On May 21, the National Medical Products Administration announced on its official website that Fazanleisen tablets (trade name: Mengping), a Class 1 innovative drug applied for by Jiangsu Coast Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yangtze River Pharmaceutical Group, has been officially approved for marketing. It is used to treat adult patients with insomnia who have difficulty falling asleep and/or maintaining sleep.The launch of this first domestically produced dual orexin receptor antagonist not only provides a new option for the huge population suffering from insomnia, but also marks a key milestone in Yangtze River Pharmaceutical's transformation from a generic drug giant to an innovative drug company, and lays the groundwork for reshaping the domestic insomnia drug market.

Insomnia has become a prevalent chronic disease. Data shows that by 2025, more than 500 million people in China will suffer from sleep problems. Long-term insomnia can easily lead to problems in multiple systems, including emotions, cognition, and metabolism. There is an urgent clinical need for new drugs that are safe, effective, and have good adherence.

Traditional sleep medications such as benzodiazepines and zolpidem can help you fall asleep quickly, but they have drawbacks such as drug tolerance, dependence, and rebound insomnia. On the other hand, orexin receptor antagonists, as a new generation of drugs with a novel mechanism of action, inhibit the arousal pathway by blocking orexin receptors in the hypothalamus, thus helping you fall asleep without changing the sleep structure. They are also non-addictive and can be used long-term, making them a hot research topic in the field of insomnia treatment.

Fazanleisen (development code YZJ-1139) is a dual orexin receptor antagonist independently developed by Yangtze River Pharmaceutical Group. It can simultaneously and effectively inhibit orexin type 1 and type 2 receptors. With its rapid absorption and moderate half-life, it achieves rapid onset of action and low residual effect the next day.

This approval is based on a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial that enrolled 1,034 adult patients with insomnia. The results showed that after 14 days of medication, sleep efficiency was significantly improved, sleep latency was shortened, and total sleep time was prolonged, with the effect lasting up to 180 days. In terms of safety, the drug was well tolerated, with a discontinuation rate of only 0.6% due to adverse events. There were no rebound insomnia or withdrawal symptoms after discontinuation, demonstrating significant clinical advantages.

From a market perspective, before the approval of Fazaresen, there were only two drugs with the same mechanism of action on the market in China: Eisai Pharmaceutical's Leboresen and Simcere Pharmaceutical's Daliresen, both of which were imported or licensed products from overseas.

The approval of Fazaresen as the first domestically produced drug of its kind breaks the monopoly of imported drugs in this field and allows Yangtze River Pharmaceutical to directly join the first tier of innovative insomnia drugs in China.

In terms of market potential, data from Menet shows that the domestic market size of oral hypnotic sedative drugs will exceed 1.7 billion yuan in 2025, with a year-on-year growth of about 30%. Among them, innovative drugs Dali Lesheng and Lebo Lesheng have rapidly increased their sales volume after being launched and have entered the top ten in the market.

With the increasing demand for medication among people with insomnia and the expectation of inclusion in medical insurance, Fazanlesen, with its domestically produced innovative price advantage and clinical advantages, is expected to quickly seize market share and become a new growth engine for Yangtze River Pharmaceutical.

The approval of this innovative drug is a microcosm of Yangtze River Pharmaceutical's innovation and transformation in recent years.

As a leading enterprise that has been deeply involved in the pharmaceutical industry for more than 50 years, Yangtze River Pharmaceutical Group has focused on generic drugs in the past. With its strong channels and quality control capabilities, it has always been among the top tier of generic drugs in China. More than 180 of its products have passed the consistency evaluation, and 66 of its products have been selected for national centralized procurement.

In recent years, with the normalization of centralized procurement and the intensification of homogeneous competition in the industry, enterprises have accelerated their transformation towards "combining imitation and innovation, and leading with innovation," implemented a "three-pronged" R&D strategy of traditional Chinese medicine, chemical drugs, and biological drugs, built four national-level innovation platforms, and achieved a series of innovative results.

In addition to the newly approved Fazanlesen, Yangtze River Pharmaceutical Group has launched several innovative drugs in recent years: in 2021, its first independently developed Class 1 chemical innovative drug, Levofloxacin Phosphate Disodium for Injection, was approved; in 2024, Yiqi Tongqiao Pill, a Class 1.1 traditional Chinese medicine innovative drug, was launched; and in 2025, Tonodafil Hydrochloride Tablets, a Class 1 chemical innovative drug, was approved. The innovative pipeline has formed a continuous output capability.

Meanwhile, the company has a rich pipeline of drugs under development. In addition to the approved products, there are many new drugs in the clinical stage, covering multiple therapeutic areas such as analgesia, neurology, and digestion, which will support future growth.

Looking ahead, the approval of Fazaresen is just the beginning of Yangtze River Pharmaceutical Group's innovative transformation. As competition intensifies in the domestic insomnia drug market, companies like Hansoh Pharmaceutical and Dongyangguang Pharmaceutical are also developing new drugs with similar mechanisms, making the competition in this sector increasingly fierce.

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