In-depth Interview | The "Deep Blue Ocean" Force in the CRO Field of Cell and Gene Therapy (CGT)

Recently, we are honored to invite Ms. Yuan Shaoxiong, Deputy General Manager and Medical Business Director of Zhengzhou Deep Blue Ocean Biopharmaceutical Technology Co., Ltd., to decode the "Deep Blue Ocean" force in the CRO field of cell and gene therapy.
 

01 Early Layout: Seizing Opportunities and Forging "Time Barrier" - type Competitiveness

With the issuance of the Administrative Measures for Stem Cell Clinical Research (Trial) in 2015, China's stem cell and related fields officially entered a "dual-regulation parallel" management model. Consequently, Zhengzhou Deep Blue Ocean Biopharmaceutical Technology Co., Ltd. established a dedicated team, which began accumulating experience step by step starting from its engagement with China's first CAR-T therapy.

Entering the field early enabled us to achieve "two firsts": participating in the clinical research of China's first CAR-T therapy and completing the CRO services for China's first gene editing project. Due to the uniqueness of this field, these experiences have allowed us to gain a deeper understanding of technical rules and regulatory requirements earlier than our peers. When faced with clients' needs regarding cell therapy and gene diagnosis therapies targeting different sites, we can quickly identify risk points and core technical essentials - this is a competitiveness forged through time.
 

02 Full-process Empowerment: From Top-level Design to Clinical Implementation, Facilitating Efficient R&D of Innovative Drugs

Guided by the goal of "taking the end as the beginning, conducting top-level design, and being a full-process partner in new drug creation", we have been involved in various links of the new drug R&D process for sponsors. For instance, in the early stage of protocol design, considering the individualized characteristics of cell and gene diagnosis and treatment, we need to customize the protocol based on target characteristics and clinical needs, explore the effective dose for First-in-Human (FIH) studies, and screen indications with potential expected efficacy. In the clinical execution stage, relying on a cooperative network of Grade A tertiary hospitals across the country, we can quickly match research centers to realize the rapid initiation of Investigator-Initiated Trials (IIT) and registration studies. The most crucial link is that we have a professional clinical registration team, which, starting from the top-level design, takes into account regulatory requirements and legal provisions to help sponsors enter green channels such as breakthrough therapy designation and conditional marketing authorization as early as possible.
 

Q: What therapeutic areas do the current cooperative projects involve? Are there any impressive cases?
 

At present, the cooperative projects of Zhengzhou Deep Blue Ocean Biopharmaceutical Technology Co., Ltd. cover a wide range of areas, from hematological tumors to solid tumors, and from rare diseases to neurodegenerative diseases. We have participated in a number of rare disease projects, including indications such as infantile Pompe disease and Duchenne Muscular Dystrophy (DMD). Take infantile Pompe disease caused by GAA gene mutation as an example - children with this disease are labeled with a "death sentence" from birth, and untreated children mostly die of cardiopulmonary failure within one year of age. Our team has been involved in the entire process, including protocol design, Investigational New Drug (IND) application, clinical trial implementation, and follow-up, to support the marketing of the enterprise's products.
 

03 Three Core Advantages: Experience, Quality, and Focus, Building an Industry Trust Moat

It can be summarized into three pillars: "experience, quality, and focus".
 

As China's first CRO company engaged in cell and gene therapy, we have been involved in multiple targets and fields such as BCMA, CD19, CD20, CD3, and exosomes, including many first-in-global technologies. Based on the accumulation of these experiences, the company has specially established a cell and gene therapy team (covering registration, medical affairs, and operations), and trained a strong team in this track. This team is familiar with domestic and international regulatory and registration requirements and assists enterprises in applying for qualification certifications such as Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Breakthrough Therapy Designation (BTD).
 

Particularly for international projects, enterprises are faced with challenges such as the application for the Human Genetic Resources Administration of China (HGRAC), customs clearance and inspection of clinical samples, and the selection and confirmation of domestic research centers. Our company has successfully helped enterprises overcome each hurdle through document drafting, submission, and professional communication, promoting the smooth initiation of clinical trials and product marketing.
 

04 Insight into Trends: Focusing on Solid Tumors and Internationalization to Seize the Next "Technology High Ground"

The cell and gene therapy industry is in a "technology explosion period", and there are two trends worthy of special attention: first, the breakthrough from hematological tumors to solid tumors, which will be the next technology high ground; second, the acceleration of international cooperation. More and more Chinese innovative pharmaceutical enterprises are seeking to enter the global market, while overseas pharmaceutical companies also want to enter the Chinese market. This puts forward higher requirements for the global service capabilities of CROs. Zhengzhou Deep Blue Ocean Biopharmaceutical Technology Co., Ltd. provides full-process one-stop services in links such as Sino-US dual filing registration affairs, HGRAC application, and international transportation and customs clearance, and has successfully assisted domestic and foreign clients in the smooth implementation of a number of international multi-center clinical trials.
 

About Us

At present, the company has carried out more than 2,000 clinical research projects, including dozens of Class I innovative drug projects and dozens of IIT studies every year. In addition to conducting business in fields such as rheumatology and immunology, oncology, cardiovascular and cerebrovascular diseases, and endocrinology, it has taken the lead in providing first-in-China and first-in-global clinical research services in fields such as medical aesthetics (supporting the approval and marketing of China's first fat-dissolving injection), medical food, cell and gene therapy drugs, and vaccine prevention, filling a number of gaps at home and abroad.
 

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