She often falls asleep on the bus, while reading, and during meetings to review contracts... 28-year-old Ms. Jiang (pseudonym) seems to have the superpower of "falling asleep instantly" anytime and anywhere.
Others laughed at her as a "god of sleep", and her mother once thought she was "naturally lazy", but the real reason was narcolepsy, a chronic and rare neurological disease. In 2023, narcolepsy was officially included in my country's "Second Batch of Rare Disease Catalogue".
On October 15, the world's first innovative drug for this disease, Ozeyue® (generic name: Opreton Tablets), was officially launched exclusively on JD Health.
This is a new target innovative drug that was developed and applied for simultaneously in multiple centers around the world. In July this year, relying on the State Food and Drug Administration’s accelerated review and approval of new drugs with significant clinical advantages, China became the first country in the world to approve the marketing of Aozeyue®. It only took 6 months from acceptance to approval, which is regarded by the industry as a historic breakthrough of "the original target innovative drug developed by multiple centers around the world was reported for the first time in China."
However, going online is only the first step. For a world-first innovative drug, what lies between the time it is approved and when patients actually use it? The answer to this question is becoming a new yardstick for measuring the core capabilities of out-of-hospital platforms.
The “China Speed” of a New Drug for Rare Diseases
On July 23, 2026, the official website of the State Food and Drug Administration issued a notice that through the priority review and approval process, it approved the listing of the Class 1 innovative drug Opreton Tablets (trade name: Ozeyue®) applied by the multinational pharmaceutical company Takeda for use in adolescents and adult patients with narcolepsy type 1 (NT1) aged 16 years and above.
As the world's only highly selective OX2R agonist targeting the cause of NT1, Auzeyue® was the first to submit a marketing application in China in January 2026 under the background of simultaneous research and development in multiple centers around the world, and was the first to complete review and approval in China, becoming the first market in the world to be approved for this drug. From submission to approval, it only took about 6 months. In the global R&D landscape of multinational pharmaceutical companies, this phenomenon in which China is the first to submit an application ("first filing") and be the first to be approved for marketing ("first filing") is called "first filing" in the industry.
"Generally speaking, in the past, everyone focused on the U.S. Food and Drug Administration. After preparing the English content first, they would then translate it into Chinese or fine-tune it, and then submit it to China. This would take at least several months." Li Ning, chief physician of the National Cancer Center's Drug Clinical Trial Center, once described the past practice, "But for this drug, the first thing to do is to prepare China's marketing application materials and submit a marketing application to the China Food and Drug Administration."
Behind the "first report" of Aozeyue® reflects the systematic improvement of China's innovative drug development environment.
2026 is the first year of the "15th Five-Year Plan". This year's government work report clearly lists biomedicine as an "emerging pillar industry" at the national level for the first time. The "15th Five-Year Plan for National Health" further proposes that the entire chain support the development and application of innovative drugs and medical devices.
From the review perspective, the General Office of the State Council previously issued a document calling for accelerated review and approval of drugs for rare diseases. The State Food and Drug Administration continues to deepen reforms and relies on multiple fast-track channels such as breakthrough therapy designation and priority review and approval to press the "accelerator button" for innovative drugs that are urgently needed for clinical needs, prevention and treatment of major diseases, and rare diseases.
From a clinical perspective, the State Food and Drug Administration's 2025 "China New Drug Registration Clinical Trial Progress Annual Report" shows that the total number of drug clinical trials in my country has exceeded 5,000 for the first time, and international multi-center clinical trials have reached 410 in 2025. What’s more important is the change in the depth of participation: Chinese research teams have participated simultaneously in the Phase I clinical trials of Aozeyue®.
Dr. Liu Yan, President of Takeda China, said, "China has become the first market in the world to approve the marketing of AoZeyue®, which is the result of a combination of conditions. As the Chinese market becomes more and more important in the world, from the perspective of global pharmaceutical companies, there may be more new drugs that hope to be launched in China first in the future."
According to Cai Xiao, a cooperation expert with JD Internet Hospital and director of the Sleep Medicine Center of Chengdu Fourth People's Hospital, the significance of this change goes beyond just one medicine.
"In the past, China would not be chosen for early clinical research on cutting-edge drugs. With the improvement of scientific research capabilities and the increase in policy support, China's clinical research capabilities have entered the forefront of the world." She said, "Chinese patients can use this innovative drug first in the world, without having to wait for approval from Europe and the United States. This also shows that China's drug review and approval reform, clinical research capabilities and data quality are recognized."
"It is a signal to the industry that global innovative drugs will consider China earlier." Director Cai Xiao emphasized, "This is the world's first approval. It is not just an approval of a drug. It marks that China has started to lead in the field of innovative sleep medicine drugs from following and running together, and at some points starting to lead."
A “protracted battle” between cognition and diagnosis
"Doctor, I can't help but fall asleep, what should I do?"
At the Sleep Medicine Center of Chengdu Fourth People’s Hospital, such questions are not uncommon. This is not laziness or weakness of will. Director Cai Xiao said that they are suffering from a rare disease - narcolepsy. The essence of this disease is not a psychological problem, nor is it a simple insomnia, but a problem with the switch between wakefulness and sleep in the brain.
"The core mechanism is that there are fewer neurons called orexin and hypocretin in the hypothalamus, which is especially obvious in patients with type 1." She made an analogy, "It is like the brain's 'awake fuel'. When it is missing, people will suddenly feel sleepy during the day, fall asleep for a second, and may even cataplexy when excited." Typical manifestations include excessive daytime drowsiness, cataplexy, sleep paralysis, pre-sleep hallucinations and poor sleep at night, but not everyone has all five.
In 2023, narcolepsy was included in the second batch of national rare disease catalogs. According to Han Fang, director of the Department of Respiratory and Sleep Medicine at Peking University People's Hospital, there are an estimated 700,000 narcolepsy patients in my country. At present, the number of confirmed cases in our country is only about 5,000, and a large number of patients have not yet been discovered.
"It's so good at disguise," Cai Xiao said. When people feel sleepy during the day, the first thing that comes to mind is lack of sleep, depression, anemia, or snoring and lack of oxygen; when children fall asleep in class, they are easily mistaken for ADHD or laziness; cataplexy - when the legs become weak and fall when laughing or being emotional - is often mistaken for epilepsy, syncope, hypoglycemia or even psychological problems. "Many patients first go to the psychiatry department, neurology department, respiratory department, and pediatrics department, and it takes several years before they are transferred to the right place."
Diagnosis is not just a blood draw. Cai Xiao said that this requires detailed medical history, overnight sleep monitoring, multiple sleep latency tests, and sometimes checking the orexin in the cerebrospinal fluid. “Not all hospitals can do these examinations, especially at the grassroots level.” Therefore, it often takes several years from onset of illness to diagnosis. The data given by Cai Xiao is that the average is 8 to 10 years.
After going through a long journey to seek medical treatment, the second hurdle that patients face is treatment. For a long time, treatment for NT1 has mainly relied on symptomatic control: using stimulants to "refresh" from the outside, or using antidepressants to suppress cataplexy, often requiring a combination of multiple drugs. Patients face the dilemma of unsatisfactory efficacy and difficult long-term management.
The approval of Aozeyue® broke this situation. It selectively activates orexin type 2 receptors and restores the sleep-wake signaling pathway damaged by orexin deficiency. "It's like equipping this signal light with a spare key, turning on the wake-up switch directly, allowing the brain to receive the signal of 'it's time to be awake' again." Director Cai Xiao said, "It is not a stimulant or an antidepressant, but directly targets the orexin pathway, closer to the core mechanism of the disease. It is not a cure, but the direction is different."
However, approval of a new drug does not mean that patients can use it immediately. From approval to admission, you usually have to go through inter-provincial procurement, hospital pharmaceutical committee meetings, etc. For rare disease drugs, the situation is more complicated: patients are scattered, the dosage of a single disease is small, and county diagnosis, treatment and medication capabilities are insufficient.
After there is a cure, how to get the medicine to the patients becomes the next problem.
Get through the last mile after the "first launch"
To truly deliver new rare disease drugs to patients, third-party supply chains often need to fill the gap.
There are three reasons: patients with rare diseases are scattered across the country, and individual hospitals have limited willingness to stock up; molecular stability requirements are high; and a large proportion of drug users are not in provincial capital cities. Taking Auzeyue® as an example, this drug needs to be taken regularly and for a long time. This means that for new drugs, “getting it available” itself is a hard indicator of accessibility.
In order to help more patients find medicines, JD Health has launched the "Global Drug Search" platform. Search for a certain drug through the JD App. After the search fails, you can submit a drug search request. After receiving the demand, JD.com staff will communicate with pharmaceutical companies to promote the introduction and launch of relevant drugs. After Aozeyue was approved, more than 120 patients have consulted on the global drug search platform.
On the morning of October 15, Aozeyue® was launched on JD Health. On the same day, nearly 20 hospitals across the country, including Xuanwu Hospital of Capital Medical University, Huashan Hospital of Fudan University, and Dongfang Hospital of Tongji University, issued the first batch of prescriptions simultaneously.
Behind this "synchronization" is JD Health's years of deep cultivation in the field of rare diseases.
On February 27, 2021, JD Health launched the "Rare Disease Care Plan", launched the "Rare Disease Care Center", and established a rare disease care fund in conjunction with the Beijing Sickness Challenge Charity Foundation. It is worth mentioning that Takeda Pharmaceutical, as the R&D company of Aozueyue®, was one of the first participants on the day the program was launched.
For pharmaceutical distribution platforms, rare disease drugs are often a “low-frequency, high-cost” long-tail business. A person in charge of JD Health's pharmaceutical business once said bluntly: "You may not be able to sell much in a year, but if someone needs it, you must prepare it!" By the end of 2025, JD Health can purchase 88 types of rare disease drugs and 35 types of special medical foods; in 2025 alone, nearly 30,000 users purchased more than 70,000 rare disease treatment drugs through the platform.
The ability to support these scattered and low-frequency demands relies on JD Health’s continuous investment in pharmaceutical supply chain infrastructure over the past decade: Today, it has deployed 40 pharmaceutical warehouses and 22 professional cold chain warehouses across the country, covering 95% of districts and counties across the country; in emergency scenarios in more than 400 cities and towns, the delivery speed can be as fast as less than 30 minutes. These daily accumulations form the underlying network for Aozeyue® to quickly reach patients after it is launched.
But for chronic diseases like NT1 that require lifelong management, the delivery of the drug does not mean the end of the service, but the beginning of a long-term test - who will be responsible for the follow-up after medication, dose adjustment, and adverse reaction monitoring, and how to continue it?
Faced with this long-term examination question, JD Health’s tens of thousands of pharmacists have become “long-term companions” around patients. Pharmacists are not only responsible for reviewing prescriptions, but also extend services after diagnosis: providing medication guidance, risk warnings, collecting feedback on adverse reactions, and providing follow-up prescription reminders to help patients complete long-term treatment more safely and standardizedly.
From "first reporting" to "first release", China has achieved "acceleration" in the launch of innovative drugs for rare diseases; but from "first release" to actual "use", a long-distance race on accessibility has just begun. The lifelong management of rare diseases is destined to not be accomplished by a single platform alone. It requires a network covering county logistics, cold chain temperature control, prescription review and long-term follow-up. It also requires the joint efforts of hospitals, pharmaceutical companies, platforms and the whole society. After all, the most valuable goal of "global premiere" is to prevent every "few people" from being given up.
