(Yicai) Oct. 27 -- Gilead Sciences has benefited from China's accelerated regulatory reforms in granting market access for innovative drugs, with the country's pilot zones enabling near-simultaneous global product launches, according to a vice president of the US biopharmaceutical company.

"Over the past few years, China has made significant policy changes in drug review and approval, particularly in encouraging and supporting innovative drugs to get approved and launched faster," Jin Fangqian, who is also Gilead’s China general manager, told Yicai at a media briefing ahead of the eight China International Import Expo, which opens in Shanghai on Nov. 5. 

"All companies in the pharmaceutical industry, whether multinational or local innovative drugmakers, can benefit from these policy changes, which have undoubtedly greatly accelerated the launch speed of our innovative products in China," Jin noted. “Gilead Sciences has already seen tangible results.”

Gilead will exhibit several of its latest achievements at the upcoming CIIE, including Lenacapavir, a twice-yearly pre-exposure prophylaxis jab for the human immunodeficiency virus whose Phase III clinical trial results the California-based company first showed at last year's expo. The drug was approved for use in Boao Lecheng International Medical Tourism Pilot Zone in China's Hainan province just eight working days after it received approval from the US Food and Drug Administration in June, with the first Chinese patient receiving the treatment on Oct. 22.

Lenacapavir brings a paradigm shift in HIV prevention by eliminating the need for patients to take daily pills, which has long made it difficult for patients to stay on track, Jin said. Gilead is already developing its next-generation HIV drug pipeline, exploring once-a-year prevention shots while working to extend pill doses from daily to weekly, monthly, or even bi-annually, Jin added.

Gilead will also exhibit Seladelpar at this year's CIIE. The new treatment for primary biliary cholangitis, a chronic autoimmune liver disease, was approved in August under a pilot program in Beijing's Tianzhu Comprehensive Bonded Zone. 

Gilead chose to first launch Seladelpar in Tianzhu due to the zone's specific focus on rare diseases, Jin noted, adding that a separate application in Boao is also expected to be approved this year.

The pilot zone authorizations run parallel to formal registration filings with China’s Center for Drug Evaluation, creating a dual-track strategy, Jin pointed out. The real-world data gathered from these areas "can enrich the clinical data for formal applications and ultimately promote earlier drug launch to some extent," he said.

China's regulatory reforms are fueling growth in its pharmaceutical market, which will likely reach CNY2.24 trillion (USD308 billion) by the end of this year, with innovative drugs accounting for 30 percent of the total, according to research firm CRI.

In addition, Gilead has benefited from China's national reimbursement catalog, which includes eight of its 13 drugs approved in the country, with all products to feature at its CIIE booth.

Gilead is also deepening its China commitment through localized research and development. It has 16 R&D projects in the country, with 90 percent of its oncology programs developing concurrently with global timelines, eliminating the lag usually faced by Chinese patients in accessing new therapies.

On the commercial side, Gilead will expand its cooperation with contract sales organizations in China, Jin noted, calling them an "effective supplement" for drug accessibility and channel coverage.

He also pointed to the trend of collaborating with local innovators, citing recent deals with Hong Kong-based CytoSwant and Shenzhen’s Pregene Biopharma. "Many more projects are currently in negotiation," he said, without disclosing any details.

China's innovative drugs industry has seen explosive growth in global expansion since the start of this year. Domestic firms have penned over 70 out-licensing agreements in the six months ended June 30, with their value surging 129 percent to USD60 billion from a year earlier, exceeding last year's total, according to figures from global drugs data platform Pharmcube.

Editor: Martin Kadiev