Joinn Biologics Aims to Become a Globally Leading CDMO with End-to-End Solutions for Over 300 Biotherapeutic Projects in Five Years

In 2018, the "Industrial Classification for Strategic Emerging Industries (2018)" was released, listing the biopharmaceutical industry as a national strategic emerging industry. Since then, the biopharmaceutical sector has entered a new phase of explosive growth. According to data from the "2019 China Life Sciences and Biotechnology Development Report," the market size of China's biopharmaceutical industry exceeded RMB 350 billion in 2018.

Amid the rapid development of the biopharmaceutical industry, domestic drug regulatory and review standards are undergoing a series of enhancements and reforms to accelerate the drug review and approval process and improve drug quality. The continuously rising quality requirements, coupled with the goal of cost reduction and efficiency improvement, have driven increased demand for outsourcing services among innovative pharmaceutical companies, making Contract Development and Manufacturing Organizations (CDMOs) a focal point for market and capital attention. Furthermore, with the issuance of the “Notice on Organizing the Implementation of Special Projects for the Construction of Contract Research and Production Service Platforms in the Biopharmaceutical Sector” in 2018, contract research and manufacturing services in the pharmaceutical industry have further developed.CDMOs have become an indispensable part of the pharmaceutical industry chain. Collaborating with CDMOs has emerged as a key strategy for innovative drug companies to enhance R&D efficiency, reduce production costs, and mitigate risks.。

In this context,A pharmaceutical CDMO enterprise dedicated to becoming the most trusted by customers and a global leader—Beijing Joinn Biologics Co., Ltd. (hereinafter referred to as “Joinn Biologics”)—was established accordingly.。

Joinn Biologics, established in 2018, is a CDMO enterprise incubated by Beijing Joinn Laboratories (China) Co., Ltd. (hereinafter referred to as “Joinn Laboratories”), the leading domestic CRO company, to expand and extend its service business segments.Leveraging the extensive industry and project experience of its core team, Joinn Biologics has established two major R&D and production bases in China and the United States. It provides global innovative drug developers with one-stop biologic CDMO solutions, covering developability studies, process scale-up and optimization, quality research, pilot-scale manufacturing, and commercial production.。

The establishment of Joinn Biologics was driven by the demand from biopharmaceutical clients of Joinn Laboratories.

As a specialized CRO established in 1995, Joinn Laboratories has secured a substantial volume of client orders, leveraging the extensive experience and industry reputation it has accumulated over nearly three decades of development. However, the continuous surge in order volume has also brought new “challenges” for Joinn Laboratories: when clients’ scheduled experimental timelines arrive, the required samples have not been produced in time.

Therefore,In response to client demand for biologics and to provide partners with expanded CDMO services, the team established Joinn Biologics. Taking into account factors such as the characteristics of CDMO business development and the needs of service teams and technical personnel, Joinn Biologics will launch CDMO operations building upon its existing business foundation.。

Following its official establishment, Joinn Biologics rapidly completed team building and forged partnerships with numerous pharmaceutical companies both domestically and internationally. This success is underpinned by the leadership and guidance of its core founding team.

Both co-founders of Joinn Biologics, Dr. Geng Shusheng and Dr. He Tao, have accumulated over 20 years of experience in research, development, and management within the biopharmaceutical industry.

Dr. Geng Shusheng is a seasoned R&D professional and entrepreneur with over 20 years of experience in the research, development, and management of biologic macromolecule therapeutics.. Dr. Geng has led and directly participated in the research and development of nearly 20 antibody drugs, advancing these candidates to various stages of clinical trials across multiple therapeutic areas, including oncology, infectious diseases, and immunotherapy. Furthermore, Dr. Geng possesses extensive expertise in cell line development and process optimization and scale-up, and has led or participated in more than 10 national and municipal-level scientific and technological special projects.

Dr. Tao He has over 20 years of experience in the discovery and development of innovative protein/monoclonal antibody therapeutics, having held key positions at leading global pharmaceutical companies including Novartis, Wyeth, and Pfizer.. As the team leader, Dr. He has led and directly participated in the development of multiple biologic macromolecule drugs that have successfully gained clinical approval or reached the market, and is a senior expert in the developability assessment of macromolecular candidate drugs and drug characterization analysis.

In addition, Joinn Biologics has also attracted senior experts in the fields of antibodies, vaccines, and recombinant proteins to join. Currently,Has built a core technical team of over 500 professionals with extensive industry experience and in-depth knowledge of Chinese and foreign new drug regulations.。

Among them,Zhao Jian, Vice President of R&DDr. has over 10 years of work experience in the fields of antibodies, recombinant proteins, and protein vaccines., led and participated in the development and research of multiple antibody biosimilars, innovative antibody drugs, and recombinant vaccine drugs, among which several have successfully received clinical trial approval or been launched on the market.VP of Production, Liu DonglianWith nearly 30 years of experience in biologic drug process development and commercial manufacturing, has led the R&D and commercial-scale manufacturing of multiple recombinant proteins, viral vaccines, monoclonal antibodies, and antibody-drug conjugates (ADCs), and possesses experience in the construction and operation of commercial manufacturing facilities. The PB-Hybrid Technology cell expansion platform he founded has been widely adopted for the commercial production of antibodies.

Currently, Joinn Biologics’ R&D and production bases in China and the United States have been completed and put into commercial operation, with an existing total capacity of 34,000 liters; future commercial total capacity is expected to reach 100,000 liters.

Joinn BiologicsMultiple production facilities with capacities of 1,000 L, 500 L, and 200 L, compliant with FDA GMP standards, have been established in the United States. In Beijing, 15 single-use large-molecule drug substance production lines with a capacity of 2,000 L, meeting international standards including those of China, the United States, the European Union, and the WHO, have been built, along with high-end formulation workshops for various dosage forms such as lyophilized products, aqueous injections, and pre-filled syringes. Meanwhile, the company possesses reactors ranging from 50 L to 5,000 L, capable of meeting the production needs for commercial-scale batches of active pharmaceutical ingredients (APIs) under complex processing conditions.。

Leveraging its two R&D and production bases, Joinn Biologics provides global innovative drug developers with a one-stop solution encompassing developability studies, process scale-up and optimization, quality research, pilot-scale manufacturing, and commercial production.

Services and Solutions Provided by Joinn Biologics | Image source: Based on Joinn Biologics data, graphic by VCBeat

Among them,The testing laboratories established and operated by Joinn Biologics’ analytical testing service platform have successfully passed the assessment conducted by the China National Accreditation Service for Conformity Assessment (CNAS) and have been awarded the CNAS Laboratory Accreditation Certificate (Registration No.: CNAS L20078).. The platform boasts a research team of over 100 members with international professional expertise, providing comprehensive analytical services across all stages of the drug development lifecycle.

Furthermore, it is crucial for pharmaceutical companies to select an appropriate CDMO partner to effectively enhance efficiency and reduce production risks and costs. Taking the manufacturing of antibody-based drugs as an example, the upstream process of constructing expression systems is particularly important, with the selection of host cells being critical. If the contracted CDMO chooses to use host cells licensed from other institutions or even those lacking intellectual property (IP) rights, it may result in the client having to pay long-term IP royalties during later stages of research, development, and production, or even trigger IP-related risks.

Joinn Biologics can help pharmaceutical companies address this issue. Building on its proprietary CHO-K1 cell line, the company’s technical team generated a completely afucosylated host cell line through fucose knockout. Following antibody characterization and functional validation, the team established CHO-K1-TGZ, an afucosylated cell line suitable for industrial-scale production.

To date,Joinn BiologicsWe possess full intellectual property rights to three host cell lines suitable for pilot-scale and commercial production: CHO-K1, fucose-deficient CHO-K1, and GS-knockout CHO-K1. These cell lines have well-documented origins, high expression levels, excellent expression and genetic stability, and a strong competitive advantage in pricing.。

In recent years, the number of CDMO companies has continued to rise, leading to increasingly fierce industry competition. Since the beginning of this year, the stock prices of major listed CDMO companies in China have experienced significant declines. Over the past year, the CDMO sector has been marked by considerable instability, with frequent reports of plant closures and layoffs as leading CDMO firms accelerate industry-wide adjustments.

Nevertheless, Joinn Laboratories has successfully weathered the “capital winter” and secured a foothold amid fierce market competition.What has enabled Joinn Biologics to navigate market cycles is the industry qualifications and collaborative experience it has accumulated over the past five years, along with its differentiated advantages and technological barriers. Most importantly, Joinn Biologics possesses a forward-looking vision, allowing it to strategically position itself in advance according to market developments, enter emerging fields, and optimize its competitive edge in niche segments, thereby providing professional, comprehensive, one-stop service solutions to clients across diverse sectors.。

Taking the antibody-drug conjugate (ADC) sector as an example, enthusiasm for the research and development of innovative ADC drugs has surged in the past two years, with numerous candidate drugs entering clinical trials. According to data published by Frost & Sullivan, 15 to 57 ADC candidate drugs have entered clinical trials annually since 2018. As of June 2023, there were more than 500 ongoing clinical trials worldwide involving 231 ADC candidate drugs.

The demand for outsourced services in the clinical and preclinical pipelines of antibody-drug conjugates (ADCs) is also continuing to grow. By the end of 2022, the global outsourcing rate for ADC discovery, development, and manufacturing had reached approximately 70%, surpassing the 34% observed outsourcing rate for biologics overall. By 2030, the global market for ADC outsourcing services is projected to expand significantly, reaching $11 billion, with a compound annual growth rate (CAGR) of 28.4% from 2022 to 2030.

Faced with the booming ADC outsourcing services market, Joinn Biologics has long been prepared. Currently,Joinn Biologics provides global clients with one-stop R&D and manufacturing services for ADC drugs, ranging from molecular discovery to IND filing, including ADC discovery, lead compound development, and preclinical studies.In addition,Joinn Biologics is continuously expanding its ADC manufacturing capacity, with a new pilot and commercial production line for ADCs scheduled to be completed and officially put into operation by the end of this year.。

Leveraging its professional, comprehensive one-stop CDMO services, Joinn Biologics has gained market recognition and attracted investor interest. Currently, Joinn BiologicsHas provided R&D and manufacturing services for approximately 300 large-molecule biologic drug projects, obtained over 30 IND approvals globally, and signed contracts for 5 BLA projects.。

Furthermore,In December 2019, Joinn Laboratories completed a $60 million Series A financing round; less than two years later, in August 2021, the company announced the completion of a $200 million Series B financing round.. To date, the company has raised over RMB 1.5 billion in cumulative financing, with investors including CPE Yuanfeng, Huagai Capital, Sinowood Capital, Yingke Capital, LifeSpring Capital, Hong Kong Hualian Holding Group, and Xiangtang Venture Capital.

Currently, Joinn Biologics is accelerating capacity expansion by fast-tracking the construction of 100,000-liter bulk drug substance and related formulation production lines that comply with GMP standards in China, the United States, and the European Union. The company is continuously strengthening and enhancing its team’s delivery and technical capabilities, while actively advancing its international market layout to secure additional commercial project orders on top of completing existing projects.

Looking ahead, Joinn Biologics will continue to expand its business scope by incorporating more cutting-edge biopharmaceutical products, thereby providing professional and comprehensive services and solutions to a broader range of global biopharmaceutical companies across diverse fields.

Acknowledgement: Thanks to Haier Capital for its support of this article.

Qingdao Haier Venture Capital Co., Ltd. (hereinafter referred to as “Haier VC”) was established in 2010. Leveraging Haier’s industrial background, the company adheres to an ecosystem-oriented investment strategy and operates both a fund of funds (branded as “Haichuang Fund of Funds”) and direct investment funds. Its investment focus centers on hard technology and general health. To date, Haier VC has invested in over 400 projects, with more than 70% being high-tech enterprises such as “Specialized, Refined, Differential, and Innovative” (SRDI) companies, and 45 of its portfolio companies have gone public. Haier VC is committed to collaborating with ecosystem partners to support the national strategies of building a leading science and technology power and advancing Healthy China. By nurturing an industrial ecosystem through its funds, Haier VC aims to promote the high-quality development of the real economy and better serve to enhance people’s quality of life and well-being.