Partnership with US drugmaker paying off

"All was lost for me except for the excruciating pain, but with the promising outcomes of this treatment, I feel hope again," said former rural teacher Huang Zhanying, who has been battling lymph cancer for about a decade.

Cancer cells had been eating at Huang's lymph nodes since 2009, even though she had endured chemotherapy, tried generic drugs and borrowed money to buy steeply-priced medicine from overseas. On New Year's Eve 2017, she slipped into a coma and was transferred to a large hospital in Beijing.

It was different this time. She enrolled in a clinical trial program featuring immunotherapy, an emerging cancer treatment that works by boosting a patient's immune system to target and kill tumors.

In about two months, her tumor had shrunk. Gradually, she recovered some of her appetite and regained strength. Huang is now able to travel alone from her home in Shijiazhuang, Hebei province, to Beijing each month to continue the treatment.

Known as Tyvyt, the infusion that saved Huang's life is jointly developed by Innovent Biologics, a domestic biopharmaceutical company established in 2011, and Eli Lilly and Company, a drug manufacturing giant headquartered in Indiana, United States.

The treatment mainly tackles relapsed classic Hodgkin lymphoma. In China, the incidence rate for cancer in lymph nodes stands at about 6.9 per 100,000 people, and the classic Hodgkin's type accounts for about 10 percent of all cases, according to the National Health Commission.

In December, the innovative drug gained market approval from the National Medical Products Administration. Three months later, it was announced that Tyvyt would be sold at 7,838 yuan ($1,140) per 100 milligrams, less than half of the listed price for imported drugs with similar curative effects.

It is still considered a rare feat for Chinese pharmaceutical companies to succeed in developing innovative drugs or treatments.

For decades, domestic drug manufactures have been used to producing generic versions of foreign drugs, which make up about 80 percent of its market.

According to a report looking into sustainability in China's pharmaceutical sector, more than half of the innovative drugs worldwide have been created in the United States, followed by Japan, the United Kingdom, Germany and Switzerland, which have each contributed 5 to 10 percent. China is among the tertiary group. The report was jointly issued by several industry groups, including the China Pharmaceutical Enterprises Association in 2016.

Michael Yu, founder, chief executive officer and chairman of Innovent, had anticipated the challenge ahead when he started the company in 2011.

"It is universally acknowledged that it will take at least 10 years and $1 billion for a new drug to enter the market," he said. "In the early years of Innovent－a startup with limited financial backup－it was apparently a risky move to take the innovation route."

In 2014, an infusion sample from Yu's company－one of the prototypes for Tyvyt－drew attention from global companies for its advanced precision and effectiveness in reaching target cells. However, it was not until late 2015 that the Chinese business cemented cooperation with its US partner. Yu described the initial relationship as a melodrama of the poorboy-after-rich-girl chase.

"Eli Lilly and Company had sent an inspection team of 157 people and scoured every corner of our manufacturing facilities to avert risks that might disrupt originality and cause regulation issues," he said.

Yu was soon presented with a lengthy list of rectification requirements, mainly surrounding its manufacturing practice.

"Apparently, no cooperation is in sight if we do not meet the highest standards," he said.

Meanwhile, there were increasing doubts on whether the young company should stick to its original approach of inventing novel therapies.

"I had been working in the United States for more than 10 years. In the US, I was able to buy a wide range of products that are made in China, but there were no Chinese-made biomedical drugs," Yu said. He decided to take a leap of faith.

The company set out to transform and upgrade its manufacturing lines in 18 months. During the facility renovation, it missed the opportunity to accelerate the market approval of another generic drug.

"There is no denying that China has lagged behind some developed countries in terms of R&D into biomedicine, but it's unacceptable to always chase after key players in the industry," Yu said. "We should at least make all-out efforts to align ourselves with them."

Yu's perseverance eventually paid off. After striking a deal with the US company in late 2015, Innovent was able to collect sufficient funds to ensure smooth operations from basic research and development and clinical trials to production and sales.

"We are also exploring new methods of payment that would further cut down on patients' financial burdens; in the meantime, more than 20 clinical trial programs are underway to test Tyvyt's role in tackling other types of tumor cells," Yu said.

Like Innovent, domestic pharmaceutical companies are picking up the pace to address unmet medical needs.

According to the National Medical Products Administration, it handled registration applications for 115 types of innovative drugs developed in China last year, a rise from 112 in 2017 and 77 in 2016.

"The outlook is bullish for us," Yu said. "With the acceleration in approval process headed by the administration, more high quality and effective innovative drugs will reach patients in need sooner."