Breakthrough Topical Treatment for Diabetic Neuropathic Pain Gains Approval in China, Addressing Unmet Needs of Over 200 Million Patients

(Source: Xinkangjie)

Source: Xinkangjie

On December 9, China Biologic Products announced that Beijing Tide Pharmaceutical Co., Ltd. ("Tide Pharmaceutical"), a subsidiary under its umbrella, had received approval for the new indication of its self-developed Lidocaine Gel Patch (Debaining) to be marketed for the relief of painful diabetic peripheral neuropathy (DPNP).

Public data shows that the lidocaine gel patch is the world's first and China's only approved patch medication for the treatment of DPNP. Prior to this, oral preparations were mainly used for DPNP treatment. This breakthrough not only fills the gap in topical first-line treatments both in China and globally, but also provides a safer and more convenient new treatment option for hundreds of millions of diabetes patients with DPNP in China.

Competition in the oral drug market is fierce.

With the changes in people's lifestyles, the incidence and prevalence of diabetes have been increasing year by year. Diabetes and its complications have become one of the most important public health issues in China. Among them, diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes.

Studies show that the number of diabetes patients in China has exceeded 200 million, among which the prevalence of DPN in type 2 diabetes patients is as high as 52.9%. Moreover, DPNP, as one of the complications, accounts for 19.2% of the latter group, and the prevalence rate rises to 34.5% in patients with a disease duration of over 10 years.

The most common symptom in DPNP patients is symmetric peripheral neuropathic pain, primarily affecting the distal limbs. It can also manifest as mononeuralgia or brachial plexus and lumbosacral plexus neuralgia. DPNP causes persistent suffering for patients, and severe symptoms can impact their quality of life, even disrupting normal daily activities. Some patients require long-term use of sleep aids.

It is reported that the third-generation calcium channel modulator Mirogabalin Besylate is currently the mainstream drug in the market, which has a good analgesic effect and fewer adverse reactions, effectively improving patients' sleep and quality of life. The drug mainly works by regulating calcium channels, reducing calcium ion influx, thereby inhibiting neuronal overexcitation and excessive release of neurotransmitters.

Mirogabalin besylate was originally self-developed by Daiichi-Sankyo. In January 2019, mirogabalin besylate was approved for the first time in Japan. In June 2024, Daiichi-Sankyo (China) announced that the drug had been approved for entry into the Chinese market for the treatment of adult DPNP.

Since its launch, Milnacipran Besylate Tablets have demonstrated significant market potential, with increasing revenue showcasing the drug's impressive capabilities. As a breakthrough product addressing the lack of treatment options in its field, it has inevitably attracted keen attention from companies in China. Meanwhile, the compound patent for Daiichi-Sankyo's Milnacipran Besylate Tablets is set to expire in September 2028.

Against this background,Milnacipran Besylate TabletsOnly half a year after entering the Chinese market, it has attracted a rush of imitations from many pharmaceutical companies, and a wave of generic drugs in the painkiller segment has already emerged.

In 2024, there are a total of 3 companies.CHIATAI TIANQING, Qilu Pharmaceutical,Chengdu Easton Bio Pharmaceuticals Co.,Ltd, submitted a generic drug listing application for Mirogabalin Besylate Tablets. Among them, CHIATAI TIANQING took the lead in launching the initiative in August. By 2025, the number of competing companies will surge.Huirui Pharmaceutical, Betta Pharmaceuticals,North China Pharmaceutical(Maintenance of Rights), Hekang Pharmaceutical, Daguang Pharmaceutical, and Jiuhua Huayuan Pharmaceutical / Huayi PharmaceuticalHave all joined the fray. Currently, the drugs from the aforementioned companies are all in the review stage.

Clinical Needs Are Urgent

It is important to note that, due to the complex pathogenesis of DPNP, the current analgesic drugs and treatment options are limited and insufficient to fully meet clinical needs. Patients with DPNP urgently need more diverse pain management solutions, especially in special populations such as those with oral intolerance and elderly patients.

Research data show that a single drug can only reduce pain scores by ≥50% in 30%-50% of patients, and 20%-30% of patients do not respond to first-line drugs, relying only on second-line or invasive treatments.

In response to the significant unmet clinical needs of DPNP patients, topical formulations play a crucial role.Moreover, compared with traditional patches, gel patches usually have better skin compatibility, adhesion, and drug release performance, offering a better experience for patients.

It is reported that Lidocaine Gel Patch, as the world's first topical patch for DPNP indication, adopts a unique skeleton-type hydrogel cross-linking technology, containing 700mg high-dose lidocaine, combined with various permeation enhancers and 37% matrix water content, ensuring the slow release of the drug. In a long-term follow-up of 7.6 years, 20 elderly DPNP patients continuously used the patch without any reduction in efficacy.

In addition, lidocaine gel patches can also be used in combination with oral medications, acting as an "efficacy enhancer and dosage reducer." Research data shows that for patients with insufficient efficacy from single oral medications, combining them with lidocaine gel patches can increase the pain relief rate to 78.2%. Some patients who responded effectively to the combined treatment were able to reduce or discontinue their oral medication.

In multiple guidelines or consensus documents related to diabetic peripheral neuropathy, lidocaine gel patches are recommended for the treatment of pain in DPNP. The "Expert Consensus on Pharmacological Treatment of Diabetic Peripheral Neuropathy," latest published in October 2025, also recommends it: Studies comparing lidocaine gel patches with pregabalin for PDPN found that both significantly reduce the severity of pain in PDPN patients. Combined use of the two can further enhance analgesic effects, with good tolerability and safety.

The emergence of lidocaine gel plaster has broken the long-standing treatment dilemma in China, where there were limited topical options for diabetic peripheral neuropathic pain.In Chinese-produced drugs, this type of locally applied topical pain-relief medicated patch remains a blue ocean, effectively filling the market gap.

Apart from Beijing Tide Pharmaceutical Co., Ltd.,Jiudian Pharmaceutical, Leming Pharmaceutical,Huahai Pharmaceutical, Haina Pharmaceutical, Huana Dayao Factory and other competitors emerged, successively filing for the market application of generic Lidocaine Gel Plaster this year.

Industry analysis indicates that lidocaine gel patches, as one of the representative products of topical DPNP formulations, have a core value in providing an efficient, safe, and precise localized pain relief solution.It is not intended to completely replace oral medications but rather to provide doctors and patients with another important tool, particularly excelling in reducing treatment side effects, improving quality of life, and enhancing treatment adherence.

The reference materials are from publicly available information on the Internet, including news reports, official corporate websites, and government documents.