Charting the frontier of cell therapy | the innovative practice and vision of leading oncologist professor Shen Lin

Author: Zhu Ping

Professor Shen Lin of Peking University Cancer Hospital stands at the vanguard of China's pharmaceutical sector, combining scientific expertise with clinical insight to redefine the industry. Having witnessed China's transition from an innovation follower to a global peer, she uses her strategic vision to facilitate the global launch of original, Chinese-developed therapies for gastrointestinal tumors.

Professor Shen Lin

Her influence extends far beyond individual patient care; she is actively constructing the national innovation ecosystem. Professor Shen emphasizes the need for "full-process empowerment"—a comprehensive support system spanning from the laboratory to the bedside. Her philosophy centers on closing the loop between scientific, clinical, and market value, requiring rigorous alignment between policy, industry, and clinical sectors.

From developing the world's first solid tumor CAR-T therapy to designing treatment regimens that have transformed international practice, Professor Shen has demonstrated that Chinese researchers have evolved from "executors" into "rule-definers." Driven by the core tenet that "innovation must be grounded," she is steering China's medical innovation from quantitative growth to qualitative leadership, ensuring laboratory breakthroughs translate into tangible patient benefits.

China's pharmaceutical sector is currently experiencing a dynamic surge, particularly in frontier fields like cell and immune therapy, where homegrown innovations are taking center stage. Professor Shen Lin characterizes this as a pivotal transition period—shifting from "following" to "running in parallel," and in select areas, striving to "lead the field."

"Our nation's support for early-stage innovation is unprecedented, providing fertile soil for original ideas," she notes. "However, a great innovation cannot remain confined to academic papers and laboratories. Its ultimate value is defined by its translation—whether it reaches patients and delivers a cure."

Professor Shen believes that choosing the right direction for innovation requires "audacious" decision-making. As the principal investigator for the world's first clinical trial of CAR-T therapy targeting Claudin 18.2 in solid tumors, she intimately understands the triumphs and hardships of translational medicine.

Reflecting on the project's genesis, she jokes that it began when she was "just wandering around" the 2017 International Gastric Cancer Congress. She bumped into Dr. Li Zonghai, and they hit it off immediately. "I suppose I was quite bold," she reflects.

In reality, this was not a moment of impulsive daring, but a strategic move underpinned by her mastery of digestive oncology and a rigorous evaluation of the target's characteristics. She points out that Claudin 18.2 is highly tissue-specific; in normal tissue, it is expressed only in the gastric mucosa, sparing other organs. Crucially, Professor Shen offered a unique clinical insight: the gastric mucosa possesses powerful self-renewal capabilities. This creates a physiological "buffer mechanism" to withstand potential off-target toxicity from CAR-T therapy—a safety net provided by nature.

Spanning nearly a decade since that 2017 meeting, the project has moved through rigorous systematic R&D. The data is compelling: among 98 patients treated with solid tumors, the Overall Objective Response Rate (ORR) exceeded 40%, while the gastric cancer subgroup approached 60%. These unprecedented results represent a breakthrough in late-stage gastric cancer treatment. Notably, concurrent studies in the United States have yielded highly consistent results, further validating the approach's scientific reliability.

In a discussion with Artery Network, Professor Shen revealed that the team gained critical experience from the very first patient, who suffered from an anastomotic recurrence. Although the patient experienced adverse reactions, the team successfully managed them, proving the therapy's potent anti-tumor activity while highlighting the need for careful anatomical selection. Consequently, her team established a new set of screening standards to balance safety with efficacy.

Today, this project serves as a global benchmark. As the world's first clinical study of CAR-T therapy targeting Claudin 18.2, its findings have been published in The Lancet, presented at ASCO, and featured in Nature reviews—signaling that China has reached an international leading level in solid tumor cell therapy.

Professor Shen Lin compares the journey of an innovative drug to a relay race. It is not a solo sprint; it requires what she calls "full-chain support" and "end-to-end management." The critical "last mile" of innovation—transforming a lab discovery into a patient cure—involves a complex web of translation, clinical development, regulatory review, and reimbursement.

While the Claudin 18.2 CAR-T therapy is a classic example of medical insight meeting engineering capability, moving forward requires an ecosystem that evolves alongside the science. When entirely new treatment paradigms emerge, global regulators face a difficult question: How do we evaluate something that has never existed before?

In recent discussions, industry experts highlighted several hurdles and potential solutions to optimize this ecosystem:

In essence, true innovation demands a new level of trust and synergy between the three pillars of the industry: the regulators, the biotech companies, and the clinical researchers.