After returning to China from living and working in the US for many years, Jianxin Chen, Chairman and chief executive officer (CEO) of Zencore Biologics developed mammalian cell culture technology platform and related technology for Henlius, Junshi Biosciences and other well-known innovative pharmaceutical companies in China. He also founded or co-founded several biotechnology companies, from drug discovery to contract development and manufacturing organization (CDMO) services, He also witnessed the landscape transformation of biopharmaceutical industry in China for the last decade and profoundly contributed to the improvement.
He participated in the establishment of antibody platform at both Henlius and Junshi Biosciences.
The year 2010 will be remembered as the beginning of modern biopharmaceutical industry in China. About 20 biopharmaceutical enterprises, such as Henlius, Teruisi, and Innovent, were established around that time. Most of them were established to develop biosimilars, which requires comprehensive technologies and expertise in process development.
Prior to returning to China, Jianxin Chen has accumulated many years of experience in process development and scale up engineering platform for the production of high titer antibodies, therapeutic proteins and vaccines abroad.
In 2009, Jianxin Chen joined MedImmune, the biologics division of global pharmaceutical company AstraZeneca. At MedImmune, he developed the process of fed batch culture of mammalian cells antibody production, resulted in record titer of 14.5 g/L. The process has been scaled up to 12,500 L. In 2012, he returned home at the right time with the skills in high demand. He first joined Henlius to develop cell culture technology platform for Henlius's biosimilar projects, which include Hanlikang, the first ever biosimilar in China. He summed up his experience at Henlius succinctly: "titer increase and process stability".
Soon after that, he led the development of high-yield cell culture technology platform for Junshi Biosciences, which discovered and developed China's first innovative antibody drug, anti-PD-1 (programmed cell death protein 1) antibody, Toripalimab injection (trade name: Tuoyi). Tuoyi's quality and yield are leading the pack of several companies engaged in anti-PD-1 antibody discovery and development both in China home and abroad, contributed to the lowest pricing for any anti-PD-1 antibodies in the world when it was listed, the affordability of premier quality anti-PD-1 antibody benefited all of the cancer patients in China so far. The drug has been approved by FDA as a "breakthrough therapy" in the United States.
In 2013, Jianxin Chen, co-founded Destiny Biotech, which was engaged in CDMO technology services for macromolecular drugs. Shenzhen Langrun first invested in Destiny Biotech, and later acquired it.
Entering the CDMO business
In recent years, as the market potential for macromolecular biopharmaceuticals has become increasingly clear, Jianxin Chen founded the Biologics CDMO company, Zencore Biologics, in November 2017 to take advantage of his rich experience in process development, medium development, scale up engineering, as well as biopharmaceutical project development and product commercialization in China.
Because of this pristine reputation and respect from business partners or associates in the industry, orders started to pour in as soon as he had the businesses set up and running, Jianxin Chen acknowledged with a smile. The first order came from Junshi Biosciences, an innovative drug developer, who discovered, developed and commercialize the first anti-PD1 antibody in China. Thereafter, Zencore Biologics won another first order from Hansoh Pharma, a large and successful pharmaceutical company traded on Hong Kong Stock Exchange, through bidding. Both projects have received the NMPA approval for initiating clinical trials from the NMPA without any supplement document.
So far, Zencore Biologics has received more than 80 CDMO orders for various drug modalities such as monoclonal antibody, bispecific antibody, multi-specific antibody, antibody drug conjugates, fusion protein and cytokines. For many of the projects we worked on, the applications for clinical trial initiation were submitted to regulatory agencies in both China and US.
In March 2020, Zencore Biologics completed Series-A financing of US $55 million. This round of financing will be mainly used for talent recruitment , R&D (research and development) center expansion, construction of GMP (good manufacturing practice) facility in Lin-gang Specific Area of Shanghai Pilot Free Trade Zone (including biologics pilot and commercial GMP production, commercial GMP production of media, GMP pilot production for ADC (antibody drug conjugate) drug, etc.) and the establishment of Zencore Innovation Center (US).
Fast follow up strategy, CDMO will provide the edge in performance vs. cost competition
In the last few years, the rapid development of biopharmaceutical industry in China has propelled it to become one of the main players in the global biopharmaceutical industry. Initially, it started with the development of biosimilars for most biopharmaceutical companies in China. As the industry grows and mature, more and more companies are getting into discovering and developing fast follow-up or even first-in-class therapies. The speed of the drug discovery and development are getting faster and faster, and the outputs from these efforts could disrupt the global landscape for biopharmaceutical industry. Take Junshi Biosciences as an example, it took only six years from 2012 for it to commercialize the anti-PD-1 antibody from the very beginning; Furthermore, the quality of drugs discovered and developed in China is on-par with the best drugs available in the other countries. We are also very competitive in productivity and manufacturing cost.
For patients in China, the rapid development of the biopharmaceutical industry resulted in cost-effective drugs and related services for many of them. Again, let's use the anti-PD-1 antibody as an example, the annual cost of using an anti-PD-1 antibody drug is about $200,000 per year per patient in the United States, that number drops to 100 thousand RMB (~$15,600, $1 equals to about 6.4 RMB) in China last year. This year, three anti-PD-1 antibody drugs have entered the Chinese medical insurance. It is reported that the annual out of pocket cost for anti-PD-1 antibody treatment for Chinese patients, could go to as low as 10-30 thousand RMB (~$1,560--$4,680) per year after the medical insurance coverage.
To meet the strong demand for both performance and cost, CDMOs and pharmaceutical companies will need to work collaboratively. During the discovery stage, CDMO enables pharmaceutical companies to focus on discovering novel drugs. During the development stage, CDMO can enable the move of products to market as soon as possible with competitive cost performance ratio, and enhance the competitiveness of the pharmaceutical companies as whole.
The rapid advancement of any industry can be realized only after specialization has occurred. Extreme specialization will further propel the progress and development of the industry. For the whole pharmaceutical market, providing cost-effective process technology and large-scale production technology are the top priorities for any CDMO who wants to be competitive and viable for the long term. For Zencore, we are working hard to provide our customers cost advantage, scale and speed, without the sacrifice of product quality. The completion of the 5,000 liter stainless steel reactor in early 2022, together with our advantages in process development, scale-up and consistency of quality production, will enable us to provide pharmaceutical companies with fast and cost-effective services and to greatly shorten the drug discovery and development cycles, including R&D and regulatory filing, all comes with the great product quality.
Furthermore, our extensive experiences gained from developing various drugs could also provide guidance to our customers so that they avoid any un-necessary delay during the R&D process. For nearly all biopharmaceutical companies focus on early stage of drug discovery, it is impractical for any of them to build and construct the large bioreactors required for the development and commercial manufacturing of their drugs. CDMO, like Zencore Biologics, will not only provide the necessary capacity needed for most biopharmaceutical companies, but also the cost-effective services in other areas, such as purification and overall analytical method development.
CDMO industry is competing on scale and globalization
Jianxin Chen said, "at present, CDMO industry is competing on scale and globalization. Zencore Biologics is unwavering in our commitment to scale and globalization, we are moving at the lightning speed. For capacity, we are investing 1.5 billion RMB to construct the commercial production facility at Lin-gang. For globalization, we have attracted many orders from abroad and build a team with experiences in global biopharmaceutical companies." From the technical perspective, CDMO is built on mammalian cell culture. Zencore Biologics is very competitive in this technology. For capacity, Zencore Biologics boasts the first large-scale stainless steel reactor in CDMO focused companies.
So far, Zencore Biologics has built a 4,500 ㎡ biomedical R&D center and laboratory in Zhoupu International Medical Zone, and a 4,000 square foot (ft²) Innovation Center in Maryland, USA. In Lin-gang Special Area, the 200 L/500 L GMP production line and a 200 metric ton/year GMP media commercialization production facility have been officially started operation in November 2020; Additionally, the construction of Zencore Biologics commercial manufacturing facility with a total investment of nearly 1.5 billion yuan has started in late September 2020, and it will be put into production in early 2022. This will include the 500L perfusion, 2,000L, and 5,000L commercial liquid production lines and finished product filling lines.
Jianxin Chen also told reporters, "In Lin-gang, we will build an ADC platform, as ADCs is becoming a very effective treatment for major diseases. ADCs could be any combinations of large molecules, medium molecules and small molecules. As computer-aided drug design (CADD) will become commonplace, CDMO will need tools and means to make the virtually designed drug from CADD after the completion of design and validation. To enabling this, Zencore Biologics is planning to build a second commercial manufacturing facility, we are currently exploring a few options for the site selection. From 2021, laboratories in the United States will be further expanded, and project management and business expansion will be implemented in the United States."
The success of any enterprise depends on all kinds of talents. In just three years and half from the beginning, Zencore Biologics has grown from a team of 52 employees in 2018 to more than 300 employees and we are still growing. In addition to the CDMO business, Zencore Biologics has a team of more than 60 people engaged in the development of culture media formula and production, and we are the leading player for this area in China. Zencore Biologics is building an experienced and strong team from all over the world and further expand into the global market in the near future.
To maintain the competitive position in the CDMO business, Zencore Biologics is investing heavily in many key technologies, such as cell line development. We are utilizing the innovative genetic engineering methods in our pursue of continued improvement in production time and stability, expression quantity and quality of cell lines. In parallel, the variety and application scope of culture medium will be further expanded; To meet the demands for large-scale production of biologics, Zencore Biologics is planning a large-scale commercial dry powder production facility for various culture media. All we have done, are doing and will be done, will enable the pharmaceutical companies achieve the production cost goals, on time, and become more competitive in the market place, which is especially relevant for the fierce competitive domestic biopharmaceutical market.
The ultimate goals for Zencore Biologics are to provide the most value-added services to the mid-sized biopharmaceutical companies, to contribute to the realization of a healthier world by providing affordable treatments to all patents. CDMO, like Zencore Biologics, is uniquely positioned to leverage the comprehensive collaborations among the biopharmaceutical companies, capital providers and CDMO to speed up the drug development process along the industry value chain, to maximize the impact that CDMO may have on the industry, Jianxin Chen added.
About Zencore Biologics
Zencore Biologics was founded by several returned overseas personnel in the Lin-gang Special area of China (Shanghai) Pilot Free Trade Zone in 2017. Its core business includes research and development of Macromolecule biologicals, CDMO services (including cell line development, process development and engineering amplification, 200L / 500L GMP pilot production, and so on. In the process of construction, there are many businesses, such as 2,000L / 5,000L commercial GMP production, IND and BLA filing, process characterization and verification, project transfer, medium development and 200 tons of animal cell culture medium production.
