Zhejiang Hisun Pharma Set to Become Third Domestic Manufacturer to Launch Acarbose Tablets in China's $1.1B Market

Author:Cai Cai

Zhejiang Hisun Pharmaceutical’s new Class 4 generic drug “Acarbose Tablets” marketing application (Acceptance No.: CYHS1900124) is currently “under review,” with approval expected in the near term; upon approval under the new registration classification as a Class 4 product, it will be deemed to have passed the consistency evaluation.

(Source: NMPA)

Three-way Split in the Domestic Market

Acarbose is an α-glucosidase inhibitor. The original manufacturer is Bayer, Germany. It was approved for marketing by the NMPA in September 1999, with the brand name Glucobay.

As a novel oral hypoglycemic agent, acarbose competitively inhibits intestinal alpha-glucosidases, thereby suppressing the breakdown of starches into glucose and reducing intestinal glucose absorption, which ultimately lowers postprandial hyperglycemia. Since acarbose primarily reduces glucose absorption by inhibiting alpha-amylase, it is particularly suitable for Asian populations whose diets are predominantly composed of carbohydrate-rich staples such as rice and wheat products. Consequently, its sales performance in China has been significantly stronger than in European and American markets.

Currently, there are four approved manufacturers of acarbose preparations in China: the originator Bayer, Huadong Medicine (Zhongmei Huadong), Luye Pharma, and Beijing Fuyuan Pharmaceutical (formerly Beijing Wansheng Pharmaceutical). Among them, Bayer, Huadong Medicine, and Beijing Fuyuan produce tablet formulations, while Luye Pharma produces capsule formulations. Huadong Medicine’s generic acarbose was first approved in 2002 under the brand name Kaboping, with strengths of 50 mg and 100 mg; its chewable tablet formulation was approved for marketing in 2015. Beijing Fuyuan Pharmaceutical’s acarbose tablets (50 mg) were approved for marketing in December 2019 (approval under Class 4 application is considered equivalent to passing the consistency evaluation). Huadong Medicine (50 mg, 100 mg), Luye Pharma (50 mg), and Beijing Fuyuan (50 mg) have all passed the consistency evaluation.

According to data from Zhongkang CMH, domestic sales of acarbose in China reached RMB 7.568 billion in 2019. Among this, the original research product from Bayer held approximately 60% of the market share, Huadong Medicine accounted for over 30%, and the remainder was comprised of Luye Pharma’s capsule formulation. In the 2017 edition of the National Reimbursement Drug List, acarbose was upgraded from Category B to Category A, accelerating import substitution. According to industry insiders, Huadong Medicine’s sales revenue for acarbose tablets was expected to exceed RMB 3 billion in 2019, representing a year-on-year growth rate of 30%. It has consistently remained the domestically produced oral hypoglycemic agent with the highest market share in China.

(Data source: Zhongkang CMH)

Huadong Medicine Loses Bid in Centralized Procurement

On January 20, 2020, Huadong Medicine issued an announcement stating that its wholly-owned subsidiary, Zhongmei Huadong, failed to win the bid for its product acarbose tablets (brand name: Capon) in the second batch of the national centralized drug procurement due to pricing factors. The announcement indicated that on January 17, Zhongmei Huadong’s acarbose tablets, which had passed the consistency evaluation of quality and efficacy for generic drugs, participated in the second national centralized drug procurement. Following the bid opening by the Joint Procurement Office and the evaluation according to the established rules, Zhongmei Huadong’s acarbose tablets failed to secure the bid this time due to pricing factors.

(Source: CNINFO)

Based on the previous centralized procurement bidding results, Zhongmei Huadong, Bayer, Luye Pharma, and Beijing Fuyuan simultaneously participated in the bidding. The quoted prices from the four companies were RMB 13.96, RMB 9.60, RMB 5.42, and RMB 12.98, respectively, with all specifications being 50 mg/30 tablets (capsules). According to the pricing, Bayer and Luye Pharma won the bid.

Huadong Medicine’s 2019 revenue reached approximately RMB 35.446 billion, with sales of acarbose accounting for about 9% of the total revenue. Affected by losing bids in the centralized volume-based procurement program, Huadong Medicine’s market capitalization once plummeted by RMB 7 billion.

Intense Market Competition

According to the official website of the Center for Drug Evaluation (CDE), the overall competition for acarbose is currently very intense. In addition to four formulated products already on the market, more than 30 companies have drugs in development. Among them, several pharmaceutical companies, including CSPC, HISUN, and Qianjin, are in the process of applying for marketing approval for acarbose tablets; meanwhile, Shandong Lukang, China Resources Saike, and CSPC Ouyi, among others, are conducting clinical trials.

(Source: CDE)