Why Chinese biopharmaceutical companies building factories to expand production

On December 16, BeiGene announced the official completion of its second plant in Guangzhou's Guangzhou Biopharmaceutical Production Base in the Sino-Singapore Knowledge City, and the construction of its third plant was also started simultaneously. BeiGene said that after the completion of the second plant, its Guangzhou base has already built 24,000 liters of biopharmaceutical production capacity, and the total production capacity is expected to reach 64,000 liters after the completion of the third plant in the future.

It is reported that in the future, the production capacity of this plant will be used in the production of biological drugs including the anti-PD-1 monoclonal antibody tislelizumab, which is the main product of BeiGene macromolecules, and it has been the most concerned product in the national medical insurance negotiations in the past two years. , What impact will the production capacity issue have on the PD-1 pattern and the future impact of the entire Chinese biopharmaceutical industry?

In addition to BeiGene, major domestic biopharmaceutical R&D companies that are approaching commercialization or have already achieved commercialization are basically realizing self-built production capacity at the same time. The interface news reporter summarizes the current production capacity of major manufacturers as follows:

BeiGene: The Guangzhou production base has completed 24,000 liters, and the current production capacity is provided by Boehringer Ingelheim.

Junshi Bio: It has two production bases in Wujiang, Suzhou and Lingang, Shanghai. The Wujiang production base in Suzhou has a commercial production capacity of 3,000 liters, and the first phase of the Shanghai Lingang production base has a fermentation capacity of 30,000 liters, which was obtained at the end of 2019. "Drug Production License", and launched the trial production of anti-PD-1 monoclonal antibodies and anti-PCSK9 monoclonal antibodies. The Lingang production base also undertook the clinical drug production of the new coronavirus neutralizing antibody drug JS016.

Cinda Bio: The Suzhou plant currently has a total production capacity of 24,000 liters in operation, and another 36,000 liters of production capacity is under construction, which is expected to be completed by the end of next year.

Henlius: At present, Shanghai Xuhui base has 20,000 liters of commercial production capacity certified by China and Europe. The first phase of Shanghai Songjiang base has completed 24,000 liters of clinical sample production capacity, and the second phase of Songjiang base is under construction.

Kangfang Bio: It has a production capacity of 4,000 liters. Two new plants are planned to have a total capacity of 84,000 liters. It is expected that the first phase of the Guangzhou plant will have a capacity of 20,000 liters in early 2021. CStone Pharmaceuticals: The Suzhou plant is under construction, and the structure is expected to be topped off by the end of 2020. The overall civil construction will be completed in the second half of 2021. The designed production capacity of biopharmaceuticals is 26,000 liters.

Sansheng Guojian: The Shanghai plant has built a production capacity of 38,000 liters, of which a commercial production capacity of 30,000 liters.

Biotech: Guangzhou plant has built a production capacity of 30,000 liters, of which 7,000 liters of commercial production capacity.

Hisun vPro: The existing production capacity is about 20,000 liters.

Hengrui Pharmaceuticals: In 2020, the main production base of Hengrui PD-1, Suzhou Shengdia, will have a production capacity of 8000L.

In addition, Qilu Pharmaceutical did not disclose its current biological drug production capacity.

Whether it is PD-1 or rituximab, bevacizumab, adalimumab and other domestic biosimilar drugs, at the beginning of commercialization, they need to quickly increase their volume to seize the market. In addition to the role of the front-end market department, the continued supply of back-end products is also a key.

But in fact, due to the difficulty of biopharmaceutical production, even if the production capacity is built, continuous debugging and optimization are required to achieve continuous and stable production in a variety. As such, the former Fuhong Hanlius’ rituximab and Qilu Pharmaceutical’s bevacizumab have been out of stock after commercialization, and the bevacizumab of another domestic biopharmaceutical company was approved after the approval It has not yet been commercialized due to capacity issues.

For example, BeiGene used disposable reactors in the first phase of its production capacity design, and switched to stainless steel reactors in the second phase. This approach of emphasizing speed at the initial stage and subsequent emphasis on continuous cost reduction is basically adopted by the industry.

Previously, the industry has also overly debated whether domestic biopharmaceutical companies are keen to build factories, and even said whether there will be "overcapacity" in biopharmaceuticals. However, in fact, although the production capacity of tens of thousands of liters, domestic biopharmaceuticals It is far from the point of overcapacity, and even at the stage of undercapacity.

This is because, from the completion of the designed production capacity to the final commercial production, a series of processes such as the inspection of production site changes by the drug regulatory department are required. Dr. Liu Jian, senior vice president of BeiGene and head of biopharmaceuticals, told the interface news reporter Said that this process (adding a new production base) often takes 3-5 years abroad, which also includes various production debugging, and BeiGene is expected to achieve commercial production of the first phase of the Guangzhou production base in 2021.

Looking at the production capacity data of various companies, it is not difficult to find that there are not many commercial production capacity of each company at present. Excluding the undisclosed Qilu, the largest domestic production capacity for commercial batches should be Sansheng Guojian. 30,000 liters, followed by Cinda Biotech and Fuhong Henlius.

These production capacities also need to be scheduled and coordinated between commercialized varieties, between commercialized varieties and clinical stage varieties.

Of course, for a company, the production capacity problem is not difficult to solve. WuXi Biologics CEO Dr. Zhisheng Chen told Jiemian News that adopting CMO (contract commissioned production) for production will have a speed advantage in capacity improvement. The self-built plant and its vacant depreciation cost will also have cost advantages.

In fact, after a number of domestic biosimilar drugs were approved for the market this year, the call for centralized procurement of biopharmaceuticals has also increased. However, news was posted at the centralized procurement meeting at the national level this month to suspend the centralized procurement of biopharmaceuticals and continue to follow. the study.

Previously, people from biopharmaceutical research and development companies have repeatedly mentioned to Jiemian reporters that the issue of production capacity is a major challenge for domestic biopharmaceuticals. If the current major players are unable to achieve continuous supply, once centralized procurement How to guarantee supply?

In addition, senior executives of domestic biopharmaceutical companies believe that another trigger condition for centralized procurement-the large price gap between original research drugs and generic drugs does not exist in the current biosimilar drug field, and the current maximum price gap between domestic and imported drugs is only 30%. , And taking into account the issue of production capacity, the centralized procurement of biosimilar drugs should be carried out at least 5 years after the entire business is relatively stable.