On June 24, the listing application of Chengdu shengnuo biotechnology Co., Ltd. (hereinafter referred to as “shengnuo biotechnology”) was officially accepted.
Founded in 2004, shengnuo biotechnology is subordinate to Chengdu shengnuo Technology Development Co., Ltd., which was established in 2001. It has more than 50 key technologies for large-scale production of peptides that have been listed at home and abroad. It is an international enterprise specialized in large-scale production of peptide and amino acid drugs.
Before the listing of the science and technology innovation board, shengnuo biotechnology has changed the listing board for many times. shengnuo biotechnology started listing guidance and filing in May 2018. It originally planned to be listed on the SME board or gem, and then applied to change to the science and technology innovation board, and then went back and forth on the gem and the scientific and technological innovation board twice.
shengnuo biotechnology plans to raise 349 million yuan for polypeptide API production line and other projects.
According to the prospectus, 2014-2022 is the peak period of patent expiration of polypeptide blockbuster drugs in the world. At present, a number of varieties have not yet been listed in China or only imported original research drugs have been listed. Among them, the global sales volume of more than 1 billion US dollars includes such heavyweight drugs as glatelle, liraglutide, exenatide and goserellin.
Patent of polypeptide blockbuster expired in 2014-2022
This provides a development opportunity for domestic generic pharmaceutical enterprises, and also drives the growth of upstream peptide API market demand, which also becomes the main reason why shengnuo biotechnology hopes to expand its market share with the help of scientific and technological innovation board.
Take liraglutide, the original research drug of danmainuo and Novo Nordisk, as an example. In 2019, the global sales of liraglutide were US $7.198 billion, which was the first overseas sales of diabetes drugs. Liraglutide injection was also the only GLP-1 analogue in the medical insurance list.
This is also one of the six main drug substances (liraglutide, enflutide, bivalirudin, etibatide, octreotide acetate and thymopentin) that the company intends to raise funds for the listing.
Novo Nordisk’s core patent zl97198413.1 in China expired in August 2017, and other patents have also expired.
shengnuo biotechnology started to prepare generic drugs four years before the expiration of liraglutide patent.
In 2013, “preparation method of liraglutide” (Patent No. zl201410265582.6) was applied, and “a method of synthesizing liraglutide” (Patent No. zl201410265582.6) was applied in 2014. By 2015, DMF has been submitted to the United States and has been activated for filing.
At present, few API manufacturers of some kinds of polypeptides have been certified by us DMF.
For example, in addition to Novo Nordisk, only 6 companies with MF record numbers, such as Bachem of Switzerland, Ambio of the United States, Beijing intercontinental Xinze Pharmaceutical Technology Co., Ltd., Jiangsu Nuotai aosanuo biopharmaceutical Co., Ltd., Hanyu Pharmaceutical Co., Ltd. and SINOCHEM have MF record numbers, so the market competition is relatively peaceful.
If we can successfully land on the scientific and technological innovation board, we will speed up the market share of shengnuo biotechnology.
At present, shengnuo biotechnology has registered with DMF in the United States (in the active state) on 8 varieties including liraglutide, which can support the research and development of customer preparations and prepare to be listed in the United States and Europe. And through the development of liraglutide, glatirel and other difficult products, we have maintained cooperation with international pharmaceutical enterprises.
In terms of domestic market, shengnuo biotechnology has obtained 18 domestic drug registration approval numbers for peptide drugs, including 8 polypeptide raw materials and 12 peptide preparation specifications. It is the first imitator of enflutide and carbetoxine in China.
Biopharmaceutical research and customized production service
From the composition of research and customized production services, we can also see that the proportion of independent R & D activities is increasing.
Compared with the international API manufacturers, China has a significant cost advantage in the production of chemical synthetic peptide APIs. Therefore, most of the protective amino acids, protective resins and reagents used in the synthesis of chemical synthetic polypeptide APIs are produced in China. This provides more opportunities for enterprises like shengnuo biotechnology to improve their independent R & D.
At present, shengnuo biotechnology has realized the large-scale production technology of long peptide chain peptide raw materials composed of more than 30 amino acids, such as enflutide, liraglutide, tripatide, exenatide, etc., in the field of high difficulty peptide synthesis, which breaks through the process problems of high impurity quality caused by disulfide bonds and cyclic peptides in the structures of zikonotide and linalopeptide.
The R & D capability and large-scale production capacity of shengnuo biotechnology for high-difficulty peptide drugs enable it to provide bulk drug support for many multinational generic pharmaceutical enterprises in the international standardized market, and also be able to launch the first generic product in the domestic market, so as to seize the new market and avoid vicious competition.
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Shengnuo Biotechnology is a high-tech China polypeptide manufacturers,who has over 19 years experience for the biotechnology .Our Products involve peptide raw materials,polypeptide drug.
Our 0 defect has passed the FDA certification, and has become the first-class professional polypeptide drug and product development and large-scale production and export industry in China .
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Thymopentin for Injection、 Thymalfasin for Injection 、 Bivalirudin 、Bulk Drug、 Liraglutide ……
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