Looking at Ma Jing's CV, the dominant theme is clearly "safety evaluation" and "toxicology." Yet, before she specialized in tox, she spent eleven years teaching pharmacology at a medical college. "Once I moved into toxicology, I never looked back," she reflects on her career pivot. She readily admits that the field was a perfect fit—a discipline worthy of her lifelong dedication.
The Pivot to Tox: Embarking on the GLP Path
Though toxicology is now her lifelong passion, her shift into the field was somewhat unexpected, yet it proved to be the right move at the right time. In 1995, after a decade teaching pharmacology at Jining Medical College, Ma Jing planned to relocate to Shanghai to join her husband, who was beginning a postdoctoral fellowship at Shanghai Second Medical University. She decided the best path was to pursue graduate studies there herself. In 1996, she interviewed and was accepted by both Shanghai University of Traditional Chinese Medicine and the Shanghai Institute of Pharmaceutical Industry (SIPI). Their offers differed: the university valued her teaching experience, offering a combined research and teaching role; SIPI, however, was in the process of establishing the National Shanghai Center for New Drug Safety Evaluation (the "Center") and her prospective supervisor, Professor Qian Beili, was a key architect of China's GLP (Good Laboratory Practice) system. Weighing her options, she chose SIPI. Her career in toxicology had begun.
After graduating in 1999, she stayed on at the Center as a study director. In 2000, she began a part-time Ph.D. under Academician Hou Huimin in SIPI's Pharmaceutics department, tackling a research project that bridged both pharmaceutics and toxicology. This was a period of intense development for the Center.
In late 2002, Ma Jing became Assistant Director, gradually taking on its daily management. In May 2003, the Center officially passed its GLP certification, becoming one of China's first GLP-compliant institutions. She was promoted to Executive Deputy Director in 2006 and later to Director. Her appointment as the GLP Responsible Person coincided with the lead-up to the Center's first GLP re-inspection. Successfully navigating this re-inspection was her first major task as Director. The Center's GLP management system earned high marks from the auditors, and the re-inspection was passed smoothly. Subsequently, Ma Jing was invited by drug regulators to help revise the national GLP inspection standards. At the time, China's GLP operations were still aligning with international norms, and the country was building its own GLP system through practical experience. During the revision process, Ma Jing drafted sections on Instrument Qualification (3Q) and requirements for test article analysis. These were areas where China's GLP regulations initially lacked explicit requirements for instrument validation or for analyzing the concentration, homogeneity, and stability of formulations used in animal studies. Drawing on GLP management concepts learned from international client projects and the Center's own practices, Ma Jing helped bring these critical aspects of GLP management up to international standards. She also promoted these standards at various NMPA-organized GLP training workshops. "Back then, no one had much experience; we were all navigating uncharted waters," she recalls.
Quality: The Bedrock of the GLP Pyramid
Reflecting on the Center's development, Ma Jing observes, "We were pushed forward by our most demanding clients." For instance, Ascentage Pharma, preparing an IND submission to the US FDA, brought in international GLP experts to audit the Center's system. Multinational pharma companies like Pfizer and Sanofi, seeking to develop drugs for the Chinese population, also selected local partners like the Center. Through these collaborations, the Center continuously honed its quality system and technical capabilities. "GLP quality is the foundation of the pyramid, the absolute bedrock of safety evaluation research. Without that foundation, even the most scientifically sound study design yields nothing but worthless paper," Ma Jing emphasizes. She notes that quality is built on scientific understanding. Seemingly simple aspects—like determining the shelf life of reagents, managing flammable materials, defining storage locations for solids and liquids, or placing temperature probes in refrigerators—all must be codified in SOPs, backed by chemical and scientific rationale. The Center's SOPs were developed from this scientific logic and refined through practice. "SOPs tell you how to do something, but you must understand why," she reflects. "Writing SOPs is the process of building a quality system; every revision represents an improvement."
When Ma Jing assumed the roles of Chairman and CEO of Shanghai Taichu Biotechnology Co., Ltd. (the "Taichu Group") in mid-2022, she moved rapidly: facility construction, quality system establishment, simulation studies, GLP certification application, and finally, the inspection itself. Inspectors even remarked it was the fastest any Chinese lab had gone from build-out to inspection in the history of GLP. While updated regulations played a part, this was primarily the result of accumulated experience and the concerted effort of Ma Jing and her team. "I started planning the quality system during construction," she explains. Some suggested simply copying the Center's SOPs, but she firmly rejected the idea. "Not only did I not take a single SOP when I retired, but it would have been plagiarism. More importantly, the facilities and layouts are different; copying would be pointless."
Retirement and a New Venture: Building a Tech-Enabled CRDMO
In 2010, as part of Shanghai's plan to transition the Center away from its public institution status, Shanghai Yinuosi Biotech Co., Ltd. ("Yinuosi") was established with SASAC approval. Ma Jing was appointed Chairman, leading the team to expand its services from toxicology into preclinical and clinical pharmacokinetics, and translational medicine research. After steering Yinuosi through its shareholding reform and the construction of its Haimen subsidiary, Ma Jing retired in 2018. She then served as Chief Biopharmaceutical Consultant for Shanghai Lingang Group and the Nanjing municipal government, helping draft their biopharmaceutical industry "14th Five-Year Plans." When she later became Chairman of Taichu Group, her vision was to create a full-service enterprise integrating CRO and CDMO capabilities, tailored for the rapidly evolving biopharmaceutical industry and powered by proprietary technology.
Safety evaluation providers are often perceived as service shops with limited scientific depth. Ma Jing firmly counters this, stating they can be highly scientific. New drug safety evaluation, or drug toxicology, is a branch of toxicology—an interdisciplinary field. Drug toxicologists need a strong grounding in basic medicine, clinical medicine, veterinary medicine, and pharmaceutical sciences. They must also keep pace with the latest drug R&D advances, constantly updating their knowledge to design robust studies, draw accurate conclusions, and enable clinical trials. Now, after just over a year and a half of operation, the Taichu Group has filed over 10 patents, with 6 already granted. The group adheres to the principle of "doing what others do, but better, and doing what others don't do," aiming to establish distinctive platform technologies. Specialized teams are collaborating to build these proprietary technologies.
Building a Full-Stack Service Platform
Taichu Bio and its subsidiaries have strategically built an innovation-driven, integrated service platform for innovative drug non-clinical R&D. "Achieving druggability requires a multi-disciplinary, integrated effort," Ma Jing explains, outlining the rationale for the full-stack approach. Taichu Bio itself is the innovative drug non-clinical research and service platform and has established a Shenzhen branch—Taichu (Shenzhen) Biotech. "Taichu Bio is the parent company, housing my core expertise. But crucially, toxicology spans the entire drug R&D lifecycle. It begins at lead discovery. The tox report is the most critical document for the IND, marking the exit from preclinical development. Tox follow-up continues through clinical trials, and even post-marketing adverse event monitoring may require further toxicology research," Ma Jing emphasizes.
After establishing this "starting point," Taichu Bio expanded into drug discovery and pilot-scale process development. It acquired AceMab , relocating it from Hunan to Shanghai to share the parent company's building, creating a full-human antibody discovery and engineering CRO platform. Next, Taichu established Tarlead Biologics as an antibody drug process development and manufacturing CDMO platform. With her background in pharmaceutics, Ma Jing also turned her attention to advanced drug delivery when building the platform. "Advanced drug delivery is a genuine bottleneck in China. Despite the large market, advanced formulations account for only about 6%, and truly complex ones are even rarer," she observes. To address this, she built a team focused on advanced delivery systems, creating Tyzen and its drug product process development and manufacturing platform. With the rise of nucleic acid drug R&D, she also established a oligonucleotide CDMO company—TJR BIO . From the end of 2020, in just over three years, Taichu Bio completed its full-stack platform build-out. This rapid expansion occurred even as the domestic biotech sector entered a challenging "winter," increasing operational pressures for all companies.
Regarding this, Ma Jing states bluntly: "The absolute priority is survival." As a new player unwilling to compete on price alone, the projects Taichu Bio wins are often the more difficult ones. "Several are true world-firsts," she says with a mix of resignation and pride in her team's capability. Clients are more mature now; they assess a project's difficulty to see if a CRO has the right "tools" for the "tough nut." While price is a factor, partners with technical strength are ultimately chosen. "In drug evaluation, tox has common elements, but it's not just about checking guideline boxes. Innovative drugs are increasingly complex; the more novel, the more customized the approach. This is where deep scientific understanding is critical," Ma Jing points out. Above the non-negotiable red line of quality, greater innovation demands more sophisticated scientific design; toxicology must be integrated and serve the clinical purpose. "Clients would rather pay more than risk their project failing," Ma Jing notes. Currently, Taichu Bio's projects are not won on being the lowest bid. "We compete on the complexity and scientific rigor of the experimental design. The cost of a CDE rejection is simply too high," she explains.
Taichu Bio is still building its brand, often relying on "science" to attract clients and secure projects. Client meetings frequently feature Ma Jing leading her scientific team alongside BD. "I introduce my new role, my new position, and my new team, and we dive straight into the science," she says. The BD team identifies the client's challenge, and Ma Jing's team provides the scientific "solution."
Looking back on her career, Ma Jing recalls her early ambition: "In my career, to have contributed to the toxicology packages of 30 Class 1 innovative drugs approved in China, safeguarding their path to patients." She has kept a careful count. "It's 26 so far. This year, it should reach 29," she shares. With her initial goal in sight, she adds, "Perhaps we'll even surpass it."
