First domestic generic! Jimin Kexin’s Ropinirole Hydrochloride Sustained-Release Tablets approved for marketing

September 1, 2024  Source: drugdu 57

"/Nanjing Hengsheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Nanjing Hengsheng"), a subsidiary of Jimin Trustworthy Group, received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration (NMPA), approving the company's ropinirole hydrochloride sustained-release tablets (specification: 2mg) for sale. This variety is the first generic drug of ropinirole hydrochloride sustained-release tablets approved for sale in China. It is mainly used to treat patients with Parkinson's disease in the early, middle and late stages and non-motor symptoms. It is developed by the Innovative Technology Drug Research Institute under Jimin Trustworthy Group and Nanjing Hengsheng is in production.

Parkinson's disease is a common degenerative disease of the elderly nervous system. Symptoms include resting tremor, muscle rigidity, bradykinesia, cognitive impairment, etc. The condition worsens over time, causing great burdens on patients' families and society. Ropinirole hydrochloride is a new dopamine receptor agonist that can enter the central nervous system and act on dopamine receptors on the postsynaptic membrane. Through its pharmacological effects, it can improve the patient's clinical manifestations such as bradykinesia, limb tremor, and increased muscle tension. It is one of the commonly used drugs for the treatment of Parkinson's disease.

Ropinirole hydrochloride sustained-release tablets are mostly used in combination with levodopa to treat Parkinson's disease. They can delay the disease and significantly reduce the off-period (when Parkinson's patients take dopamine replacement drugs, their symptoms will suddenly fluctuate between relief and aggravation. The relief period is also called the on period, and the aggravation period is called the off period). It has good safety and reduces the number of times it is taken compared to ropinirole ordinary tablets, greatly increasing the patient's medication compliance.

According to data from Minnet, the terminal sales of ropinirole hydrochloride sustained-release tablets in public medical institutions across the country have exceeded 100 million yuan in the past five years, accounting for less than 1% of the total sales of dopamine agonists in the market. As the aging population in my country further intensifies, the future market space for ropinirole sustained-release tablets is huge. As the first domestic generic product, it will help more Parkinson's disease patients benefit.

The project originated from Jimin Kexin's high-end oral solid preparation platform, which is affiliated to the Innovative Technology Drug Research Institute of Jimin Kexin R&D Center. It covers immediate-release preparations, sustained-release preparations, solubilization of poorly soluble drugs (including hot-melt extrusion) and multi-particle delivery systems. The R&D facilities are advanced and complete, and it has rich experience and resources in preparation R&D and industrialization technology. In recent years, relying on this platform, Jimin Kexin has achieved technological breakthroughs in several high-end generic drugs, and many products have been approved. Many projects under development have completed scale-up production and clinical BE, and related products are expected to be approved for listing one after another.

https://mp.weixin.qq.com/s/ol4jI2oeqIua1zrBETtnzQ

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