After "ten years of sharpening a sword," a new drug reaching patients still has a "Long March" to cross.

Ask AI · How can enterprises break through hospital access bottlenecks to reach medicine and medical devices?

From R&D to approval for launch, an innovative drug or medical device is often seen as the victory of “earning it after a decade of sharpening a sword.” However, in the real healthcare ecosystem, obtaining the license for commercialization is only the first step of a “long march of 10,000 miles.”

To truly reach patients, these medicines and devices must also cross two thresholds: “payment” and “admission.” Getting medicines and devices covered by national medical insurance negotiations (the national “medicare deal,” or “guo tan”) can help address patients’ payment issues, but it still does not mean hospitals will automatically purchase them. In-hospital access involves complex procedures such as review by the pharmacy and therapeutics committee, and it is also constrained by multiple factors, including hospital performance and management requirements, doctors’ familiarity with new products, and real clinical demand.

Recently, departments including the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Health Commission, and the Shanghai Municipal Drug Administration jointly hosted an “Medicine and Enterprise Face-to-Face” exchange meeting. The event aimed to use the government as a platform to break the information asymmetry between patients/clinicians and enterprises, and to accelerate the transformation of locally developed innovative achievements into tangible clinical benefits.

In this dialogue, government departments hoped to help “new high-quality drugs and devices” reach clinical settings faster and support the growth of local enterprises. Enterprises’ greatest anxiety was how to get through hospital access after launch. What doctors care about most, meanwhile, is whether the product truly solves the problem, whether the evidence is sufficient, and whether it can be further iterated. Concerns that do not fully overlap among the three parties were repeatedly coordinated in the same setting, sketching the current supply-and-demand landscape of China’s innovative drug and medical device market.

Tackling the Pain Points

In recent years, Shanghai’s innovative drugs and devices have continued to emerge, and the industry’s scale has steadily grown. At the same time, the Science and Technology Commission and relevant departments have worked hard to advance initiatives such as the “Shanghai Municipal List of ‘New and Excellent Drugs and Medical Devices’ Products,” among other efforts, to close the “last mile” of clinical adoption for innovative products.

The “new and excellent drugs and medical devices” list is a policy supporting the development of locally innovative drugs and medical devices in Shanghai. For products included in the list, support is provided in areas such as in-hospital application, recommendations for inclusion in the medical insurance formulary, and commercial insurance design. It also promotes hospitals to start procurement within 1 month of being included in the list under an “should be supplied as needed” principle—functionally a “green channel” for admission. As of January 2026, the list has selected 7 batches comprising 220 products in total, including 70 medicines and 150 medical devices.

All three companies’ products at the meeting are included in this list. They are not disruptive therapies in the field of neurology, but they all target pain points in current clinical diagnosis and treatment that have long remained unmet.

The aminocaproic acid oral solution aerosol from Yingyao Bio-Technology (Shanghai) is aimed at infantile spasms, a rare disease. Over the past decade or more, this internationally recognized first-line medication has remained absent in China for a long time. Yu Lifei, Deputy Director of the Department of Neurology at Children’s Hospital Affiliated to Fudan University, candidly said at the meeting that before there was a drug, parents of affected children could only “try everything they could,” seeking drugs via overseas sourcing from other countries, while doctors could only take the corresponding medication risk. In 2023, this product entered the medical insurance list, filling the domestic gap in compliant treatments.

The levetiracetam sustained-release granules promoted by Shanghai Aimbien Pharmaceutical Technology Co., Ltd. are a typical case of pharmaceutical formulation innovation. As a classic anti-epileptic drug, levetiracetam is already available on the market in the form of regular tablets and oral solutions. Epilepsy treatment is often a “marathon” lasting for years or even a lifetime. The company has seized on the “adherence” challenge faced by “the elderly and the young” epilepsy patients: the sustained-release granules are convenient to carry, the taste is more agreeable, the dosing frequency is reduced to once daily, and the drug concentration in the blood is more stable.

The digital electroencephalography (EEG) device from Shanghai Nuocheng Electric Co., Ltd. represents the path of domestic medical device replacement. The company emphasized features such as high-throughput capability, synchronized stimulation, quantitative analysis, multimodal interfaces, and its adaptability to research and brain-computer interface application scenarios.

Today, a significant portion of medical products may not necessarily be disruptive innovations; rather, they are improvements around gaps in demand within existing diagnosis and treatment workflows. Some fill empty indications, some improve adherence and accessibility, and some enhance equipment performance and application scenarios.

Although companies want to get these products into hospitals quickly, the final decision still rests with doctors. A staff member from Yingyao Bio told The Paper’s (Pengpai) Science and Technology team that although their drug had already achieved 90% market share last year, and had previously been included in the “green channel” list of “new and excellent drugs and medical devices,” it still could not enter some hospitals—“the hospital decides based on actual conditions.”

Maximizing Clinical Value

At the meeting, the doctors’ remarks would bring the discussion back to clinical scenarios from product logic: which patients truly need the product, whether the evidence is sufficient, whether indications can be further expanded, and whether the equipment can be made closer to users’ habits.

Ding Jing, Director of the Department of Neurology at Zhongshan Hospital Affiliated to Fudan University, affirmed the value of the aerosol formulation of aminocaproic acid oral solution: “This is a drug we were hoping for, because there was no drug before.” She said that the incidence of infantile spasms is not high; it is a typical rare disease, but the problem does not become smaller just because there are fewer patients. As healthcare levels improve, more children survive and grow up, and then adult neurology will also encounter “grown-up patients with infantile spasms.” This means that a small drug that appears limited to pediatrics could create new use scenarios over a longer disease course.

However, existing products have proven efficacy only in infant patients. Prescribing the drug to adult patients means “off-label use,” which requires doctors to bear the medication risk. “We should organize a standardized clinical study to prove its efficacy in adult patients,” she said. The levetiracetam sustained-release granules have a similar issue: while feedback in pediatrics has been good, the approved patient population for the product is those aged 12 and above.

For EEG device products, Ding Jing also pointed out that high-end EEG equipment from abroad often keeps underlying data closed, preventing clinicians from conducting subsequent research on brain function and brain-computer interfaces. If local enterprises can provide open-source support and flexible customization paradigms, it would greatly enhance their competitiveness in research-oriented hospitals.

Yu Lifei said that children’s head circumference varies greatly from infancy to adolescence. If local enterprises can, like adjusting a car seatbelt, develop a portable EEG cap that automatically adapts to different head circumferences, and pair it with AI large models to assist doctors in reading images to support diagnosis, it would bring tremendous help to pediatric neurology diagnosis.

Wu Jinglei, Chairman of the Shanghai Medical Association, noted that if innovative drugs and devices are not “number one in the world,” and not absolute-original innovations in the strict sense, then for enterprises to win over doctors and hospitals, they must clarify their differentiation more clearly.

“Where are you different from imports? If the quality is the same, do you have a price advantage? Is the service better than abroad?” In his view, the Chinese market includes not only Shanghai’s large hospitals, but also many primary-care and county-level hospitals. To truly open channels, products cannot only target top experts; they also need to consider how they will be accepted and used across a broader medical system.

Hospitals are not naturally opposed to innovation, but they must make decisions under constraints of limited budgets, limited management space, and real payment conditions. Even if a product is included in medical insurance, if it increases departmental cost pressure, lacks sufficient evidence-based support, and is used infrequently, then pushing it within the hospital will still be slow. The doctors’ remarks at the meeting show that for enterprises to “break through” under these constraints, they must maximize the clinical value across each scenario.

From Symptom Relief to Treating the Root

Products that fill gaps, improve formulations, and provide domestic replacement are indispensable. But participating doctors also said that among the unmet clinical needs, the most urgent often lies in more effective disruptive innovation therapies.

Professor Wang Jian from the Department of Neurology at Huashan Hospital Affiliated to Fudan University has long worked on clinical treatment and scientific research for Parkinson’s disease. At the meeting, he introduced two cutting-edge paths being advanced in collaboration with enterprises: one is gene therapy, and the other is stem cell therapy. Unlike the projects from the earlier companies, these programs are still in the stage of clinical research and still have a distance to go before widespread application. However, what they correspond to is the most fundamental desire of neurologists—changing the course of disease, not only suppressing symptoms.

When discussing Parkinson’s disease, he said that existing drugs are already considered to have “pretty good symptomatic effects” among neurodegenerative diseases, but as time goes on, the drug effect declines, and patients will develop complications such as on-off phenomenon and dyskinesia. The disease is still progressing slowly. “There are still very important demands that have not been met.”

Can degeneration truly be delayed, or even function repaired? Through his projects, Wang Jian pointed out that gene therapy increases dopamine synthesis in the brain, and new therapies via stem cell transplantation “replace” damaged neurons—already demonstrating potential in clinical trials.

Yu Lifei also mentioned that for children with gene-related rare diseases and developmental epileptic encephalopathy, parents are expecting more thorough treatments. “For them, the expectation for drugs that only improve a single symptom is no longer that high. What they most long for are gene therapies, enzyme replacement therapies—the weapons that can truly change the root course of disease.”

Such achievements are emerging in Shanghai in increasing numbers—such as predicting Alzheimer’s disease with precision 15 years earlier, and brain repair gels that repair necrotic brain tissue. But whether it is these disruptive technologies or a small pack of sustained-release granules that address swallowing difficulties, only when the value of innovation finally penetrates hospital access barriers and lands steadily on patients can the closed loop of the pharmaceutical and medical industry be considered truly complete. Participants said this requires more communication and joint building between both medical institutions and enterprises.