Haifeng Bio: Breaking Bottlenecks in Drug Efficacy Evaluation with a Public Technology Platform to Accelerate New Drug Translation

New drug development involves multiple processes, with non-clinical validation being a critical milestone. By starting with the pathogenesis of clinical diseases and patient needs, scientifically designing trial protocols, and effectively managing early-stage procedures, it is possible to anticipate clinical risks in advance, avoid unnecessary losses, thereby enhancing clinical translation efficiency and accelerating drug development.

However, there are currently few large-scale, standardized, and high-level research platforms in the industry, and insufficient non-clinical efficacy evaluation has become one of the major bottlenecks constraining new drug development.

Recently, at the [innovate 2023 Smart Regulation · Intelligent Manufacturing Future Annual Summit] hosted by VBInsight,Dr. Yu Yuan, Vice President of Haifeng Biotechnology and Executive Vice President of the Chengdu High-Tech Zone Biological Industry Experts Association, delivered a keynote speech titled “Public Technical Service Platforms Accelerate the Rapid Translation of New Drug Achievements.”

At the forum, Dr. Yu Yuan, Vice President of Haifeng Biotechnology, delivered a keynote speech.

Dr. Yu Yuan elaborated on the general development of the biopharmaceutical industry and the High-Tech Zone’s efforts to build public technical service platforms that accelerate the translation of new drug achievements. He shared best practices from Haifeng Biology in recent years, highlighting its one-stop new drug evaluation services, including preclinical efficacy evaluation bases and intelligent equipment.

At the forum, VCBeat conducted an exclusive interview with Dr. Yu Yuan of Haifeng Biology. The following are the key points from his speech and the interview:

The global biopharmaceutical and general health industries are experiencing robust growth, regarded as one of the most promising and significant sectors of the 21st century. Key core technologies and critical industrial chains have become focal points, with the pharmaceutical and health industry demonstrating substantial potential, intelligent transformation, full-chain integration, and innovation-led development.

China’s life science services industry is experiencing robust demand and holds immense potential for growth. However, due to the relatively late start of scientific research in the country, there remains a significant gap compared with developed nations in terms of the ratio of R&D expenditure to GDP and per capita R&D spending.

As the state’s emphasis on scientific research has deepened, years of domestic new drug R&D have begun to bear fruit, driving rapid expansion in demand for life science services in China and further accelerating the development of the domestic life science services industry. Meanwhile, rising public health awareness and consumer spending power, coupled with the rise of the digital economy and the deep integration of technologies such as 5G, blockchain, artificial intelligence, and ChatGPT into the pharmaceutical industry, are hastening the sector’s transition toward intelligent, innovation-driven growth.

In recent years, a continuous stream of new technologies—such as cell and gene therapies, bispecific antibodies, multispecific antibodies, antibody-drug conjugates (ADCs), and theranostic radiopharmaceuticals—has been injecting fresh vitality into the biopharmaceutical industry. Furthermore, as the specialization within China’s biopharmaceutical sector becomes increasingly refined, the CRO industry has experienced growth, with most pharmaceutical companies opting to outsource non-core business activities.

Meanwhile, the industry is also facing new challenges. For instance, compliance requirements under pharmaceutical regulations, along with the continuous emergence of drugs targeting novel mechanisms and new therapeutic approaches, have rendered existing evaluation methods inadequate for scientifically, rigorously, efficiently, and accurately assessing innovative drugs and therapies. Additionally, China’s heavy reliance on overseas brands for high-end formulations and equipment further constrains the development of domestic innovation.

Leveraging proof-of-concept (PoC) studies to facilitate the translation of innovative achievements can effectively avoid unnecessary losses, enhance the efficiency of clinical translation, and accelerate drug development. Furthermore, it provides a scientific basis for investment and financing decisions by capital entities and for policy support by government agencies.

Haifeng Biologics, established in 2016 and located in the core area of Chengdu Tianfu International Bio-town, covers an area of 83.6 mu with a designed building area of 117,000 square meters. It is a professional contract research organization (CRO) specializing in non-clinical efficacy evaluation. The founding and research teams of Haifeng Biologics have over 30 years of in-depth experience in the field of non-clinical efficacy evaluation. By building a standardized, large-scale, and international platform for non-clinical efficacy evaluation and establishing key generic technology platforms, the company aims to address the long-standing lack of a standardized evaluation system for non-clinical drug efficacy.

Haifeng Platform Inauguration Ceremony

The platform integrates new drug screening, advanced formulation development, efficacy evaluation technical services, and high-end testing services. By integrating and consolidating key technologies, resources, and talent across the upstream and downstream segments of new drug R&D, it meets the technical service needs in the process of translating new drug innovations into tangible outcomes, reduces R&D risks for biopharmaceutical companies, and on this basis, establishes a pharmaceutical achievement trading platform. Through resource assurance services, it fosters innovation and accelerates the translation of biopharmaceutical innovative achievements.

According to Dr. Yu Yuan, the commercialization of scientific achievements should be viewed as two distinct components: “achievements” and “commercialization.” The first step is to evaluate the value of these achievements. Based on this principle, Haifeng Biotechnology has established a database of industry experts to conduct preliminary assessments of the value of such achievements.

Secondly, translation is also divided into outcome validation and industrialization of outcomes. Haifeng Biotechnology chooses to enter the process of outcome validation to promote the conversion of results, leveraging its strong expert resource pool, integrated platform advantages, and clinical doctor resources from West China Hospital. Ultimately, this can be consolidated into a non-clinical efficacy evaluation plan oriented towards clinical needs.

According to Dr. Yu Yuan, by integrating the advanced formulation platform with the efficacy platform, the unified platform can optimize formulation prescriptions and immediately observe any changes in pharmacokinetics resulting from formula adjustments, thereby rapidly addressing the drug developability of the product.

As advanced drug formulations directly impact the efficacy and developability of pharmaceuticals, and China currently lacks relevant new technologies and raw/excipient materials in this sector, Haifeng Biotech has partnered with Academician Schubert from the German National Institute for Soft Matter Research. By applying innovative polymeric materials to delivery systems—which offer targeted delivery and visualization capabilities—this collaboration can rapidly address challenges related to raw/excipient materials and drug delivery systems.

Given China’s current reliance on imported high-end equipment for advanced drug formulations, Haifeng Biotech will also deploy specially customized equipment, aiming to overcome domestic constraints in this field.

Meanwhile, the platform has also established a molecular imaging and radiopharmaceutical R&D platform. Molecular imaging is positioned to enable visualization in drug development, while radiopharmaceuticals are aimed at addressing existing gaps. Currently, Haifeng Biotech is collaborating with top global expert teams in radiopharmaceutical R&D.

Notably, Haifeng Biotech has also established the Haifeng Fund to further promote the industrialization of scientific achievements, extend the value chain of technology transfer, and provide crucial support for scientists launching startups. “The Haifeng Fund provided a validation framework for an incubation project at a university in Shenzhen. By generating positive validation data, it helped increase the project’s valuation eightfold,” introduced Dr. Yu Yuan.

According to reports, Haifeng Biology’s pharmacokinetics platform is equipped with 13 high-end liquid chromatography-mass spectrometry (LC-MS) systems, and the first phase of its in vitro technology platform, covering 2,000 square meters, has been put into operation. The experimental animal facility is planned to cover 47,000 square meters, with 10,000 square meters already in use, and more than 200 animal models have been established for diseases such as cardiovascular and cerebrovascular disorders, neuropsychiatric conditions, tumors, and metabolic diseases. Dr. Yu Yuan stated that upon completion of the integrated preclinical efficacy evaluation platform, it is expected to conduct 1,000 efficacy evaluations and screenings annually.

Meanwhile, Haifeng Biology has established partnerships with internationally renowned instrument and equipment manufacturers such as Thermo Fisher Scientific, Waters, and SCIEX, as well as domestic high-end analytical instrument companies like United Imaging Healthcare and Puju Medical. By leveraging high-end equipment to ensure high-quality experimental data, the company aims to capitalize on resource advantages for mutually beneficial cooperation and accelerate the substitution of imported products with domestically produced alternatives.

By leveraging international common platforms for biopharmaceuticals and resource-sharing service platforms, Haifeng Biology drives platform development through strategic resource acquisition, aggregates innovation resources to foster industry growth, and establishes an international foundation for biopharmaceutical R&D. This approach ultimately facilitates the rapid translation of new drug R&D achievements in a faster, better, and more cost-effective manner.