DEYANG, China, Aug. 31, 2021 /PRNewswire/ — Sichuan Deebiotech Co., Ltd. (hereinafter referred to as Deebio) recently celebrated its 20th anniversary of continuous exports to the EU during the 86th API China. The company’s European partners sent congratulatory video, while domestic partners attended and delivered congratulatory speeches.
From a small workshop in the 1990s which could only produce one crude API to a world-leading bio-enzyme manufacturer with strong R&D capability today, the world’s largest pancreatin supplier and China’s first EU GMP-certified bio-enzyme API producer, Deebio has sold its products to over 30 countries and regions, and starts a broaden view of global journey.
Burgeoning business presence after 27 years of growth
In 1990, Zhang Ge, currently chairman and president of Deebio, graduated from Sichuan University (formerly Chengdu University of Science and Technology) as a biochemical major and started his career at Deyang Biochemical Pharmaceutical Factory as a technician and laboratory director. In the fourth year, a chance that enterprise restructuring aroused, he took over the company and brought in some partners to rebuild the ageing facilities by hand. In December 1994, Sichuan Deyang Biochemical Products Co., Ltd. was officially established.
Nobody expected that Deebio nearly bankrupt only less than one year after its foundation.
“In the early 1990s, awareness of quality in the domestic bio-enzyme industry was generally not strong, and our understanding of enzymes was still at the stage where enzyme activity is everything.” Zhang Ge recalled. In March 1995, the newly founded Deyang Biochemical Products received its first order: the export of crude kallidinogenase to Japan. However, the exported goods were returned due to the difference of a few milligrams in fat content. “Our company would have gone bankrupt if the client had claimed a compensation at that time as the sum of money was an astronomical figure for us. Fortunately, after some negotiation, the client agreed to let us resupply product rather than asking us for compensation,” explained Zhang Ge.
Risks and opportunities always coexist. The lesson we learned from the above case was that we needed to set the bar very high for the quality. During the subsequent 27 years, Deebio committed itself to rigorous quality standards and, as a result, had been able to steadily grow.
Today, Deebio has both the qualifications and the capabilities to produce over 10 bio-enzyme APIs, of which, its kallidinogenase occupies a majority of the global free market while the market share of pancreatin, pepsin, chymotrypsin and other products has each reached 30% or more. Deebio is also the only Chinese supplier for elastase, clear solution pepsin and high lipase pancreatin APIs in the global market.
Leading the industry on the back of a strong and constantly improved foundation
It has not been an easy ride for the development of Deebio.
In 1997, when Deebio was able to maintain its normal operation, it began to develop close industry-university-research cooperation with universities and research institutes, including Tsinghua University, Chinese Academy of Sciences, Sichuan University, China Pharmaceutical University, etc. As a result, Deebio soon became an industry leader in technical capability.
In January 2003, to further improve quality, Deebio established a joint venture, Deyang Sinozyme Pharmaceutical Co., Ltd. jointly with a German partner that had better technologies and management capabilities. During the 18 years of cooperation, the German partner has regularly visited Deebio to give guidance and supervision, introducing advanced quality system management methods to Deebio, so as to raise Deebio’s quality system management capabilities to the highest international level.
During the business in EU market, Sanofi, Novartis and several other companies regularly conducted audits in Deebio. These rigid audits helped in large measure to further improve Deebio’s processes and technologies. To cite an example, in 2018, Deebio collaborated with technical experts from Berlin-Chemie to jointly solve an important technical issue in production, which, once resolved, vastly improved the quality of product.
Thanks to years of experience and dedication to scientific practices, Deebio has led the industry in terms of product quality and management capabilities, and has developed a unique full-process enzyme activity protection technology. Through non-destructive activation, zymogen can be awakened with precision, and the key control technology of the full-process enzyme activity protection can be used to achieve high activity, high purity and high stability of bio-enzyme products.
Exports to EU and over 30 other countries and regions
As is well known, EU GMP is among the most rigorous drug standards globally. More than 20 years ago, domestic bio-enzyme API manufacturers were beset with challenges when trying to comply with the standard.
“My philosophy has always been, as long as I do what others don’t do, I will do it best and hit the ground running.” In the face of difficulties, Zhang Ge sets goals and then sets out to find a way to meet them.
In 2005, despite several challenges, Deebio became the first Chinese manufacturer to obtain EU GMP certificate for bio-enzyme APIs. The firm subsequently passed the Chinese GMP certification, and, more recently, it has quality system management capabilities of the US FDA, Japan PMDA, and South Korea MFDS.
Benefiting from more than 20 years of commitment to rigorous quality requirements, and sparing no effort in its quest for innovation and in obtaining the necessary investment, Deebio has established long-term partnerships with global pharmaceutical giants including Novartis, Sanofi, Berlin-Chemie and Nichi-Iko Pharmaceutical. The company’s products have been exported to Europe, the US, Japan and South Korea for more than 20 years, with sales channels into more than 30 countries and regions.
Nevertheless, Deebio never stop stepping forward.
The company has completed its MFDS registration in South Korea, and has submitted its registration files for Japan PMDA, while the USA FDA certification is on track to be completed within two years. The new GMP workshop built according to FDA standards is now entering the trial production stage. Deebiotech (Chengdu) Co., Ltd., located in Wenjiang, Chengdu, is scheduled to formally start operation in October.
Looking ahead, Zhang Ge is full of confidence. “Deebio is going to be a very impressive platform with complete GMP qualifications, full-fledged technologies, rigorous management, and consistent product quality. We are also willing to work closely and transparently with like-minded friends to do more together, with the goal of living up to the expectations of the era and embracing a win-win opportunity in the rapidly growing global pharmaceutical market of today.”
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