SDM: Bioanalytical Laboratory, a New Engine for One-Stop CRO Services

China's clinical CRO industry has experienced a wave of rapid growth over the past decade, along with the progress in innovative drug development. Data from Huajing Industry Research Institute shows that China's CRO market has reached 101.4 billion yuan in 2023, with a CAGR of 19.35% from 2019 to 2023.

However, in the past two years, the slowdown in the growth rate of China's innovative drug industry and the tightening of the financing environment reshape the CRO sector on how to provide more cost-effective services, expand the client base and redefine the competitive position and profitability.

Founded in 2005, SDM is a clinical CRO providing one-stop clinical research relying on its highly specialized and international team. SDM provides a full range of services including global clinical development strategy, regulatory interations, clinical research, laboratory testing and non-clinical pharmacodynamics, covering therapeutics, prophylactic vaccines and medical devices.

SDM clinical CRO team has exceeded 1,000 dedicated professionals with resident personnel covering more than 80 domestic cities. SDM also setup overseas offices in the United States, Southeast Asia and other countries and regions to better serve regional clients, and it has established long-term cooperative relationships with more than 600 renowned organizations, and has successfully served more than 300 clients and completed more than 1,000 projects in the last 3 years.

In July 2024, SDM opened a new laboratory in Daxing, Beijing ShouYan Lab Service Co., Ltd.“Beijing Shouyan”), focusing on bioanalytics in the fields of prophylactic vaccines, small molecule therapeutics and innovative traditional Chinese medicines.

A part of Beijing Shouyuan

In November of the same year, through the completion of the acquisition of Amador Bioscience (Hangzhou) Co., Ltd (“Hangzhou Amador”), SDM officially operated its laboratory in Xiaoshan, Hangzhou, and continued its strengths and focus on bioanalytical and biomarker services for XDC, large molecules and CGT modalities.

The laboratory business unit mark the completion of SDM's one-stop clinical development service development strategy, further consolidating its leading position in the CRO industry. Dr. Bao Yuanwu, responsible for the laboratory business unit, has more than 20 years of experience in the bioanalytical field. Dr. Bao has worked for many well-known pharmaceutical companies, such as WuXi AppTec, BioDuro and CStone Pharmaceuticals, and served as CEO of two bioanalytical CROs, Triapex biotechnology and Jollin Lab, successively.

Recently, around the establishment of the decision of “self-built and self-operated labs”, as well as the current capabilities and future plans of SDM Labs, we had a conversation with Dr. Bao.

Dr. Yuanwu Bao

 General Manager, Early-Stage Clinical and Laboratory Business, SDM

 (Shanghai Shouyan, Beijing Shouyan and Hangzhou Amador)

1、Service “integration” strategy: building a laboratory business in line with international standards.

Drug R&D is a systematic project covering translational medicine and quantitative pharmacology, bioanalysis and biomarkers, clinical research and registration, and involves multiple disciplines. Given the high investment in drug R&D, most pharmaceutical companies tend to cooperate with CROs in order to compress the drug development cycle, reduce costs and improve efficiency through outsourcing services.

However, the traditional “subcontracting model”, i.e., large CROs outsourcing certain aspects to small CROs, has been exposed to the high cost of communication, complicated processes, quality control issues, etc. The trend is now a vertical integration through the industry upstream and downstream of the development.

To further empower lab service and competitiveness, SDM is expanding its service areas in various aspects since 2020 to create the“one-stop clinical development services”and focusing on solving technical barriers in early clinical research, especially on translational medicine and quantitative pharmacology, bioanalysis and biomarkers and other modules with higher technological thresholds. We are focusing on solving technical barriers in early-stage clinical research, especially on modules with high technical threshold such as translational medicine and quantitative pharmacology, bioanalytics and biomarkers.

By building a professional and specialized team, SDM has separated the early stage clinical business from the phase II and III clinical business unit, and gradually built up the laboratory business. At present, early clinical and laboratory business are managed by Dr. Bao, with a team of over 200 members.

Dr. Bao introduced that the reason for separating early clinical from “big clinical” is to consider that “as the first gate from nonclinical to clinical drug development, early clinical carries the highest risk and represents demanding technical support for clinical trial design”, and to establish a professional team to provide customers with a “second set of eyes” to scrutinize projects and minimize or mitigate development.

In the bioanalytical and biomarker segment, SDM has opened two laboratories in Beijing Shouyan in July 2024 and Hangzhou Amador in November 2024, respectively.

Dr. Bao emphasized Hangzhou Amador's “core competency” in the relevant fields. In the six years of operation Hangzhou Amador has supported hundreds of projects in the fields of XDC, macromolecules and CGT, including many innovative drug development projects of MNCs and multinational innovative pharmaceutical companies, and its technical strength has been recognized by all parties.

Hangzhou Amador also has expertise in operations between China and the U.S., and has accumulated rich experience in the construction of quality system meeting international standard, cross-cultural communications and collaborations, and the import and export of clinical samples. In particular, Hangzhou Amador is the first company in Zhejiang to receive accredited on the “white-listed” for special item importations.

A part of Hangzhou Amador

The laboratory services fit well to SDM's “integration” strategy, which can consolidate SDM's overall competitiveness in three aspects: quality control, efficiency improvement and cost reduction. Dr. Bao expects that the laboratory in the future may become the backbone to feed the development of the overall business of SDM.

2、Tailor-made bioanalytical solutions for the entire clinical development process

SDM Laboratories currently has six testing/service platforms: enzyme immunoassay, immunogenicity, cellular, molecular, mass spectrometry and cellular immunoassay.

Dr. Bao said that the laboratories have their own characteristics and technical advantages. Beijing Shouyan has built several P2 and P2+ laboratories and complete PCR testing facilities, and is a rare domestic testing organization focusing on vaccine and TCM bioanalysis; while Hangzhou Amador focuses on XDC, macromolecules, and CGT, etc., and its one-stop bioanalysis service for XDC is the leader in the business.

Specifically, Hangzhou Amador team has successfully developed a non-clinical general-purpose method based on LC-MS/MS platform, which is suitable for the quantitative detection of ADC drugs containing cleavable linkers and humanized/fully human antibodies.

The method is validated in various nonclinical and clinical programs, and the bioanalytical results (total antibody, coupled drug and free drug) generated from the method can not only be used to evaluate the pharmacokinetic characteristics, but also observe the dynamic changes of DAR (Drug-to-antibody Ratio) value of ADCs in vivo, so as to assess the impact on the efficacy and safety evaluation.

“Compared with the mainstream LBA methods in the market, the method developed by Hangzhou Amador holds advantages in specificity and selectivity, sensitivity and linear range, specific antibody dependence, speed of analysis and development, and richness of information.”Dr. Bao further cited as an example, “Changes in DAR values are crucial for understanding the safety and efficacy of ADC molecules, and it is difficult for LBA to detect changes in the DAR values of ADC drugs, but LC-MS/MS can; in terms of efficiency, with the LBA method, three substances have to be measured three times with three methods, whereas with LC-MS/MS, the sample needs to be analyzed just analyze the sample once.”

With these technical advantages, Hangzhou Amador has already accumulated a considerable number of high-quality clients, including “top ADC companies, both domestic and foreign, major players in bispecific antibody and also, cell and gene therapy companies,”many of which are returned customers.

Dr. Bao said that in vaccine lab service, the team is equipped with top-notch experts in the industry, specializing in pathogenic microbial testing and immunogenicity assessment. At the same time, based on a professional team with diverse backgrounds and rich hands-on R&D experience, Beijing Shouyan can provide “value-added” services in testing and R&D strategies, analyzing testing solutions from the perspective of the entire clinical development process to help clients improve efficiency and reduce costs.

“We routinely advise our clients technically and strategically what must be tested and what doesn't have to, what needs to be explored and what needs to be fully validated and so on, to give our clients a customer-tailored, targeted and cost-effective solution,” said Dr. Bao. The company's products and services are also available in a wide range of sectors, including traditional Chinese medicine (TCM), for example, due to the formular of TCM with a variety of ingredients and high sensitivity requirements of the characteristics of the practice. The most difficulty in the detection of TCM ingredients often lies in how to find the best balance between cost control and detection accuracy. 

Based on its experience and technology in the development of testing methods and knowledge of TCM ingredients, Beijing Shouyan's TCM team is able to provide corresponding support. For example, in a recent TCM project, SDM's Beijing Shouyan team, with solid knowledge and experience in TCM and with pretest results, accurately predicated and identified the potentially potent ingredients and metabolites with a certain amount of exposure in the human, to help the clinical trials to narrow down the focus to the target ingredients from forty to seven, realizing the balance between the science, the efficiency, and the cost of the product development.

3、Expanding business and markets by focusing on service and technology

CRO industry is reshaping. Built on the quality of the reputation is the“lifeline”, in the “price” and “service, technology” between the package of Dr. Bao choices Will focus on the latter. “CROs used to do 'water seller' or doer type of things. Now water is gone. Nowadays CRO can no longer only do the simple handling but have to consider the forward-looking technologies” he further explained.

Specifically for SDM Labs, thanks to SDM's “one-stop” attribute and the accumulation of the past 20 years, the laboratory already has the opportunity to quickly access to new targets, technologies and projects. On the other hand, the laboratory has set up a “New Technology Development Group”, which is responsible for the development of cutting-edge modalities and technologies. A “New Technology Development Group” has been set up within the laboratory to conduct real-time testing and tracking research on cutting-edge modalities and technologies.

In the future, SDM Labs plans to continue to plow ahead and develop in both business and market dimensions.

SDM has a relatively comprehensive platform of laboratories and defined business system. The future work will focus on releasing production capacity. Dr. Bao also plans to further expand biomarker testing business to include cytokines, genes and other areas such as“immunohistochemistry commonly used in the development of oncology drugs, etc.”.

From the market point of view, most of the customers of SDM Laboratories at this stage are still concentrated in the domestic market. Development of overseas market will become a priority. In this regard, Hangzhou Amador in the previous six years in the development of the establishment of the international standard SOP, the accumulation of cross-border project experience can help. Dr. Bao is confident that it is the “technical strength and delivery capability” that will determine how far the bioanalytical lab can go.