According to the "China Pain Medicine Development Report (2020)," there are over 300 million chronic pain patients in China, and this number is rapidly increasing by 10 to 20 million annually. While pain doesn't directly threaten life like other diseases, it can lead to a decline in quality of life and may contribute to suicide, premature death, Alzheimer's disease, depression, and anxiety. Pain is mainly divided into acute pain and chronic pain. Chronic pain refers to pain that persists or recurs for more than three months, and its harmfulness far exceeds that of acute pain.
On April 13, 2026 , according to the latest announcement on the official website of the Center for Drug Evaluation ( CDE ) of China, Humanwell Pharmaceutical US, Inc., a subsidiary of Humanwell Healthcare Group, received implied approval for its clinical trial application for hydrocodone bitartrate extended-release tablets, submitted under chemical drug registration category 5.2 . The proposed indication is for the treatment of severe pain requiring long-term, daily opioid therapy that is not adequately relieved by alternative therapies . The clinical trial application for this drug was approved by the CDE on January 13, 2026.
According to publicly available information, hydrocodone is an analogue of codeine and has similar anesthetic, analgesic, and antitussive effects. Most of these effects are related to the central nervous system and smooth muscle. As an agonist of μ-opioid receptors, hydrocodone binds to these receptors in the brain and spinal cord, inhibiting the transmission of pain signals and reducing the body's perception of pain and emotional response . A commonly used formulation is hydrocodone tartrate, which is often combined with acetaminophen to relieve moderate to severe pain.
On November 20, 2014, the U.S. FDA approved Hysingla ER (hydrocodone tartrate extended-release tablets), a potent opioid analgesic from Purdue Pharma. Hysingla ER is a single-component extended-release hydrocodone tablet for the care of severe chronic pain requiring long-term use when other treatment options are unavailable. Hysingla ER is manufactured using Purdue Pharma's RESISTEC™ extended-release oral solid dosage form process, which effectively prevents the extraction of its active ingredient, hydrocodone.
Hysingla ER, prepared using the RESISTEC™ sustained-release oral solid dosage form platform, makes it difficult to extract its main active ingredient, hydrocodone, through common methods such as crushing, decomposition, or dissolution, for use in similar drug administration methods such as nasal inhalation or injection. Hysingla ER contains a high molecular weight polymer processed using a unique technology. This process results in tablets that are not only highly rigid but also, when dissolved, at most form a thick hydrogel, making them difficult to administer intravenously.
Nearly 12 years later, Humanwell Healthcare submitted a clinical trial application for hydrocodone bitartrate extended-release tablets, which has been accepted, potentially filling a gap in the domestic market. It is worth noting that hydrocodone bitartrate extended-release tablets utilize a special extended-release process, allowing the drug to be slowly released in the body, achieving two key effects:
Stable blood drug concentrations : Compared to immediate-release formulations that need to be taken every 4-6 hours, extended-release tablets avoid the "peak and trough" phenomenon of drug levels in the body. Research data shows that once-daily hydrocodone extended-release tablets can significantly reduce the fluctuation range of blood drug concentrations, keeping drug levels stable over 24 hours.

Sustained pain control : This smooth release ensures consistent and continuous analgesia over dosing intervals of up to 24 hours. This means patients can “forget the pain” rather than experience its recurrence before the next dose.

Currently, there are two main categories of commonly used medications for pain treatment in clinical practice. The first category is nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and aspirin, which are mainly used for pain caused by inflammation or trauma in peripheral areas, such as toothache and muscle soreness. The second category is opioid analgesics , such as morphine, fentanyl, and codeine. Because they can block the transmission of pain signals to the spinal cord and brain, their analgesic effect is theoretically often stronger.

To this day, the development path of the painkiller field can be said to revolve around the effectiveness of nonsteroidal anti-inflammatory drugs and the evolution of gastrointestinal reactions, while on the other hand, it revolves around how to reduce the addictiveness of opioids. Various new drugs have emerged during this period to compensate for each other's limitations, but they also continue to create limitations. In the past 200 years, no painkiller has been perfect.

Hydrocodone bitartrate extended-release tablets, as a long-acting opioid analgesic, offer core clinical advantages primarily in their stable analgesic effect, lower fluctuations in blood drug concentration, better patient compliance, and unique anti-abuse properties . These characteristics make them a unique option for the management of chronic moderate to severe pain requiring long-term, 24-hour treatment. It is hoped that Humanwell Healthcare's subsequent clinical trials of hydrocodone bitartrate extended-release tablets will proceed smoothly, providing more treatment options for patients as soon as possible.

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