Core Viewpoint - Jinghua Pharmaceutical has received approval from the National Medical Products Administration for two drug registration certificates for its controlled-release capsules of carbidopa and levodopa, enhancing its product pipeline in the Parkinson's disease treatment sector [1] Group 1: Product Approval - The company is the third entity in China to obtain approval for the controlled-release capsules of carbidopa and levodopa (specification: carbidopa 50mg, levodopa 200mg) [1] - The controlled-release capsules (specification: carbidopa 25mg, levodopa 100mg) represent the first generic version in China, with the original product not registered for sale domestically [1] Group 2: Market Opportunities - The approval of the controlled-release capsules enriches the company's product offerings in the Parkinson's disease treatment field [1] - The introduction of the small specification product as the first generic in the domestic market provides the company with additional business opportunities in this niche market [1]

Core Viewpoint - The approval of the controlled-release formulation of Carbidopa-Levodopa by the National Medical Products Administration enhances the company's product pipeline in the Parkinson's disease treatment sector, particularly with the introduction of a first generic version in the domestic market [1] Group 1: Product Approval - The company received two drug registration certificates for Carbidopa-Levodopa controlled-release tablets [1] - The specifications for the approved products include Carbidopa 50mg and Levodopa 200mg, and Carbidopa 25mg and Levodopa 100mg [1] - The latter specification is the first generic version in China, as the original product has not been registered for sale domestically [1] Group 2: Market Impact - The approval enriches the company's offerings in the Parkinson's disease treatment market, providing a significant opportunity in a niche segment [1] - The controlled-release formulation is recognized as the "gold standard" for treating Parkinson's disease according to the "Chinese Parkinson's Disease Treatment Guidelines (2020 Edition)" [1] - The availability of the smaller dosage form improves medication convenience for patients with mild symptoms [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for two drug registration certificates for Carbidopa-Levodopa Extended-Release Tablets, enhancing its product pipeline in the Parkinson's disease treatment sector [1] Group 1: Product Approval - The Carbidopa-Levodopa Extended-Release Tablets (specification: Carbidopa 50mg, Levodopa 200mg) is the third approved product in the domestic market [1] - The Carbidopa-Levodopa Extended-Release Tablets (specification: Carbidopa 25mg, Levodopa 100mg) is the first generic version in the domestic market, with no original product registered for sale [1] Group 2: Market Opportunities - The approval of these products expands the company's opportunities in the Parkinson's disease treatment market [1] - The new products may lead to increased business prospects in this niche market [1] Group 3: Sales Uncertainty - The production and sales of the drugs may be influenced by changes in the market environment and other comprehensive factors, leading to certain uncertainties in sales performance [1]

公司卡左双多巴缓释片(规格：卡比多巴50mg、左旋多巴200mg)为国内第三家获批企业，卡左双多巴缓 释片(规格：卡比多巴25mg、左旋多巴100mg)则为国内首仿且该规格原研产品没有在国内进行注册销 售。 卡左双多巴缓释片的获批，丰富了公司在帕金森病治疗领域的产品管线，特别是其小规格产品成为国内 首仿，为公司在这一细分市场领域赢得了更多商机。卡左双多巴缓释片是左旋多巴与卡比多巴按4:1比 例组成的复方缓释制剂，被《中国帕金森病治疗指南(2020年版)》列为治疗帕金森病的"金标准"。公司 卡左双多巴缓释片的成功获批，为帕金森病患者提供了比较好的原研替代产品，其中小规格的获批，为 轻症患者的服药带来了便利性。 智通财经APP讯，精华制药(002349.SZ)发布公告，近日，公司收到国家药品监督管理局核准签发的卡左 双多巴缓释片的两个《药品注册证书》。 ...