Biopharma's rapid growth signals China's rise in medical field

China, today's second-largest medical consumption market, has the potential to become the world's No 2 medical player after its local biopharmaceutical enterprises rise to satisfy unmet medical needs from patients at home and abroad, said a senior executive of a local drugmaker.

The high-speed growth of innovative Chinese biopharmaceutical companies -- after more than a decade of progress in terms of new drug development, conducting clinical trials, and the talent reservoir -- may last for years, said Yang Dajun, chairman and CEO of Ascentage Pharma, a Suzhou-based biopharmaceutical company.

"China has shown its biomedical capability during the COVID-19 pandemic, including developing diagnostic kits and vaccines that have benefited local and overseas individuals, hospitals, and disease control authorities," said Yang, whose company will make its debut at the 2021 China International Fair for Trade in Services, kicking off in Beijing on Sept 2.

The new addition of a health exhibition zone for this fair also showed that the country is supporting local biotech companies to go global, Yang said.

"When domestic biopharmaceutical enterprises stride toward the world and serve international patients, it's an important way to contribute Chinese wisdom to the development of the entire human community," he said.

Ascentage is dedicated to developing first-in-class or best-in-class novel therapies to satisfy patients' unmet medical needs in the areas of cancer, chronic hepatitis B, and age-related diseases with a global orientation.

The company established in 2009 has more than 40 Phase I and II clinical trials underway for its eight originally innovative drug candidates in the US, Australia, Europe and China.

One of the major exhibits at the fair will be its core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), which afflicts an estimated 10,000 patients in the country each year, Yang said.

The orally taken drug has been granted orphan drug designation and fast track designation by the United States Food and Drug Administration. A new application for the drug has also been submitted in China and it was granted priority review status and a breakthrough therapy designation by the country's drug review authority, according to the company.

"There is no similar therapy in the domestic market so far. The drug can be life-saving to those drug-resistant CML patients," Yang said.

Only one drug treating such patients is available in the global market.

Last year, Ascentage obtained 10 orphan drug qualifications from the US FDA, becoming the enterprise with the largest number of such qualifications in the world that year.

Altogether, four of the company's candidate drugs have been granted 12 orphan drug qualifications by the US FDA so far, allowing it to become the enterprise with the largest number of such qualifications domestically, according to the company.

"The sign of China becoming a major and strong player in biomedicine is that local biopharmaceutical enterprises are able to not only satisfy domestic patients' unmet medical needs but also secure some seats in the global market," Yang said.

He said such an ultimate target echoes the purpose of the 2021 China International Fair for Trade in Services.

"We provide service to the world with China at the core," Yang said. "To serve the world's patients, we need to depend on our innovation competency as well as development and market promotion abiding by international standards."

The company has nearly 150 authorized patents worldwide, and has submitted applications for another 500-plus patents, he said.

Both the high-end markets, including the US, Europe, and Japan, and the burgeoning ones are critical for domestic biopharmaceutical companies' global development blueprint, said Yang.

"The burgeoning markets include Southeast Asia and South America as well as some countries and regions along the Belt and Road Initiative. They actually add up to roughly one-third of the world's total market," he said, adding that Ascentage is facilitating collaborations with those markets.

At the fair in Beijing, the company will ink strategic collaborations with different players in the health sector, including a precise testing provider, and insurance companies, to prepare to help patients use the right therapy, improve drug accessibility, and ease patients' financial burden after the drug candidate's market approval, which may be expected in the fourth quarter of this year.