Biomedical companies seek intl growth

Innovative research and development-driven domestic biopharmaceutical companies are expected to have a strong presence in the global market over the coming decade with their first-in-class pipeline, persuasive quality and down-to-earth international expansion footprint, industry experts said.

Some of these businesses, which have risen rapidly over the years due to the accumulation of clinical trial experience over decades, the country's streamlined medical regulatory mechanism and an ecosystem encouraging vibrant innovation under the Healthy China 2030 initiative, may even secure places in the world's first echelon of this frontier sector, the experts said.

"Some powerful Chinese enterprises are already equipped with the skill sets to address unmet medical needs not only for Chinese patients but also for those around the world," said Jay Mei, founder of Shanghai-based Antengene Corp Ltd.

"We've already seen that some medicines first discovered or developed in China and with clinical trials initiated in China and other markets simultaneously are benefiting international patients. I'm convinced that more will come," added Mei, who is also chairman and CEO of the company dedicated to therapeutics in hematology and oncology.

The company's oral drug Selinexor, which works in a mechanism different from all existing approved therapies, was approved on July 29 in South Korea, the first overseas market in Asia, to treat relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma, a form of cancer.

The drug, the first product of the company, had obtained approvals from the United States Food and Drug Administration in 2019. This was followed by Israel, the United Kingdom and the European Union.

Besides South Korea, the company also submitted new drug approval applications of the drug in five other markets in the past eight months. They are the Chinese mainland, Australia, Singapore, and China's Hong Kong and Taiwan.

Mei said the enterprise was established in 2017 and had a pipeline of 13 products. It initiated a strategy of being rooted in China and then expanding to the Asia-Pacific and beyond.

"Our development in South Korea was the result of full preparations. We have a team in that country. Members of the team are locals with a profound understanding of the market and the regulatory system and most have global pharmaceutical company experience," he said.

A growing number of innovative homegrown medical companies are exhibiting their strength in the international arena and attracting capital investment, according to industry reports.

Data showed that in 2020, the total market value of local biotechnology companies and ecosystem participants listed on the Nasdaq, the Hong Kong stock exchange and the Shanghai Stock Exchange was roughly $220 billion.

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

The company was established in 2009. It is conducting more than 40 Phase I and II clinical trials for its eight original innovative drug candidates in the US, Australia, Europe and China.

A key drug candidate was developed for the treatment of drug-resistant chronic myeloid leukemia, which affects an estimated 10,000 patients in the country each year, said Yang Dajun, chairman and CEO of Ascentage Pharma.

The orally taken drug has been granted orphan drug and fast track designation by the US FDA. A new drug application for the drug has also been submitted in China. It was granted priority review status and a breakthrough therapy designation by the country's drug review authority, the company said.

"There is no similar therapy in the domestic market so far. The drug can be lifesaving to those drug-resistant blood cancer patients," Yang said, adding there has been only one drug treating such patients in the global market.

Twelve of the company's candidate drugs have been granted orphan drug designation by the US FDA, allowing the enterprise to become the No 1 in getting the largest number of such qualifications among Chinese peers, the company added.

"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.

Chen Kaixian, an academician with the Chinese Academy of Sciences, said the performance of domestic biopharmaceutical players showed to the global medical community that innovative therapies from China are accelerating to benefit patients in the country and even the world with their cutting-edge research, standardized R&D processes and high quality.

China has also shown its biomedical capability during the COVID-19 pandemic, including developing diagnostic kits and vaccines that have benefited many local and overseas individuals, hospitals and disease control authorities, the industry experts said.

Shanghai-based medical testing solutions provider 3DMed Diagnostics said a testing kit, the first to be granted market approval in China to screen individuals for both the novel coronavirus and influenza virus at once, is under active preparation to enter some overseas markets.

"Some foreign countries and regions have expressed strong interest in the product and we're preparing for its registration to access those markets," said Xiong Lei, founder and chairman of the company, which is among the top Chinese enterprises with the largest export volume of COVID-19 nucleic acid test kits and automatic testing equipment.

Industry experts said the high-speed growth of medical research results from China is a result of more than 15 years in new drug development experience, clinical trials and a deep reservoir of talent.

Mei from Antengene said he believes the young generation of talent will play a key role in China's rise in the biotech arena on the world stage as they are open-minded, receptive to new products and ideas, and internationally-oriented.

He also said the increasing capability of Chinese biopharmaceutical companies will probably bring in more medical solutions to diseases that are common in Chinese and Asians compared to people in the West.

Most drugs, if not all of them, developed over the past decades were from Western enterprises, and diseases that are common among Asians were not thoroughly studied, the experts said.

"Now the Chinese companies have the strength and it's time to change," Mei said.

He added that although some multinational companies are working on R&D programs focusing on the needs of Chinese patients, their local counterparts will have an absolute advantage in efficiency of decision-making.

Ma Jun, an expert with the Chinese Society of Clinical Oncology and director of the Harbin Blood Disease and Tumor Institute of Harbin First Hospital in Heilongjiang province, said he estimated the current explosive era of growth in the country's biomedical sector will remain for around a decade.

Such a phase may bring about homogeneous competition, he said. For example, there are dozens of PD-1 inhibitors－potential tumor therapies－being developed by local companies.

"However, homogeneous competition shouldn't be discouraged at all times as they can often bring treatment options at lower prices and ultimately benefit patients," Ma said. "For example, it used to cost hundreds of thousands of yuan to treat a child suffering from leukemia, but it has been reduced significantly thanks to the rich options of similar medical therapies."