Yearender: The new chemistry of "Made in China"-Xinhua

Yearender: The new chemistry of "Made in China"

Source: Xinhua

Editor: huaxia

2025-12-28 13:12:00

BEIJING, Dec. 28 (Xinhua) -- China's rise in manufacturing has rarely been associated with drug discovery. That, quietly, is starting to change -- giving "Made in China" a new chemistry.

Earlier this week, Chinese biotech innovator Jacobio Pharma reached an agreement to license an experimental cancer drug targeting a notoriously difficult genetic mutation to pharmaceutical giant AstraZeneca.

The potential 2 billion U.S. dollar partnership underscored a banner year for Chinese drugmakers. In the first ten months of 2025, Chinese pharmaceutical companies signed more than 100 overseas licensing deals, with a combined value exceeding 100 billion U.S. dollars, nearly double the total recorded in 2024.

Many in the industry believe China's innovative pharmaceutical sector has reached its "DeepSeek moment," the point at which years of sustained investment in research, infrastructure and regulatory capacity are beginning to deliver tangible breakthroughs.

Today, China ranks second only to the United States in the number of new drugs under development, with its pipeline accounting for more than one-fifth of the global total.

Since 2021, over 110 homegrown innovative drugs have received market approval in China, representing more than half of all new drug approvals during that period.

According to Pharmcube, a pharmaceutical consultancy, China surpassed the United States in the number of original drugs developed between 2015 and 2024, cementing its place among the world's leading innovators in pharmaceuticals.

Over that decade, the cumulative value of overseas licensing deals involving Chinese innovative drugs exceeded 1.2 trillion U.S. dollars. Eighteen China-developed original medicines were approved abroad, with several outperforming foreign-origin drugs in head-to-head clinical trials.

These results highlight the transformation of China's pharmaceutical sector, which was once dominated by imitative medicines, commonly referred to in the industry as "me-too" or "me-better" drugs.

Bill Anderson, chief executive of Bayer, the German multinational pharmaceutical and biotechnology company, has observed this transformation firsthand. China, he told Xinhua, is evolving from a "follower" into a "source" of original biopharmaceutical innovation.

CHINA SPEED

Describing it as "China speed," Anderson is impressed by the country's efforts to better align technological know-how with industrial innovation to accelerate.

A key plank of that effort is a policy document released in November, which promotes pilot-scale platforms to bridge laboratory research and industrial-scale production. Biopharmaceuticals are highlighted among several priority sectors.

In addition to sustained policy support, Anderson also pointed to China's strength in possessing a highly dynamic research and development ecosystem and a strong healthcare market demand that helps translate innovation into practical use.

In 2023, Chinese researchers ranked second globally -- after the United States -- in the number of papers published in Cell, Nature and Science in the biopharmaceutical sector.

In July, China proposed using its national health insurance data platform to analyze disease patterns and clinical drug demand, aiming to guide innovative drug development. "This helps companies, research institutes and hospitals set priorities, plan pipelines, and pursue differentiated innovation," said Wang Guodong, an official with the National Healthcare Security Administration.

Technology is also accelerating discovery. At a drug research facility of SSY Group Limited in Shijiazhuang -- known as the "medicine hub of China" -- an AI-powered virtual screening system runs around the clock, scanning a molecular database.

"With intelligent screening, we can identify more than 100 new compounds from a library of 300 million in just over a month. Previously, this would have taken two to three years," said Sun Lijie of the company.

FULL-SPECTRUM SUPPORT

To foster high-quality innovation, China has been strengthening regulatory support to propel its pharmaceutical industry beyond imitation and toward original discovery.

China's drug regulatory reform, launched in earnest in 2015, has introduced fast-track pathways for breakthrough therapies, conditional approvals, and priority reviews, compressing timelines across the drug-development cycle. The country joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017 to align its drug-approval standards with international norms.

Average review times for innovative-drug clinical trials have been slashed by over half, to 50 days in 2024 from 108 in 2018. Last year, the review of China's innovative-drug applications took an average of 225 days, or just 162 days under priority review.

Since 2018, the National Medical Products Administration (NMPA) has approved 265 innovative drugs, including 68 by November 2025, more than six times the total approved in all of 2018.

Outlining NMPA's plans for the next five years, its head Li Li said regulators will concentrate on first-in-class, globally novel therapies and domestically developed solutions to critical technological bottlenecks, providing early engagement and tailored guidance throughout the review process.

Chen Kaixian, an academician specialized in medicine at the Chinese Academy of Sciences, noted that China now has a full-fledged biopharmaceutical innovation system. "It spans drug design and screening, preclinical studies, safety evaluation, clinical trials, and regulatory review, all aligned with international standards," he said.

Despite strong momentum, some warn that China's drug industry still needs greater capacity to pursue new targets and attract talent and capital. Facing the funding squeeze common to biotech firms, Wang Yongqiang, founder of a company developing innovative vaccines and drugs, called for broader financial support.

He and other industry leaders hope for more diversified funding channels, particularly greater risk tolerance in government-backed funds, as well as sustained investment in basic research and industrialization to attract private capital and ensure stable, long-term funding for drug innovation.

GLOBAL REACH

In 2025, Chinese-developed therapies have won global attention with headline deals. In May, Shenyang-based 3SBio announced a licensing agreement with a potential total value of 6 billion U.S. dollars to grant Pfizer worldwide rights, outside the Chinese mainland, to develop, manufacture and sell its cancer drug. Two months later, Hengrui Pharma, based in east China's Lianyungang City, inked a deal with GlaxoSmithKline covering multiple innovative drugs, potentially worth 12.5 billion U.S. dollars.

Industry observers point to a strategic shift among global drugmakers behind the surge in overseas licensing. They note that under pressure to innovate and facing soaring in-house R&D costs, multinational pharmaceutical companies are increasingly turning to China in search of high-quality, cost-effective innovative assets.

Beyond traditional licensing, the primary route for Chinese drugmakers to go global, new approaches are beginning to emerge. Some firms are setting up overseas ventures, granting them the rights to develop, manufacture and commercialize core innovative drugs. Others are independently pursuing overseas clinical trials, regulatory approvals and product launches.

In early December, China introduced a key measure to support the global expansion of its drugmakers, a drug price registration system that provides online and offline registration and inquiry services for international pharmaceutical companies. Observers note that it addresses a long-standing challenge for Chinese new medicines entering foreign markets, namely the absence of domestic reference prices.

"While benefiting patients at home, we have been pursuing an international strategy to strengthen our global competitiveness," said Yang Dajun of Suzhou-based Ascentage Pharma.