By Wang Yunna, People’s Daily
“I used to enjoy seafood with beer when I was younger, but for years, I haven’t dared to indulge,” said 63-year-old Lu Ping, diagnosed with gout eight years ago. “Because of tophi, my big toe joint swelled so severely that even the slightest movement caused excruciating pain. I had to wear size-52 shoes.”
During a hospital visit, Lu learned that a new innovative drug was undergoing clinical trials and immediately signed up. “The pain from gout attacks was unbearable, and I wanted to try any potential solution,” he explained.
Now, he takes one pill a day, under the close supervision of his doctors, who monitor safety and assess the drug’s effectiveness by testing his uric acid levels every month or two.
The new drug was developed by ApicHope Pharmaceutical Group Co., Ltd., based in Guangzhou, the capital of south China’s Guangdong province. Gouty arthritis is intensely painful, and patients have a significant demand for effective treatments. When reviewing global research on gout therapy, the company’s R&D team discovered that there had never been an oral medication specifically designed to dissolve tophi.
“Developing new drugs is highly challenging, but if we can solve this problem, we will fill a major gap in the market,” said Li Hanxiong, chairman of ApicHope.
The process of identifying a potential compound involves screening between 5,000 and 10,000 molecules. “It’s like searching for a needle in a haystack,” explained Yang Wenqian, head of a research institute under ApicHope.
An even greater challenge was pinpointing a viable drug target. “Much like aiming an arrow, a drug only works if it targets specific proteins or nucleic acids within the body. However, these targets are hidden among trillions of cells. There are no shortcuts, only patience and persistence,” Yang added.
After several attempts, the team identified a urate transporter protein. Normally, most uric acid filtered by the kidneys is reabsorbed into the bloodstream through this transporter, boosting the body’s antioxidant and anti-infection capacity.
“By inhibiting this transporter, could we lower uric acid levels in gout patients?” the team wondered.
Building on this hypothesis, the team began developing urate transporter inhibitors while optimizing molecular structures to minimize side effects and enhance efficacy.
At the end of 2022, China’s National Medical Products Administration (NMPA) approved clinical trials for the drug to ensure its safety and effectiveness before it could be released to the market. More than 1,500 patients have since participated in the trials.
“Leveraging the wealth of top-tier hospitals in Guangzhou, we partnered with local doctors and doctors to accelerate research, clinical testing, and market entry,” said Li.
Beyond medical resources, Guangzhou has also rolled out supportive policies to foster a robust biopharmaceutical industry ecosystem. The combined efforts of the government and enterprises have significantly accelerated the development and approval of innovative drugs.
The city has introduced policy measures to support the high-quality growth of the biopharmaceutical sector, invested in global science initiatives such as the human cell atlas and human proteome project, and now hosts 45 institutions certified under good clinical practice standards. These efforts create a comprehensive support system covering the entire innovation process.
“Our new drug follows a model where R&D is carried out in the Greater Bay Area, while regulatory filings are made globally,” Li noted. The NMPA’s Greater Bay Area branch has designated the drug as a priority project, providing early-stage guidance in clinical research to accelerate the approval process.
With strong infrastructure, sound policies, and a supportive environment, companies are better able to attract top talent, refine their R&D and commercialization systems, and bring new treatments to market more rapidly.
“Our company has 15 innovative drugs in the pipeline, with more soon to move into mass production,” he added.
Recently, China’s National Healthcare Security Administration and the National Health Commission issued 16 measures to promote the high-quality development of innovative drugs, injecting fresh momentum into the industry.
Since last year, the NMPA has piloted reforms in 11 provincial-level branches, cutting the review period for supplemental drug applications requiring verification from 200 working days to just 60. The agency is also exploring a 30-day approval timeline for priority innovative drug trials.
In the first half of this year alone, China approved 43 innovative drugs, up 59 percent year on year, demonstrating that reform dividends are driving industry growth.
Over the past five years, China has approved 210 innovative drugs, maintaining rapid growth. Today, China accounts for about 30 percent of the world’s innovative drugs in development.
