Introduction:

Recently, Mr. Chen Zhidong, Chairman of Guangzhou CATO Research Chemicals Inc., was specially invited to accept an interview for the "Innovation 100" project of Instrument.com.cn.

The following is the interview content excerpted from Instrument.com.cn: https://www.instrument.com.cn/news/20211019/594678.shtml

Holding the "Ruler" to Bring Chinese Standards to the World

Instrument.com.cn CEO Ms. Tang Haixia (second from right) visits the company accompanied by CATO Chairman Chen Zhidong (second from left) and General Manager Feng Weizhao (first from right)

Hope China's "ruler" will no longer be choked off by foreign countries — bring Chinese standards to the world

The global reference standard market can be divided into segments such as food and beverage, environmental protection, pharmaceutical/life sciences, forensics, veterinary, and petrochemicals. Among them, the pharmaceutical/life sciences reference standard market is divided into reference standards for cosmetics, herbal/plant drugs, secondary pharmaceuticals, drug impurities, pharmacopoeia standards, and fluorescent particles.

Survey results show that as of 2015, North America held the largest share of the global analytical reference standard market, followed by Europe. Companies such as Merck KGaA, LGC Limited, Agilent Technologies Inc., Waters Corporation, and Restek Corporation are major players in the global analytical reference standard market.

However, research institutions predict that from 2020 to 2025, Asia-Pacific will become the region with the highest compound annual growth rate in this market. Increased research funding in life sciences, increased outsourcing of clinical trials from developed countries to Asia-Pacific countries, increased chromatography-based research activities, increased application of chromatography in the food and environmental protection industries, and the continual outbreak of food safety issues are among the many factors continuously stimulating the growth of the analytical reference standard market in the Asia-Pacific region.

"Reference standards are the 'ruler' that measures a country's quality. We hope our country's 'ruler' will no longer be choked off by foreign countries, and bring Chinese standards to the world." It was with this original aspiration and patriotic sentiment that Chen Zhidong founded CATO (CATO Research Chemicals Inc.) in 2016. Over the past five years, CATO has been committed to becoming a reference standard R&D institution that meets global quality regulatory requirements. The company's current products cover more than 90% of the reference standard categories required for testing by domestic regulations, and more than 95% of the supporting drug impurities for existing drugs.

Moreover, CATO is further committed to providing customers with custom synthesis services for scarce and brand-new small-molecule compounds. To date, the company has become a national high-tech enterprise, an expert committee member of the National Reference Material Committee, and an enterprise with dual CNAS/ANAB ISO 17034 reference material producer competence accreditation.

Relying on accumulated drug impurity synthesis technology, we will devote greater efforts to tackling "hard nuts"

At present, CATO has provided more than 10,000 testing institutions and manufacturing enterprises worldwide with 32,000 reference standards needed for analytical testing in fields including pharmaceuticals, food, pesticide residues, veterinary drug residues, consumer products, environment, and natural extracts. The company's products cover more than 90% of the reference standard categories required for testing by domestic regulations, and can also provide more than 95% of the supporting pharmaceutical impurities for existing drugs.

"Building on our existing stable product portfolio, we will devote greater efforts to tackling 'hard nuts' — relying on the technical accumulation from custom synthesis of challenging drug impurities and our experience in designing synthesis routes for over 100,000 actual compound orders, we will establish expert-level custom synthesis capabilities for small-molecule compounds, focusing on products that are highly synthesis-dependent, scarce in the industry, and complex in preparation conditions," said Chen Zhidong.

CATO currently has 150 employees, 72% of whom are technical staff, led by a postdoctoral fellow from Yale University in the United States and a national "Thousand Talents" young talent expert. CATO's R&D team is full of talent, with a synthesis and analysis team formed by four PhDs, all of whom have senior industry experience. For example, Dr. Liang previously served as the head of a drug R&D project at LONZA, participating in the process development, optimization, and commercial production of blockbuster new drugs worldwide. Moreover, the company's average annual R&D investment has exceeded 20% over the past three years, and it has successively carried out technical cooperation with national institutions including the Shanghai Institute of Organic Chemistry, Sun Yat-sen University, Southern University of Science and Technology, Jinan University, and Guangdong Pharmaceutical University.

A corner of the CATO laboratory

Dual-system accreditation puts "double insurance" on products — focusing on product and service innovation

Speaking of enterprise innovation, Chen Zhidong continued to introduce to the Instrument.com.cn team that CATO focuses on innovation in products and services.

First is product innovation:

1. Custom synthesis of brand-new reference standards: The company collaborates with pharmaceutical enterprises on drug R&D projects to synthesize specific drug impurities; based on the latest regulatory adjustments to product testing, we develop corresponding new reference standards. These innovative products include berberine series impurities, prostaglandin series impurities, peptide series impurities, genotoxic impurities, phosphorus-based flame retardants, new plasticizers, new varieties added under REACH regulations, and veterinary drug isotope products.

2. Optimization of existing products: The company's launched 1-10 polybrominated biphenyl mixed standards, complete RoHS 2.0 mixed standards, 40 glucocorticoid mixed standards, 18 sulfonamide drug mixed standards, etc., effectively optimizing the laboratory analytical testing process.

Second is service innovation:

In 2021, the company will launch a more complete production management system that combines IoT and 5G technologies to make errors impossible to occur rather than merely reducing them. At the same time, the company's internal investment in a BI (Business Intelligence) system improves management capabilities at three levels: data analysis, anomaly alerts, and automated decision-making. The investment in multiple management systems will provide customers with more services, such as real-time order tracking, reminders for storage conditions and expiration dates, precise weighing labels, and online certificate downloads. The company's dual CNAS/ANAB ISO 17034 accreditation means that the enterprise must strictly comply with the system's quality control requirements, putting "double insurance" on product quality. For users, this effectively reduces the difficulty of screening product purchases and avoids potential product quality risks.

At the end of the interview, Chen Zhidong also shared his views on the development of the domestic reference material industry during the "14th Five-Year Plan" period. He believes that the national "14th Five-Year Plan" explicitly adheres to the path of high-quality development and proposes to "improve the national quality infrastructure, strengthen the construction of systems and capabilities in standards, metrology, and patents, and deeply carry out quality improvement actions." It can be foreseen that, with the country's growing emphasis on high-quality development, quality monitoring of various products will be strengthened, thereby generating new demand for reference materials and expanding existing demand. At the same time, the country will put forward higher standardization requirements for reference standard manufacturers that provide quality benchmarks. In September 2020, the founding of the National Reference Material Expert Advisory Committee and the 2020 working meeting, initiated by the China Association for Standardization, was precisely aimed at further advancing the reform of national reference materials and promoting the scientific development of the national reference material cause.

In addition, CATO moved into the BestHigh Smart Park in Huangpu District, Guangzhou in 2021, laying a solid hardware foundation for its further transformation. The company's new R&D center currently covers more than 5,000 square meters and is equipped with 150 sets of high-end instruments including NMR and triple quadrupole mass spectrometers. In the future, the company will take its advantageous "custom synthesis of small-molecule compounds" technology as its core, deepen its three major business segments of pharmaceutical intermediates, drug impurities, and consumer product reference standard custom synthesis, while also providing compound preparation, separation, and structural confirmation services, striving to become a benchmark enterprise in the field of custom synthesis of small-molecule compounds.