Four Generic Drug Candidates Recommended for Priority Review; Anbison Pharmaceuticals' Applications Still Under NMPA Review

April 2 (Medicine Network) – On March 29, the Center for Drug Evaluation (CDE) published on its official website the latest list of products proposed for priority review. The list includes eight application numbers covering four drug products (counted by product name and applicant company). All four products are submitted for marketing approval under Class 3 generic drug applications. They are proposed for inclusion in the priority review program on the grounds that they are manufactured on the same production line as products already marketed in the United States. Upon approval for production, they will be deemed to have passed the consistency evaluation.

 

Table 1: Products Proposed for Inclusion in Priority Review

(Source: CDE official website, Menet database)

 

Figure 1: Competitive Landscape of Bupropion Hydrochloride Extended-Release Tablets (I)

(Source: Menet One-Click Search)

 

Currently, there are no bupropion hydrochloride extended-release tablets (I) listed for sale in the domestic market. The original manufacturer, GlaxoSmithKline PLC., is applying for import approval; its import application was accepted by the Center for Drug Evaluation (CDE) on May 9, 2018, and is currently under review and approval. Two generic drug manufacturers, Sinotherapeutics Inc. and Shanghai Anbison Lab. Co., Ltd., have submitted marketing applications under Category 3 generics, both of which are currently in the "under review and approval (at the Center for Drug Evaluation)" status.

 

Figure 2: Sales of Metformin Hydrochloride Tablets at Public Medical Institution Terminals in China, 2013–2017 (Unit: 10,000 Yuan)

(Source: Competitive Landscape of China’s Public Medical Institutions Terminal, Menet)

 

According to data from Menet, the sales of metformin hydrochloride tablets at public medical institution terminals in China reached RMB 3.081 billion in 2017, representing a year-on-year increase of 18.74%, with the originator manufacturer Bristol-Myers Squibb capturing more than half of the market. Currently marketed formulations of metformin hydrochloride tablets include immediate-release tablets, extended-release tablets, and enteric-coated tablets, among others; there are 114 manufacturers holding production approvals for metformin hydrochloride tablets.

 

Figure 3: Status of Consistency Evaluation Applications for Metformin Hydrochloride Tablets

(Source: Menet One-Click Search)

 

Two companies have submitted marketing applications for Metformin Hydrochloride Tablets under the new registration classification, namely Dongguan Yangzhikang, a subsidiary of HEC Pharm.Pharmaceuticalsand Guangdong Saikang Pharmaceutical Factory, the products of Dongguan Yangzhikang Pharmaceutical are expected to accelerate their market launch through the pathway of foreign-to-domestic transfer submission and priority review, which is deemed as having passed the consistency evaluation.

 

There are 25 companies.EnterpriseThe application was submitted as a supplemental application for consistency evaluation. Four companies’ products have passed or are deemed to have passed the consistency evaluation, among which CSPC Ouyi Pharmaceutical’s Metformin Hydrochloride Tablets were approved for production under the Class 6 generic drug application, becoming the first to pass the evaluation.

 

Source: Menet Database, CDE Official Website