Date: March 14, 2016
Source: People’s Daily Online

 

Ahead of this year’s Spring Festival, the 9th T-Cell Lymphoma Forum was held in San Francisco, United States. Among the 4 oral presentations and 11 posters delivered by Chinese experts at the conference, 4 focused on clinical data analysis of the anti-cancer drug Chidamide.

 

Chidamide is an original anti-cancer drug with independent intellectual property rights developed in China. Its emergence has brought new hope to lymphoma patients worldwide. Its inventor is Dr. Lu Xianping, founder of Shenzhen Chipscreen Biosciences Co., Ltd., widely known as a “fighter in innovative drug development.”

 

Using Knowledge to Transform China’s Original Drug Industry

 

In the 1990s, Dr. Lu achieved academic success and built a strong career in the United States. He served as head of a research department at a pharmaceutical company’s North American R&D center, leading and organizing the design and synthesis of novel chemical molecules, drug screening, preclinical studies, and Phase I clinical research.

 

Although he could have continued a comfortable life in the U.S., he turned his focus back to China. “At that time, after 20 years of reform and opening-up, many industries in China had developed rapidly, but the pharmaceutical sector had lagged far behind,” Dr. Lu recalled. China had outstanding scientists, a vast market, and a solid pharmaceutical foundation—yet its industry remained at the lower end of the global value chain.

 

In 1999, during a gathering of Chinese students in the U.S., discussions about the state of China’s pharmaceutical industry inspired him for the first time to “do something for the country’s drug development.”

 

Soon after, action followed. In 2000, at Dr. Lu’s home, five young Chinese scholars from different fields joined hands and decided to return to China to “use their knowledge to change the state of China’s original drug industry.”

 

For the founding team of Chipscreen Biosciences, the greatest challenge in starting a business back in China was not technology, but severe financial constraints. In 2001, the company secured its first round of venture capital funding of RMB 50 million, which was still far from sufficient for original drug development.

 

Globally, innovative drug R&D is a high-investment, long-cycle endeavor, often taking 10 to 15 years, with significant risk of failure throughout the process.

 

“Because of the long development cycle, large investment, and lack of early financial returns, fundraising was extremely difficult,” Dr. Lu recalled. In 2005, due to financing challenges, all employees—including Dr. Lu—took a 50% pay cut. Two of the five original founders eventually left due to financial pressure.

 

To generate its own funding, Chipscreen Biosciences decided in 2006 to out-license overseas patents for Chidamide, which was still under development. As the drug had not yet entered clinical trials, the early licensing resulted in limited financial returns—but it ensured the company’s survival.

 

After overcoming these difficulties, and as product development entered a more predictable risk stage, the company’s investment value gradually gained recognition, completing six rounds of financing. With the successful launch of Chidamide, the company’s sales are expected to reach RMB 500 million over the next five years.

 

Currently, only three companies worldwide produce similar drugs, two of which are based in the United States, with monthly treatment costs of RMB 280,000 and RMB 140,000 respectively. By comparison, Chidamide costs just over RMB 20,000 per month. In addition, Chidamide is administered orally, rather than through intravenous injection as is common with similar drugs overseas, making it more convenient for patients.

 

A Virtuous Cycle Is Essential to Ignite Pharmaceutical Innovation

 

Beyond Chidamide, Chipscreen Biosciences has advanced multiple internally developed innovative drugs. Chiglitazar sodium, for the treatment of type 2 diabetes, has entered Phase III clinical trials; a drug candidate targeting solid tumors (CS12192) has entered Phase I; and treatments for rheumatoid arthritis are currently under development.

 

The company has established multiple original drug pipelines in oncology, diabetes, and immunological diseases, and has filed 73 global invention patents for compounds, with 45 granted.

 

“If we did not have the ability to manage risk or the underlying technology, the probability of success for Chipscreen Biosciences would be zero,” said Dr. Lu. At the core of the company is its integrated drug discovery and early evaluation platform based on chemical genomics.

 

Through this platform, scientists can predict and evaluate whether designed chemical structures and selected targets have drug potential, enabling informed decisions on whether to proceed or terminate development early. This is critical because once a drug enters clinical trials, both time and financial costs increase significantly, and failure becomes extremely costly.

 

By leveraging genome-wide expression analysis, computer-aided structure design, and data mining based on informatics, the company generates strong predictive data. “Even if the probability of success increases by only 50%, it means our chances of developing a drug are doubled, while our costs are significantly lower,” Dr. Lu explained.

 

In his view, although China has excellent scientists and a solid pharmaceutical foundation, the long-standing reliance on imitation rather than innovation has kept the industry at the lower end of the value chain. Only by establishing a virtuous ecosystem for innovative drug development can China truly ignite its pharmaceutical innovation momentum.

 

When he first returned to China, the pharmaceutical regulatory system—especially policies and legal frameworks for innovative drug development—had many gaps, hindering healthy and rapid industry growth. Dr. Lu has frequently spoken at forums and conferences, advocating for improved regulatory systems, more robust venture capital mechanisms, and stronger intellectual property protection.

 

“Beyond company growth and research success, what I’ve gained most is a group of like-minded partners,” Dr. Lu reflected. Despite more than a decade without profits, what has held the team together is their passion for scientific innovation and a strong sense of responsibility—values that form the essence of Chipscreen’s culture.

 

In 2000, when Dr. Lu left his family to start a business in China, his younger son was only three and a half years old. Today, that child has reached college age. Although Dr. Lu travels back to the United States monthly to reunite with his family, he still hears occasional complaints from across the ocean.

 

“Despite the complaints, they understand,” Dr. Lu said. “To return to my homeland and give back with what I have learned is my greatest dream. And to heal and save lives through scientific innovation is my greatest achievement. Perhaps this is a sentiment shared by many people born in the 1960s.”