The entry of Qilu Pharmaceutical's gefitinib tablets into the U.Smarket marks a significant milestone, as it is now the first and only generic gefitinib product available in the United StatesThis momentous achievement highlights the progress made by the Chinese pharmaceutical industry on the global stage.

Originally developed by AstraZeneca, gefitinib was the first epidermal growth factor receptor (EGFR) small molecule tyrosine kinase inhibitor (TKI) to be approved worldwideIt received FDA approval in the United States in 2003 and made its domestic debut in 2005. As a frontline targeted therapy for non-small cell lung cancer—a condition that persists as a grim challenge for patients—gefitinib had long maintained a monopoly in the domestic market after its launchThe cost of the original gefitinib formulation has been exorbitant, usually exceeding 5,000 RMB (approximately $700) per box, leading the total treatment expenses for each patient to soar into the tens of thousands of dollars.

After an arduous seven-year research and development period, Qilu Pharmaceutical managed to create a generic version of gefitinib that is clinically equivalent to the original

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By the end of 2016, it was granted approval for domestic sale, retailing at just over 1,600 RMB per box—significantly lower than its imported counterpartThe price further dropped to 498 RMB per box by 2019. During the recent national collection renewal process, Qilu proactively reduced the price again, and the medication now costs only a couple hundred RMB.

“The series of blockbuster drugs we have developed are continually reshaping the landscape and ecosystem of clinical medication in ChinaEspecially with dozens of products that are either the first or exclusive offerings in the domestic market, we are breaking the long-standing monopoly of imported drugs or filling significant gaps that previously existed,” stated Li Yan, the President of Qilu Pharmaceutical Group, in a recent interview with journalists.

China's pharmaceutical industry is currently churning through a new developmental phase, with reforms in healthcare and medicine gaining significant traction, resulting in a record number of newly approved drugs

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Despite these advancements, Li pointed out several persistent issues: “Certain challenges remain within the industry, including intense competition and innovation stagnation, limited high-quality outcomes, and overall weak international competitiveness.”

In light of these conditions, Li Yan proposed suggestions for supporting the innovative transformation and development of the domestic pharmaceutical industry during the upcoming national conference in 2024. She emphasized the need for systematic reconstruction of policies to maximize their synergistic effects, thereby releasing new vigor for the growth of local pharmaceutical enterprises.

One important area for improvement involves the optimization of drug administration and regulatory frameworksRecent years have witnessed marked improvements in China’s pharmaceutical innovation environment, spurred by reforms in the drug review and approval system

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For instance, from 2018 to 2020, the number of domestic class 1 anti-tumor drugs approved for market entry rose impressively each year.

Despite progress, Li observed that many unmet clinical needs persistThis includes vital therapeutic areas such as oncology, autoimmune diseases, chronic conditions like hepatitis B, cardiovascular diseases, hypertension, diabetes, and many rare diseases, many of which still lack adequate treatment optionsAdditionally, given that China is a relative newcomer to high-quality innovative drugs, it still lags behind in terms of resource accumulation, a skilled workforce, and competitive edge in the industry.

According to a report from the Huajing Industry Research Institute, in 2021, the U.Saccounted for more than half of global sales of innovative drugs, whereas China only accounted for a mere 3%, significantly lower than other developed nations like the UK, Germany, and Japan that collectively represent 24% of sales.

Li emphasized that the new era of drug regulation in China comes with intricate challenges

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The balancing act of ensuring compliance alongside industrial growth requires simultaneous addressing of regulatory oversight while fostering development, amidst the demands from various stakeholders.

Thus, she proposed a comprehensive top-down approach to national drug regulation, advocating for scientific rigor while integrating public interests and industrial growth targetsAdditionally, in order to harness innovation and mitigate stunted growth due to low-level innovations, there must be clearer guidance and support for companies navigating obstacles in their innovation processes.

“Moreover, it’s vital for relevant governmental departments to enhance policy collaboration and interdepartmental connectivityBy ensuring comprehensive planned policies are synergistic and specialized policies complement one another, we can push forward reforms in our healthcare system while coordinating the development of insurance, medicine, and medical services,” Li elaborated.

A bridge for transforming research outcomes into practical applications is essential in the pharmaceutical industry

The development of innovative drugs often requires extensive effort—a difficult journey that can take years and involve many setbacksWhether drawing insights from the historical evolution of pharmaceutical development in Europe and America or examining the unique practices of China, it becomes clear that no single entity can thrive independently within this multifaceted ecosystem.

To strengthen collaboration between industry, academia, and research, Qilu Pharmaceutical has initiated partnerships with prestigious universities and research institutionsThis strategy aims to leverage resources and expertise to boost research and development timelines and qualityThe company is also increasing its investment in scientific research within new drug delivery systems and formulation processes.

New drug delivery systems represent a burgeoning realm in generic drug developmentThese innovative formulations, which include targeted nano preparations, long-acting injectable formulations, and special delivery device drugs, represent some of the highest standards in drug formulation research, offering remarkable clinical advantages over traditional systems.

Li shared that Qilu has successfully released nano-targeted formulations of paclitaxel and several orally dissolving film preparations and is currently working on over twenty projects based on new delivery systems, which encompass a variety of liposomal drugs, long-acting nanocrystalline drugs, extended-release injectable microsphere drugs, submicron emulsion drugs, and automatic injection pen drugs.

It is clear that achieving a robust innovation ecosystem hinges on collaborative synergy among the components of the industry—spanning production, research, healthcare, and regulatory practices.

To expedite technological advancements, Li Yan urged the exploration of an organized national system for innovation

Encouraging leading firms to collaborate with institutions and research centers will optimize resources through collective endeavorsThis coalition of top-tier organizations should be focused on constructing national innovation centers, facilitating participation in significant national projectsBy bridging the gap between companies and research facilities, a collaborative mechanism where government directs, enterprises pose questions, and scientists find solutions can emerge.

She also proposed that governmental financial support should guide upstream basic research while assigning clear responsibilities and objectives to downstream transformations, establishing a sound compensation mechanism for successful upstream studiesMoreover, a streamlined process for transitioning from innovation to industrial application must be instituted, reducing bottlenecks that inhibit effectiveness.

Finally, with recent advancements in deepening healthcare reforms and facilitating significant drug procurement policies, noteworthy progress has been made in addressing public concerns surrounding accessibility and affordability of healthcare services.

However, Li pointed out that even innovative drugs encounter obstacles such as brief market tenure, poor public awareness, and relatively high costs, leading to challenges in accessing clinical application opportunities

This poses issues like difficulty in hospital adoption and integration into insurance systems, resulting in overall poor accessibility for both healthcare providers and patients.

To remedy this, she calls for careful consideration of the unique characteristics of innovative drugs within market access discussionsIt is essential to address the inconsistent pricing requirements across regions, competing pathways for integration, and varying standards for classifying innovative drugsRegulatory departments should be encouraged to establish clear guidelines regarding newly launched innovative drugs, including standardized pricing measures and expedited access procedures, ensuring rapid market entry.

Furthermore, by ensuring drug quality and procurement processes remain stringent, she suggests loosening existing restrictions on classifications and enhancing the channels for high-quality drugs through comprehensive evaluations or value assessments of newly introduced medications.

Moreover, the enthusiasm of healthcare institutions in procuring innovative drugs is currently lacking, with a tendency to infrequently convene drug committees and rarely approving drugs for purchasing.

“To address this, it is essential to elevate the importance of rationally allocating and using innovative drugs in medical institutions and to intervene through administrative measures if necessary