China Medical News front page headline: MAH system pilot to let market factors flow

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"The pilot of the Drug Marketing Authorization Holder (MAH) system is a system reform in our country. Ambisheng is a beneficiary of this system reform." Recently, Lei Jifeng, general manager of Shanghai Ambisheng Pharmaceutical Technology Co., Ltd., said in an interview.

"The pilot of the Drug Marketing Authorization Holder (MAH) system is a system reform in our country. Ambisheng is a beneficiary of this system reform." Recently, Lei Jifeng, general manager of Shanghai Ambisheng Pharmaceutical Technology Co., Ltd., said in an interview.

The MAH system is a widely used drug management system in the world. Unlike China's "bundled" management model of marketing and production licenses, the MAH system separates marketing licenses from production licenses, allowing holders of drug marketing license documents to produce drugs on their own or entrust other enterprises to produce drugs.

Since the 17th meeting of the Standing Committee of the 12th National People's Congress in November 2015, the decision on authorizing the State Council to carry out the pilot project of drug marketing license holder system in some places and related issues has been deliberated and adopted. It has been nearly four years since China has carried out the pilot of MAH system. In the pilot process, the MAH system has achieved positive results in encouraging the creation of new drugs, optimizing resource allocation, and promoting industrial upgrading.

Further release of innovation vitality

Founded in 2007, Amber has been engaged in drug research and development technical services for nearly 10 years, helping domestic pharmaceutical companies to market and sell their products in the United States. However, the products developed are owned by others. When the partners are making a lot of money, Ambien is basically not profitable. In 2013, Anbisheng declared its products in the United States and found suitable commissioned manufacturers in China in advance.

In November 2015 and January 2016, Ambishon's generic drugs Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets were approved by the US Food and Drug Administration and began to be produced in China. At this time, the domestic MAH system pilot has just begun to implement. To Lei Jifeng's surprise, the pilot allows R & D institutions and scientific researchers to apply for drug registration, and holders who do not have the production conditions can entrust other qualified enterprises to produce. Under the original management mode, the first thing to do is to invest in the construction of a factory if the products of Ambien are to be listed. "in that case, I can't afford to invest (invest) any more. the investment of land requisition to build a factory is at least hundreds of millions of yuan, and it will take at least two to three years. we only have one variety, and the cost of follow-up production, operation and maintenance is also very high." Lei Jifeng said.

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

As Ambishon's Montelukast Sodium Tablets is the first product of its kind in China to pass the generic drug consistency evaluation, it has also successfully become the selected variety of the "4 7" band procurement pilot. On March 18 this year alone, hundreds of hospitals in Beijing purchased the product at the same time-its R & D investment soon had a market return.

In fact, Ambican is only a microcosm of the drug development institutions that benefit from the pilot of the MAH system. According to the data, the Class 1 innovative drug fuquintinib capsule independently developed by Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd. was approved for listing in September 2018. Thanks to the pilot of the MAH system, its approval time has been shortened from the previous 2 to 3 years. To 15 months; the innovative drug anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biomedical Technology Co., Ltd. was approved for listing at the end of 2018, benefiting from the MAH system pilot, the time to market has been shortened by 3 to 4 years.

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

further optimization of industrial structure

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

With the tightening of environmental protection policies and urban re-planning, some pharmaceutical companies are facing overall relocation. For pharmaceutical companies, the reconstruction of remote location requires not only funds, but also time. Products that have been sold on the market may even face the risk of production suspension. In 2016, Wuxi Shuhui Pharmaceutical Co., Ltd. needed to relocate as a whole. It decisively applied to become the holder, gave up the reconstruction of the factory, and directly entrusted the varieties it held to other enterprises for production. This not only saved the time for building the factory, but also saved 50 million yuan of funds for building the factory. At the same time, it accelerated the listing time of the varieties. Its main product, cyclosporine soft capsule, was commissioned for production, with a year sales of 20 million yuan.

Wang Zongmin believes that after applying to become a holder, the overall relocation enterprise has realized that it can advance or retreat: some products with good market sales can be commissioned for production in the process of rebuilding the factory building, while products with poor market sales or no sales can be put aside, which can not only ensure the market supply of listed products, but also avoid repeated construction of production lines.

In addition, some group companies have also tried to transfer the drug approval number of each holding subsidiary to the group company in the pilot process of the MAH system. Taking Shanghai Pharmaceutical Group Co., Ltd. as an example, the two product approval numbers of bromopyridostigmine tablets and carbamazepine tablets are owned by Shanghai Zhongxi Sanwei Pharmaceutical Co., Ltd. In April 2018, Shanghai Pharmaceutical Group became the holder of the above two products, with Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd. and Shanghai Pharmaceutical Group Qingdao Guofeng Pharmaceutical Co., Ltd. as the entrusted manufacturers respectively. A person from Shanghai Pharmaceutical Group said that according to the group's overall strategy, China West 3D will focus on the development of green raw materials and no longer develop solid preparation business.

"The group becoming the holder is conducive to the integration of products according to the production and processing capacity of each subsidiary, so that each subsidiary can become a production base with characteristics, advantages and scale, and promote the healthy development of the enterprise. At the same time, the group company is fully responsible for the quality of the listed products, which is conducive to ensuring the accessibility of drugs." Shanghai pharmaceutical group related people said.

"The MAH system helps professional people do professional things." North China Pharmaceutical New Preparation Factory Director Liu Shulin said. In his view, the MAH system pilot also brings many market opportunities to pharmaceutical companies with strong manufacturing and quality control capabilities. Since 2016, North China Pharmaceutical New Preparation Branch has started to prepare from various aspects such as internal quality management and production management, extensively communicated with the industry, and actively undertook commissioned production. At present, the factory has signed 8 products commissioned production agreements. "It is estimated that our capacity utilization rate has increased by 8-10 percentage points." Liu Shulin said.