The world's 4th largest peptide CDMO, low-key Angbo Pharmaceutical will be listed on the Hong Kong stock market

In 2018, 2019 and 2020, the revenue generated by Ambro Pharma’s peptide CDMO service was US$39.

For the year ended December 31, 2020, CDMO customers located in North America, Asia, Europe and other countries accounted for approximately 62.

R&D pipeline

Ambro Pharmaceuticals chose to establish strategic partnerships with some of the world's leading pharmaceutical companies, as well as leading biosimilar and generic companies, to cooperate in the development of several peptide drugs in the pipeline
.

At present, there are 12 kinds of peptide drugs under research in the product pipeline of Amberg Pharmaceuticals, of which 5 are generic peptide drugs, 5 are GLP-1 and insulin drugs and 3 sustained-release peptide drugs
.

Several major products recently launched in the product pipeline include:

Teriparatide is a bioequivalent peptide drug of Forteo®, which is a synthetic parathyroid hormone (PTH) used to treat osteoporosis
.
It is expected that the product under development will be approved by the FDA and EMA in the short term
.

Teduglutide is a bioequivalent peptide drug of Gattex®, and Gattex® is a prescription drug used to treat short bowel syndrome (SBS)
.
It is expected that the FDA will approve the bioequivalent drug of Gattex® in 2023, and the product under development will be marketed shortly before the expiration of the related patent of the original researcher
.

Liraglutide is a bioequivalent peptide drug of Victoza ®
.
Victoza® is a GLP-1 agonist developed by Novo Nordisk for the treatment of type 2 diabetes
.
It is expected to obtain relevant FDA approval before 2024
.

As far as bioequivalent peptide drugs are concerned, they have submitted 6 ANDAs to FDA, 2 application documents to EMA, 1 application document to CFIA, and more than 15 other international applications in their names
.

In 2020, there are 288 peptide projects in different stages of research and development in progress, of which 266 are in preclinical and phase I clinical trials, 16 are in phase II clinical trials, 2 are in phase III clinical trials, and 4 are in phase III clinical trials.
Has been commercialized
.

Competitive Advantage

Polypeptide is a compound formed by linking α-amino acids together by peptide bonds, and is also an intermediate product of protein hydrolysis
.
As one of the world's largest manufacturers of customized peptides, the company can produce almost any kind of peptides required by customers, including specially modified peptides.
For this reason, the company has divided into two business models-CDMO business and independent development
.

(Amber Pharmaceuticals Sino-U.
S.
Plant, from the official website)

Customize various peptide services for enterprises

Manufacture solid-phase, liquid-phase, and hybrid peptide drugs through mature company platforms and technologies.
Its peptide development services run from pre-clinical research to commercial development to scale and process certification, and finally the Food and Drug Administration (FDA) new drug listing The pre-application (NDA) process verifies the entire process and complies with the current Good Manufacturing Practice (cGMP) of the FDA for peptide manufacturing regulations
.
In addition to the production of patented peptide APIs, it also produces generic drugs for mature commercial markets and non-GMP peptides for clinical research laboratories
.

Low cost, high quality

Ambro Pharmaceuticals has developed and expanded the production scale of peptide sustained-release drug candidates under development
.
The unique business model enables the company to produce high-quality products of any scale at a lower price than most competitors.
At the same time, superior chemical technology and equipment enable them to provide first-class product quality and reasonable production costs
.

(From the company's official website)

Fast process

According to the prospectus, as of December 31, 2020, the company operates 16 peptide production lines in the United States and China, becoming one of the largest cGMP peptide production companies in the world
.
The facility is equipped with 1,000 liters of solid phase reactors and 5,000 liters of liquid phase reactors, enabling the company to produce more than 300 kilograms of peptide APIs through US and Chinese factories each year
.
Ambro Pharmaceuticals can deliver customized peptides that have been inspected and passed by the company's internal quality control team, and it only takes 3-4 weeks at the shortest time
.

China and the United States have obvious advantages

The plant in North Augusta, South Carolina in the United States has a total construction area of ​​approximately 82,566 square meters.
It is mainly responsible for the purification and quality assurance and control of peptide CDMO business, as well as peptide bioequivalent drug products and peptides under development.
Research and development of biosimilar products
.
As of December 31, 2020, the US plant has 10 peptide purification production lines with equipment specifications ranging from 20 cm to 100 cm, allowing them to produce more than 300 kg of finished peptides per year
.

The Chinese factory is located in Shanghai and is mainly responsible for large-scale production of crude peptides, which will be shipped to US facilities for further purification
.
As of December 31, 2020, the Chinese factory has 71 reactors with specifications ranging from 20 liters to 5,000 liters, and 6 peptide purification production lines, with equipment specifications ranging from 8 cm to 45 cm
.

development path

(The main subsidiary of Angbo Pharmaceutical, from the prospectus)

In 2007, it operated AmbioPharm, Inc.
and Shanghai Angbo Biotechnology Co.
, Ltd.
, the main operating subsidiary companies engaged in the peptide CDMO business
.

In 2011, founded Ambio, Inc, a subsidiary company engaged in peptide drug product development
.

In 2014, completed Series A financing, raising a total of US$24 million
.
Upon completion of the reorganization, Ambio Holdings, Inc.
became the then controlling shareholder of AmbioPharm, Inc.
and Ambio, Inc.
, the main operating subsidiaries of the CDMO business and peptide drug development business, respectively
.

In 2015, it entered into a development, supply and distribution agreement with Apotex, the world's leading pharmaceutical biosimilar company, for a period of 20 years; Bivalirudin API was approved by the FDA for commercial supply in December
.

In 2018, completed the A-2 series of financing and raised 20 million US dollars
.

In 2020, in cooperation with Apotex, the Canadian CFIA approved teriparatide drug (teriparatide) and Eli Lilly's teriparatide (Forteo) generic drugs in May
.
At the same time, it completed Series B financing and raised US$80 million
.

Conclusion

Ambro Pharmaceuticals can provide comprehensive services covering the entire peptide production and development process, as well as the ability to develop and produce difficult-to-manufacture peptides in a low-cost manner and to meet strict regulatory approval requirements of various countries' regulatory agencies
.
In addition, the company's professional technical expert team enables them to have sufficient ability to develop various peptide products required by the market, and use their market position and technical advantages to maintain sufficient competitiveness
.

Compared with traditional drugs, emerging technology drugs naturally have advantages, and peptides are no exception.
With the increasing market demand, companies are also making rapid progress in technology.
In the future, more drugs that meet market requirements may be ushered in to meet the needs of patients.
Peptide drugs for clinical needs
.

refer to:

NMPA/CDE;

Pharmacy Cloud Data, Cloud Data, FDA/EMA/PMDA;

Public disclosure by related companies;

Amber Pharmaceuticals prospectus link: https://www1.
hkexnews.
hk/app/sehk/2021/103597/documents/sehk21062502259_e.
pdf;

https:// NMPA / CDE; and the like
.