Anti-COVID-19 drug went from project approval to market launch in just 20 months

Guangzhou National Laboratory has been established for only five years and has already produced a large number of original results. Contributor provided images.

Recently, N Video reporters from Southern Metropolis visited one of the core sites of this initiative—the Guangzhou International Bio Island—accompanied by officials from the Guangzhou Municipal Bureau of Industry and Information Technology (Biopharmaceutical Industry Office).

Amid lush greenery, the Guangzhou National Laboratory campus is quiet and orderly. But unlike conventional research institutions, the sixteen-character slogan hanging on the street lamps—“Take on the mission bravely, seize every moment, think diligently, work skillfully, collaborate and innovate”—reveals a sense of urgency and mission belonging to the “national team.”

This sense of urgency is directly reflected in the laboratory’s achievement list: the world’s first in vivo tumor injection minimally invasive ablation drug, a super-fast qPCR instrument that provides nucleic acid test results in 5-10 minutes, the anti-COVID drug “Le Rui Ling”… In just five years since its establishment in 2021, why has this scientific research “national team” been able to produce so many original results?

What is the “national team” in scientific research?

In 2021, Guangzhou National Laboratory was established, led by Academician Zhong Nanshan, focusing on three major areas: respiratory infectious diseases, major chronic respiratory diseases, and respiratory diagnostic equipment. Its goal is clear: to become a globally influential source of original innovation.

The 20th National Congress report explicitly proposed “improving the new national system, strengthening the country’s strategic scientific and technological capabilities, optimizing the allocation of innovation resources, and refining the positioning and layout of national research institutions, high-level research universities, and leading technology enterprises to form a national laboratory system,” guiding the development of national laboratories.

In the national strategic landscape, as a “national team,” national laboratories have the responsibility and obligation to undertake the mission of technological independence and self-reliance, forging “national heavy equipment.” This means they must keep the “big picture” in mind, gather strategic scientific and technological strength, focus on urgent national needs, and produce key major scientific and technological achievements.

How to shoulder this heavy responsibility?

“We adopt a ‘core + base + network’ organizational model to gather integrated innovation driven by national strategic scientific and technological strength,” said Wang Huisheng, Assistant Director of Guangzhou National Laboratory. The “core” and “base” are the foundation, while the open “network” links with the National Medical Center, national key laboratories, and extensively collaborates with biopharmaceutical companies to build a comprehensive innovation system.

The reporter noted that the laboratory has mobilized research forces nationwide, establishing strategic partnerships with Tsinghua University, Fudan University, the University of Hong Kong, Chinese University of Hong Kong, and others. They explore multi-field, multi-level, and multi-form collaborative innovation, advancing a new paradigm of deep integration and exchange in science and technology, further focusing on national strategic needs and enhancing R&D capabilities and scientific strength.

Academician Zhong Nanshan used a vivid metaphor to explain the laboratory’s mission: “Our approach is like stringing pearls. We thread the pearls onto a string; if done well, it becomes a beautiful necklace.”

How to bridge the “valley of death”?

With a “network,” rules are also needed. The “string” connecting these pearls is the “dual transformation and dual promotion” concept that runs through the entire process of scientific research and translation. This is the core methodology of Guangzhou National Laboratory and its unique model of transformation.

“Dual transformation” refers to the first conversion from basic research to clinical research and from experience-based medicine to evidence-based medicine, as well as the second conversion from samples to products and then to commercial goods. It ensures all scientific activities start from real clinical needs and end with tangible patient benefits. “Dual promotion” aims to bring simple, effective, affordable, and safe technological products to market, while also promoting mature diagnostic and treatment standards from top hospitals to grassroots levels, so that innovative results truly benefit the broadest population.

The concept is clear, but crossing the “valley of death” between scientific research and product development in the biopharmaceutical industry requires extremely precise institutional design. To this end, the laboratory has focused on three key links:

First, concept validation. For translational projects, they provide five-dimensional validation services—technology, product, clinical, registration, and market—to improve technological maturity and feasibility of transformation; second, review and approval linkage. National and local drug regulatory authorities deeply serve laboratory research projects, with review experts involved early to guide, ensuring R&D and review are synchronized; third, regulatory science. To address the challenge of “no standards” for new technologies, they conduct regulatory science research to provide scientific basis for establishing review standards for drug regulatory agencies.

It is this “combination punch” that turns the vision of “dual transformation and dual promotion” into an actionable and implementable innovation engine.

How was the “20-month miracle” created?

The anti-COVID drug “Le Rui Ling” (Larebavir tablets) is a typical example of this mechanism.

In March 2023, Le Rui Ling received conditional approval for market listing from the National Medical Products Administration. This original Class 1 new drug with fully independent intellectual property rights is not only the world’s first peptide-like 3CL target COVID-19 monotherapy but also more friendly to elderly and patients with underlying conditions, directly addressing the global challenge of medication safety for high-risk populations.

“From R&D initiation to market approval, Le Rui Ling took only 20 months,” Wang Huisheng said proudly. “In the field of new drug development, 20 months is unimaginable, as it usually takes about 10 years.”

How was this “miracle” achieved? Wang explained: “It benefits from the positioning of the national laboratory as a ‘general platform and overall chain leader.’ We leverage the leading role of the core platform to connect all stages from basic research to clinical application.” Centered on the laboratory, close collaboration is maintained with national key laboratories, research institutes, universities, and excellent enterprises like Zhongsheng Pharmaceutical’s Zongsheng Ruichuang, to tackle key challenges.

Under this “stringing pearls into a chain” model, innovation synergy is accelerating across multiple tracks, forming a good momentum from “single product breakthroughs” to “matrix offensive.”

In the drug development track, besides Le Rui Ling, the world’s first anti-influenza drug targeting PB2, “Anglotavir,” has also been approved for market, providing a new “Chinese option” for flu treatment. Vaccines and drugs such as the fusion protein COVID-19 vaccine V-01 and bivalent vaccines have received emergency use approval. Multiple vaccines and drugs, including mRNA, VLP, and small molecules, are in clinical trials, forming a “ammunition depot” for respiratory diseases.

In the device and diagnostics track, the laboratory-developed “CT+AI+Circulating Tumor DNA Methylation” system has improved early lung cancer diagnosis accuracy to 91%, providing a powerful tool for “early detection and early treatment”; a super-fast qPCR instrument can deliver nucleic acid test results in 5-10 minutes, greatly enhancing emergency response efficiency.

In the smart early warning track, a more forward-looking “Smart Laboratory” project is under exploration. It aims to integrate multi-source data to build a new early warning analysis pathway for respiratory infectious diseases, potentially contributing Chinese wisdom to global diagnostic guidelines and public health decision-making in the future.

Planning: Wang Weiguo, Li Yang

Overall coordination: Yin Lai, Wang Daobin, You Manni

Reporting: Southern Metropolis Reporter Wu Yueming