AustarBio's CMC Integrated Solutions: Essential Elements for Empowering the Next Stage of China's Biopharma Industry

Around 2010, a large influx of overseas-trained pharmaceutical professionals returned to China, spurring the establishment of an early wave of biopharmaceutical companies such as Innovent Biologics, Henlius, Alphamab Oncology, and Bio-Thera Solutions. This marked the rapid entry of China’s biopharmaceutical industrialization into its first phase. It was also during this period that Dr. Luo Shun returned to China to found Jianshun Biotechnology (a subsidiary of Thousand Oaks), leading the company to pioneer domestically produced serum-free culture media and break the decades-long monopoly held by three major Western corporations in this field.

Around 2020, with the approval and market launch of China’s first batch of antibody drugs, the Chinese biopharmaceutical industry entered a golden age of commercialization. By the end of 2021, enthusiasm for new drug investment plummeted, ushering in a cyclical capital winter. Amid this downturn, the second development phase of China’s biopharmaceutical industry has arrived, presenting an opportunity for a bottom-out rebound and marking the transition into a more mature, rational, efficient, orderly, healthy, and sustainable era.

In the new phase, commercial competition among Chinese biopharmaceutical companies will become more intense. For these enterprises, future commercial competition is essentially a contest of supply chains and the service providers behind them.As a provider of integrated solutions for large-scale, compliant manufacturing, Thousand Oaks has witnessed the transformation of China’s biopharmaceutical industry, offering a new perspective through which to observe this sector.

VCBeat interviewed Dr. Luo Shun, Chairman and President of Thousand Oaks, and Dr. Kan Ziyi, CEO of Thousand Oaks, to explore how Thousand Oaks is facilitating the localization of supply chains amidst the evolving landscape of China’s biopharmaceutical industry, and how it is establishing differentiated advantages as a CDMO in the face of intense commercial competition during its second growth phase. 

Thousand Oaks is positioned for industrialization, leveraging its comprehensive, large-scale, and compliant manufacturing solutions.Dual-Pronged Strategy in Cell Culture Media and Biopharmaceutical CDMO, aiming to promote specialized division of labor in the biopharmaceutical industry through industrialized efficiency and scale, forming distinct segments for innovative drug development, manufacturing, and commercialization, thereby enhancing overall industry efficiency and scale to meet public health needs and enable more patients to access and afford high-end, safe, and effective biologics.

Cell culture media, as the most critical material in biopharmaceutical manufacturing, deliver high-efficiency, scalable, and industrial value to product development and commercialization in areas such as vaccines, protein antibodies, and cell and gene therapies. Among these, serum-free cell culture media, which carry high added value, offer superior advantages in terms of defined composition, purity, expression yield, batch-to-batch consistency, and residual contaminants, while also entailing relatively higher technical requirements.

Prior to Thousand Oaks’ successful industrialization of serum-free culture media, the domestic market for such products was nearly monopolized by overseas giants, owing to the high barriers associated with formulation development and production technologies.To date, the competitive landscape of China’s cell culture media market remains dominated by imported brands, primarily Thermo Fisher Scientific (brand: Gibco), Merck (brand: Sigma), and Cytiva (brand: Hyclone). These three brands collectively hold approximately 70% of the market share. In the global cell culture media market, Gibco mainly dominates the R&D segment, while Sigma primarily holds sway in the industrial segment.

In recent years, a cohort of outstanding emerging cell culture media companies has emerged in China. Domestic enterprises such as Thousand Oaks, OPM Biotech, BeiAnJi, Imunova, and Yuanpei Biotechnology have joined forces to break the monopoly previously held by foreign brands in the Chinese market. Their collective efforts have increased the market share of domestically produced cell culture media to 30% and reduced the prices of imported media by nearly 70%, making a significant contribution to cost reduction and efficiency improvement in the pharmaceutical industry.

According to Frost & Sullivan statistics, the localization rate of China’s serum-free cell culture medium market increased from 3.9% in 2016 to 29.6% in 2021. Thousand Oaks’ market share in China’s serum-free cell culture medium market grew from 1.2% in 2016 to 13.7% in 2021. In the overall Chinese cell culture medium market, Thousand Oaks ranks among the leading domestic enterprises in terms of market share.

Dr. Luo told VCBeat, “Compared with biopharmaceuticals, cell culture media have a shorter commercialization cycle, and they are an essential requirement for the industrial development of biomedicine. Over the past decade-plus of development, we have established a solid industrial foundation, large-scale production capacity, and a stable supply chain. In particular, over the past three years, our annual output of powdered culture media has accounted for half of the domestic market for Chinese-made culture media.”

Meanwhile, Thousand Oaks’ CDMO business is also experiencing rapid growth, having successfully delivered multiple late-stage clinical projects. Focused on biopharmaceutical products including monoclonal antibodies, bispecific antibodies, multispecific antibodies, fusion proteins, and antibody-drug conjugates (ADCs), the core team at Thousand Oaks possesses extensive experience and insight from the perspective of innovator companies in new drug development. They not only excel in drug manufacturing but also have a proven track record of successful regulatory submissions. In the areas of biopharmaceutical technology and regulatory filing, they are well-positioned to provide clients with practical, high-value recommendations.

Dr. Kan told VCBeat,“We focus more on understanding the clinical and regulatory needs throughout our clients’ R&D and commercialization processes, leveraging our extensive Reg-CMC expertise to deliver comprehensive solutions, resolve project-specific challenges, and enhance the overall competitive advantage of their products and enterprises, rather than merely generating samples and data in a mechanical manner.”

Such Party B enterprises, characterized by their proactive initiative, are actually more likely to gain the favor of downstream pharmaceutical companies. There was once a pharmaceutical company in Guangdong; before the project launch, its owner personally brought core technical staff to Thousand Oaks, where he said to Dr. Luo and Dr. Kan:“We don’t act as the ‘dominant client,’“Because we are fully confident in the capabilities of the Thousand Oaks team. I aim to work closely with you, leveraging your expertise and strengths, to drive this project to success.”

With the support of multifaceted strengths and industrial chain partners, Thousand Oaks has steadily established a core technology platform for CDMO services covering all stages of biopharmaceutical R&D. It provides comprehensive solutions tailored to customers’ customized and personalized needs, ranging from raw material supply and process development to final commercial-scale manufacturing. Its service portfolio encompasses process development and manufacturing services from the preclinical research stage through to commercial production.

Thousand Oaks has established a core technology cluster encompassing rapid protein sample preparation, cell line development, cell culture process development, and product purification process development. This capability enables the company to meet the end-to-end pharmaceutical development and commercial manufacturing needs of diverse clients, including antibody and recombinant protein R&D and production enterprises, covering the entire spectrum from cell line construction to the New Drug Application (NDA) stage.

However, since the beginning of this year, the stock prices of major listed CDMO companies in China have collectively plunged. Fundamentally, the "Biosecure Act" served merely as a trigger; the more significant factor lies in the broader shifts within the pharmaceutical industry. Weakening financial performance, overcapacity, macroeconomic changes, and intensifying industry competition constitute the most severe challenges facing the CDMO sector. Only by addressing these issues and establishing differentiated advantages and technological barriers can companies secure a foothold in this fierce competitive landscape.

Dr. Luo believes that “in the past few years, domestic pharmaceutical investment sentiment was high, with a certain amount of bubble, and some companies also suffered from the ‘side effects’ of being ‘forced to grow prematurely.’ In this situation, as company leaders, we need to remain calm and formulate our development strategies based on the characteristics of the industry’s developmental stage. Those companies that truly survive the ‘winter’ will witness the industry’s bottoming out and rebound, entering a healthier phase more aligned with the natural progression of industry development.”

Dr. Luo remarked with a smile, “Since the beginning of this year, we have clearly felt the industry’s resurgence and have directly witnessed Thousand Oaks’ rapid business growth, propelling the company onto a fast track for development.”

Beyond the cooling of capital and industry sentiment, which has become more “pragmatic” and less “inflated,” policies issued by the state in recent years have also genuinely addressed the real pain points of China’s pharmaceutical sector, providing robust support to the industry.

In August 2023, both the “Action Plan for High-Quality Development of the Pharmaceutical Industry (2023–2025)” and the “Action Plan for High-Quality Development of the Medical Equipment Industry (2023–2025)” emphasized the need to provide full-chain support, taking into account the high difficulty, long cycles, and substantial investment requirements characteristic of pharmaceutical R&D and innovation, so as to encourage and guide leading pharmaceutical enterprises to grow and strengthen.

In December 2023, Bi Jingquan, Vice Chairman of the Economic Committee of the National Committee of the Chinese People’s Political Consultative Conference and Chairman of the China Center for International Economic Exchanges, proposed “whole-chain support for innovative drugs.” He further stated that “comprehensive support should be provided across multiple stages of biomedical innovation, including R&D, translation, market access, manufacturing, clinical use, and reimbursement, so as to foster an institutional environment that encourages biomedical innovation and promote high-quality industry development.”

This year, “innovative drugs” were included in the Government Work Report for the first time during the Two Sessions, while terms such as “new quality productive forces” also became hot topics of discussion.

Furthermore, as a witness to the evolution of China’s pharmaceutical industry, Thousand Oaks has cultivated its own competitive advantages in response to dynamic sector changes.Dr. Kan stated, “When clients select a CDMO, they typically consider two factors: first, the CDMO’s compliance capabilities, and second, its delivery capabilities. However, Thousand Oaks offers an additional advantage: ‘partnership support.’ Especially in today’s fiercely competitive and rapidly evolving industry landscape, a CDMO’s ability to provide long-term, stable ‘partnership support’ has become an essential attribute.”

In terms of compliance capabilities,Thousand Oaks has established high-standard, large-scale production lines and implemented a comprehensive quality management system encompassing quality systems, material systems, equipment and facilities, laboratory systems, production systems, and packaging and labeling. The company has undergone on-site audits by domestic and international regulatory authorities, including the National Medical Products Administration (NMPA), the National Vaccine Center, the Tianjin Medical Products Administration, the Nantong Medical Products Administration, the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS), and EU Qualified Persons (QPs).

Furthermore, Thousand Oaks obtained its production license in 2019. In 2021, 2022, and 2023, it consecutively supported clients in filing for commercial production approval of their products, successfully passing the combined “registration + GMP compliance dynamic inspection (Pre-Approval Inspection, PAI)” conducted by both the National Medical Products Administration (NMPA) and provincial medical products administrations prior to approval on three occasions. The company has established a robust production system and quality management system. Additionally, Thousand Oaks can provide support for the construction of Quality Management Systems under the Marketing Authorization Holder (MAH) B-license framework, as well as assistance in building quality control (QC) product testing capabilities.

In terms of delivery capability,Thousand Oaks has established GMP-compliant production lines that simultaneously meet the standards of the NMPA, FDA, and EMA. Equipped with 50 L, 200 L, 500 L, and 2,000 L bioreactors, these facilities can accommodate clients’ needs for clinical trial materials at various scales and large-scale commercial manufacturing, as well as support global regulatory submissions for their drug development pipelines.

Notably, Thousand Oaks can deliver high-expression, high-quality stable cell lines within as little as 3–5 months, and complete all process development and method validation activities—from cell line construction to IND filing—within 9 months, significantly shortening clients’ R&D timelines. To date, Thousand Oaks has undertaken and delivered CMC development and regulatory filing services for more than 150 projects, including monoclonal antibodies, bispecific antibodies, multispecific antibodies, antibody-drug conjugates (ADCs), nanobodies, fusion proteins, Factor VIII (FVIII), and FVIII-Fc-PEG.

In terms of "accompanying" capabilities,To date, Thousand Oaks has secured cumulative financing of over RMB 3 billion, with more than RMB 2 billion invested in platform hardware infrastructure. The company has established a R&D, production, and cell culture media base in Haimen; an ADC R&D and production center in Shanghai; a laboratory for molecular druggability and developability assessment in Zhangjiang; an R&D center in San Francisco; and a cell culture media base in Lanzhou.

Dr. Luo told VCBeat, “Thousand Oaks’ fixed assets have now reached a stable stage, with no major capital expenditures anticipated in the near term. Additionally, the company currently holds nearly RMB 1 billion in cash reserves, further bolstered by the continuous cash flow generation from its cell culture media business. Over the next decade or so, we do not foresee any concerns regarding our capital chain, enabling us to partner with our clients for sustained growth in the pharmaceutical sector.”

To sustain long-term growth in the pharmaceutical and healthcare sector, companies need not only substantial capital but also a commitment to continuous learning while advancing, constantly entering emerging fields to attract more orders from niche segments.

ADC is undoubtedly a strong choice. According to Frost & Sullivan data, there have been over 100 ADC-related transactions since 2022, and the total value of deals involving ADC drugs has exceeded $6 billion since 2024.

More importantly, according to data from Frost & Sullivan,By the end of 2022, the global outsourcing rate for antibody-drug conjugate (ADC) discovery, development, and manufacturing had reached approximately 70%, surpassing the 34% outsourcing rate observed for biologics overall. Among the 15 ADC drugs approved globally (as of June 2023), 13 utilized outsourced supply services; only Pfizer opted to build its own ADC supply chain, with most companies engaging multiple contract service providers.

Meanwhile, there is robust demand for numerous antibody-drug conjugate (ADC) pipelines in both clinical and preclinical stages. Since 2018, between 15 and 57 ADC candidates have entered clinical trials annually. As of June 2023, more than 500 clinical trials involving 231 ADC candidates were underway globally.

The robust demand downstream has further fueled the explosive growth upstream. According to Frost & Sullivan’s projections, the global ADC outsourcing services market is set to expand significantly, reaching $11 billion by 2030, with a compound annual growth rate (CAGR) of 28.4% from 2022 to 2030.

Prior to the official arrival of the industry boom, Thousand Oaks was already well-prepared, with itsPossesses a 15,000-square-meter ADC manufacturing base in Lingang Blue Bay, Shanghai, including an antibody-drug conjugate R&D and GMP production platform.We provide end-to-end CDMO services, ranging from early-stage conjugation screening to GMP drug product filling and lyophilization. Leveraging our integrated platforms for ADC process development, GMP bulk antibody production, and GMP conjugation manufacturing, we empower clients to advance their ADC drug development programs in a compliant and accelerated manner.

Dr. Luo recalled, “As early as early 2021, Thousand Oaks had already determined to establish an ADC manufacturing facility; in June 2023, the ADC production base in Lingang Blue Bay, Shanghai, officially commenced operations. Since then, Thousand Oaks’ ADC CDMO business has rapidly secured orders, providing us with clear evidence of substantial unmet demand in the ADC niche sector.”

Dr. Kan added, “Thousand Oaks’ achievements in the ADC CDMO sector were not a matter of ‘sheer luck,’ nor do we blindly engage in areas outside our core competencies.”"The manufacturing processes and technologies for ADC drugs are primarily built upon the foundation of large-molecule CDMO capabilities. Thousand Oaks has established mature upstream cell culture process development and downstream purification process development, and has already provided naked antibody CDMO services to multiple ADC clients, laying a solid foundation for the production of antibody-drug conjugates."

In addition to the rapid development of its ADC business, Thousand Oaks has also accumulated technological expertise and experience in viral vector processes, leveraging its prior experience with adenovirus vector vaccine projects, thereby providing technical support to CGT clients.

Looking back, Thousand Oaks’ development has also encountered numerous challenges. Take Dr. Luo as an example: when he returned to China in 2011 to start his business, his overseas experience in the pharmaceutical industry was not directly applicable to the domestic pharmaceutical environment at that time. “Applying such overseas experience to the domestic industry required significant adjustments, as there were substantial stage-related disparities between the pharmaceutical sectors in China and abroad at that time.”

First, given that China’s biopharmaceutical sector was in its infancy at the time, cell culture media—a highly specialized and advanced field—suffered from a shortage of professional talent. Second, quality regulation in the biopharmaceutical industry has been an evolving process requiring ongoing collaboration across the sector. To this day, the quality regulatory framework for the cell culture media industry still needs continuous improvement. Furthermore, there was the issue of shifting mindsets: a decade ago, when China’s biopharmaceutical industry was in its early stages, cell culture media, as an upstream raw material segment, received little attention. Nevertheless, these challenges did not stifle the industry’s growth; instead, they fostered a natural selection process that gave rise to a cohort of companies with strong technological and industrial capabilities.

Dr. Kan added, “I don’t believe anyone is ‘holding the industry by the throat.’ We cannot claim that we are being ‘strangled’ simply because no domestic companies have entered a particular field or successfully commercialized a specific product. In fact, these unresolved industry challenges represent blue-ocean opportunities worth pursuing.”"In recent years, driven by the advancement of China's basic scientific research and the collaborative efforts across the entire biopharmaceutical industry chain, many domestic enterprises have achieved localization of key materials and consumables for biopharmaceutical manufacturing."

On one hand, Thousand Oaks has facilitated the domestic substitution of critical raw materials within the industry. On the other hand, all deliverables provided by Thousand Oaks are available in both Chinese and English. The company has established platform material and supplier management systems in accordance with the United States Pharmacopeia (USP) and the Chinese Pharmacopoeia (ChP), thereby supporting Marketing Authorization Holders (MAHs) in filing regulatory submissions in both China and the United States. Under internationally aligned management standards, Thousand Oaks has successfully expanded its global footprint through its clients’ international projects, reaching markets across Europe, the United States, Southeast Asia, India, Russia, and other countries and regions, achieving a win-win outcome for both parties.

Looking ahead, during the second phase of development for China’s biopharmaceutical industry, Thousand Oaks will leverage its established production capacity and financial foundation to prioritize enhancing industrialization efficiency. The company aims to become a CDMO with greater industrial value that better promotes specialized division of labor within the industry. We look forward to Thousand Oaks delivering more safe, effective, and highly accessible biologics to patients worldwide.