Good News on Listing | Frost & Sullivan Congratulates Shanghai Aopuima Biotechnology Co., Ltd. on Successful Listing on the Sci-tech Innovation Board

Shanghai Aopuima Biotechnology Co., Ltd. (hereinafter referred to as 'Aopuima') successfully went public on September 2, 2022, with an issue price of 80.20 yuan per share, issuing a total of 81.98 million shares.

Opmaya is a high-tech enterprise specializing in cell culture products and services. Based on excellent cell culture technology and production processes, the company accelerates the new drug research and development application process by combining cell culture medium products with CDMO services; it reduces pharmaceutical costs by optimizing products and processes, contributing to the rapid development of the biopharmaceutical industry. China has long relied on imports for cell culture media, especially in the fields of serum-free medium formulations and technology, which has greatly affected the development of biological products in our country. The company focuses on the research and development and production of culture media for antibodies and vaccines, has established large-scale culture medium production bases that meet GMP requirements, developed a variety of culture medium products that can replace imported brands, and has achieved commercial sales. These products are widely used in the production fields of protein/antibody production, vaccine production, cell therapy, and gene therapy among other biological products.

Under the combined influence of factors such as accelerating aging, increased social healthcare expenditures, and rising R&D investment, the global pharmaceutical market has maintained stable growth in the past. In 2020, the global pharmaceutical market size was $1,298.8 billion, and it is expected to reach $1,711.4 billion by 2025, with an annual compound growth rate of 5.7%. The United States and China remain the world's top two pharmaceutical markets, showing high growth rates compared to other regions of the world. The development of the pharmaceutical outsourcing market has greatly accelerated the R&D progress of pharmaceutical companies.

The Chinese pharmaceutical market consists of three parts: chemical drugs, biopharmaceuticals, and traditional Chinese medicine. In terms of market share, chemical drugs account for a relatively high proportion, while biopharmaceuticals account for a lower proportion. From the perspective of growth rate, the growth rate of biopharmaceuticals is much higher than that of chemical drugs and traditional Chinese medicine. Calculated by revenue, the annual compound growth rate from 2016 to 2020 reached 17.1%. The biopharmaceutical market is expected to reach 811.6 billion yuan by 2025, with an annual compound growth rate of 18.6% from 2020 to 2025.

Globally, the pharmaceutical market can be mainly divided into two categories: biopharmaceuticals and chemical drugs. Biopharmaceuticals can be further subdivided into multiple categories. Currently, gene and cell therapy, as well as antibody drugs, are two sub-sectors with high potential for new drug launches in the short term due to their intensive market entry. At the same time, vaccines will also maintain stable and rapid development in the future, given their solid market foundation.

Compared to the production of traditional pharmaceuticals, the production of biologics is generally more difficult and complex. During the production process of biologics, specific and precise parameter settings and control conditions are required. A slight change in any link can cause changes in the performance of biologics, such as immunogenicity, side effects, efficacy, and so on. In addition to the effectiveness and safety of the drug itself, the large-scale commercial production of biologics cannot be separated from considerations of commercial factors such as cost and efficiency. Therefore, the importance of upstream process development and large-scale production of biologics is very prominent.

The variety of monoclonal antibody drugs in China is limited and their coverage rate is low. Since 2017, the national medical insurance system has significantly expanded the coverage of monoclonal antibody drugs, which will increase the penetration rate of monoclonal antibody prescriptions in the future. At the same time, the introduction of immunotherapy products, such as PD-1 inhibitors like Opdivo and Keytruda, which have been approved in China, will further promote the expansion of the Chinese monoclonal antibody market. In 2020, the scale of the Chinese monoclonal antibody market (including oncology and non-oncology indications) was RMB 411 billion, and it is expected that by 2025, this market will grow to RMB 1945 billion, with an annual compound growth rate of 36.5% from 2020 to 2025.

According to the clinical trial statistics registered with CDE, the number of clinical registrations for antibody drugs has also shown a rapid growth trend. Especially after the issuance of the landmark 'Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices' in 2017, it greatly encouraged the enthusiasm for antibody drug research and development. The number of Phase III clinical trial registrations reached 127 in 2020. A sufficient pipeline of ongoing clinical trials ensures an adequate reserve of antibody drugs for future market launch, indicating a huge demand for production materials (such as culture media, supplements, etc.) in the future.

The most important and critical step in animal cell culture is selecting an appropriate medium for in vitro cultivation. Cell culture has now become one of the main technologies applied in life sciences. It refers to the general term for taking out some tissue from biological organisms, dispersing it into single cells or directly removing single cells from the organism, and cultivating them in an artificial environment conducive to growth. Growth media or culture solutions are either liquid or gelatinous and designed to support the growth of microorganisms, cells, or small plants. Culture medium is the most important and complex factor in controlling optimal cell growth.

Animal cell culture can use either pure natural media or a mixture of artificial/synthetic media with some natural products. Artificial media can be divided into balanced salt solutions, basic media, and complex media based on their purpose; according to the content of uncertain components such as protein/polypeptide extracts, they can be classified into serum-containing media, low-serum media, serum-free media, protein-free media, media with defined chemical components, media with defined chemical components but without protein, and media with defined chemical components but without protein/polypeptides. The certainty of their composition increases progressively.

The global biopharmaceutical market is mainly dominated by developed countries, which have entered a relatively stable stage of market growth in the past few years. The corresponding upstream culture medium market has also grown steadily, reaching a market scale of $1.7 billion in 2020, with a compound annual growth rate of 8.6% from 2016 to 2020. In China, the market size of culture media reached 1.52 billion yuan in 2020, with a compound annual growth rate of 32.3% from 2016 to 2020. It is estimated that the market size of cell culture media in China will reach 54.4 billion yuan by 2025, with a compound annual growth rate of 29.0% from 2020 to 2025.

Under the COVID-19 pandemic, the research and development of biopharmaceuticals, especially antibodies and vaccines, by pharmaceutical companies has seen a surge, driving rapid growth in the sales of culture media. In 2020, a series of domestic culture medium manufacturers achieved significant revenue growth. The overall market competition landscape has changed significantly compared to before the pandemic, with some imported manufacturers' market share overtaken by several domestic ones. In terms of market share trends, the proportion of domestic culture media has been increasing year by year, with the market share for domestic culture media rising from 18.6% in 2016 to 22.8% in 2020. The increase in the market share of domestic culture media benefits not only from continuous improvement and enhancement of quality but also from factors such as flexible and efficient supply chains and marketing strategies of domestic manufacturers in the local market.