin API filing documents to the U.S. FDA. a supplier. Etifibatide, octreotide, liraglutide, ictibant, ziconotide, and ganirelix have all been registered with the US DMF; Thymofasin has been registered with the Korea Food and Drug Administration; Enfuvirtide has been registered in Mexico . In addition, linaclotide is also in the U.S. FDA filing.

Q: According to the data disclosed in the company’s 2022 semi-annual report, what is the reason for the rapid year-on-year increase in R&D expenses in the first half of the year?

Answer: As of the first half of this year, the company’s R&D expenses have increased by 120.57% compared with the same period, which is mainly due to the rational investment of the company’s research projects in an orderly manner. Levosimendan injection in the first half of the year incurred a total of 9.0589 million R&D expenses, of which the consistency evaluation The cost is 7.1492 million yuan.

Q: How is the expansion of API production capacity?

Answer: The company’s fund-raising project “annual output of 395 kg of polypeptide raw material drug production line project” needs to be adjusted to meet planning and environmental protection requirements, so the company’s fund-raising project construction time lags behind the original plan, reaching the scheduled availability date The extension is to December 2023, and the date of reaching the scheduled full production status is August 2025.

In addition to the fundraising project, the preparation industrialization technology transformation project and the engineering technology center upgrade project have implemented the factory planning plan and entered the bidding construction stage of the factory; the 105 workshop and QC microbiological laboratory of the reconstruction project of shengnuobiotechnology  Pharmaceutical’s API workshop have been completed and completed. Put into use; Capgemini’s peptide production base technical renovation and relocation project has been relocated, and production lines are being rebuilt one after another; Huirong Biotech’s technical renovation and relocation project is under construction;

The main business of Chengdu shengnuobiotechnologytechnology Co., Ltd. is to provide pharmaceutical research and customized production services for the research and development of innovative peptide drugs for domestic and foreign pharmaceutical companies. Independent research and development, production and sales have large market capacity and strong competition at home and abroad. Powerful peptide generic drug APIs and preparations, as well as peptide drug production technology transfer services. The company’s main products are peptide drugs. The company has 25 invention patents (one of which has obtained an international patent at the same time) and a large number of non-patented technologies, and has been awarded more than ten national and provincial scientific research and technological transformation projects. “Drug Engineering Technology Research Center”, was rated as “Sichuan Enterprise Technology Center” by Sichuan Economic and Information Commission, and played an important role in the development and industrialization of peptide drugs in my country.