Core Viewpoint - Beijing Tide Pharmaceutical Co., Ltd. has received approval for its self-developed lidocaine gel patch (Debain) to treat diabetic peripheral neuropathic pain, making it the first and only approved topical analgesic for this indication globally [1][2] Group 1: Product Approval and Market Potential - The Debain patch fills a significant treatment gap for diabetic peripheral neuropathic pain, which affects over 200 million diabetes patients in China, with a substantial portion likely to develop this condition [1] - Approximately two-thirds of type 2 diabetes patients may experience diabetic peripheral neuropathy, with over half of these patients progressing to diabetic peripheral neuropathic pain, characterized by severe pain that impacts sleep and emotional well-being [1] Group 2: Product Features and Efficacy - The Debain patch utilizes a unique hydrogel cross-linking technology, delivering 700mg of high-dose lidocaine, promoting effective drug penetration while minimizing skin adverse reactions, and providing sustained analgesic effects for up to 12 hours [2] - Long-term follow-up data indicate that the patch is suitable for prolonged use, with a pain relief rate of 78.2% when used in conjunction with oral medications, allowing some patients to reduce or discontinue oral medication [2]

Core Viewpoint - Beijing Tide Pharmaceutical Co., Ltd. has received approval for its self-developed lidocaine gel patch (Dabain) to be used for the treatment of diabetic peripheral neuropathic pain, making it the first and only approved topical analgesic for this indication globally [1] Group 1: Product Approval and Market Impact - The approval of Dabain fills a treatment gap for first-line medications in China and abroad, potentially providing a safer and more convenient pain management solution for over 200 million diabetic patients in China [1] - Approximately two-thirds of type 2 diabetes patients may develop diabetic peripheral neuropathy, with more than half of these patients progressing to diabetic peripheral neuropathic pain, which significantly affects their quality of life [1] Group 2: Clinical Challenges and Limitations - Diabetic peripheral neuropathic pain is often underdiagnosed and inadequately treated, with common oral medications having significant side effects and addiction potential, particularly impacting elderly and renal impairment patients [1] - The pain associated with this condition can severely disrupt sleep and emotional well-being, leading to anxiety and depression, highlighting the need for effective treatment options [1]

Core Viewpoint - The approval of Lidocaine Gel Patch (brand name: Debain) by the National Medical Products Administration marks a significant milestone for Tide Pharmaceutical in the treatment of diabetic peripheral neuropathic pain (DPNP) [1] Company Overview - Tide Pharmaceutical has over 20 years of experience in transdermal formulation technology, focusing on this core area to build a leading modern transdermal technology platform and product matrix in China [1] - The company has successfully launched several products, including: - Fluorobuprofen Gel Patch (Debian) in 2010, capturing 90% of the domestic hospital external analgesic market with annual sales exceeding 30 billion [1] - Debain in 2018, filling a gap in external treatment for postherpetic neuralgia [1] - Suledar, an Alzheimer's treatment patch, recognized upon its initial launch in 2024 [1] - Deritro, a cough and asthma relief patch, expected to launch in 2025 [1] - Recently approved Rotigotine Parkinson's patch (Rofidin), enhancing the company's presence in the neurological field [1] Product Development Strategy - Tide Pharmaceutical plans to launch 14 transdermal delivery products by 2030, continuously improving its product layout through a strategy of "star-led, tiered collaboration" [1]