【 Interview 】 Wang Wei: Helping Accelerate the Development of Biopharmaceuticals

On March 22, 2017, accompanied by a slight rain, our reporter came to Shanghai and had the opportunity to interview Mr. Wang Wei, the general manager of Shanghai Jingze Clean Equipment Co., Ltd. (hereinafter referred to as Jingze). During the interview, Mr. Wang Wei shared with us the development status of Jingze Company and his views on the development trend of biopharmaceuticals

Shanghai Jingze Company was established in 2003 and officially renamed Shanghai Jingze Clean Equipment Co., Ltd. in 2005. Currently, it mainly serves foreign-funded pharmaceutical factories and export-oriented pharmaceutical factories. Its business scope mainly includes the design, construction, and verification of clean public engineering (USP pure water, injection water, pure steam, clean compressed air, nitrogen) and process production equipment (liquid distribution system, CIP, SIP, automation system).

Mr. Wang Wei, General Manager of Shanghai Jingze Clean Equipment Co., Ltd

Focus is the cornerstone of success

Mr. Wang Wei's major is Chemical engineering. After graduating from East China Science and Engineering, he worked in the cosmetics and food industry in foreign-funded enterprises. He has worked in the pharmaceutical industry since 1999, and now focuses on the design of clean pipelines, liquid preparation systems and CIP systems. Mr. Wang Wei said: I may belong to someone in this industry who prefers to delve into a certain field, so you can see that I train others in China and basically focus on this part, because I hope to learn related work from them forever. Jingze has always adhered to this spirit of focus, providing process design and technical installation services for pharmaceutical and biotechnology companies that comply with international cGMP. We have a team that integrates design, self-control, and construction A professional team and personnel that integrate project management and production manufacturing. 20% of the company's engineers and management personnel have experience in Fortune 500 companies, and customers can trust us very much During the conversation, the author can always feel Mr. Wang Wei's elegant and noble demeanor of being a low-key person and doing things with a high profile. Although Jingze has not yet been listed, I believe that under the leadership of Mr. Wang Wei, Jingze will have a bright future for development.

Biopharmaceuticals have a long way to go

The level of cGMP verification and hardware and software requirements for the entire pharmaceutical industry in China has seen a rapid improvement compared to ten years ago. However, Mr. Wang Wei believes that the industry is developing too fast, and the manufacturing process level is actually showing a trend of declining quality. As the ability of pharmaceutical companies to develop traditional pharmaceuticals becomes increasingly depleted and the cost of new drugs continues to rise, large pharmaceutical companies can only grow through mergers and acquisitions. However, even with this approach, the development pipeline continues to decline. So, there are currently two trends in the international market. The first pharmaceutical company with R&D as its core will now have a high market value. For example, in recent years, a certain pharmaceutical company has risen from obscurity to the top ten in the industry. Usually, the drugs they develop are very expensive, with one person spending 800000 to 1 million yuan per treatment. The second is that many internationally renowned pharmaceutical companies have turned to the development of macromolecules in order to survive, and have spared no effort in acquiring production or research and development companies for biopharmaceutical monoclonal antibody products. Although biopharmaceutics is considered to be able to solve some of the current disease problems, and some relatively novel concepts such as Targeted therapy have been passed on to the world, Mr. Wang Wei believes that biopharmaceutics is in its growth stage, and has not yet reached its peak, which is also a reason why biopharmaceutics will continue to grow.

Overall, biopharmaceuticals are showing an upward trend, while traditional pharmaceuticals are showing a downward trend, while the pharmaceutical industry is showing a steady and slow upward trend compared to other industries. Due to the inability to develop new drugs domestically, it is basically some foreign R&D experts who return to China to start their own businesses and collaborate with traditional pharmaceutical professionals in China, such as pharmaceutical companies such as Lizhu, Qilu, and Kanghong, who have applied this model. Or some people find investors to do research and development. For example, pharmaceutical factories such as BeiGene and Suzhou Xinda develop and produce biopharmaceuticals according to the foreign operation mode. They either produce innovative drugs or make some improvements in the drug structure, with innovative biopharmaceuticals accounting for a minority. It is difficult to obtain recognition from the FDA and the European Union for generic biopharmaceuticals, and the true core drugs are still held in large biopharmaceutical factories, with poor prospects. In China, due to the influence of national policies, generic biopharmaceuticals are relatively easy to pass the review. For example, in the field of engineering recently, due to the need to shorten the long investment cycle and approval cycle, new concepts such as GE Kubio modular factory buildings with an 18 month delivery time have been born. Although the quotation is very expensive, Baekje Shenzhou, Wuhan Xikang, and Hangzhou Pfizer have all purchased them, which was unimaginable before.

In addition, China needs to simplify and accelerate the approval process for biosimilars, which has given rise to a large number of domestic biopharmaceutical companies' demand for disposable products. Mr. Wang Wei recalled, "When I went to the Frankfurt exhibition last time, many international manufacturers were promoting the concept of one-time use. At that time, it was not very popular, but now it has become a trend. However, the country now attaches great importance to environmental protection, and millions of consumables are obviously not economical and environmentally friendly." Mr. Wang Wei believed that one-time use created conditions for rapid production approval, but from the perspective of the company's long-term development strategy, Hybrid hybrid Biological system combined with stainless steel at one time is more economical and applicable. If Sino Biopharmaceutical Limited industry enters the mature stage, it will use a large number of stainless steel products. After all, in mass production, more than half of the cost of disposable consumables is paid to suppliers. Of course, both methods are actually possible, which is completely related to the business model of the owner. If its product scale is not large and not very mature, now I hope to submit a batch of samples and go for approval first. The time should be fast and the initial investment cost should be low, so I will use a one-time system. If the process product technology is mature and needs to be mass-produced after completing the application, stainless steel equipment can be used to save costs. For example, it is almost impossible for domestic vaccines and other products to use disposable systems because they are traditional products without high profit margins or added value, and the process is relatively mature. Therefore, in this situation, enterprises should try to follow traditional ideas, so stainless steel solutions may be more recognized by everyone. This is an industry trend, and companies like Chutian and Dongfulong have recently invested a lot of research in it. However, China currently lacks innovative high-tech products, and the country is currently addressing this issue, allowing the industry to gradually transition from low-end to mid-end and then to high-end

In the early days of its establishment, Jingze was relatively small in scale and the transaction volume of its projects was not very high. In the early years, our clients were mainly foreign-funded enterprises with high requirements, and the technical standards were relatively easy to control, so the traditional pharmaceutical field was still doing well. With the rapid development of biopharmaceuticals, the company will gradually shift its focus to the development and design optimization of large-scale projects such as biopharmaceutical dispensing systems and CIP systems in the next five to ten years, and then integrate upstream and downstream cooperation Our goal and mission is to provide pharmaceutical companies with cost-effective biopharmaceutical equipment that truly meets international standards through the manufacturer's process system, enabling customers to produce efficiently and safely. For example, the recently completed domestic well-known CMO biological large-scale factory project and the undertaking of the first foreign enterprise independent monoclonal antibody project, Hangzhou Pfizer Biological Project, are both milestone developments for Jingze. So, relatively speaking, traditional pharmaceuticals have become auxiliary businesses Mr. Wang Wei continued to add.

At the end of the interview, Mr. Wang Wei provided some valuable suggestions to the young people. Nowadays, young people are more passionate and have the ability to think independently. Unlike the previous generation, they just think that as long as they work diligently and diligently, they will definitely achieve results. However, young people are more focused on innovative ideas. However, from the perspective of personal growth, they still need to focus more on career development, be able to draw inferences from one example, see through problems, know what they want, and then cultivate the necessary abilities. After finding the right direction, it is easy to become an expert in a certain field.