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"China Medical News" front page headline: MAH system pilot allows market elements to flow

"The pilot drug marketing authorization holder (MAH) system is a system reform in China. An Bisheng is the beneficiary of this system reform." Recently, Lei Jifeng, general manager of Shanghai An Bisheng Pharmaceutical Technology Co., Ltd., was interviewed Shi Ruo said.

"The pilot drug marketing authorization holder (MAH) system is a system reform in China. An Bisheng is the beneficiary of this system reform." Recently, Lei Jifeng, general manager of Shanghai An Bisheng Pharmaceutical Technology Co., Ltd., was interviewed Shi Ruo said.

The MAH system is a drug management system commonly adopted internationally. Unlike the “bundling” management model in which the marketing and production licenses are combined in my country, the MAH system separates the marketing and production licenses, allowing the holder of the drug’s marketing authorization certificate to produce the drug on its own or entrust other companies to produce the drug.

Since the Seventeenth Meeting of the Standing Committee of the Twelfth National People's Congress in November 2015, the "Decision on Authorizing the State Council to Conduct Pilot Drug Marketing License Holder System Pilots and Related Issues" has been reviewed and approved in China. Nearly 4 years. During the pilot process, the MAH system has achieved positive results in encouraging new drug creation, optimizing resource allocation, and promoting industrial upgrading.

Innovation vitality is further released

Established in 2007, Anbisheng has been engaged in drug R&D technical services for nearly 10 years, helping domestic pharmaceutical companies to realize the listing and sales of products in the United States. However, the products developed are owned by others. When the partners make a lot of money, An Bisheng is basically not profitable. In 2013, An Bisheng declared its products in the United States, and found suitable contract manufacturers in China in advance.

In November 2015 and January 2016, Ambient's generic drug montelukast sodium chewable tablets and montelukast sodium tablets were approved by the US Food and Drug Administration for marketing, and began domestic production. At this time, the domestic MAH system pilot has just begun. What surprises Lei Jifeng is that the pilot allows R&D institutions and scientific researchers to declare drug registrations, and holders who do not have production conditions can entrust other qualified enterprises to produce. Under the original management model, Anbisheng's products must first be invested and built in order to be listed. "In that case, I can't afford it. The land acquisition and construction of the factory will cost at least 100 million yuan, and it will take at least 2 to 3 years. We only have one variety, and the subsequent production, operation and maintenance costs are also very high." Lei Jifeng said.

In June 2018, Anbisheng's Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets were approved for marketing in China, becoming the first drug research and development institution in China to hold a drug marketing license. Because it is produced in the same line as the same variety of products listed in the United States, it is deemed to have passed the consistency evaluation of generic drugs in accordance with the relevant regulations on the quality and efficacy consistency evaluation of generic drugs. It is worth mentioning that, because there is no need to invest in building factories, the time to market of Anbisheng's products in the country has been shortened by 2 to 3 years.

Since Anbisheng's Montelukast Sodium Tablets is the first product of its kind in China that has passed the consistency evaluation of generic drugs, it has also successfully become the “4+7” pilot product of the quantity procurement pilot. On March 18 of this year alone, hundreds of hospitals in Beijing purchased the product at the same time-its R&D investment soon paid off in the market.

In fact, Ambition is only a microcosm of drug development institutions that have benefited from the pilot of the MAH system. According to the data, the first class of innovative drug fuquitinib capsules independently developed by Hutchison Huangpu Pharmaceutical (Shanghai) Co., Ltd. was approved for marketing in September 2018. Thanks to the pilot of the MAH system, its approval time has been shortened from the previous 2 to 3 years. 15 months; the innovative drug anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biopharmaceutical Technology Co., Ltd. was approved for listing at the end of 2018, benefiting from the pilot of the MAH system, and its listing time was shortened by 3 to 4 years.

"The pilot of the MAH system has greatly activated the innovative vitality of enterprises." said Wang Zongmin, director of the Drug Registration Administration of the Jiangsu Drug Administration. Up to now, there are 223 pilot applications in Jiangsu Province, of which 56 were submitted by scientific research institutions, accounting for 25.1% of the total number of applications in the province. In Shanghai, 48 applicants have submitted 125 (76 varieties) pilot application materials, 31 of which are "global new" Class 1 new drugs that have not yet been listed at home and abroad.

Further optimization of industrial structure

While further inspiring the innovation vitality of R&D institutions, the pilot MAH system is also conducive to integrating resource allocation and promoting industrial upgrading.

With the tightening of environmental protection policies and the re-planning of the city, some pharmaceutical companies face an overall relocation. For pharmaceutical companies, relocation and relocation of sites requires not only capital but also time. The products that have been put on the market are even facing the risk of production suspension. In 2016, Wuxi Shuhui Pharmaceutical Co., Ltd. needed to be relocated as a whole, and it resolutely applied to become the holder, abandoned the reconstruction of the factory, and directly entrusted the varieties to other enterprises to produce, which not only saves the time for building the factory, but also saves the fund for building the factory 5000 Ten thousand yuan, at the same time has accelerated the time to market of the holding variety. Its main product, cyclosporine soft capsules, was commissioned to produce, and the annual sales reached 20 million yuan.

Wang Zongmin believes that after the entire relocated enterprise applies to become a holder, it can be entered or returned: some products with good market sales can be commissioned in the process of rebuilding the factory, and products with poor market sales or no sales can be Let go, so that it can not only ensure the market supply of listed products, but also avoid repeated construction of production lines.

In addition, some group companies are also trying to transfer the drug approval numbers of the holding subsidiaries to the group company during the pilot process of the MAH system. Taking Shanghai Pharmaceutical Group Co., Ltd. as an example, the approval numbers of two products, brompiroxamine tablets and carbamazepine tablets, belong to Shanghai Zhongxi Sanwei Pharmaceutical Co., Ltd. In April 2018, Shanghai Pharmaceutical Group became the holder of the above-mentioned two products, with Shanghai Shanghai Pharmaceutical Chinese and Western Pharmaceutical Co., Ltd. and Shanghai Pharmaceutical Group Qingdao Guofeng Pharmaceutical Co., Ltd. as the entrusted manufacturing enterprises. According to relevant persons of Shanghai Pharmaceutical Group, according to the group's overall strategy, Sino-Western Sanwei will focus on the development of green APIs, and will no longer develop the solid preparation business.

"The group becomes the holder, which is conducive to the group's integration of products according to the production and processing capabilities of each subsidiary, making each subsidiary a production base with characteristics, advantages and scale, promoting the healthy development of the enterprise, and the group company's listing Full responsibility for product quality is conducive to ensuring the accessibility of medicines." Shanghai Pharmaceutical Group said.

"The MAH system helps professional people to do professional things." Liu Shulin, director of the North China Pharmaceutical New Preparation Branch. In his view, the MAH system pilot has also brought many market opportunities to pharmaceutical companies with strong manufacturing and quality control capabilities. Since 2016, North China Pharmaceutical's new preparation branch has started preparations from various aspects such as internal quality management and production management, communicated extensively with the industry, and actively undertake commissioned production. At present, the plant has signed commissioned production agreements for 8 products. "It is expected that our capacity utilization rate will increase by 8~10 percentage points." Liu Shulin said.

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