On May 21st, Hisilicon announced that it had received a Class 1 innovative drug, Anruikefen Injection (product name: Sishujing), issued by the National Medical Products Administration ®， R&D code: HSK21542) "Drug Registration Certificate". Anruikefen injection is a highly selective peripheral kappa opioid receptor agonist independently developed by the company. It is also the first white prescription opioid analgesic drug in the world to obtain analgesic indications without being included in the management of anesthesia drugs.

 

 

 

In addition to the currently approved indications, Hisilicon also submitted a marketing authorization application for itching indications related to chronic kidney disease in September 2024, and is expected to be approved for marketing this year.

 

 

 

On May 17th, CDE announced that the marketing application for Class 3 generic drugs of Zonisamide oral suspension from Shandong Langnuo Pharmaceutical was accepted, marking the first domestic generic drug. Single drug therapy for newly diagnosed partial seizures (with or without secondary generalized seizures) in adults; Additional treatment for partial seizures (with or without secondary generalized seizures) in adults, adolescents, and children aged 6 and above.

 

 

 

It is reported that the original research company of Zonisamide is Sumitomo of Japan, which was approved for listing in China in 2011. At present, the domestically marketed product is Zonisamide tablets, and no suspension form of the drug has been approved for marketing. Among them, the sales revenue of Zonisamide tablets in hospitals (all terminals) nationwide in 2023 was 47.17 million yuan, and in the first half of 2024 it was 17.94 million yuan. It is worth mentioning that according to the China Drug Evaluation Database, there are currently few competitors for zolpidem. In the future, after the successful launch of the Zonisamide oral suspension from Shandong Langnuo Pharmaceutical, it is expected to have significant development potential.

 

 

 

On May 8th, according to CDE, Hangzhou Muyuan Biopharmaceutical Technology Co., Ltd.'s application for the listing of bovine sulfonamide ursodeoxycholic acid capsules, classified as Class 4 according to registration classification, was accepted, becoming the first generic drug application for listing in China.

 

 

 

Ursodeoxycholic acid has antispasmodic, anticonvulsant, anti-inflammatory, and cholelithiasis dissolving effects. It is mainly used clinically to treat gallbladder cholesterol stones, primary sclerosing cholangitis, primary biliary cirrhosis, and chronic hepatitis C. Data shows that the sales revenue of hospitals (all terminals) in China in 2023 will be 100 million yuan, and in the first half of 2024 it will be 31 million yuan, with only original manufacturers selling. In the future, after domestic drugs are launched, they are expected to seize more of the original drug market.

 

 

 

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Since the beginning of this year, several first generic drugs have also been approved for market in China, such as nitroglycerin sublingual tablets from Shenzhen Taili Biopharmaceutical Co., Ltd., epistine hydrochloride eye drops developed by Guangzhou Runer Ophthalmology, and guanidine hydrochloride sustained-release tablets from Baili Pharmaceutical. This reflects the continuous progress of China's generic drug industry in technological innovation under policy guidance, and has begun to enter the harvest period. In the future, with the continuous assistance of the government to the generic drug industry and the continuous improvement of research and development capabilities and technological levels of pharmaceutical companies, the competitiveness of domestic pharmaceutical companies in the generic drug market will become increasingly strong.