Another Batch of Generic Drugs Pass Consistency Evaluation: Shanghai Pharmaceuticals, Aosaikang Among Key Players

　　【Pharmaceutical Network Industry Dynamics】According to relevant policies in China, drugs that have passed the consistency evaluation are considered equivalent to the original research products in terms of quality and efficacy. These drugs will receive appropriate support in medical insurance reimbursement and procurement by medical institutions. With the promotion of national policies encouraging the prioritized procurement and use of such evaluated drugs, a large number of pharmaceutical companies, aiming to enhance market competitiveness and expand their market share, have proactively engaged in the consistency evaluation process. Good news about drugs passing the evaluation keeps coming. Recently, another group of drugs has passed the evaluation. Let’s take a look at which pharmaceutical companies are involved!
 

　　Shanghai Pharmaceuticals: Flunarizine Hydrochloride Capsules Approved
 

Shanghai Pharmaceuticals announced on March 4 that its holding subsidiary, Shandong Xinyi, received the "Drug Supplemental Application Approval Notice" issued by the National Medical Products Administration for flunarizine hydrochloride capsules. The drug has passed the generic drug consistency evaluation.
 

Flunarizine Hydrochloride Capsules are mainly used for the prophylactic treatment of typical (with aura) or atypical (without aura) migraines. Data from MiNe Network shows that in the first half of 2021, the total sales of Flunarizine Hydrochloride Capsules in public hospitals and grassroots terminals were approximately 340 million yuan; in 2021, the total sales at pharmacy terminals reached 124 million yuan.
 

As of now, in addition to Shanghai Pharmaceuticals, at least six other manufacturers of flunarizine hydrochloride capsules have passed the consistency evaluation, including Zhendong Pharmaceutical, Shandong Fangming Pharmaceutical, Jiangsu Pingguang Pharmaceutical (Jiaozuo), Huaxin Pharmaceutical, Zhengda Qingchunbao Pharmaceutical, and Anxin Biotechnology.
 

　　Aosaikang: Levobupivacaine Hydrochloride Injection Approved
 

Recently, Jiangsu Aosaikang Pharmaceutical Co., Ltd. announced that the company had received the "Drug Supplemental Application Approval Notice" for Levobupivacaine Hydrochloride Injection issued by the National Medical Products Administration, approving the drug to pass the quality and efficacy consistency evaluation for generic drugs.
 

The announcement shows that levobupivacaine, a new type of long-acting amide local anesthetic developed by Abbott, was approved for marketing by China's NMPA in June 2012. According to data statistics from Menet, in 2018, the sales of levobupivacaine hydrochloride injection in China’s urban, county-level, and township-level public hospitals approached 100 million yuan.
 

Currently, several companies in China have received approval for the generic drug Levobupivacaine Hydrochloride Injection, including Zhuhai Rundu Pharmaceutical and Jiangsu Hengrui Medicine. Jiangsu Aosaikang Pharmaceutical Co., Ltd. obtained approval for the 10ml:50mg specification of Levobupivacaine Hydrochloride Injection in November 2016. In November 2020, the company submitted a request for evaluation of the generic drug's consistency and recently received approval, becoming the second company in China to pass this evaluation.
 

　　Wanbangde: Pyrogallol Injection Approved
 

Wanbangde announced on the evening of March 1 that its subsidiary, Wanbangde Pharmaceutical, had received the "Drug Supplemental Application Approval Notice" from the National Medical Products Administration regarding the injection of phloroglucinol on the same day. The company's production of phloroglucinol injection has passed the consistency evaluation. It is reported that in this drug field, the company is the first pharmaceutical enterprise in China to pass the evaluation.
 

Phloroglucinol can directly act on the smooth muscles of the digestive, urinary, and reproductive systems, and has a large clinical demand. It was included in the Class B National Medical Insurance products in 2017. Data from MiNe Network shows that, in the first half of 2020, the market size of phloroglucinol in China's public medical institutions exceeded 1 billion yuan.
 

Currently, only three pharmaceutical companies in China possess the registration certificates for intravenous phloroglucinol and are engaged in its production. The intravenous phloroglucinol manufactured by Wanbangde Pharmaceutical obtained its drug approval number in 2018 and was marketed after receiving GMP certification in April 2019. The recent successful evaluation of this product is expected to significantly enhance the company's competitiveness in the hospital market and increase its market share.
 

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