news

한어Русский языкEnglishFrançaisIndonesianSanskrit日本語DeutschPortuguêsΕλληνικάespañolItalianoSuomalainenLatina

In 2023, in the field of new drug research and development, the ADC (Antibody-Drug Conjugate) track has made continuous breakthroughs in research and development, huge transactions have occurred frequently, and it has continued to create a climax in the industry.As early as 2021, Shanghai Haoyuan Pharmaceutical Co., Ltd. (hereinafter referred to as "Haoyuan Pharmaceutical") assisted in the approval and marketing of the first domestically produced ADC drug, vedicizumab. Behind this new class of anti-cancer drug, from research and development, application and production, Haoyuan Pharmaceutical assisted customers throughout the process to complete Payload-Linker's CMC services and clinical registration applications. Last year, Haoyuan Pharmaceutical undertook more than 110 ADC projects and initially completed the ADC coupling and detection platform. As of the end of 2023, Haoyuan Pharmaceutical has 12 small molecule products related to ADC drugs registered with the US FDA for DMF.

At present, Haoyuan Pharmaceutical has successfully put into operation 4 ADC production lines, which can enable customers to quickly synthesize new molecules. In addition, in the face of the rapidly growing market demand for ADC, Haoyuan Pharmaceutical has invested in the construction of the Chongqing Antibody-Drug Conjugate CDMO Base, dedicated to building a commercial ADC antibody-conjugation-filling integrated platform, providing global customers with one-stop CDMO services from antibodies, linkers and toxins, biological conjugation of payloads and antibodies to formulation filling and research and development and production.

It is reported that the 2023 Shanghai International Computational Biology Innovation Competition, hosted by the Shanghai Biomedicine Science and Technology Development Center, has currently selected 73 teams to advance to the preliminary evaluation of the wet experiment of the competition. Haoyuan Pharmaceutical's subsidiary Haoyuan Bio (MCE), as the co-organizer of this competition, provided support for compound samples in the wet experiment verification stage.

On the front end of drug discovery, Haoyuan Pharmaceutical has completed independent research and development and synthesis of more than 28,000 products, and has accumulated a reserve of more than 116,000 molecular building blocks, tool compounds and biochemical reagents. Its products are rich in variety, novel in structure and diverse in functions, providing strong support for customers' scientific research.

01

More than just a “water seller”

“We are more like gold miners”

Haoyuan Pharmaceutical's competitiveness in the ADC field stems from its highly difficult chemical drug synthesis technology platform. This is not only a challenge at the technical level, but also the result of a deep understanding of market demand and continuous optimization.

Generally speaking, because most of them are in the role of "OEM", CDMO is often regarded as similar to the "water seller" during the "gold rush" period.

"In the CDMO field, we are like 'gold miners' who adhere to long-termism, tapping into the potential of innovative drugs and continuously building differentiated and global competitive advantages," said Zheng Baofu.”

02

Outlook:

Breaking the “Matthew Effect”

In an environment where biopharmaceutical investment and financing are sluggish and the growth rate of the innovative drug industry is slowing down, competition among domestic innovative drug companies has intensified, market share is concentrated in the top companies, the industry is severely divided, and the "Matthew effect" of the strong getting stronger is becoming more and more obvious.

Want to break the "Matthew effect",

Through the life cycle,

It is inseparable from the persistence of innovation and long-termism.

Starting from scientific research, Zheng Baofu, who holds a doctorate in chemistry, led Haoyuan Pharmaceutical to start from renting equipment and sites, adopting a customer-customized service route and guiding the growth of the company with demand. After nearly 20 years of development, Haoyuan Pharmaceutical has continued to expand its layout with a forward-looking vision.

Zheng Baofu clearly realized:"Through the accumulation of technology and investment of capital, we hope to form a new biopharmaceutical infrastructure belonging to Haoyuan, actively use innovation to empower customers, build our intellectual property system, and support innovative pharmaceutical companies to develop better and move faster."”

Zheng Baofu specifically introduced a patented technology in ADC drug development. "In trastuzumab (DS-8201), ixetine is a key material. The original synthesis route has low efficiency and low yield.Through innovation, our team has reduced the number of synthesis steps, increased the yield, and generated new intellectual property.This innovation has shortened the production cycle of Exotecan by one third and reduced the manufacturing cost by half. This is not only a cost saving, but also a manifestation of green manufacturing.”

Unlike most CRO and CDMO companies, Haoyuan Pharmaceutical's services are not only in the industrial sector, but also widely cover the scientific research community.

Zheng Baofu emphasized:"An important difference of Haoyuan is that our entire life science reagent segment serves the early stages of drug discovery. Our service coverage is wider and the breadth of our services is stronger."

2022 is a key turning point. Previously, Haoyuan Pharmaceutical's CRO and CDMO businesses were mainly concentrated in the fields of intermediates and APIs. After the strategic acquisition of all the equity of Yaoyuan Pharmaceutical, Haoyuan Pharmaceutical's R&D capabilities and technical level in the fields of preparation CDMO and CMC business have been significantly enhanced, further improving its business layout.

At present, Haoyuan Pharmaceutical has established R&D centers in many places across the country and formed multiple core technology platforms, covering fields such as high-activity raw materials, vitamin D derivative drugs, ADC linkers and toxins, and has green cutting-edge technologies such as high-throughput screening technology, fluid chemistry technology, and photochemical reaction technology.

At the same time, relying on Haoyuan Pharmaceutical's products and cutting-edge technologies, its cooperative customers have published more than 37,000 biomedical and new drug development scientific research papers in many internationally renowned journals.

03

Going to sea:

"Our molecular building blocks and CDMO business currently accounts for 80% in China, and the competition is quite fierce," said Zheng Baofu. In order to maintain sustainable development capabilities in the fierce market competition and break through regional restrictions, Haoyuan Pharmaceutical has accelerated its global layout. In fact, the process of globalization is not achieved overnight.

"As early as 2017, we established a subsidiary in the United States, and also established subsidiaries in Germany, Japan and Hong Kong," Zheng Baofu added. In recent years, by increasing capital investment and optimizing production and manufacturing facilities, Haoyuan Pharmaceutical has reached the level of direct dialogue with major international pharmaceutical companies and high-quality customers, and has gained their recognition. However, in the international market, Haoyuan Pharmaceutical is still a "newcomer" in the CDMO field. Zheng Baofu admitted, "Everyone's understanding of Haoyuan is more about MCE tool compounds and front-end scientific research reagents. For customers, our production and manufacturing modules are still relatively new."

In order to gain a foothold in the international market, Haoyuan Pharmaceutical's strategy is to use vertical fields as a breakthrough point, continuously strengthen the development and research of key technologies, gradually expand into sub-sectors such as XDC, PROTAC, small nucleic acid drugs, diagnostic reagent raw materials, and cell therapy, while using AI technology to enhance product competitiveness.

Zheng Baofu revealed that Haoyuan Pharmaceutical has undertaken a total of 676 innovative drug projects, covering the Chinese, Japanese, Korean, American and European markets, and some products have entered Phase II and III clinical trials or the new drug application stage.

// Bio-talk Season 2 2024 //

Bio-talk is an interview column created by Shanghai Biomedicine Science and Technology Development Center and Shanghai Science and Technology. It aims to deeply explore the cutting-edge research and ideological sparks of scientists, entrepreneurs, and industry leaders in the field of biomedicine, inject "technological vitality" into biomedicine innovation, and promote the innovative development of Shanghai's biomedicine industry.

Author: Lan Yue

Photographed by: Zhao Zhongyi

Produced by: Gina.Z