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Qiagen (Suzhou): A precision medicine total solution provider

time:05/25/2018 page views: resource:BioBAY

Chen Xiaojuan

“I now have a real sense of satisfaction. We can directly benefit patients using our technologies and products; helping them in diagnostics and guiding their medication.”

Before founding Qiagen (Suzhou) Translational Medicine Co. Ltd. (Qiagen (Suzhou)), Nick Zhang was responsible for chemistry and manufacturing controls (CMC) for 16 years at Pfizer, OSI and Novartis, among others. He then transformed from Party A to Party B and worked as a Senior Vice President of the group and general manager of Frontage Laboratories (China), which is an outsourcing drug discovery service corporation, and successfully introduced Tigermed to acquire Frontage Lab before he left. 

At the end of 2013, Nick Zhang reached a turning point on his career. He received an offer from USP China in the general manager position , and the other was an offer from Victor Shi, Asia Pacific President of QIAGEN, to join Qiagen (Suzhou).

The former position was to manage and operate Greater China Business Unit, which required strong technological and professional expertise, calling for his expertise in the CMC field.

“This is an accustomed position, like turning back to the previous line of business at the transnational corporations.” In contrast, joining Qiagen (Suzhou) as CEO meant venturing into a brand new companion diagnostics sector of the precision medicine, a sector that was unfamiliar to Zhang. In his opinion, though there are many unknowns, companion diagnostics is an emerging sunrise industry in the wave of precision medicine and can directly benefit patients, and solve the medical pain points. He preferred it. 

“Only when doing something one loves can one be passionate and motivated,” Zhang remarked.

Qiagen (Suzhou) CEO Nick Zhang 

Five years after joining Qiagen (Suzhou), Zhang’s passion for entrepreneurship has remained unabated in words and deeds. He has learned quickly and modestly called himself a half expert in companion diagnostics. Under his leadership, Qiagen (Suzhou) has gradually transformed from “1.0 Era” to “2.0 Era”, from a R&D-oriented era to a market-oriented demand and diversified commercialization era. Externally, Qiagen (Suzhou) has partnered with the Chinese Society of Biotechnology and many other renowned enterprises to establish China Precision Medicine and Companion Diagnostics Committee and agreed to help establish the industrial criteria and CFDA companion diagnostics guideline. 

Zhang has restated that Qiagen (Suzhou) is not a simple diagnostics company. It is an innovation-oriented business focused on drug discovery and release and providing total solutions for precision medicine. In the process of drug discovery, it will develop companion diagnostic products in cooperation with pharmaceutical companies, and make pre-clinical validation of targets and biomarkers, identify patients in the clinical trials, accelerate drug discovery process and significantly increase the success rate of clinical trials. Following the launch of the drug into the market, the companion diagnostic products will also be released to provide patients in hospitals and clinics medication guidance and tests to realize the efficacy of precision medicine. 

Qiagen (Suzhou), established in 2013, is a joint venture between Germany-based Qiagen and Suzhou BioBay. It is a “R&D” center established by Qiagen to fully explore the Asian market. With Qiagen’s mature technical platforms and BioBay’s complete new drug discovery industrial chain, Qiagen (Suzhou) aims at speeding up the development of local translational medicine and companion diagnostic products applicable for the Asia-Pacific population. 

During its establishment, Qiagen (Suzhou) was not a fully commercialized company, but a state-holding one. In order to fully marketize the company, Qiagen (Suzhou) conducted a non-incremental share adjustment and introduced two strategic partners to take up majority of the state-owned assets in 2016. The following year, it completed a RMB175 million Series A round financing led by Qiming Venture Partners and Quanchuang Capital. “Currently the company has a fresh, motivated and commercial equity structure,” Zhang said. 

Drug pathway:

Preclinical studies of new drug, New drug discovery Clinical Trial Phase I, II and III, IND and new drug approval 

Diagnostic pathway:

Validation and verification of biomarkers, Validation of diagnostic methods, Availability of companion diagnostics in market.

Preclinical study Clinical trials Patient testing and treatment

Discovery of biomarker Development of translational medicine Realization of precision medicine  

Business model of QIAGEN (Suzhou)

In the next stage, Zhang prioritized the promotion of the company’s companion diagnostics product (CDx) into the market. After witnessing implementation of the two-vote system of drugs in China, Zhang predicts that a similar system for medical devices will be launched soon. He plans to take advantage of the occasion by acquiring a domestic channel and preparing for the product release of Qiagen (Suzhou).  

The second step is to enter the United States market. Most pharmaceutical corporations that partner with Qiagen (Suzhou) are engaged in global new drug discovery and need to make international multi-center clinical studies. This requires partnering companies to simultaneously support domestic and overseas companion diagnostics businesses. Zhang is targeting the international market and seeks to acquire qualified labs abroad. Meanwhile, he plans to accelerate the introduction of new technologies and new platforms to better serve the drug discovery and application of precision medicine. 

In Qiagen (Suzhou), Zhang prefers to position himself as Party C. “Pharmaceutical companies are not normally involved with what we are doing.” Zhang opines that  the technology, platform, market, management team and development ideas of companion diagnostics differ from pharmaceutical companies. Cooperation between pharmaceuticals and Qiagen (Suzhou) is mostly Party A-Party C partnership, different from the Party A-Party B concepts existing between pharmaceutical companies and CROs. 

Since the first breast cancer targeted drug Herceptin and its companion diagnostics test - HER 2/NEU test, were simultaneously approved by FDA in 1998, more and more companion diagnostic products have been developed with targeted drugs. In 2014, FDA issued a guidance for companion diagnostic devices and requested the products must be developed together with curative drugs. Despite China having no companion diagnostics regulations promulgated yet, the move by diagnostics companies to partner with pharmaceutical companies to develop drugs and companion diagnostic reagents has gradually become one of the mainstream business modes. Qiagen (Suzhou) is one among them.

For example, carcinogenic effect of c-MET gene regulation failure as the biomarker to develop targets. The c-MET encoded HGF receptor is a member of RTKs family that activates the downstream signaling channel through receptor-mediated phosphorylation. The c-MET mutation causes cancer. Therefore, Qiagen (Suzhou) has developed a companion diagnostic product to identify the new biomarker c-MET exon 14 skipping mutations.  

The first step of Qiagen (Suzhou) is to validate c-MET exon 14 skipping as a new biomarker. The second step is to develop reagents used for testing RNA sample c-MET exon 14 skipping on the basis of the PCR platform. The third step is to partner with a pharmaceutical company to identify patients for the clinical trials. As a total solution provider, Qiagen (Suzhou) provides all-round services from IHC testing c-MET protein expression, FISH testing c-MET gene amplification, PCR testing c-MET exon 14 skipping, NGS screening for new biomarkers and targets of c-MET gene. Qiagen (Suzhou) is a year ahead of Qiagen Headquarters’ in the United States in the development of this aspect.

Currently, Qiagen (Suzhou) has established partnership with more than 50 domestic and overseas companies and medical institutions and involved in the development of targeted therapies, immunotherapies, cardiovascular disease and infectious diseases, among others.    

In the process of developing companion diagnostic products of biomarkers in partnership with others, Qiagen (Suzhou) has established a complete translational medicine platform, including the high quality tissue and blood sample preparation platform, nucleic acid and protein-based multiomics R&D platforms, PCR/digital PCR-based generation 1/1.5 and generation/2 generation sequencing technologies and bioinformatics, ELISA, MSD electrochemiluminescence and a comprehensive service platform for pathological detection technologies. In this way, the company's team can address sensitivity and specificity challenges by using different technologies and platforms based on different biomarkers. Meanwhile, Qiagen (Suzhou) has also entered the B2B2C or B2C field to provide services for mass health and early screening. 

Presently, Roche Diagnostics, QIAGEN, Thermo Fisher and other foreign companies, AmoyDx, Qiagen (Suzhou), 3G Biotech, TopGen in China are involved in the development of companion diagnostics. However, these companies focus mainly on in-vitro diagnostics, leaving Qiagen (Suzhou) with few rivals. Currently only AmoyDx’s companion diagnostic product ctDNA-EGFR detection kit is reviewed and approved as a companion diagnostic reagent in China. 

The development of companion diagnostic products faces the following difficulties, notes Zhang: first, how to validate target's relevance, medicine action and biomarker through a large number of cells, animal and patient samples; second, which technologies are used to develop companion diagnostic products with excellent sensitivity and specificity to effectively identify biomarkers; third, establish partnership with pharmaceuticals companies to support drug clinical trials and verify the medication guidance of companion diagnostic products.

“In addition to overcoming these three difficulties, especially supporting the drug clinical development, one must have GMP certified workshops for developing companion diagnostic products and produce high quality and batch stable products,” Zhang points out. He believes that China has many diagnostics companies, but only a few could make it. And companies that can provide comprehensive biomarkers and full-platform services from DNA and RNA to protein are rarer. “Qiagen (Suzhou) is such a unique total solution provider,” adds Zhang.  

The technical support from Qiagen at the very beginning of the joint venture boosted ability of Qiagen (Suzhou) to establish a complete translational medicine platform and a management team with drug discovery and diagnostics technological background. This unique pathway is difficult to replicate. From the perspective of services, Zhang compares the company to “WuXi AppTec, that is dedicated to biomarkers and companion diagnostics”. What is different is that Qiagen (Suzhou) has its proprietary diagnostic products. 

Actually Qiagen (Suzhou) boasts of a diversified customer base. In the translational medicine research, its customers are drawn from hospitals and research institutions; in terms of the biomarker development and clinical patient grouping, its clients are drawn mainly from pharmaceutical companies for the preclinical study and target validation; as for the molecule diagnostics and health screening services, it has mainly high-end customers from insurers, banks, and centers for clinical laboratories. 

In addition to such services, Qiagen (Suzhou) is doubling down on its own companion diagnostic products development and commercialization. “We will prioritize the commercialization of these products with independent intellectual property rights to eventually benefit more patients and further contribute to precision medicine,” Zhang noted. 

Source: DrugRNDer